Programs & Groups

Biomedical Research Division Clinical Research Division Core Transversal Groups and Units Transversal Services

Thoracic Tumors Group

Early Clinical Drug Development Group

Gynecological Malignancies Group

Breast Cancer Group

Melanoma and Other Cutaneous Tumors Research Group

Cell Engineering and Hematologic Immunotherapy Group

Lymphoid Malignancies Group

Myeloid Malignancies Research Group

Prostate Cancer Group

Hereditary Cancer Genetics Group

Head and Neck Cancer Group

Radiation Oncology Group

Hepatobiliary Pancreatic Cancer and Endocrine Tumors Group

Gastrointestinal Tract Tumors Group

Genitourinary (non-prostate), Central Nervous System Tumors (CNS), Sarcomas, and Tumors of Unknown Origin Group

Clinical Trials at a Glance

Clinical Trials Office

Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch

Clinical Research Oncology Nurses

Clinical Research Oncology Pharmacy Unit

Academic CRO

Quality and Processes Unit

Oncology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2025

Hematology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2025

Group Leader Enriqueta Felip Medical Oncologists Susana Cedres, Patricia Iranzo, Alex Martínez-Martí, Laura Masfarré, Nuria Pardo, Ilaria Priano, Pedro Rocha, Augusto Valdivia Senior Postdoc Researcher Rocío Caro-Consuegra Postdoc Lab Manager Barbara Sinigaglia PhD Student Gerard Romero Bioinformatician Sara Polo Clinical Nurse Specialist Mireia Soleda Data Entries Aina Arbusà, Lucía Cané

Research Groups

Thoracic Tumors Group

Summary

VHIO’s Thoracic Oncology Group is dedicated to advancing cancer treatment and care for patients suffering from thoracic malignancies including lung cancer, mesothelioma, and thymic malignancies. We focus on disease prevention, early detection and a more precise diagnosis and staging of cancer that improves clinical outcomes.

We aim to match currently available targeted therapies with specific molecular alterations identified in patients, advance insights into the molecular mechanisms of acquired cancer drug resistance and optimize novel strategies for cancer immunotherapy.

For our patients with early-stage thoracic malignancies, we collaborate closely with a multidisciplinary team comprising thoracic surgeons, radiation therapists, radiologists, pulmonologists, pathologists, and biologists. In so doing, we are potentiating several treatment approaches and modalities. Given that our patients can suffer from severe symptoms, our efforts also focus on ameliorating clinical outcomes by working closely with other healthcare professionals from a wide range of disciplines.

Precision medicine for the treatment of advanced lung cancer is no longer an ambition. It is a guiding principle. We establish molecular determinants of disease in individual tumors and perform circulating cell-free DNA (cfDNA) analysis by liquid biopsy to more effectively tailor therapies to the specificities of each individual patient's disease.

Through sustained and active participation in lung cancer–focused clinical trials, we have significantly contributed to the integration of innovative therapies into the management of thoracic malignancies. These efforts include the introduction of tarlatamab in small cell lung cancer (SCLC), the incorporation of immunotherapy into the perioperative setting of non–small cell lung cancer (NSCLC), and the advancement of targeted therapies for patients with advanced NSCLC, among others.

  • Develop novel drug treatments targeting alterations in oncogenes such as KRAS and EGFR, and immunotherapy combination strategies through clinical trials.
  • Identify predictive or prognostic molecular biomarkers of response to immune checkpoint inhibitors (ICIs) and targeted therapies in thoracic malignancies (i.e. the value of tumor mutational burden, somatic copy number alteration burden, and the tumor microenvironment, among others).
  • Demonstrate the clinical utility of liquid biopsy to:
    • Diagnose patients with metastatic non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
    • Predict disease progression and identify resistance mechanisms by studying tumor evolution under treatment.
    • In patients with early-stage NSCLC, identify those at higher risk of disease relapse by developing machine learning algorithms.
  • Study intratumor heterogeneity and its clinical implications by multi-site genomic and spatially-aware transcriptomic characterization in paired primary lung tumors and metastatic lesions.
  • We continue to provide patients with opportunities to participate in clinical trials that are developing innovative cancer therapies.
  • We have further strengthened the collaboration between our translational and clinical teams. By integrating bioinformatics, molecular biology and clinical expertise, we aim to advance our understanding of lung cancer pathophysiology and response to therapy.
  • We participate in national and international collaborations of excellence.
  • We have expanded our translational research in small-cell lung cancer (SCLC).
  • Expand clinical and translational research in KRAS-mutant lung cancer beyond KRAS G12C mutations.
  • Develop new treatment combinations targeting EGFR-mutant tumors.
  • Evaluate antibody-drug conjugates (ADCs) in non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC).
  • Study the potential of immunotherapy in mesothelioma and thymic malignancies.
  • Develop  artificial intelligence-based models to predict immunotherapy efficacy in NSCLC patients by integrating multisource data.
  • Apply spatially-aware single-cell technologies for the study of intratumor heterogeneity and biomarker discovery.
  • Continue exploring the potential of different omics (genomics, transcriptomics, methylomics) in liquid biopsy from lung cancer patients that offer non-invasive opportunities for treatment monitoring and better patient stratification.
  • Felip E, Altorki N, Zhou C, Vallières E, Csoszi T, Vynnychenko IO, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA; IMpower010 Study Investigators. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. J Clin Oncol. 2025 Jul 20;43(21):2343-2349.
  • Barlesi F, Yao W, Duruisseaux M, Doucet L, Martínez AA, Gregorc V, Juan-Vidal O, Lu S, De Bondt C, de Marinis F, Linardou H, Kim YC, Jotte R, Felip E, Lo Russo G, Reck M, Michenzie MF, Yang W, Meade JN, Korytowsky B, Mok TSK; KRYSTAL-12 Investigators. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial. Lancet. 2025 Aug 9;406(10503):615-626.
  • Felip E, Rojas CI, Schenker M, Kowalski DM, Casarini IA, Csöszi T, Şendur MAN, Martins J, Calles Blanco A, Wang CC, Wang M, Ramirez Fallas RAL, Yoshioka H, Nair S, Song X, Deng X, Lala M, Eiras R, Takahashi T. Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial. Ann Oncol. 2025 Jul;36(7):775-785.
  • Yang JC, Lu S, Hayashi H, Felip E, Spira AI, Girard N, Kim YJ, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourão Dias J, Besse B, Passaro A, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Thomas M, Nguyen D, Ou SI, Mukhedkar S, Prabhash K, D'Arcangelo M, Alatorre-Alexander J, Vázquez Limón JC, Alves S, Stroyakovskiy D, Peregudova M, Şendur MAN, Yazici O, Califano R, Gutiérrez Calderón V, de Marinis F, Kim SW, Gadgeel SM, Owen S, Xie J, Sun T, Mehta J, Venkatasubramanian R, Ennis M, Fennema E, Daksh M, Roshak A, Man J, Knoblauch RE, Bauml JM, Baig M, Shah S, Sethi S, Cho BC; MARIPOSA Investigators. Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2025 Oct 30;393(17):1681-1693.
  • Enriqueta Felip was recognized as a Highly Cited Researcher 2025 (Clarivate) for the eighth successive year under the category of Clinical Medicine.
  1. Project title: AI-based personalised care for respiratory disease using multi-modal data in patient stratification -AI4Lungs. Funding entity: European Commission Horizon Europe. PI participant: Enriqueta Felip. Duration: 2024-2027.
  2. Project title: Spatial and temporal characterization of intratumor heterogeneity in lung cancer. Funding entity: Instituto de Salud Carlos III. PI: Enriqueta Felip. Duration: 2024-2026.
  3. Project title: Integrative science, Intelligent data platform for Individualized LUNG cancer care with Immunotherapy (I3Lung). Funding entity: European Commission Horizon Europe. Co-PI: Enriqueta Felip. Duration: 2022 – 2026.
  4. Project title: A Machine learning approach to Identify patients with resected non-small-cell lung cancer with high risk of relapse (MIRACLE). Funding entity: Instituto de Salud Carlos III. Co-PI: Enriqueta Felip. Duration: 2022-2025.
  5. Project title: "Inestabilidad cromosómica e infiltración immune del tumor como factores determinantes del potencial metastásico en cáncer de pulmón". Funding Entity: Instituto de Salud Carlos III. PI: Enriqueta Felip Duration: 2021-2025
  6. Project title: “Sex-Based Biomarkers and Molecular Profiles as Predictors of BiTEs Therapy Response in Small Cell Lung Cancer”. Funding Entity: IASLC PI: Pedro Rocha. Duration: 2025-2026
  7. Project title: “Molecular and immune profilling of SCLC histological transformation: exploring new therapeutic opportunities”. Funding Entity: SEOM. PI: Laura Masfarré Duration: 2025-2026
  1. Barlesi F, Yao W, Duruisseaux M, Doucet L, Martínez AA, Gregorc V, Juan-Vidal O, Lu S, De Bondt C, de Marinis F, Linardou H, Kim YC, Jotte R, Felip E, Lo Russo G, Reck M, Michenzie MF, Yang W, Meade JN, Korytowsky B, Mok TSK; KRYSTAL-12 Investigators. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial. Lancet. 2025 Aug 9;406(10503):615-626. doi: 10.1016/S0140-6736(25)00866-9. PMID: 40783289.
  2. Forde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, Lu S, Felip E, Swanson SJ, Brahmer JR, Kerr K, Taube JM, Ciuleanu TE, Tanaka F, Saylors GB, Chen KN, Ito H, Liberman M, Martin C, Broderick S, Wang L, Cai J, Duong Q, Meadows-Shropshire S, Fiore J, Bhatia S, Girard N; CheckMate 816 Investigators. Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. N Engl J Med. 2025 Aug 21;393(8):741-752. doi: 10.1056/NEJMoa2502931. Epub 2025 Jun 2. PMID: 40454642.
  3. Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, Fang Y, Lu S, Dong X, Wu L, Shinno Y, Daniele G, Yang TY, Kim HR, Ruiter G, Zhao J, Novello S, Miao L, Jänne PA, Goto K, Rüttinger D, Descamps T, Brase JC, Bao W, Li R, Brega N, Grassi P, Girard N, Tan DS; SOHO-01 Investigators. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Nov 6;393(18):1819-1832. doi: 10.1056/NEJMoa2511065. Epub 2025 Oct 17. PMID: 41104928.
  4. Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gümüş M, Lugini A, Zhu B, Yu Y, Korantzis I, Han JY, Ciuleanu TE, Ahn MJ, Rocha P, Mazières J, Lau SCM, Schuler M, Blackhall F, Yoshida T, Owonikoko TK, Paz-Ares L, Jiang T, Hamidi A, Gauto D, Recondo G, Rudin CM; DeLLphi-304 Investigators. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jul 24;393(4):349-361. doi: 10.1056/NEJMoa2502099. Epub 2025 Jun 2. PMID: 40454646.
  5. Heymach JV, Ruiter G, Ahn MJ, Girard N, Smit EF, Planchard D, Wu YL, Cho BC, Yamamoto N, Sabari JK, Zhao Y, Tu HY, Yoh K, Nadal E, Sadrolhefazi B, Rohrbacher M, von Wangenheim U, Eigenbrod-Giese S, Zugazagoitia J; Beamion LUNG-1 Investigators. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Jun 19;392(23):2321-2333. doi: 10.1056/NEJMoa2503704. Epub 2025 Apr 28. PMID: 40293180.
  6. Felip E, Popat S, Dafni U, Ribi K, Pope A, Cedres S, Shah R, de Marinis F, Cove Smith L, Bernabé R, Früh M, Nackaerts K, Greillier L, Scherz A, Massuti B, Nadal E, Vila Martinez L, Talbot T, Roschitzki-Voser H, Dimopoulou G, Schär S, Ruepp B, Savic S, Peters S, Stahel R; ETOP 13-18 BEAT-meso Collaborators. A randomised phase III study of bevacizumab and carboplatin-pemetrexed chemotherapy with or without atezolizumab as first-line treatment for advanced pleural mesothelioma: results of the ETOP 13-18 BEAT-meso trial. Ann Oncol. 2025 May;36(5):548-560. doi: 10.1016/j.annonc.2024.12.014. Epub 2025 Jan 13. PMID: 39814199.
  7. Felip E, Rojas CI, Schenker M, Kowalski DM, Casarini IA, Csöszi T, Şendur MAN, Martins J, Calles Blanco A, Wang CC, Wang M, Ramirez Fallas RAL, Yoshioka H, Nair S, Song X, Deng X, Lala M, Eiras R, Takahashi T. Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial. Ann Oncol. 2025 Jul;36(7):775-785. doi: 10.1016/j.annonc.2025.03.012. Epub 2025 Mar 27. PMID: 40157574.
  8. Tomasini P, Wang Y, Li Y, Felip E, Wu L, Cui J, Besse B, Spira AI, Neal JW, Goto K, Baik CS, Marmarelis ME, Ichihara E, Zhang Y, Lee JS, Lee SH, Yang JC, Michels S, Anastasiou Z, Curtin JC, Lyu X, Mahoney J, Demirdjian L, Meyer CS, Zhang Y, Leconte I, Lorenzini P, Knoblauch RE, Trani L, Baig M, Bauml JM, Cho BC; CHRYSALIS-2 Cohort C. Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. J Clin Oncol. 2026 Jan;44(1):54-65. doi: 10.1200/JCO-24-02835. Epub 2025 Dec 1. PMID: 41325571; PMCID: PMC12736406.
  9. Sands J, Ahn MJ, Lisberg A, Cho BC, Blumenschein G Jr, Shum E, Pons Tostivint E, Goto Y, Yoh K, Heist R, Shimizu J, Lee JS, Baas P, Planchard D, Pérol M, Felip E, Su WC, Zebger-Gong H, Lan L, Liu C, Howarth P, Chiaverelli R, Paz-Ares L. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. J Clin Oncol. 2025 Apr;43(10):1254-1265. doi: 10.1200/JCO-24-01349. Epub 2025 Jan 6. PMID: 39761483; PMCID: PMC11949215.
  10. Felip E, Altorki N, Zhou C, Vallières E, Csoszi T, Vynnychenko IO, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA; IMpower010 Study Investigators. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. J Clin Oncol. 2025 Jul 20;43(21):2343-2349. doi: 10.1200/JCO-24-01681. Epub 2025 May 30. PMID: 40446184.
  11. Rudin CM, Johnson ML, Paz-Ares L, Nishio M, Hann CL, Girard N, Rocha P, Hayashi H, Sakai T, Kim YJ, Hu H, Qian M, Singh J, Godard J, Tang M, Ahn MJ. Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial. J Clin Oncol. 2026 Feb;44(4):261-273. doi: 10.1200/JCO-25-02142. Epub 2025 Oct 14. PMID: 41086386; PMCID: PMC12834294.
  12. Awad MM, Forde PM, Girard N, Spicer J, Wang C, Lu S, Mitsudomi T, Felip E, Broderick SR, Swanson SJ, Brahmer J, Kerr K, Saylors GB, Chen KN, Gharpure V, Neely J, Balli D, Hu N, Provencio Pulla M. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer. J Clin Oncol. 2025 Apr 20;43(12):1453-1462. doi: 10.1200/JCO-24-02239. Epub 2025 Jan 8. PMID: 39778121; PMCID: PMC12005868.
  13. He J, Tsuboi M, Weder W, Chen KN, Hochmair MJ, Shih JY, Lee SY, Lee KY, Nhung NV, Saeteng S, Liu L, Xing L, Gia NH, Murakami S, Han Y, Saavedra MP, Yoon SH, Teixeira CHA, Escriu C, Martinez-Marti A, Blakely CM, Yatabe Y, Dacic S, Rukazenkov Y, Huang X, Dayal A, Chaft JE; NeoADAURA Investigators. Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Oncol. 2025 Sep 10;43(26):2875-2887. doi: 10.1200/JCO-25-00883. Epub 2025 Jun 2. PMID: 40454705.
  14. Steuer CE, Hayashi H, Su WC, Nishio M, Johnson ML, Kim DW, Massarelli E, Felip E, Gold KA, Murakami H, Baik CS, Kim SW, Smit EF, Fujimura M, Fan PD, Truchon K, Su X, Sternberg DW, Jänne PA. Patritumab Deruxtecan (HER3-DXd; MK-1022) in Non-Small Cell Lung Cancer After Platinum-Based Chemotherapy and Immunotherapy. J Clin Oncol. 2025 Sep;43(25):2816-2826. doi: 10.1200/JCO-24-02744. Epub 2025 Jun 24. PMID: 40554742; PMCID: PMC12393064.
  15. Wermke M, Gambardella V, Kuboki Y, Felip E, Sanmamed MF, Alese OB, Sayehli CM, Arriola E, Wolf J, Villaruz LC, Bertulis J, Studeny M, Bouzaggou M, Fang X, Morgensztern D. Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas. J Clin Oncol. 2025 Sep 20;43(27):3021-3031. doi: 10.1200/JCO-25-00363. Epub 2025 Jul 24. PMID: 40706016; PMCID: PMC12440289.
  16. Yang JC, Wang M, Doucet L, Fan Y, Lv D, Sun M, Huang D, Greillier L, Planchard D, Hong Q, Mazieres J, Felip E, Li X, Hu Y, Fang J, Bazhenova L, Ghiringhelli F, Cobo Dols MA, Rodriguez LP, Bearz A, Pellini B, Kim YJ, Bosch-Barrera J, Shim BY, Luo YH, Tiseo M, Yang TY, Carcereny E, Memmott RM, Zalcman G, de Castro Carpeno J, Di Noia V, Parra HS, Streich G, Lee DH, Shum E, Han JY, Jaime JC, Brungs D, John T, D'Arcangelo M, Joaquin AB, Liu G, Antonuzzo L, Hinojal GF, Le X, Zheng L, Jänne PA; WU-KONG1B. Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B). J Clin Oncol. 2025 Oct 10;43(29):3198-3208. doi: 10.1200/JCO-25-00788. Epub 2025 Sep 9. PMID: 40923280.
  17. Pérol M, Li W, Pennell NA, Liu G, Ohe Y, De Braud F, Nagasaka M, Felip E, Xiong A, Zhang Y, Fan H, Wang X, Li S, Lai RK, Ran F, Zhang X, Chen W, Bazhenova L, Zhou C. Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. J Clin Oncol. 2025 Jun;43(16):1920-1929. doi: 10.1200/JCO-25-00275. Epub 2025 Apr 3. PMID: 40179330; PMCID: PMC12118623.
  18. Johnson ML, Smit EF, Felip E, Ramalingam SS, Ahn MJ, Tsao A, Johnson BE, Offin M, Hussein M, Dagogo-Jack I, Goldman JW, Clarke JM, Negrao MV, Sanborn RE, Morgensztern D, Usari T, Wilner K, Alejandro L, Rifi N, Zhang X, Riely GJ. Updated Overall Survival Analysis From the Phase II PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer. J Clin Oncol. 2025 Dec 10;43(35):3706-3713. doi: 10.1200/JCO-25-02023. Epub 2025 Oct 19. PMID: 41109959; PMCID: PMC12680272.
  19. Ahn MJ, Lisberg A, Goto Y, Sands J, Hong MH, Paz-Ares L, Pons-Tostivint E, Pérol M, Felip E, Sugawara S, Hayashi H, Cho BC, Blumenschein G Jr, Shum E, Lee JS, Heist RS, Cornelissen R, Chang WC, Kowalski D, Zebger-Gong H, Chargualaf M, Gu W, Lan L, Howarth P, Joseph R, Okamoto I. A Pooled Analysis of Datopotamab Deruxtecan in Patients With EGFR-Mutated NSCLC. J Thorac Oncol. 2025 Nov;20(11):1669-1682. doi: 10.1016/j.jtho.2025.06.002. Epub 2025 Jun 12. PMID: 40516821.
  20. Krebs MG, Cho BC, Hiret S, Han JY, Lee KH, Pérez CL, De Braud F, Haura EB, Sanborn RE, Chih-Hsin Yang J, Shu CA, Goto K, Nishio M, Zhao J, Wang Z, Tomasini P, Felip E, Goldman JW, Ignatius Ou SH, Boyer M, Gao G, Qu S, Curtin JC, Lyu X, Schnepp RW, Kim P, Thayu M, Knoblauch RE, Lorenzini P, Baig M, Spira AI, Leighl NB. Amivantamab in Participants With Advanced NSCLC and MET Exon 14 Skipping Mutations: Final Results From the CHRYSALIS Study. J Thorac Oncol. 2025 Sep;20(9):1289-1301. doi: 10.1016/j.jtho.2025.05.012. Epub 2025 May 16. PMID: 40383434.
  21. Besse B, Goto K, Wang Y, Lee SH, Marmarelis ME, Ohe Y, Bernabe Caro R, Kim DW, Lee JS, Cousin S, Ichihara E, Li Y, Paz-Ares L, Ono A, Sanborn RE, Watanabe N, de Miguel MJ, Helissey C, Shu CA, Spira AI, Tomasini P, Yang JC, Zhang Y, Felip E, Griesinger F, Waqar SN, Calles A, Neal JW, Baik CS, Jänne PA, Shreeve SM, Curtin JC, Patel B, Gormley M, Lyu X, Chen J, Chu PL, Mahoney J, Trani L, Bauml JM, Thayu M, Knoblauch RE, Cho BC. Amivantamab Plus Lazertinib in Patients With EGFR-Mutant NSCLC After Progression on Osimertinib and Platinum-Based Chemotherapy: Results From CHRYSALIS-2 Cohort A. J Thorac Oncol. 2025 May;20(5):651-664. doi: 10.1016/j.jtho.2024.12.029. Epub 2025 Jan 2. PMID: 39755170.
  22. Cho BC, Li W, Spira AI, Sauder M, Feldman J, Bozorgmehr F, Mak M, Smith J, Voon PJ, Liu B, Tian P, Tan JL, Yang CT, Shih JY, Karadurmus N, Cundom JE, Bertollo G, Cicin I, Nieva J, Ortega-Granados AL, Tomasini P, Nguyen D, Felip E, Schuchard J, Murphy SP, Anderson BG, Romero T, Xia Y, Sheng S, Bauml JM, Mahadevia PJ, Kam J, Nematian-Samani M, Simoes J, Wildgust M, Girard N. Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial. J Thorac Oncol. 2025 Oct;20(10):1517-1530. doi: 10.1016/j.jtho.2025.07.117. Epub 2025 Sep 9. PMID: 40923969.
  23. Reck M, Patel JD, Gray JE, Reguart N, Cobo M, Pradera JF, Felip E, Cappuzzo F, Garon EB, Neal JW, Mekan S, Safavi F, Fernando N, Zavodovskaya M, Jürgensmeier JM, Chisamore M, Cho BC. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study. J Thorac Oncol. 2025 Oct 30:S1556-0864(25)02890-4. doi: 10.1016/j.jtho.2025.10.016. Epub ahead of print. PMID: 41173143.
  24. Lee SH, Lu S, Hayashi H, Felip E, Spira AI, Girard N, Kim YJ, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Dias JM, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Chih-Hsin Yang J, Besse B, Thomas M, Shah S, Baig M, Curtin JC, Zhang J, Xie J, Sun T, Sethi S, Wang M, Fennema E, Daksh M, Ennis M, Bauml JM, Cho BC. Lazertinib Versus Osimertinib in Previously Untreated EGFR-Mutant Advanced NSCLC: A Randomized, Double-Blind, Exploratory Analysis From MARIPOSA. J Thorac Oncol. 2025 Nov;20(11):1655-1668. doi: 10.1016/j.jtho.2025.06.030. Epub 2025 Jul 3. PMID: 40617394.
  25. Calles A, Navarro A, Doger de Speville Uribe BG, Colomé EÁ, de Miguel M, Álvarez R, Arregui M, Moreno V, Rocha P, Calvo E, Ramon-Patino J, Corral de la Fuente E, Alcalá-López D, Boix O, Fernández-Pinto M, Rodríguez-Morató J, Palmero R, Nadal E, Jove M, Felip E. Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study. J Thorac Oncol. 2025 Jul;20(7):969-982. doi: 10.1016/j.jtho.2025.02.005. Epub 2025 Feb 10. PMID: 39938593.
  26. Riely GJ, Ahn MJ, Clarke JM, Dagogo-Jack I, Esper R, Felip E, Gelsomino F, Goldman JW, Hussein M, Johnson M, Marrone KA, Morgensztern D, Nadal E, Negrao MV, Offin M, Provencio M, Ramalingam SS, Roof L, Sanborn RE, Smit EF, Tsao A, Usari T, Alcasid A, Wilner K, Tonkovyd S, Zhang X, Johnson BE. Updated Efficacy and Safety From the Phase 2 PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic NSCLC-A Brief Report. J Thorac Oncol. 2025 Oct;20(10):1538-1547. doi: 10.1016/j.jtho.2025.05.023. Epub 2025 Jun 4. PMID: 40480428; PMCID: PMC12451588.
  27. Nassar AH, Kim C, Adeyelu T, Bou Farhat E, Abushukair H, Rakaee M, Matteson K, Lau SF, Takabe Y, Ocejo A, Ardeshir-Larijani F, Leal T, Ramalingam S, Alam S, Gray JE, Hicks J, Kaldas D, Baena J, Berjaga MZ, Nana FA, Grohe C, Leuders H, Citarella F, Cortellini A, Mingo EC, Pancirer D, Das M, Ellis-Caleo TJ, Cheung JM, Lin JJ, Watson AS, Camidge DR, Sridhar A, Parikh K, Crowley F, Marron TU, Aggarwal V, Ahmed M, Sankar K, Kawtharany H, Zhang J, Owen DH, Li M, Nagasaka M, Pinato DJ, Awosika N, Alhamad K, Puri S, Zaman U, Gupta DM, Lau C, Khan H, Liauw J, Velazquez AI, Brown T, Moliner L, Mosteiro M, Rocha P, Evans M, Vanderwalde A, Elliott A, Nieva J, Lopes G, Ma PC, Borghaei H, Lee M, Young L, Aljumaily R, Mirza H, Kwiatkowski DJ, Herbst RS, Flavell RA, Naqash AR, Chiang AC. Integrated molecular and clinical characterization of pulmonary large cell neuroendocrine carcinoma. Nat Commun. 2025 Aug 19;16(1):7717. doi: 10.1038/s41467-025-63091-0. PMID: 40830141; PMCID: PMC12365225.
  28. Xu Y, Yang JC, Zhao Y, Doucet L, Zhou J, Wang Y, Planchard D, Fan Y, Jin B, Han Z, Greillier L, Mazieres J, Sun M, Hu Y, Song X, Ding C, Wu L, Tang K, Liang L, Yao Y, Cheng Y, He Y, Ferreira BP, Ghiringhelli F, Felip E, Bosch-Barrera J, Liu A, Yu Y, Dong X, Gao J, Camidge DR, Nian W, Zhou C, Yang R, John T, Gao B, Bazhenova L, Nagasaka M, Wang J, Ren X, Xu F, Li W, Zhao D, Wang H, Sun S, Huang J, Zhu X, Zheng L, Jänne PA, Wang M. Genetic biomarker study of sunvozertinib for clinical prognosis and prediction in NSCLC with EGFR exon 20 insertion mutation. Cell Rep Med. 2025 May 20;6(5):102121. doi: 10.1016/j.xcrm.2025.102121. Epub 2025 May 6. PMID: 40334661; PMCID: PMC12147912.
  29. Ghiringhelli F, Lawrence YR, Felip E, Zer A, Greillier L, Greystoke A, Pardo N, Al-Sakaff N, Helms HJ, Prizant H, Pintoffl J, Lim FL, Lim SM, Cho BC. Atezolizumab and bevacizumab, with or without radiotherapy, versus docetaxel in patients with metastatic non-small cell lung cancer previously treated with a checkpoint inhibitor and chemotherapy: results from the randomized, phase Ib/II MORPHEUS-Lung study. J Immunother Cancer. 2025 Aug 4;13(8):e011892. doi: 10.1136/jitc-2025-011892. PMID: 40759444; PMCID: PMC12323520.
  30. Bernatowicz K, Amat R, Prior O, Frigola J, Ligero M, Grussu F, Zatse C, Serna G, Nuciforo P, Toledo R, Escobar M, Garralda E, Felip E, Perez-Lopez R. Radiomics signature for dynamic monitoring of tumor inflamed microenvironment and immunotherapy response prediction. J Immunother Cancer. 2025 Jan 11;13(1):e009140. doi: 10.1136/jitc-2024-009140. PMID: 39800381; PMCID: PMC11749429.
  31. Jimenez-Labaig P, Mirallas O, Martin-Quesada AI, Rullan A, Trapani D, Amaral T, Felip E, Tabernero J, Harrington KJ. Second-event endpoints (EFS2, PRFS2 and PFS2) after anti-PD-(L)1-based RCTs: a systematic review and meta-analysis. J Immunother Cancer. 2025 Nov 28;13(11):e013072. doi: 10.1136/jitc-2025-013072. PMID: 41314984; PMCID: PMC12666152.
  32. Aggarwal C, Martinez-Marti A, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sánchez-Hernández A, Dakhil S, Camidge DR, Pillet M, Brown M, Paliompeis C, Dowson A, Cooper ZA, Kumar R, Herbst RS. Durvalumab Alone or Combined With Novel Agents for Unresectable Stage III Non-Small Cell Lung Cancer: Update From the COAST Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518440. doi: 10.1001/jamanetworkopen.2025.18440. PMID: 40663352.
  33. Jänne PA, Planchard D, Goto K, Smit EF, de Langen AJ, Goto Y, Ninomiya K, Kubo T, Pérol M, Felip E, Hayashi H, Nakagawa K, Shimizu J, Nagasaka M, Pereira K, Taguchi A, Ali A, Karnoub M, Yonemochi R, Leung D, Li BT. Trastuzumab Deruxtecan for ERBB2-Mutant Metastatic Non-Small Cell Lung Cancer With or Without Brain Metastases: A Secondary Analysis of Randomized Clinical Trials. JAMA Netw Open. 2025 Nov 3;8(11):e2543107. doi: 10.1001/jamanetworkopen.2025.43107. PMID: 41222935; PMCID: PMC12612940.
  34. Seguí E, Brasó-Maristany F, Pascual T, Sanfeliu E, Victoria I, Saura C, Hierro C, López-González A, Izarzugaza Y, Ciruelos E, Gavilá J, Racca F, Cejalvo JM, Amillano K, Paz-Ares L, Juan M, Felip E, Garralda E, González B, Arance A, Martín-Liberal J, Conte B, Walbaum B, Indacochea A, Castillo O, Blasco P, Pardo F, Aguirre Á, Sirenko V, González X, Galván P, Vivancos A, Ferrero-Cafiero JM, Mulero-Sánchez A, Salvador F, Villacampa G, Mesía R, Cervantes A, Prat A, Tabernero J. Efficacy of anti-PD1 therapy in PD1-high mRNA tumors across multiple cancer types: results from cohort 1 and cohort 2 of the phase II SOLTI-1904 ACROPOLI trial. ESMO Open. 2025 Oct;10(10):105838. doi: 10.1016/j.esmoop.2025.105838. Epub 2025 Sep 30. PMID: 41033278; PMCID: PMC12514499.
  35. Dienstmann R, Vivancos A, Nuciforo P, Aguilar S, Ruiz-Pace F, Viaplana C, Gonzalez J, Fite B, Pedrola A, Elez E, Saura C, Felip E, Macarulla T, Capdevila J, Fariñas-Madrid L, Carles J, Mateo J, Muñoz-Cosuelo E, Balmaña J, Braña I, Garralda E, Tabernero J. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO Open. 2025 Nov;10(11):105888. doi: 10.1016/j.esmoop.2025.105888. Epub 2025 Nov 6. PMID: 41202500; PMCID: PMC12639418.
  36. Carbone DP, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Felip E, Cheng Y, Juan-Vidal O, Alexandru A, Mizutani H, Reinmuth N, Lu S, Reck M, John T, Scherpereel A, De Marchi P, Aoyama T, Sathyanarayana P, Grootendorst DJ, Hu N, Ip V, Hung YH, Paz-Ares LG. Nivolumab plus ipilimumab with chemotherapy as first-line treatment of patients with metastatic non-small-cell lung cancer: final, 6-year outcomes from CheckMate 9LA. ESMO Open. 2025 Jun;10(6):105123. doi: 10.1016/j.esmoop.2025.105123. Epub 2025 May 29. PMID: 40446626; PMCID: PMC12166824.
  37. Chiang AC, Olmedo Garcia ME, Carlisle JW, Dowlati A, Reguart N, Felip E, Jost PJ, Steeghs N, Stec R, Gadgeel SM, Loong HH, Jiang W, Hamidi A, Parkes A, Paz-Ares L. Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy. ESMO Open. 2025 Apr;10(4):104538. doi: 10.1016/j.esmoop.2025.104538. Epub 2025 Apr 4. PMID: 40187110; PMCID: PMC12002761.
  38. Sierra Rodero B, Martínez-Toledo C, Nadal E, Molina-Alejandre M, García Campelo R, Gil-González Á, Massuti B, García-Grande A, Dómine M, Insa A, de Castro Carpeño J, Huidobro Vence G, Majem M, Martinez-Marti A, Megias D, Lobato D, Collazo-Lorduy A, Calvo V, Provencio M, Cruz-Bermúdez A. Peripheral memory B cell population maintenance and long-term survival after perioperative chemoimmunotherapy in NSCLC (NADIM trial). Oncoimmunology. 2025 Dec;14(1):2513109. doi: 10.1080/2162402X.2025.2513109. Epub 2025 Jun 5. PMID: 40468805; PMCID: PMC12143677.
  39. Jiménez-Labaig P, Lorini L, Gurizzan C, Kinloch E, Burton S, Forster MD, Metcalf R, Ferrarotto R, Bossi P, O Leary B, Hanna G, Felip E, Garcia IB, Harrington KJ. Clinical trials for patients with salivary gland cancers: A systematic review of worldwide registers and an evaluation of current challenges. Crit Rev Oncol Hematol. 2025 Jul;211:104747. doi: 10.1016/j.critrevonc.2025.104747. Epub 2025 Apr 26. PMID: 40294876.
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  41. Cedres S, Valdivia A, Priano I, Rocha P, Iranzo P, Pardo N, Martinez-Marti A, Felip E. BAP1 Mutations and Pleural Mesothelioma: Genetic Insights, Clinical Implications, and Therapeutic Perspectives. Cancers (Basel). 2025 May 6;17(9):1581. doi: 10.3390/cancers17091581. PMID: 40361508; PMCID: PMC12071723.
  42. Valdivia A, Mascaro-Baselga P, Salva-de Torres C, Geng-Cahuayme A, Torresan S, Yaringaño J, Priano I, Iranzo P, Pardo N, Masfarre L, Mirallas O, Farfan K, Cedres S, Rocha P, Martinez-Marti A, Felip E. Insights on Oligometastatic Non-Small-Cell Lung Cancer. Cancers (Basel). 2025 Jul 24;17(15):2451. doi: 10.3390/cancers17152451. PMID: 40805152; PMCID: PMC12345762.
  43. Jones DR, Opitz I, Harpole D, Yanagawa J, Lim E, Tsutani Y, Tan DSW, Dacic S, Ganti AK, Bodla S, Batig A, Lyfar P, Forcina A, Felip E. TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non-small cell lung cancer. J Thorac Cardiovasc Surg. 2026 Jan;171(1):1-9. doi: 10.1016/j.jtcvs.2025.09.017. Epub 2025 Sep 19. PMID: 40976544; PMCID: PMC12536336.
  44. Gridelli C, Mok T, Jänne P, Passaro A, Felip E, Ramalingam SS, Attili I, de Marinis F. Debate on first-line treatment strategies in advanced non-small cell lung cancer with EGFR mutation: An expert panel meeting by the Italian Association of Thoracic Oncology (AIOT). Lung Cancer. 2025 Mar;201:108100. doi: 10.1016/j.lungcan.2025.108100. Epub 2025 Jan 23. PMID: 39986216.
  45. Nadal E, Martín-Martorell P, Benítez JC, Sala MÁ, Cedrés S, Álvarez C, Dómine M, Sais E, Saigí M, López R, Vilà L, Massutí B, García-Campelo R, Mesas-Ruiz A, Insa A, Plans-Marín S, Hijazo-Pechero S, Muñoz-Pinedo C, Brenes J, Provencio M; Spanish Lung Cancer Group. Efficacy and safety of bintrafusp alfa evaluated in a phase II single-arm clinical trial in previously treated advanced pleural mesothelioma. Lung Cancer. 2025 May;203:108545. doi: 10.1016/j.lungcan.2025.108545. Epub 2025 Apr 17. PMID: 40253943.
  46. Dingemans AC, Syrigos K, Livi L, Paulus A, Kim SW, Chen Y, Felip E, Griesinger F, Ohashi K, Zalcman G, Hughes BGM, Sørensen JB, Blais N, Ferreira CGM, Lindsay CR, Dziadziuszko R, Ward PJ, Obiozor CC, Wang Y, Peters S. Intracranial activity of sotorasib vs docetaxel in pretreated KRAS G12C-mutated advanced non-small cell lung cancer from a global, phase 3, randomized controlled trial. Lung Cancer. 2025 Sep;207:108683. doi: 10.1016/j.lungcan.2025.108683. Epub 2025 Jul 29. PMID: 40774040.
  47. Pronsati N, Liu G, Bauer TM, Felip E, Goto Y, Green G, Grizzard M, Hamel M, Mazieres J, Mok T, Snow S, Solomon BJ, Stratmann J, Culver K. Managing lorlatinib together: An overview and practical guide for patients by ALK-positive NSCLC patients and medical experts. Lung Cancer. 2025 Aug;206:108662. doi: 10.1016/j.lungcan.2025.108662. Epub 2025 Jul 10. PMID: 40714367.
  48. De Cock E, Oskar S, Lourdudoss C, Eiras R, Pietanza MC, Arunachalam A, Alves G, Martinengo GL, Felip E. A Time and Motion Study Comparing Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab in Combination with Chemotherapy for the Treatment of Metastatic Non-small Cell Lung Cancer. Adv Ther. 2025 Dec;42(12):6175-6189. doi: 10.1007/s12325-025-03365-7. Epub 2025 Oct 21. PMID: 41116141; PMCID: PMC12618432.
  49. Chopra D, Lan Z, Waterhouse DM, Wolf J, Felip E, Moradian H, Karim N, Obiozor C, Stollenwerk B. Matching-Adjusted Indirect Comparison of Sotorasib Versus Adagrasib in Previously Treated Advanced/Metastatic Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation. Adv Ther. 2025 Sep;42(9):4300-4317. doi: 10.1007/s12325-025-03259-8. Epub 2025 Jun 21. PMID: 40542959; PMCID: PMC12394275.
  50. Sanborn RE, Zhou C, Tang KJ, Cho BC, Cheng S, Popat S, Ono A, Lu S, Majem M, Aguilar A, Del Rosario Garcia Campelo M, Hayashi H, Lee KY, Lee SH, Delmonte A, Alatorre-Alexander J, Richardson G, Santos V, Dooms C, Sabari JK, Shu CA, Girard N, Mansfield AS, Park K, Xia Y, Bhattacharya A, Buyukkaramikli N, Perualila N, Diels J, Acharya S, Chandler C, Proskorovsky I, Dearden L, Wortman-Vayn H, Mahadevia PJ, Knoblauch RE, Agrawal T, Baig M, Felip E. Amivantamab-Chemotherapy in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions: Impact of Treatment Crossover and Other Endpoints from the Phase III PAPILLON Study. Target Oncol. 2025 Nov;20(6):979-989. doi: 10.1007/s11523-025-01182-0. Epub 2025 Nov 3. PMID: 41184595; PMCID: PMC12669286.
  51. Reinmuth N, Couraud S, Paz-Ares L, Garassino MC, Baijal S, Daniel D, Garrido P, Kato T, Percent I, Rittmeyer A, Parra HS, Mekan S, Patel M, Radford M, Zhang E, Pelligra CG, Guo S, Felip E. Patient-Reported Symptoms and Quality of Life With Sacituzumab Govitecan Versus Docetaxel in Metastatic NSCLC: The Phase 3, Randomized EVOKE-01 Trial. JTO Clin Res Rep. 2025 Oct 30;7(2):100929. doi: 10.1016/j.jtocrr.2025.100929. PMID: 41584718; PMCID: PMC12828819.
  52. Lee JM, Brunelli A, Cummings AL, Felip E, Shu CA, Solomon BJ, Tsuboi M, Wakelee H, Saqi A, Wu YL, Li PC, Gitlitz BJ. Phase 3 Trials of Neoadjuvant, Perioperative, and Adjuvant Chemoimmunotherapy for Resectable, Early-Stage NSCLC: Comprehensive Review and Detailed Analysis. JTO Clin Res Rep. 2025 Jun 19;6(9):100866. doi: 10.1016/j.jtocrr.2025.100866. PMID: 40785843; PMCID: PMC12332858.
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  54. Tomasini P, Juan-Vidal O, Califano R, Lin CC, Hulo P, Dooms C, Fang J, Blasco A, Kowalski D, Salinas J, Babu G, Mun TL, Bearz A, Surmont V, Baldotto C, Sharma R, Arrieta O, Stencel K, Card C, Zer A, Massarelli E, Fang B, Mashru S, Schuchard J, Sermon J, Diels J, Chu PL, Withelder M, Bauml JM, Shah S, Baig M, Felip E. Patient-Relevant Outcomes From the Phase III MARIPOSA-2 Trial: Amivantamab-Chemotherapy Versus Chemotherapy in EGFR-Mutant Advanced Non-Small-Cell Lung Cancer Following Disease Progression on Osimertinib. Clin Lung Cancer. 2025 Dec 20;27(2):38-47. doi: 10.1016/j.cllc.2025.12.005. Epub ahead of print. PMID: 41544603.
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  56. Benitez-Fuentes JD, Lastra Del Prado R, Borregon-Rivilla M, de Luna Aguilar A, Lazaro-Sanchez AD, Ferrández-Arias A, Rodríguez Payá P, Grau Mirete B, Quintanar Verduguez T, Asensio Martinez E, Iranzo P, Callejo A, Cruellas Lapeña M, Gómez Ulla J, Rodriguez-Lescure A. Revisiting Alma Ata: A Blueprint for Cancer Care. Cancer Control. 2025 Jan-Dec;32:10732748251363701. doi: 10.1177/10732748251363701. Epub 2025 Jul 30. PMID: 40735860; PMCID: PMC12317243.
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  59. Pacheco-Barcia V, Obispo B, Tomas E, Salva de Torres C, Quintanar T, Paez D, Leon-Mateos L, Cancio H, Cortegoso A, Anido U, Quilez A, Tarazona N, Jimenez-Labaig P, Sanchez-Martinez DA, Sesma Goni A, Fernandez-Montes A, Felip E, Rodriguez C, Elez E. Interventional strategies to address burnout in young medical oncologists: results from the Resilience-Spanish Society of Medical Oncology (SEOM) Study and a university hospital experience in Spain. Clin Transl Oncol. 2025 Dec 23. doi: 10.1007/s12094-025-04171-x. Epub ahead of print. PMID: 41436708.
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  • 2024-0386; Beamion LUNG-2: A Phase III, open-label, randomised, active-controlled, multi-centre trial evaluating orally administered BI 1810631 compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non–small cell lung cancer harbouring HER2 tyrosine kinase domain mutations; III
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  • 2025-0874; “A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small Cell Lung Cancer (DeLLphi-312)”; III
  • 2024-0952; A Randomized, Multi-Center, Double-blind, Placebo Controlled, Phase 3 Study to Investigate Safety and Efficacy of GSK4428859A in combination with Dostarlimab compared with Placebo in combination with Pembrolizumab in Participants with Previously Untreated Locally Advanced, Unresectable or Metastatic PD-L1 Selected Non-Small Cell Lung Cancer (NSCLC); III
  • 2022-1054; A Phase 2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated Locally Advanced/Metastatic Programmed Death Ligand 1-Positive Non Small Cell Lung Cancer.; II
  • 2022-1035; A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in multiple regimens in patients with Advanced or Metastatic Solid Tumors including Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer (PALOMA-2); II
  • 2024-0204; A Phase 2, open-label, randomized trial evaluating the impact of enhanced versus standard dermatologic management on selected dermatologic adverse events among patients with first-line locally advanced or metastatic EGFR-mutated NSCLC treated with amivantamab + lazertinib; II
  • 2021-0477-III; A Phase 3 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation.; III
  • 2024-0711; A Randomized Study of Two Dosing Regimens of Adagrasib in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation; II
  • 2025-0518; A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment; II
  • 2022-0439; AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES; IV
  • 2024-0820; A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations.; III
  • 2023-0240; Phase 1b/2a safety and feasibility study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced (stage IIIb) or metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation; II
  • 2022-0192; A PHASE IIII, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF BIOMARKER- SELECTED PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NONSMALL CELL LUNG CANCER,; III
  • 2025-0313; A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF BIOMARKER-SELECTED PATIENTS FOLLOWING CURATIVE INTENT RESECTION FOR NON-SMALL CELL LUNG CANCER .; II
  • 2024-0714; estudio con Divarasib, el farmaco KRAS de Roche, en comparación con otro fármaco KRAS G12C, en segunda línea tras fallo a IO+CT en pacientes KRAS+.; II
  • 2024-0503; "A randomized, phase 3, open-label study to evaluate SGN-B6A compared with docetaxel in adult subjects with previously treated non-small cell lung cancer with or without actionable genomic alterations"; III
  • 2025-0755; A Study to Learn About the Study Medicine Called Sigvotatug Vedotin in People with Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer with High Levels of PD-L1; III
  • 2023-1137; Randomized, Open-label, Multicenter Phase III Trial to Compare the Efficacy and Safety of Repotrectinib and Crizotinib in Participants with Locally Advanced or Metastatic TKInaïve ROS1 Positive NSCLC; III
  • 2020-0957; Pan Tumor Study for Long Term Follow-up of Cancer Survivors who have participated in Trials investigating Nivolumab.; IV
  • 2024-1063; A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Stage IV or Recurrent Non-squamous Non-small Cell Lung Cancer; III
  • 2025-0519; A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Non‐squamous Histology and KRAS G12C Mutation; III
  • 2025-0854; A Phase 2 Trial of BMS-986504 in Participants with Advanced and or Metastatic Non-Small Cell Lung Cancer with Homozygous MTAP Deletion After Progression on Prior Therapies; II
  • 2024-0720; A randomized, double-blind, parallel-group study of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda® in adult participants with untreated unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).; III
  • 2025-1094; An open-label, multi-center, single arm, rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies; IV
  • 2025-0806; ESTUDIO DESCRIPTIVO DE LA EVOLUCIÓN EN EL DIAGNÓSTICO Y TRATAMIENTO DE PACIENTES CON CÁNCER MICROCÍTICO DE PULMÓN EN ESPAÑA; IV
  • 2022-0865; A multicenter, Phase II, open label, randomized trial evaluating the efficacy of Tedopi plus docetaxel or Tedopi plus nivolumab as second-line therapy in metastatic non-small-cell lung cancer progressing after first-line chemo-immunotherapy (Combi-TED); II
  • 2025-0876; "A phase IIIb study of durvalumab as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent or sequential chemoradiation therapy in Spain"; III
  • 2022-0668; A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON); III
  • 2025-0239; A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1; III
  • 2025-0207; “Estudio fase III aleatorizado, doble ciego, multicéntrico, internacional de rilvegostomig o pembrolizumab en combinación con quimioterapia basada en platino para el tratamiento en primera línea de cáncer de pulmón no microcítico no escamoso metastásico con expresión de PD-L1” (ARTEMIDE-Lung 03)”; III
  • 2024-0451; A Phase III, Open-label, Randomised Study of MEDI 5752 in combination with Platinum-Pemetrexed Chemotherapy Versus Investigator’s Choice of Platinum-Pemetrexed Chemotherapy or Nivolumab + Ipilimumab in Unresectable Malignant Pleural Mesothelioma; III
  • 2022-0707; "Phase 2 open-label trial of neoadjuvant and adjuvant treatment in Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer."; II
  • 2022-0345; A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9); III
  • 2023-0597; A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung07); III
  • 2022-0495; A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-Small Cell Lung Cancer without Actionable Genomic Alterations (Tropion-LUNG08); III
  • 2024-0961; A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice (TPC) in Subjects with Relapsed Small Cell Lung Cancer (SCLC) (IDeate-2); III
  • 2024-1096; A PHASE 1B/2, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD), A B7-H3 ANTIBODY DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER (ES SCLC); II
  • 2023-0259; A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation.; III
  • 2021-0233; A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy and stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the primary tumour, in patients with synchronous oligo-etastatic nonsmall cell lung cancer.; II
  • VHIO-0023; A multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligo-symptomatic brain metastases; III
  • VHIO-0029; ETOP LUNGSCOPE; IV
  • 2023-0532; A global, phase 3, randomized, multicenter, open-label study to investigate the efficacy and safety of furmonertinib compared to  platinum-based chemotherapy as first-line  treatment for patients with locally  advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations; III
  • 2025-0414; A Prospective, Open-label, Randomized, Parallel-group, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06); III
  • 2022-1056; A Phase II study of pembrolizumab, lenvatinib and chemotherapy combination in first line extensive-stage small cell lung cancer (ES-SCLC); II
  • 2022-0284; PHASE II CLINICAL TRIAL OF AMG510 (SOTORASIB) IN STAGE III UNRESECTABLE NSCLC KRAS p.G12C PATIENTS AND MEDICALLY INELIGIBLE FOR CONCURRENT CHEMO-RADIOTHERAPY; II
  • VHIO-0015; Study of ctDNA as prognostic factor on resectable stage IIIA NSCLC patients treated with neoadjuvant treatment in real world; IV
  • 2025-0468; Phase II clinical trial with an adaptive design according to response to cemiplimab monotherapy using ctDNA and subsequent treatment with chemotherapy (CT) and cemiplimab or cemiplimab monotherapy in first line advanced NSCLC patients; II
  • 2023-0334; Phase II clinical trial of Neo-adjuvant chemo/immunotherapy followed by adjuvant treatment depending on the resection status for the treatment of NSCLC patients diagnosed with pancoast tumor. A multicenter exploratory study; II
  • 2025-0655; Phase II clinical trial of chemotherapy +Atezolizumab + Tiragolumab for stage IIIA and IIIB non-small cell lung cancer followed by Atezolizumab + Tiragolumab treatment after surgery or chemoradiotherapy; II
  • 2024-1044; "A PHASE III CLINICAL TRIAL OF ADJUVANT TREATMENT WITH SACITUZUMAB AND ZIMBERELIMAB FOR STAGE IB-IIIA-IIIB(N2) PREVIOUSLY RESECTED (R0) NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS THAT DID NOT ACHIEVE PATHOLOGICAL COMPLETE RESPONSE AFTER NEOADJUVANT TREATMENT"; III
  • 2024-0955; Study of antitumor immune response generated after concurrent chemo-radiotherapy (cCRT) and IO treatment in non-resectable stage IIIA/B and IIIC NSCLC patients treated in real world; IV
  • 2025-0807; Estudio internacional, multicéntrico, aleatorizado, abierto, de fase III de sacituzumab govitecan frente al tratamiento estándar en participantes con cáncer de pulmón de células pequeñas en estadio extendido (CPCP-ES) previamente tratado.; III
  • 2022-1166; "A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations"; III
  • 2021-0818; A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC.; III
  • 2024-0310; Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression; III
  • 2025-0362; "A Phase 3, Multi-center, Double-blind, 2-part Study in Participants with KRAS G12C-Mutant, Non-Small Cell Lung Cancer Comparing the Efficacy and Safety of Olomorasib in Combination with Standard of Care to Placebo in Combination with Standard of Care as Adjuvant Treatment after Platinum-based Chemotherapy"; III
  • 2025-0393; A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy; III
  • 2024-0754; A Randomized, Phase 2/3 Study to Evaluate the Optimized Dose, Safety and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in untreated metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC); II
  • 2025-0499; A phase II study assessing the safety and efficacy of Repotrectinib in ROS1-positive non-small cell lung cancer (NSCLC) patients with active brain metastasis (BMs).; II
  • 2024-0509; Phase 3 study of MK-1084 in combination with pembrolizumab compared to pembrolizumab monotherapy as first line treatment in patients with KRAS G12C mutant, advanced NSCLC with PD-L1 TPS ≥50%.; III
  • 2023-0820; “Phase 3 study of MK-2870 vs. Docetaxel or Pemetrexed in Advanced or Metastatic nsq-NSCLC Patients with EGFR Mutations or Other Genomic Alterations Progressed on Prior TKIs and Platinum-based Therapies”; III
  • 2024-0215; "A Phase 3 Study of MK-2870 in Combination with Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer with PD-L1 TPS ≥ 50%"; III
  • 2024-0435; A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab with or without MK-2870 in Resectable Stage II to IIIB (N2) NSCLC for Participants not Achieving pCR after Receiving Neoadjuvant Pembrolizumab with Platinum based Doublet Chemotherapy Followed by Surgery; III
  • 2024-0578; A Randomized Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Paclitaxel or Nabpaclitaxel followed by Maintenance Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Participants With Metastatic Squamous Non-small Cell Lung Cancer; III
  • 2018-0388; A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.; IV
  • 2024-0817; A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK 3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS ≥50%”; III
  • 2021-0529-II; A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Investigational Agents for the Treatment of Participants With PD-1/L1-refactory Extensive Stage Small Cell Lung Cancer in Need of Second-Line Therapy.; II
  • 2022-0380; Open label Phase 3 Study MK7684A (Coformulation of MK-7684 200mg and pembrolizumab 200 mg) in Combination with cCRT Followed by MK7684A Vs cCRT Followed by Durvalumab in Participants with Unresectable, Locally-advanced, Stage III NSCLC (All-comers regardless of PD-L1 status).; III
  • VHIO-0020; A Time and Motion (T&M) study comparing subcutaneous (SC) pembrolizumab co-formulated with hyaluronidase (MK-3475A) versus intravenous (IV) pembrolizumab in metastatic non-small cell lung cancer (mNSCLC); IV
  • 2024-1069; A randomized, open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to Immune Checkpoint Inhibitor (ICI)- ARTEMIA study; III
  • 2024-0558; Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer (PolyDamas); II
  • 2025-0390; Maintenance Pembrolizumab at Usual or Low doSE in nonsquamous lung cancer: a non-inferiority study; III
  • 2024-0755; A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 antibody) in Combination with Cemiplimab (Anti-PD-1 antibody) versus Cemiplimab Monotherapy in First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with Tumors Expressing PD-L1 ≥50%; II
  • 2025-1162; Phase 3 Study of RMC-6236 in Previously Treated Patients with RAS-Mutant NSCLC; III
  • 2024-0296; “A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)”; IV
  • 2024-1128; A Phase II Study of SKB264 Monotherapy or in Combination with Pembrolizumab with or without Chemotherapy in Patients with Advanced or Metastatic Non-small Cell Lung Cancer; II
  • 2024-0214; A randomized, controlled, multiregional Phase 3 study of ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy for the first-line treatment of metastatic squamous NSCLC; III
  • 2025-0704; Randomized phase 2/3 study in the first-line setting for stageIIIB/C-IV NSCLC patients with positive PD-L1 expression and without EGFR or ALK mutations. The study is exploring a chemotherapy-free combination of a first-in-class antigen-presenting cell (APC); III
  • 2020-0159; A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1).; II
  • 2023-1131; “A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer.; III
  • 2024-0832; "Phase 3 adjuvant pembro with or without V940 after neoadjuvant pembro+chemo in patients with resectable Stages II-IIIB(N2) NSCLC who have not achieved a pCR"; III
.

Group Leader, Early Clinical Drug Development Group, Director, UITM – CaixaResearch Elena Garralda Associate Investigators, Senior Consultants Judith Balmaña, Irene Braña, Joan Carles, Mª Elena Élez, Enriqueta Felip, Elena Garralda, Teresa Macarulla, Eva Muñoz, Ana Oaknin, Cristina Saura, Josep Tabernero CORE Phase I Investigators Guzmán Alonso, Irene Braña, Vladimir Galvao, Alberto Hernando-Calvo, Julia Lostes, Oriol Mirallas, Arjun Oberoi, Belen Ortega, Giulia Pretelli, Victoria Sánchez, Maria Vieito Phase I Investigators Daniel Acosta, Guzmán Alonso, Angeles Arnaldos, Miriam Arumi, Iosune Baraibar, Pere Barba, Meritxell Bellet, Maria Borrell, Francesc Bosch, Jaume Capdevila, Cecilia Carpio, Florian Castet, Susana Cedrés, Carlo Cicala, Mara Cruellas, Nely Merci Díaz, Marc Diez, Santiago Escrivá, Lorena Fariñas, Inmaculada Fernández, Maria Laura Fox, Vladimir Galvao, Alejandro Garcia, Carmen Garcia, Cristina Garcia, Sara Garrido, Mercedes Gironella, Diego Gomez, Nadia Gomez, Patricia Gómez, Macarena González, , Alberto Hernando, Jorge Hernando, David Garcia Illescas, Gloria Iacoboni, Patricia Iranzo, Daniel López, Maria Julia Lostes, David Marmolejo, Alexandre Martínez, Joaquín Mateo, Gaspar Molina, Rafael Morales, Arjun Oberoi, Mafalda Oliveira, Roberta Mazzeo, Oriol Mirallas, Belén Ortega, Núria Pardo, Isabel Pimentel, Ilaria Priano, Alba Puyuelo, Maria Teresa Quiñones, Alejandra Rezqallah, Angélica Rodriguez, Marta Rodríguez, Katerin Ingrid Rojas, Francisco Javier Ros, Omar Saavedra, Francesc Salvà, Mario Sanchez, Lucia Sanz, Ángel Serna, César Serrano, Kreina Sharela, Pedro Filipe Simoes, Maria Sola, Cristina Suarez, Eduardo Terán, Augusto Valdivia, Claudia Mª Valverde, Pilar Velarde, María Vieito, Ester Zamora Data Manager Armando Mel Clinical Nurse Specialist Marta Sanz

Research Groups

Early Clinical Drug Development Group

Summary

With a particular focus on cell signaling, and immuno-oncology (IO), we develop and lead proof-of-concept clinical trials with targeted therapies and novel inmunotherapeutics. These include first-in-human studies of targeted therapies, antibody drug conjugates, bispecifics, rational combinations, and studies in molecularly selected populations.

We link clinical research at our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch —also led by Elena Garralda—with different translational research projects led by VHIO investigators. To identify novel biomarkers and advance insights into mechanisms of action and cancer drug resistance, we leverage state-of-the-art molecular biology approaches and disease-relevant tumor models in combination with pharmacology and innovative clinical research.

Our group co-leads VHIO’s Molecular Prescreening Program for the molecular profiling of patients’ tumors. This program helps us to select the optimal treatment for individual patients included in our broad portfolio of promising novel anticancer therapies. In close collaboration with VHIO’s Cancer Genomics Group led by Ana Vivancos, we are also pursuing several projects focused on novel immuno-oncology (IO) biomarkers for patient selection and enrolment in our phase I clinical trials, as well as on the use of liquid biopsy to support patient selection and treatment monitoring.

VHIO is a founding member of the WIN - Worldwide Innovative Network (WIN) Consortium in Personalized Cancer Medicine and the Cancer Core Europe (CCE) alliance ( 240, 227). These academic collaborations foster collaborative projects that connect internationally renowned cancer centers to develop cutting-edge cancer diagnostics and new personalized therapies for oncology patients.

In collaboration with VHIO’s UITM – CaixaResearch, we lead the Basket of Baskets (BoB) clinical trial, with Irene Braña as global principal investigator. Sponsored by CCE and supported by several pharmaceutical companies, this innovative, multi-country academic study integrates flexible molecular prescreening with the development of new companion diagnostic tests. This platform study allows for testing novel targeted therapies in patients diagnosed with tumors harboring specific molecular alterations who have a high probability of deriving benefit from matched therapies.

Our group also coordinates the EU-funded Cancer Core Europe consortium’s Building Data Rich Clinical Trials (CCE-DART) project. By harnessing the power of cutting-edge technologies, new methodologies and platforms, CCE-DART investigators collaborate to accelerate the design and development of a new generation of data rich, dynamic studies in oncology. Achievements to date include the development of new tools for tracking cancer evolution in academic investigator-initiated trials (IITs) including CCE’s BoB. Importantly, CCE-DART prioritizes the empowerment and active involvement of patients, ensuring that their perspectives and needs are integrated throughout. This project concluded in 2025.

In collaboration with VHIO’s UITM – CaixaResearch, our teams continue to establish VHIO as a leading reference in cancer drug discovery and development. In 2025, 645 patients were enrolled in our portfolio of 322 active phase I and basket studies in oncology. Supported by VHIO’s CaixaResearch Advanced Oncology Research Program CaixaResearch, we have conducted several clinical trials targeting oncogenic mutations and structural alterations in common cancer driver genes.

Thanks to our VHIO - BBVA Foundation Comprehensive Program of Cancer Immunotherapy & Immunology – CAIMI, now in its second edition (CAIMI-II), we lead several innovative studies including the NEXTGEN-TIL trial. Conducted in collaboration with Alena Gros, Head of VHIO’s Tumor Immunology and Immunotherapy Group, this study was designed to evaluate neoantigen selected tumor-infiltrating lymphocytes (TILs) in epithelial tumors and melanoma.

Importantly, we have continued working in the PragmaTIL project: Pragmatic approach to Adoptive Cell Therapy (ACT) using Tumor Infiltrating Lymphocytes (TIL) in selected solid tumors, launched last year. This consortium comprises 12 partners across 6 countries, including the ”la Caixa” Foundation, and is supported by funding received from the European Union’s Horizon Europe research and innovation program. The main objectives of this project are to optimize TIL-ACT therapy in patients with melanoma, lung cancer, and cervical cancer, and facilitate the clinical implementation of this treatment modality in academic hospitals. Coordinated by Elena Garralda, the PragmaTIL academic clinical trial has been designed to reduce the toxicity associated with the use of high-dose interleukin 2 (HD-IL-2) post-TIL infusion, which is required to sustain expansion and activation of TIL in vivo, while maintaining efficacy. This strategy aims to enhance the clinical management of patients, decrease the potential risks of treatment, and improve the quality of life of patients undergoing therapy. During 2025 the trial started recruiting in Spain and Denmark, and the Netherlands has received full approval for the trial. This is a major milestone as each country will be producing their own TILS, marking a new model to develop cell therapies in academic consortiums.

Funded under the Europe’s Beating Cancer Plan by EU4Health, we also participate in PCM4EU - Personalised Cancer Medicine for all EU Citizens. Comprising partners from 15 countries across Europe, this project aims to facilitate the use of precision cancer medicine diagnostics and pragmatic trials across Europe, and also promotes the development of DRUP-like trials in Europe.

Lastly, canSERV is an EU-funded project under the Horizon Europe programme to make cutting-edge and customized research services available to the cancer research community EU wide. We are working alongside canSERV’s project partners to help stimulate innovative R&D projects and extend precision medicine to an increasing number of patients across the EU.

  • Promote early clinical drug development of best-in-class targeted therapies and determine optimal treatment schedules for matched patient populations who are most likely to benefit from these therapies.
  • Innovative clinical trial design for testing novel molecular targeted cancer therapies.
  • Link clinical research at our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch with selected translational research projects led by VHIO investigators.
  • Expand our collaboration with different partners in early clinical drug development and translational research (phase I units, academic centers, consortia, and pharmaceutical companies).
  • Build a solid unit for the development of cell therapy, both academic and pharma driven clinical trials.
  • We have continued to evaluate best-in-class drugs and have performed several phase I clinical trials with new targeted therapies, novel combinations, cancer immunotherapies, antibody-drug conjugates (ADCs), and epigenetic drugs.
  • VHIO’s CaixaResearch Advanced Oncology Research Program, enables us to assess the efficacy of novel targeted therapies tailored to patients’ clinical and molecular features. We have conducted several clinical trials targeting specific molecular alterations in a wide range of targets with innovative agents.
  • Supported by the VHIO - BBVA Foundation Comprehensive Program of Cancer Immunotherapy & Immunology - CAIMI, now in its second edition (CAIMI-II), we have continued to characterize hyperprogressive disease which is an adverse effect of immunotherapy. In collaboration with VHIO’s Molecular Oncology and Biomarkers and Clonal Dynamics groups, led by Paolo Nuciforo and Rodrigo Toledo, respectively, and Sergio Quezada at the University College London - UCL (UK), we are unravelling the biological mechanisms of this phenomenon.
  • Within the scope of our CAIMI program and the AstraZeneca Partners of Choice network, we are validating a radiomics signature to predict response to immunotherapy. We are correlating our results with the genomic evolution of disease observed in patients. This research is carried out in collaboration with Raquel Perez- Lopez, Head of VHIO’s Radiomics Group.
  • Within the scope of the DART project and the AstraZeneca Partners of Choice network, we have studied the role of ultrasensitive ctDNA monitoring to evaluate response to immunotherapy in collaboration with Rodrigo Toledo, Head of VHIO’s Biomarkers and Clonal Dynamics Group.
  • In collaboration with Alena Gros’ Tumor Immunology Group, we have implemented our own academic program focused on the development of tumor infiltrating lymphocytes (TIL) therapy.
  • Launched in 2023, we coordinate the EU-funded PragmaTIL project: Pragmatic approach to Adoptive Cell Therapy (ACT) using Tumor Infiltrating Lymphocytes (TIL) in selected patients with solid tumors. We aim to establish if the toxicity associated with the use of high-dose interleukin 2 (HD-IL-2) post-TIL infusion can be reduced, while still maintaining the efficacy of therapy.
  • In collaboration with Rodrigo Dienstmann, Head of VHIO’s Oncology Data Science (ODysSey) Group, we are working on a project to accelerate the digitalization of phase I units: SMART Experimental Cancer Medicine Trials eNABLED. This work is supported by a Cancer Research UK (CRUK) Accelerator grant.
  • Continue developing best in class innovative medicines.
  • Strengthen our role in the development of academic cell therapies.
  • Build translational projects in the field of ADCs.
  • Strengthen our capacities to develop radioligand therapies.
  • Martín-Lluesma S, Dafni U, Vervita K, Karlis D, Dimopoulou G, Tsourti Z, Villacampa G, Galvao V, Lostes J, Muñoz-Couselo E, Rotxés M, Villalobos X, Muñoz S, Haanen JBAG, Svane IM, Piulats JM, Martin-Liberal J, Gros A, Coukos G, Garralda E. Safety of adoptive therapy with tumor-infiltrating lymphocytes and high-dose recombinant interleukin 2 in advanced cutaneous melanoma: a systematic review and meta-analysis. Ann Oncol. 2025 Aug;36(8):909-919.
  • Balaguer-Montero M, Marcos Morales A, Ligero M, Zatse C, Leiva D, Atlagich LM, Staikoglou N, Viaplana C, Monreal C, Mateo J, Hernando J, García-Álvarez A, Salvà F, Capdevila J, Elez E, Dienstmann R, Garralda E, Perez-Lopez R. A CT-based deep learning-driven tool for automatic liver tumor detection and delineation in patients with cancer. Cell Rep Med. 2025 Apr 15;6(4):102032.
  • Dienstmann R, Vivancos A, Nuciforo P, Aguilar S, Ruiz-Pace F, Viaplana C, Gonzalez J, Fite B, Pedrola A, Elez E, Saura C, Felip E, Macarulla T, Capdevila J, Fariñas-Madrid L, Carles J, Mateo J, Muñoz-Cosuelo E, Balmaña J, Braña I, Garralda E, Tabernero J. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO Open. 2025 Nov;10(11):105888.
  • Sacher AG, Miller WH Jr, Patel MR, Paz-Ares L, Santoro A, Ahn MJ, Dziadziuszko R, Freres P, Luo J, Bowyer S, Desai J, Markman B, De Miguel M, Deva S, Falcon A, Alonso G, Guedes JD, Kim SH, Krebs MG, Laurie SA, Massarelli E, Medina L, Prenen H, Amatu A, Van Dongen M, Choi Y, Hou X, Qi T, Lin MT, Koli K, Mayo MC, Yau KK, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL, Lorusso P; GO42144 Investigator Study group; GO42144 Investigator Study Group. Single-Agent Divarasib in Patients With KRAS G12C-Positive Non-Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study. J Clin Oncol. 2025 Oct 20;43(30):3249-3253.
  1. SMART Experimental Cancer Medicine Trials eNABLED; Fundación Científica de la Asociación Española Contra el Cáncer; ELENA GARRALDA
  2. Building Data Rich Clinical Trials — CCE_DART; EUROPEAN COMISSION-DART; ELENA GARRALDA
  3. Providing cutting edge cancer research services across Europe; EUROPEAN COMMISSION; ELENA GARRALDA
  4. Pragmatic approach to Adoptive Cell Therapy (ACT) using Tumor Infiltrating Lymphocytes (TIL) in selected solid tumors; EUROPEAN COMMISSION; ELENA GARRALDA
  5. Personalised Cancer Medicine for all EU citizens; EUROPEAN COMMISSION; ELENA GARRALDA
  6. Desarrollo preclínico y prueba de concepto clínica de GlioHook, un dispositivo médico implantable para el tratamiento del glioblastoma; Ministerio de Ciencia e Innovación; MARIA VIEITO
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  2. Balaguer-Montero M, Marcos Morales A, Ligero M, Zatse C, Leiva D, Atlagich LM, Staikoglou N, Viaplana C, Monreal C, Mateo J, Hernando J, García-Álvarez A, Salvà F, Capdevila J, Elez E, Dienstmann R, Garralda E, Perez-Lopez R. A CT-based deep learning-driven tool for automatic liver tumor detection and delineation in patients with cancer. Cell Rep Med. 2025 Apr 15;6(4):102032. doi: 10.1016/j.xcrm.2025.102032. Epub 2025 Mar 20.
  3. Dienstmann R, Vivancos A, Nuciforo P, Aguilar S, Ruiz-Pace F, Viaplana C, Gonzalez J, Fite B, Pedrola A, Elez E, Saura C, Felip E, Macarulla T, Capdevila J, Fariñas-Madrid L, Carles J, Mateo J, Muñoz-Cosuelo E, Balmaña J, Braña I, Garralda E, Tabernero J. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO Open. 2025 Nov;10(11):105888. doi: 10.1016/j.esmoop.2025.105888. Epub 2025 Nov 6.
  4. Sacher AG, Miller WH Jr, Patel MR, Paz-Ares L, Santoro A, Ahn MJ, Dziadziuszko R, Freres P, Luo J, Bowyer S, Desai J, Markman B, De Miguel M, Deva S, Falcon A, Alonso G, Guedes JD, Kim SH, Krebs MG, Laurie SA, Massarelli E, Medina L, Prenen H, Amatu A, Van Dongen M, Choi Y, Hou X, Qi T, Lin MT, Koli K, Mayo MC, Yau KK, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL, Lorusso P; GO42144 Investigator Study group; GO42144 Investigator Study Group. Single-Agent Divarasib in Patients With KRAS G12C-Positive Non-Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study. J Clin Oncol. 2025 Oct 20;43(30):3249-3253. doi: 10.1200/JCO-25-00040. Epub 2025 Jul 9.
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  45. Arenillas C, Celada L, Ruiz-Cantador J, Calsina B, Datta D, García-Galea E, Fasani R, Moreno-Cárdenas AB, Alba-Linares JJ, Miranda-Barrio B, Martínez-Montes ÁM, Alvarez-Escola C, Lecumberri B, González García A, K Flores S, Esquivel E, Ding Y, Peitzsch M, Robles-Guirado JÁ, Regojo Zapata RM, Pozo-Kreilinger JJ, Iglesias C, Dwight T, Muir CA, Oleaga A, Garrido-Lestache Rodríguez-Monte ME, Del Cerro MJ, Martínez-Bendayán I, Álvarez-González E, Cubiella T, Lourenço DM Jr, A Pereira MA, Burnichon N, Buffet A, Broberg C, Dickson PV, Fraga MF, Llorente Pendás JL, Rueda Soriano J, Buendía Fuentes F, Toledo SPA, Clifton-Bligh R, Dienstmann R, Villanueva J, Capdevila J, Gimenez-Roqueplo AP, Favier J, Nuciforo P, Young WF Jr, Bechmann N, Opotowsky AR, Vaidya A, Bancos I, Weghorn D, Robledo M, Casteràs A, Dos-Subirà L, Adameyko I, Chiara MD, Dahia PLM, Toledo RA. Convergent Genetic Adaptation in Human Tumors Developed Under Systemic Hypoxia and in Populations Living at High Altitudes. Cancer Discov. 2025 May 2;15(5):1037-1062. doi: 10.1158/2159-8290.CD-24-0943.
  46. Ledermann JA, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Banerjee S, García-Donas J, Swisher EM, Lebreton C, Konecny GE, McNeish IA, Scott CL, Maloney L, Goble S, Lin KK, Coleman RL. Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial. Eur J Cancer. 2025 Jul 25;225:115584. doi: 10.1016/j.ejca.2025.115584. Epub 2025 Jun 17.
  47. El-Deiry WS, Bresson C, Wunder F, Carneiro BA, Dizon DS, Warner JL, Graff SL, Azzoli CG, Wong ET, Cheng L, Mani SA, Safran HP, Williams C, Meissner T, Solomon B, Rubin E, Porgador A, Berchem G, Saintigny P, Onn A, Bar J, Berger R, Gantenbein M, Chen Z, Souza CP, Reis RMV, Sekacheva M, Cervantes A, Dahut WL, Annunziata CM, Gober K, Musallam KM, Al-Shamsi HO, Abu-Gheida I, Salazar R, Limaye S, Aref AT, Reddel RR, Homsi MUA, Rouf A, Dermime S, Suwaidi JA, Vlad C, Buiga R, Omari AA, Abdel-Razeq H, Oñate-Ocaña LF, Nielsen FC, Graham L, Rueter J, Joshua AM, Girda E, Libutti S, Riedlinger G, Salem ME, Farhangfar CJ, Mesa RA, Faltas BM, Elemento O, Pramesh CS, Sengar M, Aoyama S, Ikeda S, Berindan-Neagoe I, Gaddipati H, Kulkarni M, Auzias E, Gerogianni M, Wolikow N, Istolainen S, Schlafrig P, Frankel NZ, Ferraro AR, Palma J, Gimenez AP, Hernando-Calvo A, Felip E, Tsimberidou AM, Herbst RS, Tabernero J, Schilsky RL, Liu J, Lussier Y, Raynaud J, Batist G, Magidi S, Kurzrock R. Worldwide Innovative Network (WIN) Consortium in Personalized Cancer Medicine: Bringing next-generation precision oncology to patients. Oncotarget. 2025 Mar 12;16:140-162. doi: 10.18632/oncotarget.28703.
  48. Baldini C, Verlingue L, Goldschmidt V, Doger de Spéville B, Lostes J, Italiano A, Cousin S, Falchook GS, Necchi A, Reig Torras O, Fontana E, Carter L, Rodon Ahnert J, Brown JR, DeMars LR, Josephs K, Dickson A, Xu C, Bader J, Campbell C, Sharma R, McKean M. First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation. J Clin Oncol. 2025 Dec 10;43(35):3728-3738. doi: 10.1200/JCO-25-00559. Epub 2025 Nov 6.
  49. Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Braña I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50. doi: 10.1056/NEJMoa2415434. Epub 2025 Jun 18.
  50. Lopez J, Powles T, Braiteh F, Siu LL, LoRusso P, Friedman CF, Balmanoukian AS, Gordon M, Yachnin J, Rottey S, Karydis I, Fisher GA, Schmidt M, Schuler M, Sullivan RJ, Burris HA, Galvao V, Henick BS, Dirix L, Jaeger D, Ott PA, Wong KM, Jerusalem G, Schiza A, Fong L, Steeghs N, Leidner RS, Rittmeyer A, Laurie SA, Gort E, Aljumaily R, Melero I, Sabado RL, Rhee I, Mancuso MR, Muller L, Fine GD, Yadav M, Kim L, Leveque VJP, Robert A, Darwish M, Qi T, Zhu J, Zhang J, Twomey P, Rao GK, Low DW, Petry C, Lo AA, Schartner JM, Delamarre L, Mellman I, Löwer M, Müller F, Derhovanessian E, Cortini A, Manning L, Maurus D, Brachtendorf S, Lörks V, Omokoko T, Godehardt E, Becker D, Hawner C, Wallrapp C, Albrecht C, Kröner C, Tadmor AD, Diekmann J, Vormehr M, Jork A, Paruzynski A, Lang M, Blake J, Hennig O, Kuhn AN, Sahin U, Türeci Ö, Camidge DR. Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. Nat Med. 2025 Jan;31(1):152-164. doi: 10.1038/s41591-024-03334-7. Epub 2025 Jan 6.
  • 2022-0544; “An open-label fixed sequence trial to investigate the potential drug-drug interaction when BI 907828 is co-administered with an OATP1B1 and/or OATP1B3 transporter inhibitor in patients with various solid tumours”; I
  • 2020-0295; A First–in-human Phase I, non-randomized, open-label, multicenter dose escalation trial of BI 764532 administered by repeated intravenous infusions in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.; I
  • 2023-1067; A Phase I, open-label, dose escalation and expansion trial to investigate safety and tolerability of BI 764532 in combination with standard of care (platinum and etoposide) in first-line treatment of patients with neuroendocrine carcinomas (NEC); I
  • 2021-0772; Phase I dose-finding study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers.; I
  • 2024-0981; "A Phase II, multicenter, open-label study to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumors "; I
  • 2024-0758; A Phase Ib dose escalation and Phase II dose optimization, randomized, open-label, multicenter trial of oral zongertinib  (BI 1810631) in combination with intravenous trastuzumab deruxtecan (T-DXd) or in combination with intravenous trastuzumab emtansine (T-DM1) for treatment of patients with advanced HER2+ metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC); I
  • 2022-1040; Phase Ia, first in human open-label trial evaluating BI 1703880, a non-CDN STING agonist, in combination with ezabenlimab for treatment of advanced solid tumours; I
  • 2023-0326; A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer; I
  • 2021-1236; A PHASE 1B, MASTER PROTOCOL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF AMG510 IN SUBJECTS WITH AVANCED SOLID TUMORS WITH KRAS P.G12C MUTATION; I
  • 2024-0591; “Primer estudio en humanos de fase 1 que evalúa la seguridad, tolerabilidad, farmacocinética y eficacia de AMG 355 en monoterapia y en combinación con pembrolizumab en sujetos con tumores sólidos avanzados”; I
  • 2023-0877; Primer estudio en humanos de fase 1 para evaluar la seguridad, tolerabilidad y farmacocinética de AMG 305 en sujetos con tumores sólidos avanzados; I
  • 2024-0766; A PHASE 1B/2 STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACO KINETICS, AND EFFICACY OF AMG 193 ALONE OR IN COMBINATION WITH OTHER THERAPIES IN SUBJECTS WITH ADVANCED THORACIC TUMORS WITH HOMOZYGOUS MTAP DELETION; I
  • 2024-0877; A Phase 1B/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG193 Alone or in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract or Pancreatic Cancers With Homozygous MTAP Deletion; I
  • 2024-0936; A Phase 1B Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Subcutaneous Tarlatamab in Subjects with Extensive-Stage Small Cell Lung Cancer (DELLPHI-308); I
  • 2025-0979; A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer; I
  • 2025-0916; Phase 1/1b study in Metastatic/Locally Advanced Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma or Pancreatic Adenocarcinoma whose tumors have Claudin (CLDN) 18.2 expression; I
  • 2024-0842; A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors; I
  • 2024-0731; “An open‐label,  phase  1,  first‐in‐human,  dose escalation  and expansion  study  to evaluate  the  safety,  tolerability,  maximum  tolerated  or  administered  dose,  pharmacokinetics, pharmacodynamics, and tumor response profile of the diacylglycerol kinase zeta inhibitor (DGKzi) BAY 2965501 as monotherapy, and in combination, in participants with advanced solid tumors”; I
  • 2025-0666; A Phase 1/2 Master Protocol to Assess the Safety and Efficacy of DNA-Damage Repair Inhibitors, as Monotherapies or in Combination with Other Anti-Cancer Agents in Adult Participants with Solid Tumors; I
  • 2024-0850; An open-label, phase 1, first-in-human, dose escalation and expansion study to evaluate the safety, tolerability, maximum tolerated or administered dose, pharmacokinetics, pharmacodynamics, and tumor response profile of the diacylglycerol kinase alpha inhibitor (DGKai) BAY 2862789 in participants with advanced solid tumors; I
  • 2024-0918; A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors; I
  • 2025-0737; "A Phase I Clinical Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in Participants with Advanced Solid Tumors"; I
  • 2025-0335; “Estudio de fase I/II, aleatorizado, multicohorte para evaluar la seguridad, tolerabilidad, farmacocinética y actividad clínica de GSK5733584 en combinación con otros tratamientos contra el cáncer en participantes con tumores sólidos avanzados.”; I
  • 2025-0775; A Phase1b/2, multicenter, randomized, open-label study to evaluate the efficacy and safety of GSK5764227 alone and in combination in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors; I
  • 2025-0119; AN OPEN-LABEL, MULTICENTRE PHASE 1B/2A CLINICAL TRIAL OF BI-1607, AN FC-ENGINEERED MONOCLONAL ANTIBODY TO FCγRIIB (CD32B), IN COMBINATION WITH IPILIMUMAB AND PEMBROLIZUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA; I
  • 2024-1129; A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation; I
  • 2025-1073; A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in combination with Standard of Care (SOC) or other agents in Participants with Advanced Solid Tumors; I
  • 2024-0974; A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation; I
  • 2023-1136; Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumors; I
  • 2017-0401; A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors; I
  • 2020-0720; A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER).; I
  • 2022-0699; "A Phase 1b/2, open-label, study of amivantamab monotherapy and in combination with chemotherapy in patients with advance metastatic colorectal cancer"; I
  • 2024-0593; Ensayo fase 1b/2 con ramas de Amivantamab en monoterapia y en combinación con Paclitaxel o Pembrolizumab.; I
  • 2023-1060; A Phase I Study of JNJ-79032421, a T-cell Redirecting Agent Targeting Mesothelin for Advanced Stage Solid Tumors; I
  • 2023-1000; “Estudio en Fase I de JNJ-86974680, un antagonista del receptor A2a, administrado en monoterapia y en combinación con cetrelimab y radioterapia para Cáncer de pulmón de célula no pequeña.”; I
  • 2024-0302; A Phase 1 Study of Intratumoral Delivery of JNJ 87704916 in Combination with Systemic Immunotherapies in Patients with Non-Small Cell Lung Cancers; I
  • 2024-0210; “Estudio en Fase I de JNJ-87890387, un anticuerpo biespecífico frente al Miembro 3 de la familia de las Ectonucleótido Pirofosfatasas/Fosfodiesterasas (ENPP3) y CD3 en tumores sólidos avanzados.”; I
  • 2025-0238; A Phase I Study of JNJ-89402638, a T-cell Redirecting Agent Targeting GUCY2C, for Advanced Stage Colorectal Cancer; I
  • 2025-0757; A Phase I/IIa Open Label Study of ABX-001 Administered With and Without Anti-PD-1 Checkpoint Inhibitor in Participants With Advanced Solid Tumors; I
  • 2022-1114; A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors; I
  • 2021-1309-II; A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR expressing Cancers; I
  • 2024-0352; A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti Claudin1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti-PD-1 antibody) in Adult Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma; I
  • 2025-0548; A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Squamous Solid Tumors; I
  • 2024-0411; A first-in-human, open-label Phase 1/2 study to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with relapsed/refractory advanced solid tumors; I
  • 2023-068-1; feasibility of using Accelerometers to measure Physical Activity in Cancer patients on Early phase clinical trials. A feasibility study evaluating the use of accelerometers to capture physical activity levels in cancer patients on early phase clinical trials; PRODUCTO SANITARIO
  • 2024-0415; A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors; I
  • 2023-0140; IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination with Pembrolizumab or Standard of Care Chemotherapy in Participants Aged 18 Years or Older with Locally Advanced or Metastatic Solid Tumor Malignancies.; I
  • 2022-0370; First-in-human study of BAY2927088 in patients with advanced cancer harboring an EGFR and/or HER2 mutation.; I
  • 2024-1084; Basket study of BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations; I
  • 2024-1107; First-in-human Phase 1 study of the SOS1 inhibitor BAY 3498264 administered alone and in combination with sotorasib in participants with advanced KRASG12C-mutated solid tumors; I
  • 2025-0467; Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Antitumor Activity of a Chimeric Degradation Activating Compound (CDAC) Degrading Epidermal Growth Factor Receptor (EGFR), BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC); I
  • 2023-0681; “A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors”; I
  • 2025-0076; A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor in Patients With Advanced Solid Tumor; I
  • 2024-0495; A multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-B01D1 in subjects with metastatic or unresectable NSCLC; I
  • 2022-0506; First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer.; I
  • 2022-0445; “First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors”; I
  • 2021-0254; TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL.; I
  • 2023-0740; A phase Ib/II, open-label, multicenter study evaluating the safety, activity, and pharmacokinetics of GDC-6036 in combination with other anti-cancer therapies in patients with previously untreated advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation; I
  • 2023-1068; AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF RO7616789 IN PARTICIPANTS WITH ADVANCED SMALL CELL LUNG CANCER AND OTHER NEUROENDOCRINE CARCINOMAS; I
  • 2023-1030; A Phase I, open-label study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7589831 in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR); I
  • 2024-0979; AN OPEN-LABEL, MULTICENTER, DOSEESCALATION, RANDOMIZED, PHASE I STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF RO7567132 AS SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS; I
  • 2021-0708; Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression.; I
  • 2021-0261; Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies.; I
  • 2018-0975; A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL).; I
  • 2025-0535; AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS; I
  • 2025-0412; AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046032 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES; I
  • 2023-0512; A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab in Participants with Advanced Solid Tumors; I
  • 2025-0310; A Phase 1/2a, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BMS-986507-01 (BL-B01D1) combinations in adult participants with advanced lung cancers; I
  • 2022-0237; A Phase Ib Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide and Tislelizumab in Induction and with Tislelizumab in Maintenance Treatment Phase.; I
  • 2022-0241; A Phase Ib Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Radiotherapy with or without Temozolomide and in Recurrent Glioblastoma as Single Agent.; I
  • 2022-0337; A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Whole-body Distribution, Radiation Dosimetry and Anti-tumor Activity of [177Lu]-NeoB Administered in Patients With Advanced Solid Tumors Known to Overexpress Gastrin-releasing Peptide Receptor (GRPR).; I
  • 2025-0525; “Estudio de fase Ib de búsqueda de dosis en el que se evalúan la seguridad y la actividad de [177Lu]Lu-NeoB en combinación con ribociclib y fulvestrant en participantes con cáncer de mama avanzado receptor de estrógenos positivo, receptor 2 del factor de crecimiento epidérmico humano negativo y receptor del péptido liberador de gastrina positivo que hayan presentado una recidiva temprana con la terapia endocrina (neo)adyuvante o que hayan progresado con la terapia endocrina en combinación co; I
  • 2024-1116; Phase 1, Modular, First-in-Human Study to Assess the Safety, Tolerability and Antitumor Activity of CDR404 in HLA-A*02:01+ Participants with MAGE-A4 Positive Solid Tumors; I
  • 2025-1050; Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/​HER2- Breast Cancer and Other Advanced Solid Tumors; I
  • 2023-1021; A Phase 1/2 Open-Label, Multicenter, Global Trial to Characterize the Safety, Tolerability and Preliminary Efficacy of CFT1946 as Monotherapy and in Combination with Trametinib in Subjects with BRAF-V600 Mutant Solid Tumors.; I
  • 2024-0282; A randomized, double-blind, parallel-group study to compare pharmacokinetics of GME751 (proposed pembrolizumab biosimilar) and US-licensed and EU-authorized Keytruda® in participants with stage II and III melanoma requiring adjuvant treatment with pembrolizumab; I
  • 2023-0699; “Estudio de fase I/Ib, multicéntrico, abierto y de búsqueda y expansión de dosis de HRO761, en monoterapia y en combinación, en pacientes con tumores sólidos avanzados con inestabilidad de microsatélites alta o con alteración del sistema de reparación de errores de replicación”; I
  • 2021-0833; “Estudio de fase I, multicéntrico y abierto de IAG933 oral en pacientes adultos con mesotelioma avanzado y otros tumores sólidos”; I
  • 2023-0662; A phase I, open-label, multi-center study of KFA115 as a single agent and in combination with tislelizumab in patients with select advanced cancers; I
  • 2024-0839; "Phase 1b/2 trial of S095029 and pembrolizumab in MSI-H/dMMR locally advanced unresectable or metastatic CRC and S095029, pembrolizumab and trastuzumab in HER2-positive locally advanced unresectable or metastatic GEJ and GA"; I
  • 2025-1156; Fase I/II para evaluar la seguridad, tolerancia, farmacocinética y actividad preliminar de S95035 (un inhibidor de MTA2A) en monoterapia y también en combinación con taxanos en pacientes previamente tratados con tumores sólidos avanzados o metastásicos con supresión homocigota MTAP y/o falta de expresión de MTAP.; I
  • 2024-0410; An open-label, phase I/IIa first-in-human, dose escalation and cohort expansion study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and anti-tumour activity of ERK1/2 inhibitor IPN01194 as single agent in participants with advanced solid tumours; I
  • 2025-0327; “An open‐label, phase I/II  first‐in‐human, dose escalation and confirmation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic  and  anti‐tumour  activity  of  IPN01195  as  single  agent  in  adult participants with advanced solid tumours”; I
  • 2022-0493; Estudio de fase I, abierto, de escalada de dosis y expansión de MGY825 en pacientes adultos con cáncer de pulmón de células no pequeñas en estadio avanzado; I
  • 2018-0398; "A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE NEGATIVE BREAST CANCER (MORPHEUS TNBC)"; I
  • 2021-0596; "A PHASE IB, OPEN-LABEL, DOSE-ESCALATION AND DOSEEXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF INAVOLISIB IN COMBINATION WITH PACLITAXEL AND WITH OR WITHOUT TARGETED THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS".; I
  • 2021-0317; Phase 1b/II umbrella, adaptive design study The first cohort of the new Breast Cancer study will target 2L or 3L metastatic or inoperable locally advanced ER+ Breast Cancer patients who had disease progression during or following treatment with a CDK4/6i.; I
  • 2019-0678; An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments.; IV
  • 2024-0914; A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that are Antigen-rich (START-001); I
  • 2024-1193; “A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients with Advanced Solid Tumors”; I
  • 2024-1065; A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-01 as Monotherapy and Combination Therapy in Subjects with Intermediate or Advanced Hepatocellular Carcinoma (BCLC Stage B or C) with Preserved Liver Function (Child-Pugh Class A); I
  • 2023-1079; “A Phase 1b/2 Open-label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer”; I
  • 2021-1149; A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF FADRACICLIB (CYC065), AN ORAL CDK2/9 INHIBITOR, IN SUBJECTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA.; I
  • 2024-1106; "A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation"; I
  • 2024-0372; A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies; I
  • 2021-1305; A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer.; I
  • 2025-0565; A Phase I/IIa Multi-Center Global Open-Label Modular Dose Exploration, Optimization and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD0022 as Monotherapy and in Combination with Anti-cancer Agents in Participants Harbouring a KRASG12D Mutation; I
  • 2022-0706; "A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)"; I
  • 2024-0377; A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants with Selected Advanced or Metastatic Solid Tumors (CYCAD-1); I
  • 2024-0405; A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors; I
  • 2022-1010-6; A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03); I
  • 2022-1010-1; A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03); I
  • 2022-1010-2; A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03); I
  • 2022-1010-4; A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03); I
  • 2022-1010-3; A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03); I
  • 2023-0649; A Modular Phase 1, Open-label, Dose-escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Tumors; I
  • 2021-0542; A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, anti-TIM-3 and anti PD-1 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors .; I
  • 2020-0714; A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Doseexpansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2-Overexpressing Gastric Cancer (DESTINY-Gastric03).; I
  • 2021-0136; Phase 2, Multicentre, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors .; I
  • 2021-0093; A Modular Phase I/IIa, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5305 monotherapy and in combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies.; I
  • 2025-0710; A Phase I/II Study Master Protocol to Investigate Biomarker-Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants with Advanced/Metastatic Ovarian Cancer (Ovarian Platform); I
  • 2024-0526; A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours That are MTAP Deficient; I
  • 2024-0397; A Phase 1 Open-Label Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a Sensitive CYP3A Probe Substrate (Midazolam) in Patients with Advanced Gastrointestinal Stromal Tumor (GIST); I
  • 2020-0504; A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors.; I
  • 2024-0242; Phase 1 dose expansion study of Debio 0123, a highly selective and potent Wee1 inhibitor, as monotherapy in patients with advanced solid tumors who have previously been treated with standard therapy or for which standard of care therapy is not suitable.; I
  • 2023-0333; Multi-center, open-label, non-randomized, uncontrolled, dose-escalation study of Debio 0123 in combination with carboplatin and etoposide in adult participants with small cell lung cancer that recurred or progressed after previous standard platinum-based therapy, followed by an expansion in adult participants with small cell lung cancer that recurred or progressed after previous standard platinum-based therapy.; I
  • 2023-0462; A phase 1/2 open label study of Debio 0123 in combination with temozolomide in adult participants with recurrent glioblastoma, and Debio 0123 in combination with temozolomide and radiotherapy in adult participants with newly diagnosed glioblastoma; I
  • 2021-1019; A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications; I
  • 2024-0070; A PHASE 1, 2-PART, MULTICENTER, FIRST-IN-HUMAN DOSE-ESCALATION AND DOSE-EXPANSION STUDY OF DS-1103A COMBINATION THERAPY IN SUBJECTS WITH ADVANCED SOLID TUMORS (DS-1103A COMBINATION THERAPY FIRST-INHUMAN STUDY); I
  • 2025-0864; A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination with Deruxtecan Antibody-drug Conjugates in Subjects with Solid Tumors; I
  • 2025-0320; PHASE 1/2, OPEN-LABEL, MULTICENTER, FIRST-IN HUMAN STUDY OF DS-3939a IN SUBJECTS WITH ADVANCED SOLID TUMORS; I
  • 2025-0130; A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants with Advanced/Metastatic Solid Tumors.; I
  • 2025-0290; A PHASE 2 PAN-TUMOR, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH RECURRENT OR METASTATIC SOLID TUMORS; I
  • 2024-0941; Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy or in Combination with Anti-Cancer Agents in Participants with Advanced Malignancies; I
  • 2024-1034; “FIRST-IN-HUMAN PHASE 1/2 TRIAL OF EGL-001 IN ADULT PATIENTS WITH SELECTED ADVANCED AND/OR METASTATIC SOLID TUMORS”; I
  • 2025-0466; “A first in-human, Phase 1/2, openlabel, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, as monotherapy and in combination in patients with advanced solid tumors”; I
  • 2024-0230; "A Phase 1a/1b Study of ELVN-002 for the Treatment of HER2 mutant or HER2 amplified solid tumors"; I
  • 2024-0679; "A Phase 1a/1b Study of ELVN-002 Combined with Trastuzumab in Advanced Stage HER2+ Solid tumors, and ELVN-002 Combined with Trastuzumab and Chemotherapy in  Advanced Stage HER2+ Breast Cancer or Colorectal Cancer"; I
  • 2022-1050; A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies; I
  • 2024-1102; A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer; I
  • 2025-0851; Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 monotherapy in Subjects with Advanced Solid Tumors; I
  • 2022-0603; Single cell characterization of persistent cells upon treatment with durvalumab (MEDI4736) with or without Tremelimumab in MSS and MSI colorectal and endometrial tumors: the SERPENTINE clinical trial; I
  • 2024-0865; "First-In-Human Phase 1/2 open-label trial to assess safety and efficacy of STX-241 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) resistant to third generation EGFR tyrosine kinase inhibitors (TKIs)"; I
  • 2024-0432; F8394-201"A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF class 1 and class 2 alterations, in participants with cancer harboring BRAF alterations • Sub Protocol A: Solid tumors with BRAF fusion (excluding colorectal cancer or pancreatic ductal adenocarcinoma) • Sub Protocol B: High-grade gliomas with BRAF fusions or V600 mutation • Sub Protocol C: Colorectal Cancer with V600 or Class 2 mutations in combination with an EGFRi Ab • Sub Protocol D: c; I
  • 2020-0851; A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects with Advanced Malignancies.; I
  • 2024-0478; First-In-Human, Open-Label, Dose Escalation Trial with Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy With a PD-1 Inhibitor in Subjects With Malignant Solid Tumors; I
  • 2025-0077; “A First-In-Human, Open-Label, Dose Escalation Trial to Evaluate the Safety and Preliminary Efficacy of GEN1057 in Subjects with Malignant Solid Tumors; I
  • 2025-0162; First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1078 in subjects with malignant solid tumors; I
  • 2022-0637; Phase Ib/II multicohort trial of different schemes of PM14 in monotherapy and in combination with radiotherapy in soft tissue sarcomas and other solid tumors.; I
  • 2023-0291; A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS; I
  • 2023-0843; A PHASE I, OPEN-LABEL, MULTICENTER, DOSEESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7656594 IN PATIENTS WITH ADVANCED OR METASTATIC PROSTATE CANCER; I
  • 2025-0372; Ph1a/b open-label, multicenter, dose escalation/expansion study in solid tumors evaluating RO7759065 as a single agent and in combination with atezolizumab; I
  • 2025-0267; A PHASE I/II DOSE-ESCALATION AND DOSE-EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC 7035 IN PATIENTS WITH ADVANCED SOLID TUMORS WITH A KRAS G12D MUTATION; I
  • 2023-1032; “A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination with Anticancer Treatments in Patients with Solid Malignancies”; I
  • 2024-0449; A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti–PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors; I
  • 2023-0680; "A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination with an Anti-PD-1 Monoclonal Antibody in Adults with Advanced Solid Tumors"; I
  • 2022-0346; A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients with Advanced Solid Tumors.; I
  • 2025-0939; “A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations”; I
  • 2019-1012; A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study).; I
  • 2023-0679; "An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors"; I
  • 2023-0223; FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST); I
  • 2023-0769; "A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers"; I
  • 2024-1005; A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC P115 C as a Single Agent and in Combination with Standard of Care Agents in HLA A*02:01 Positive Participants with Advanced PRAME Positive Cancers; I
  • 2024-0471; A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants with Selected Advanced PIWIL1-Positive Cancers; I
  • 2025-0124; "A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (anti-FRα antibody-drug conjugate) in Adult Patients with Recurrent Endometrial Cancer and Recurrent, High-Grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers"; I
  • 2023-0161-I; A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer -cohorte 7; I
  • 2023-0844; A Phase 1, Open-Label, Multicenter Study of INCA033890 as Monotherapy in Participants With advanced or metastatic Solid Tumors; I
  • 2024-0913; Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors with KRAS G12D Mutation.; I
  • 2022-0676; A phase I trial evaluating the safety, tolerability and pharmacokinetic profile of INP12 in patients with advanced solid tumors; I
  • 2022-1098; A Phase I/Ib, Open-label, Multicentre, Multiple Ascending Doses Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral ITF3756 as Monotherapy and in Combination with an Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Agent in Patients with Advanced Solid Tumors; I
  • 2024-1108; Phase 1a/1b Study of LY3962673 in Patients with KRAS G12D-Mutant Solid Tumor; I
  • 2025-0392; "A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with KRAS Mutant Solid Tumors"; I
  • 2025-0766; A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants with Selected Advanced Solid Tumors; I
  • 2024-1091; A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients with Unresectable Locally Advanced or Metastatic Cancer; I
  • 2022-0489; "A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein targeting CTLA-4, in Patients with Unresectable Locally Advanced or Metastatic Cancer"; I
  • 2025-0196; Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients with Advanced Solid Tumors; I
  • 2025-0159; A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Malignancies; I
  • 2024-0699; “Phase I, first-in human, open-label, dose escalation and cohort expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumour activity of LB-208 (HTR1B antagonist) in adult patients with relapsed or refractory solid tumours and lymphoma”; I
  • 2024-0067; A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF NILK-2301, A BISPECIFIC CEACAM5 x CD3 ENGAGING NTIBODY, IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC LOW TUMOR VOLUME COLORECTAL CANCER; I
  • 2025-0733; “A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF NI-1801, A BISPECIFIC MESOTHELIN x CD47 ENGAGING ANTIBODY, AS A SINGLE  AGENT, IN COMBINATION WITH ANTI-PD-1 ANTIBODY, AND IN COMBINATION WITH  WEEKLY PACLITAXEL (STANDARD OF CARE) IN PATIENTS WITH MESOTHELIN - EXPRESSING OVARIAN, PANCREATIC, NON-SMALL CELL LUNG AND TRIPLE-NEGATIVE  BREAST CANCERS”; I
  • 2024-0752; A PHASE I STUDY OF THE CEACAM5 x CD47 ANTIBODY NILK2401 AS SINGLE AGENT OR IN COMBINATION WITH ANTI-PD-1 ANTIBODY IN SOLID CANCERS; I
  • 2024-0879; “A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants with Recurrent, Advanced or Metastatic Solid Tumors”; I
  • 2024-0852; "A first-in-Human, Phase 1a/1b Trial to assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an AntibodyDrug Conjugate T -Expressing Tumor Cells, in Participants with Selected Advanced Solid Tumors"; I
  • 2018-0358; "A Phase 1 Study of Oral LOXO-292 in Adult Patients with Advanced Solid Tumors, Including RET-Fusion Non-Small Cell Lung Cancer, Medularry Thyroid Cancer, and Other Tunors with Increased RET Activity".; I
  • 2024-0819; Estudio fase 1, el primero en seres humanos, multicéntrico y abierto con escalado de dosis para determinar la seguridad, tolerabilidad, farmacocinética y dosis recomendada para la fase 2 de LIVMONIPLIMAB (ABBV-151) en monoterapia y en combinación con BUDIGALIMAB (ABBV-181) en sujetos con tumores sólidos localmente avanzados o metastásicos; I
  • 2023-0366; A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors; I
  • 2024-0226; A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors.; I
  • 2025-0632; A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer; I
  • 2022-0496; “Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors”; I
  • 2018-0267; Phase 1 dose escalation and cohort expansion study evaluating single-agent MCLA-158 in metastatic colorectal cancer and other advanced solid tumors.; I
  • 2024-1074; Estudio clínico de fase 1/1b, abierto y multicéntrico, de MK-0472 en monoterapia y en tratamiento combinado, en participantes con tumores sólidos avanzados/metastásicos; I
  • 2024-0896; A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers; I
  • 2021-1144; Estudio de fase 1, abierto y multicéntrico para evaluar la seguridad, la tolerabilidad, la farmacocinética y la eficacia de MK-1084 en monoterapia y en combinación con pembrolizumab en sujetos con tumores sólidos avanzados con KRASG12C mutado.; I
  • 2025-0664; A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03C in Participants with Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy; I
  • 2015-0785; Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158); I
  • 2022-0847; "Estudio adaptativo de ramas tipo paraguas, fase 1/2 y abierto, con fármacos en investigación con o sin pembrolizumab en participantes con carcinoma urotelial localmente avanzado o metastásico resistente a inhibidores de PD-1/L1 (KEYMAKER-U04): Subestudio 04A" MK-3475-U04/MK-3475-04A: Phase 1/2 Umbrella Study of Investigational Agents With or Without Pembrolizumab in PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma. MK-3475-U04/MK-3475-04B: Phase 1/2 Umbrella Study of Pem; I
  • 2024-0750; A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) in Combination With Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C; I
  • -0675-1; Subestudio MK-5684-01A: Subestudio en paraguas de fase 1/2 del protocolo maestro MK-5684-U01 para evaluar la seguridad y la eficacia de combinaciones terapéuticas basadas en MK-5684 o de MK-5684 en monoterapia en participantes con cáncer de próstata resistente a la castración metastásico (CPRCm); I
  • 2025-0285; A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants with High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy.; I
  • 2025-0265; A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Recurrent Extensive-Stage Small Cell Lung Cancer; I
  • 2021-0678; An Open-label, Multicenter, Phase 2 Study of Pembrolizumab Plus Lenvatinib in Combination With MK-6482 in Multiple Solid Tumors.; I
  • 2024-0456; A Phase 1/2 Substudy of the MK-9999-U02 Master Protocol to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers; I
  • 2025-0209; “A  Phase  1  Study  of MOMA‐313  Given  as  Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors”; I
  • 2022-0576; A Phase I, Two-Part, Multicenter, Open-Label First in Human Study of anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants with Advanced Solid Tumors; I
  • 2025-0272-2; PROCEADE PanTumor Substudy NSCLC: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer; I
  • 2024-0904; An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination with the ATR Inhibitor Tuvusertib in Participants with Advanced Solid Tumors; I
  • 2023-0998; A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Malignancies; I
  • 2024-1064; An open-label, phase I/II multicenter clinical trial of NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor therapy in patients with solid tumors; I
  • 2022-0208; A Phase 1/2 study of the highly selective ROS1 inhibitor NUV-520 in patients with advanced NSCLC and other solid tumors.; I
  • 2022-0388-II; A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1); I
  • 2023-0499; A Phase 1b Study to evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 administered intravenously in combination with different drugs in Patients with advanced Solid Tumors (OMO-103-02); I
  • 2025-1031; Phase 1b Dose Escalation Trial of OMTX705, an Anti‐Fibroblast  Activation  Protein  Antibody‐Drug  Conjugate,  in  ombination  with Gemcitabine/Nab‐Paclitaxel  and  Tislelizumab  in  Patients  with  Advanced/Metastatic Pancreatic Adenocarcinoma; I
  • 2024-1043; A Phase I/Ib Dose Escalation and Cohort Expansion Study of OMX-0407 a Salt[1]inducible Kinase inhibitor in patients with previously treated unresectable solid tumour; I
  • 2024-1187; "An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2  Alteration"; I
  • 2024-1137; "An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer"; I
  • 2025-0361; "An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors, Including Sarcomas"; I
  • 2025-0788; An Open-Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring; IV
  • 2017-0546; Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors; I
  • 2024-0960; A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation; I
  • 2025-0236; A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT7732 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation; I
  • 2023-0867; A Phase 1, First-in-Human, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Subjects with Advanced Solid Tumors; I
  • 2023-0139; A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer; I
  • 2022-0698; A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer; I
  • 2024-0995; A Phase 1b/2 Open-Label, Multicenter Study of RMC-6291 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with KRASG12C-Mutated Solid Tumors – Subprotocol A; I
  • 2024-1014; A Phase 1b/2 Open-Label, Multicenter Study of RMC-6236 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with RAS-Mutated Solid Tumors – Subprotocol B; I
  • 2025-0915; Open-Label, Multicenter Study of Zoldonrasib (RMC-9805) in Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC); II
  • 2025-0356; A Phase 1b/2, Safety Lead-in and Dose Expansion, Open label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation; I
  • 2025-0307; Fase Ib/II de Vorasidenib en combinación con Temozolomida en pacientes con diagnóstico nuevo de Astrocitoma IDH1 o IDH2 mutado grado 4.; I
  • 2024-0603; A multicenter, open-label, phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced/metastatic solid tumors; I
  • 2020-0902; A Phase 1 Study of SGN-B6A in Advanced Solid Tumors.; I
  • 2022-0234; A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors.; I
  • 2024-0757; "A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors"; I
  • 2024-0769; A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2.; I
  • 2022-0291; A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors; I
  • 2023-0622; An Open-Label, Phase 1B Study of SL-172154 (SIRPα-Fc-CD40L) Administered With Pegylated Liposomal Doxorubicin or Paclitaxel to Subjects With Platinum-Resistant Gynecological Cancers; I
  • 2025-0789; A PHASE 1, OPEN-LABEL DOSE ESCALATION AND EXPANSION STUDY OF SNV1521 IN PARTICIPANTS WITH ADVANCED SOLID TUMORS; I
  • 2024-0851; A Phase 1b/2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression; I
  • 2024-0066; Phase I/II dose expansion study for an EGFRxCD28 costimulatory bispecific antibody in combination with cemiplimab in patients with advanced solid tumors; I
  • 2022-0634; A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor alpha (FolRα) Antibody Drug Conjugate (ADC), in Combination with Bevacizumab in Patients with Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers).; I
  • 2024-0193; First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor; I
  • 2024-0315; First-In-Human Study of STX-721 In Participants With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations; I
  • 2023-1115; An open-label, phase I/II study of T3P-Y058-739, a genetically-modified strain of the bacterium Yersinia enterocolitica, in patients with advanced solid tumors.; I
  • 2023-0319; AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPENLABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER: SUB-STUDY A-C4891006 (ARV-471 IN COMBINATION WITH ABEMACICLIB) and SUB-STUDY B- C4891023 (ARV-471 IN COMBINATION WITH RIBOCICLIB); I
  • 2024-0270; Phase 1b/2 TACTIVE-U (Umbrella) study to evaluate the safety, efficacy and PK of ARV-471 in combination with other anti-cancer therapies in participants with ER+ Advanced or Metastatic Breast Cancer.; I
  • 2024-0470; A Phase 1/2, Firstin-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer; I
  • 2024-0862; An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study; I
  • 2025-0866; Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects with Advanced Solid Tumors; I
  • 2023-0823; An open-label, multicenter Phase 1/2 dose escalation and expansion study of THOR-707 as a single agent and as a combination therapy in adult subjects with advanced or metastatic solid tumors; I
  • 2023-0759; First-in-human, open-label, multicenter, dose escalation and expansion study for the evaluation of the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activities of SAR445877 administered intravenously as a single agent and in combination with atezolizumab in adult participants with advanced unresectable or metastatic solid tumors.; I
  • 2025-0705; A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor activity of TH9619 in Subjects with advanced solid tumors; I
  • 2024-0772; A phase 2, Multicenter Study of TILs Treatment in Advanced Tumors with Alterations in the SWI/SNF Complex: the TILTS Study.; II
  • 2023-0279; A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors; I
  • 2024-0335; “A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor, TOS-358, in Adult Subjects with Select Solid Tumors”; I
  • 2023-1167; “Estudio de fase Ib/II, no aleatorizado, no comparativo, de dos cohortes de niraparib y dostarlimab más (quimio)radioterapia en carcinoma de células escamosas de cabeza y cuello localmente avanzado (RADIAN)”; I
  • 2023-1169; A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects with Advanced Solid Tumors; I
  • 2025-0410; Sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma with KRAS p.G12C mutation; I
  • 2023-0508; "A Multicenter, Open-Label Phase 1/2 Study of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors with Activating FGFR3 Gene Alterations"; I
  • 2024-0864; “A Phase 2, Multicenter, Multicohort, OpenLabel, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors (HERTHENA-PanTumor01"; I
  • 2020-0146; A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF U3-1402 IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER.; I
  • 2018-0467; Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours.; I
  • 2021-0821; A Phase I study to assess the safety and tolerability of ex vivo neoantigen-selected Tumor-infiltrating Lymphocytes (TILs) in advanced epithelial tumors and refractory melanoma.; I
  • 2022-0482; PHASE IB STUDY WITH A SAFETY LEAD-IN COHORT AND EXPANSION PHASE, OF THE SAFETY, TOLERABILITY, BIOLOGICAL EFFECT AND EFFICACY OF ALLOGENIC NATURAL KILLER CELLS IN COMBINATION WITH TRASTUZUMAB AND PERTUZUMAB IN ADULT PATIENTS WITH REFRACTORY METASTATIC HER2 POS BREAST CANCER.; I
  • VHIO-0022; “Phase II randomized study evaluating a Pragmatic approach to Adoptive Cell Therapy (ACT) using an IL2 analog (ANV419) vs High dose IL2 after Tumor Infiltrating Lymphocytes (TIL) Therapy in patients with melanoma, NSCLC and cervical cancer”; I
  • 2023-0957; "A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)"; I
  • 2022-0947; A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic HER2-Expressing Cancers.; I
  • 2024-0953; A first-in-human, open label, multicenter study of the NRF2 antagonist VVD-130037 in adult patients with advanced solid tumors; I
  • 2024-1151; A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of VVD-130850 as Single Agent and in Combination with Checkpoint Inhibition in Participants with Advanced Solid and Hematologic Tumors; I
  • 2019-0383; A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC).; I
  • 2021-0554; A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC).; I
  • 2022-0225; A PHASE IA/B OPEN-LABEL STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7276389 ALONE AND IN COMBINATION WITH COBIMETINIB IN PARTICIPANTS WITH BRAF-V600 MUTATION-POSITIVE ADVANCED SOLID TUMOR OR BRAF-V600 MUTATION-POSITIVE MELANOMA WITH CENTRAL NERVOUS SYSTEM METASTASES; I
  • 2023-0511; A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors; I
  • 2024-0649; A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer; I
  • 2023-0851; A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy with Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Advanced Solid Tumor Malignancies.; I
  • 2024-0976; An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer; I
  • 2024-0627; Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors with or without brain metastases.; I

Group Leader Ana Oaknin (until end December), Lorena Fariñas-Madrid (since end December) Clinical Investigators and Medical Oncologists Carmen García Durán, David Garcia-Illescas, Irene Giannubilo, Roberta Mazzeo

Research Groups

Gynecological Malignancies Group

Summary

VHIO’s Gynecologic Cancer Group is dedicated to advancing clinical and translational research across the full spectrum of gynecologic malignancies. As part of VHIO’s highly integrated and internationally recognized research ecosystem, the group focuses on the development and clinical implementation of innovative therapeutic strategies aimed at improving outcomes for women with these cancers.

Through active leadership and participation in major international clinical trials, the team has contributed to the development of therapies that are now part of the standard of care in several gynecologic tumors. A particular emphasis is placed on expanding treatment options for metastatic cervical cancer, including immunotherapy-based approaches that are reshaping the therapeutic landscape.

The group’s research spans ovarian, endometrial, cervical, vulvar, and vaginal cancers, with a strong focus on next-generation targeted therapies. Among these, antibody–drug conjugates (ADCs) represent a key area of innovation, alongside other precision treatment strategies designed to enhance efficacy while minimizing toxicity. By combining clinical excellence with translational insight, the team continues to bring novel, practice-changing therapies to patients.

  • Determine the best treatment approaches against advanced gynecologic malignancies through optimally designed international clinical trials.
  • Contribute to early clinical drug development in gynecologic cancers through bridging our translational research efforts with innovative clinical interventions.
  • Develop and advance novel ADCs for the treatment of endometrial cancer and cervical cancer.
  • Apply cellular therapy to patients with metastatic cervical cancer through VHIO’s Advanced Therapy Program of tumor infiltrating lymphocytes (TILs).
  • Consolidate our position as a reference site for clinical research in gynecologic malignancies.
  • Continue to be a referral center for patients who seek to participate in our clinical studies.

Our group continues to lead other clinical trials toward defining next generation treatment regimens:

  • Leadership in next-generation clinical trials, contributing to the definition of innovative treatment regimens and generating data that impact international clinical practice.
  • Strong commitment to clinical research, accelerating patient access to cutting-edge therapies through active participation in high-impact studies.
  • Innovation in targeted therapies, including leadership in the development and evaluation of antibody–drug conjugates (ADCs) and other precision treatment strategies.
  • Advancement of immunotherapy approaches, particularly for difficult-to-treat and metastatic gynecologic cancers such as cervical cancer.
  • Comprehensive research across gynecologic malignancies, spanning ovarian, endometrial, cervical, vulvar, and rare tumors, with a focus on translating tumor biology into personalized treatments.
  • Integrated translational and multidisciplinary approach, fostering close collaboration between clinicians, molecular biologists, and translational researchers to rapidly move laboratory discoveries into clinical application.
  • Active international collaboration, partnering with global institutions to accelerate innovation and improve outcomes for women with gynecologic cancers.
  • Develop and advance novel antibody drug conjugates (ADCs) for the treatment of gynaecological tumors.
  • Consolidate our position as a reference site for clinical research in gynecologic malignancies.
  • Continue to be a referral center for patients who seek to participate in our clinical studies.
  • Dienstmann R, Vivancos A, Nuciforo P, Aguilar S, Ruiz-Pace F, Viaplana C, Gonzalez J, Fite B, Pedrola A, Elez E, Saura C, Felip E, Macarulla T, Capdevila J, Fariñas-Madrid L, Carles J, Mateo J, Muñoz-Cosuelo E, Balmaña J, Braña I, Garralda E, Tabernero J. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO Open. 2025 Nov;10(11):105888.
  • Bhatia S, Topalian SL, Sharfman W, Meyer T, Steven N, Lao CD, Fariñas-Madrid L, Devriese LA, Moore K, Ferris RL, Honma Y, Elias I, Srirangam A, Garnett-Benson C, Lee M, Nghiem P. Nivolumab With or Without Ipilimumab in Patients With Recurrent or Metastatic Merkel Cell Carcinoma: A Nonrandomized, Open-Label, International, Multicenter Phase I/II Study. J Clin Oncol. 2025 Mar 20;43(9):1137-1147.
  • Ramírez SP, Fidalgo AP, Ginesta MPB, De Juan Ferré A, Madrid LF, Martínez AG, Montosa FG, Madariaga A, Gómez TM, Gil-Martin M. SEOM-GEICO clinical guidelines on endometrial cancer (2025). Clin Transl Oncol. 2025 Dec;27(12):4368-4380.
  • Gallego A, Madariaga A, Estévez-García P, Albertí F, Carbó A, Palacio I, Churruca C, Gálvez F, Ortega ME, Murata P, Manzano A, Masvidal M, Martín-Lorente C, Hernando B, Lozano I, Cueva JF, García-Illescas D, Gost E, Mendiola M, Redondo A. An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study). Int J Gynecol Cancer. 2025 Jul;35(7):101903.
  1. Grantor: Grupo Español de Investigación en Cáncer de Ovario (GEICO) Project title: Incidencia de mutaciones BRCA somáticas y germinales en la cohorte amplia de pacientes procedentes de hospitales españoles con cáncer de ovario epitelial no mucinoso con validación de técnica somática entre laboratorios (BORNEO) Duration: 11/12/2017 – 31/12/2025 PI: Ana Oaknin
  2. Grantor: AstraZeneca Farmacéutica Spain, S.A. Project title: Non‐ Randomized, Open‐Label, Prospective Phase II Trial to Better Characterize the Status of HRD leading to a Benefit from Olaparib in Combination with Bevacizumab in Patients with Advanced FIGO Stage III‐ IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer After Standard First‐ Line Treatment” Duration: 14/10/2022 – 31/12/2027 PI: Ana Oaknin
  3. Grantor: Ministerio de Ciencia e Innovación Project title: Overcoming Resistant tumors using CCR9-focused ADCs Duration: 30/09/2024 – 29/09/2027 PI: Ana Oaknin
  4. Grantor: FSEOM (Fundación Española de Oncología Médica) Project title: Alteración del ciclo celular como mecanismo de resistencia a los inhibidores de PARP en el cáncer de ovario de alto grado avanzado con deficiencia en la recombinación homóloga: Una investigación basada en biopsia líquida. Duration: 01/10/2024 – 30/09/2026 PI: Ana Oaknin 
  5. Grantor: FERO Project title: Papel del gen SMARCA4 en el carcinoma de células pequeñas de ovario del tipo hipercalcémico y su potencial como diana terapéutica. Duration: 01/06/2018 – 31/12/2025 PI: Ana Oaknin
  1. Dienstmann R, Vivancos A, Nuciforo P, Aguilar S, Ruiz-Pace F, Viaplana C, Gonzalez J, Fite B, Pedrola A, Elez E, Saura C, Felip E, Macarulla T, Capdevila J, Fariñas-Madrid L, Carles J, Mateo J, Muñoz-Cosuelo E, Balmaña J, Braña I, Garralda E, Tabernero J. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO Open. 2025 Nov;10(11):105888. doi: 10.1016/j.esmoop.2025.105888. Epub 2025 Nov 6.
  2. Bhatia S, Topalian SL, Sharfman W, Meyer T, Steven N, Lao CD, Fariñas-Madrid L, Devriese LA, Moore K, Ferris RL, Honma Y, Elias I, Srirangam A, Garnett-Benson C, Lee M, Nghiem P. Nivolumab With or Without Ipilimumab in Patients With Recurrent or Metastatic Merkel Cell Carcinoma: A Nonrandomized, Open-Label, International, Multicenter Phase I/II Study. J Clin Oncol. 2025 Mar 20;43(9):1137-1147. doi: 10.1200/JCO-24-02138. Epub 2025 Jan 31.
  3. Ramírez SP, Fidalgo AP, Ginesta MPB, De Juan Ferré A, Madrid LF, Martínez AG, Montosa FG, Madariaga A, Gómez TM, Gil-Martin M. SEOM-GEICO clinical guidelines on endometrial cancer (2025). Clin Transl Oncol. 2025 Dec;27(12):4368-4380. doi: 10.1007/s12094-025-04046-1. Epub 2025 Sep 23.
  4. Gallego A, Madariaga A, Estévez-García P, Albertí F, Carbó A, Palacio I, Churruca C, Gálvez F, Ortega ME, Murata P, Manzano A, Masvidal M, Martín-Lorente C, Hernando B, Lozano I, Cueva JF, García-Illescas D, Gost E, Mendiola M, Redondo A. An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study). Int J Gynecol Cancer. 2025 Jul;35(7):101903. doi: 10.1016/j.ijgc.2025.101903. Epub 2025 Apr 26.
  5. Gallego A, Madariaga A, Estévez-García P, Albertí F, Carbó A, Palacio I, Churruca C, Gálvez F, Ortega ME, Murata P, Manzano A, Masvidal M, Martín-Lorente C, Hernando B, Lozano I, Cueva JF, García-Illescas D, Gost E, Mendiola M, Redondo A. An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study). Int J Gynecol Cancer. 2025 Jul;35(7):101903. doi: 10.1016/j.ijgc.2025.101903. Epub 2025 Apr 26.
  6. Concin N, Matias-Guiu X, Cibula D, Colombo N, Creutzberg CL, Ledermann J, Mirza MR, Vergote I, Abu-Rustum NR, Bosse T, Chargari C, Espenel S, Fagotti A, Fotopoulou C, Gatius S, González-Martin A, Lax S, Levy B, Lorusso D, Macchia G, Marth C, Morice P, Oaknin A, Raspollini MR, Schwameis R, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Planchamp F, Nout RA. ESGO-ESTRO-ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol. 2025 Aug;26(8):e423-e435. doi: 10.1016/S1470-2045(25)00167-6. Erratum in: Lancet Oncol. 2025 Oct;26(10):e522. doi: 10.1016/S1470-2045(25)00560-1.
  7. Poveda A, Lheureux S, Colombo N, Cibula D, Elstrand M, Weberpals J, Bjurberg M, Oaknin A, Sikorska M, González-Martín A, Madry R, Rubio Pérez MJ, Ledermann J, Romero I, Özgören O, Barnicle A, Marshall H, Bashir Z, Škof E. Maintenance olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1 and/or BRCA2 mutation: Final overall survival results from the OPINION trial. Gynecol Oncol. 2025 Jun;197:74-82. doi: 10.1016/j.ygyno.2025.04.580. Epub 2025 Apr 28.
  8. Lorusso D, Oaknin A, Borges GS, Damian F, Ottevanger N, Van Gorp T, Paiva CE, Kroep JR, Kim YM, Kim HS, Lee JK, Denys H, Lalisang R, De Melo AC, Redondo A, Reyners AKL, Mora P, Closset C, Melief CJM, Hooftman L, Jamil S, Boersma L, Yoo SY, Seebach F, Lowy I, Fury MG, Mathias M, Colombo N. Cemiplimab plus peltopepimut-S vaccine in recurrent cervical cancer: A phase 2 clinical trial. Gynecol Oncol. 2025 May;196:28-35. doi: 10.1016/j.ygyno.2025.03.019. Epub 2025 Mar 27.
  9. Harter P, Marmé F, Redondo A, Reuss A, Lindemann K, Kurzeder C, Van Nieuwenhuysen E, Marth C, Pietzner K, Ray-Coquard I, Garcia-Duran C, Jonuskiene G, Heitz F, Béllier C, Pérez-Fidalgo JA, El-Balat A, Selle F, Romero I, Wimberger P, Follana P, Pardo B, de Gregorio N, Joly F, Gaba L, Burges A, Fabbro M, Hasenburg A, Fehm T, Schmalfeldt B, Pautier P. Atezolizumab With Bevacizumab and Nonplatinum Chemotherapy for Recurrent Ovarian Cancer: Final Results From the Placebo-Controlled AGO-OVAR 2.29/ENGOT-ov34 Phase III Trial. J Clin Oncol. 2026 Jan 10;44(2):103-116. doi: 10.1200/JCO-25-01210. Epub 2025 Dec 3.
  10. Oaknin A, Lee JY, Makker V, Oh DY, Banerjee S, González-Martín A, Jung KH, Ługowska I, Manso L, Manzano A, Melichar B, Siena S, Stroyakovskiy D, Fielding A, Puvvada S, Smith A, Meric-Bernstam F. Summary of Research: Efficacy of Trastuzumab Deruxtecan in HER2-Expressing Solid Tumors by Enrollment HER2 IHC Status: Post Hoc Analysis of DESTINY-PanTumor02. Adv Ther. 2025 May;42(5):2015-2018. doi: 10.1007/s12325-024-03080-9. Epub 2025 Mar 6.
  11. Liu JF, Colombo N, Oza AM, Frenel JS, Corr BR, Rubinstein MM, Nevadunsky NS, Lheureux S, Gaba L, González Cortijo L, Salutari V, You B, Chiang S, O'Connor MJ, Oplustil O'Connor L, Meulendijks D, Khatun M, Ghiorghiu D, Oaknin A. ADAGIO: A Phase IIb, Open-Label, Single-Arm, Multicenter Study Assessing the Efficacy and Safety of Adavosertib (AZD1775) as Treatment for Recurrent or Persistent Uterine Serous Carcinoma. J Clin Oncol. 2025 Sep 10;43(26):2897-2907. doi: 10.1200/JCO-24-01606. Epub 2025 Apr 22.
  12. Bosch-Barrera J, Estévez-García P, Martín-Martorell P, Sabatier R, Nadal E, Sais E, Gascón P, Oaknin A, Rodon J, Lizcano JM, Muñoz-Guardiola P, Fierro-Durán G, Pedrós-Gámez O, Pérez-Montoyo H, Yeste-Velasco M, Cortal M, Pérez-Campos A, Alfón J, Domènech C, Morán T. ENDOLUNG trial, part II. A phase II study of the Akt/mTOR inhibitor and autophagy inducer ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with squamous non-small cell lung cancer. Lung Cancer. 2025 Mar;201:108105. doi: 10.1016/j.lungcan.2025.108105. Epub 2025 Feb 7.
  13. Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer: a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201. Future Oncol. 2025 Dec;21(30):3859-3871. doi: 10.1080/14796694.2025.2595130. Epub 2025 Dec 12.
  14. Villacampa G, Eminowicz G, Navarro V, Carità L, García-Illescas D, Oaknin A, Pérez-Fidalgo JA. Immunotherapy and PARP inhibitors as first-line treatment in endometrial cancer: A systematic review and network meta-analysis. Eur J Cancer. 2025 May 2;220:115329. doi: 10.1016/j.ejca.2025.115329. Epub 2025 Feb 26.
  15. Takekuma M, Nishio S, Yamaguchi S, Yunokawa M, Nishio H, Nishino K, Kurosaki A, Minobe S, Villacampa G, Oaknin A, Okamoto A. Atezolizumab, bevacizumab, and platinum chemotherapy in cervical cancer: results of Japanese population from BEATcc. J Gynecol Oncol. 2025 Nov;36(6):e116. doi: 10.3802/jgo.2025.36.e116. Epub 2025 May 19.
  16. Eskander RN, Lee JY, Mirza MR, Lorusso D, MacKay H, Ray-Coquard I, Oaknin A, Gonzalez-Martin A, Hasegawa K, Corr BR, Wu X, Leary A, Hu T, Dutta L, Okpara CE, McKenzie J, Makker V. Randomized study evaluating optimal dose, efficacy, and safety of E7386 plus lenvatinib versus treatment of physician's choice in advanced/recurrent endometrial carcinoma previously treated with platinum-based chemotherapy and immune checkpoint inhibitors. Int J Gynecol Cancer. 2025 Sep;35(9):101812. doi: 10.1016/j.ijgc.2025.101812. Epub 2025 Apr 5.
  17. Wu Z, Hu Z, Li Q, Liu G, Oaknin A, Grau Bejar JF, Mills GB, Ma D, Sun C, Chen G. Molecular and clinical insights into early-onset endometrial cancer. Trends Cancer. 2025 Jun;11(6):503-519. doi: 10.1016/j.trecan.2025.03.002. Epub 2025 Mar 25.
  18. Grisham R, Monk BJ, Van Nieuwenhuysen E, Moore KN, Fabbro M, O'Malley DM, Oaknin A, Thaker P, Oza AM, Colombo N, Gershenson D, Aghajanian CA, Choi CH, Lee YC, Mirza MR, Coleman RL, Cobb L, Harter P, Lustgarten S, Youssoufian H, Banerjee S. GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301: a phase 3, randomized trial evaluating avutometinib plus defactinib compared with investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer. Int J Gynecol Cancer. 2025 Nov;35(11):101832. doi: 10.1136/ijgc-2024-005919. Epub 2025 Apr 19.
  19. Grussu F, Grigoriou A, Bernatowicz K, Palombo M, Casanova-Salas I, Navarro-Garcia D, Barba I, Simonetti S, Serna G, Macarro C, Voronova AK, Garay V, Corral JF, Vidorreta M, García-Polo García P, Merino X, Mast R, Rosón N, Escobar M, Vieito M, Toledo R, Nuciforo P, Mateo J, Garralda E, Perez-Lopez R. Clinically feasible liver tumour cell size measurement through histology-informed in vivo diffusion MRI. Commun Med (Lond). 2025 Nov 20;5(1):535. doi: 10.1038/s43856-025-01246-2.
  20. Oaknin A, Monk BJ, de Melo AC, Kim HS, Kim YM, Lisyanskaya AS, Samouëlian V, Lorusso D, Damian F, Chang CL, Gotovkin E, Takahashi S, Ramone D, Maćkowiak-Matejczyk B, Polastro L, Alia EMG, Colombo N, Makarova Y, Goh JC, Hasegawa K, Mora P, Pikiel J, Srivastav R, Rischin D, Rubio MJ, Perez J, Yoo SY, Gao B, Jamil S, Seebach F, Lowy I, Mathias M, Fury MG, Tewari KS. Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial. Eur J Cancer. 2025 Feb 5;216:115146. doi: 10.1016/j.ejca.2024.115146. Epub 2025 Jan 10.
  21. Tahara M, Greil R, Rischin D, Harrington KJ, Burtness B, de Castro G, Psyrri A, Braña I, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesía R, Ngamphaiboon N, Rordorf T, Ishak WZW, Lin J, Gumuscu B, Lerman N, Soulières D. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study. Eur J Cancer. 2025 May 15;221:115395. doi: 10.1016/j.ejca.2025.115395. Epub 2025 Apr 4.
  22. Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. J Clin Oncol. 2025 Sep;43(25):2782-2792. doi: 10.1200/JCO-25-00112. Epub 2025 Jul 11. Erratum in: J Clin Oncol. 2025 Nov 10;43(32):3547. doi: 10.1200/JCO-25-02377.
  23. Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N, McCollum ME, Diakos C, Clamp A, Leiser AL, Balázs B, Monk BJ, Scandurra G, McClung E, Kaczmarek E, Slomovitz B, De La Cueva H, de Carvalho Calabrich AF, Cassani C, You B, Van Gorp T, Churruca C, Caruso G, Nicum S, Bagaméri A, Artioli G, Bodnar L, Kang S, Vergote I, Kesner-Hays A, Pashova HI, Pai SG, Tudor IC, Jubb AM, Lorusso D. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025 Jun 21;405(10496):2205-2216. doi: 10.1016/S0140-6736(25)01040-2. Epub 2025 Jun 2.
  24. Oza AM, Lisyanskaya A, Fedenko A, de Melo AC, Shparyk Y, Rakhmatullina I, Bondarenko I, Colombo N, Svintsitskiy V, Biela L, Nechaeva M, Lorusso D, Scambia G, Cibula D, Póka R, Oaknin A, Safra T, Mackowiak-Matejczyk B, Ma L, Thomas D, Lin KK, McLachlan K, Goble S, Kristeleit R. Rucaparib versus chemotherapy for treatment of relapsed ovarian cancer with deleterious BRCA1 or BRCA2 mutation (ARIEL4): final results of an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Feb;26(2):249-264. doi: 10.1016/S1470-2045(24)00674-0.
  25. Eskander RN, Lee JY, Mirza MR, Lorusso D, MacKay H, Ray-Coquard I, Oaknin A, Gonzalez-Martin A, Hasegawa K, Corr BR, Wu X, Leary A, Hu T, Dutta L, Okpara CE, McKenzie J, Makker V. Randomized study evaluating optimal dose, efficacy, and safety of E7386 plus lenvatinib versus treatment of physician's choice in advanced/recurrent endometrial carcinoma previously treated with platinum-based chemotherapy and immune checkpoint inhibitors. Int J Gynecol Cancer. 2025 Sep;35(9):101812. doi: 10.1016/j.ijgc.2025.101812. Epub 2025 Apr 5.
  26. Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N, McCollum ME, Diakos C, Clamp A, Leiser AL, Balázs B, Monk BJ, Scandurra G, McClung E, Kaczmarek E, Slomovitz B, De La Cueva H, de Carvalho Calabrich AF, Cassani C, You B, Van Gorp T, Churruca C, Caruso G, Nicum S, Bagaméri A, Artioli G, Bodnar L, Kang S, Vergote I, Kesner-Hays A, Pashova HI, Pai SG, Tudor IC, Jubb AM, Lorusso D. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025 Jun 21;405(10496):2205-2216. doi: 10.1016/S0140-6736(25)01040-2. Epub 2025 Jun 2.
  • 2025-0619; "A Phase 2 Study of Relacorilant in Combination with Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (BELLA)"; II
  • 2025-0436; A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women with High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy; III
  • 2025-0289; “Estudio de fase IIIb para evaluar el uso de durvalumab en combinación con quimioterapia basada en platino seguido de durvalumab con olaparib como tratamiento de primera línea en pacientes con cáncer de endometrio avanzado de nuevo diagnóstico o recurrente con estado de MMR competente en España”; III
  • 2025-0958; A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy as First line Maintenance Therapy in HER2 Expressing Ovarian Cancer; III
  • 2025-0409; An Open-Label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors (EXPANSION COHORT ONLY); II
  • 2023-0153; Non‐Randomized, Open‐Label, Prospective Phase II Trial to Better Characterize the Status of HRD leading to a Benefit from Olaparib in Combination with Bevacizumab in Patients with Advanced FIGO Stage III‐IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer After Standard First‐Line Treatment; II
  • 2023-0914; Randomized, multicenter, open-label, phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second line platinum-based chemotherapy plus bevacizumab; III
  • 2024-1145; A randomized Phase 2 study of ocular toxicity evalutation and mitigation during treatment wiht Mirvetuximab Soravtansine in patients with recurrent ovarian cancer with high Folate Receptor-Alpha Expression; II
  • 2025-0595; A randomized Phase 2, open-label study of mirvetuximab soravtansine in patients with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression testing 2 schedules of administration for dose optimization, with a separate cohort to determine starting dose in patients with moderate hepatic impairment.; II
  • 2024-0673; "Phase II study to assess the efficacy of niraparib rechallenge treatment after surgery in ovarian cancer patients with oligometastatic progression"; II
  • 2023-1181; " A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to ompare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy"; III
  • 2024-0801; A Phase 3 Randomized, Active-Controlled, Open-Label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-Line or Third-Line Treatment for Participants with Recurrent or Metastatic Cervical Cancer; III
  • 2025-0242; A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of MK-2870 Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer; III
  • 2025-0665; Phase 3 Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumutecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer; III
  • 2023-0567; A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202 a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types.; II
  • 2024-1092; An open-label, multicenter, randomized Phase 2 study of the ATR inhibitor M1774 in combination with other DNA damage response inhibitors in participants with BRCA mutant and/or homologous recombination deficiency (HRD)-positive epithelial ovarian cancer that progressed on prior PARP inhibitor therapy; II
  • 2023-187-1; TUBectomy with delayed oophorectomy as Alternative for risk-reducing salpingo-oophorectomy in high-risk Women to assess the Safety of Prevention; IV
  • 2024-0715; Un estudio abierto, aleatorizado en fase III del tratamiento combinado con avutometinib más defactinib frente al tratamiento elegido por el investigador en pacientes con cáncer de ovario seroso de bajo grado (COSBG) recurrente (RAMP 301); III
  • 2023-0645; A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53 WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA; III
  • 2024-1195; A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN‑c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations.; II

Group Leader Cristina Saura Medical Oncologists Miriam Arumi, Judith Balmaña, Meritxell Bellet, Maria Borrell, Santiago Escrivá, Nàdia Gómez, Patricia Gómez, Mafalda Oliveira, Isabel Pimentel, Alejandra Rezqallah, Angélica Rodriguez, Esther Zamora Clinical Nurses Ana Baizán, Anna Martinez, Verónica Rodriguez, Anna Suñol, Sandra Vidal PhD-track Clinical and Research Fellows Vittoria Barberi, Mariangela Gaudio, Marta Perachino

Research Groups

Breast Cancer Group

Summary

Led by Cristina Saura, VHIO’s Breast Cancer Group integrates clinical and translational research focused on accelerating the development of innovative therapies across all major breast cancer subtypes. Through playing leading roles in national and international clinical trials and maintaining high patient recruitment, the group generates translational insights that inform drug development and optimize treatment strategies.

In HER2-positive disease, the group actively participates in major trials evaluating novel therapies and combinations, including antibody-drug conjugates, tyrosine kinase inhibitors, and cell therapy approaches. A major milestone has been the approval of a phase I clinical trial evaluating the in-house developed p95HER2-directed CAR T-cell therapy (p95HER2.CAR-TECH2Me), with recruitment scheduled to begin in 2026. These advances in systemic treatments are improving cure rates and survival rates in metastatic and early-stage disease.

In luminal disease we investigate resistance mechanisms and strategies to resensitize tumors to endocrine therapy and targeted agents using rationale-based combinations. Ongoing research integrates novel PI3K and AKT inhibitors, CDK4/6 inhibitors, selective estrogen receptor degraders (SERDs), and PARP inhibitors, alongside emerging spatial transcriptomics approaches and prospective blood collection to monitor minimal residual disease and refine adjuvant treatment decisions.

In triple-negative disease, clinical trials evaluating immunotherapy combinations and ADCs are complemented by our integrative multi-omics platform aimed at identifying predictive biomarkers of response and toxicity to chemotherapy and immune checkpoint inhibitors (ICIs) in early TNBC. To date, more than 100 patients have been enrolled, with initial results anticipated in 2026. In addition, we collaborate with VHIO’s Tumor Immunology and Immunotherapy Group on the development of personalized T-cell therapies.

A major cross-cutting priority is the advancement of circulating tumor DNA (ctDNA) technologies. In partnership with VHIO's Cancer Genomics Group, we lead multiple projects to advance ctDNA detection in early disease, including unexplored body fluids like breast milk as a source of tumor-derived biomarkers and the integration of DNA methylation profiling to improve postpartum breast cancer detection. Additionally, we continue screening metastatic patients for actionable molecular alterations, ensuring access to matched clinical trials and personalized treatment options.

  • Optimize therapies by introducing novel anti-cancer treatments and adding rational combinations to overcome mechanisms of resistance.
  • Implement platforms enabling proteomics, genomics, and ctDNA analysis to advance insights into tumor biology.
  • Apply preclinical and predictive data to help guide innovative clinical trial design in early and advanced disease.
  • Thanks to the leadership of our investigators, we continue to contribute to the approval of new therapies for breast cancer patients with early and advanced disease. We are currently involved in the development of some of the most promising therapies in breast cancer with several immune-oncology combinations, targeted therapies, cell therapies, new immunotherapies and antibody drug conjugates under development that will lead to new approvals in the near future.
  • Leveraging our collaboration with VHIO’s Molecular Prescreening Program, supported by Fundación FERO’s Institutional Advanced Molecular Diagnostics Program – DIAMAV, we continue to identify potentially matched patients with specific molecular alterations as an enrichment strategy for clinical trials in breast cancer with agents targeting PI3KCA, ESR1 or HER2 mutations.
  • VHIO’s proteomics and ctDNA platforms have also helped us to advance insights into tumor biology. Promising results in the detection of ctDNA in breast milk have led us to embark in the development of a test that has potential in the early diagnosis of breast cancer in the postpartum period.
  • Strong community engagement and philanthropic support in 2025, with multiple solidarity initiatives led by individuals, companies, and patient associations raising funds in support of the Breast Cancer Group. These contributions, including charity runs, sports tournaments, awareness campaigns, and corporate donations, underscore sustained societal commitment to advancing breast cancer research at VHIO.
  • Cortés J, Punie K, Barrios C, Hurvitz SA, Schneeweiss A, Sohn J, Tokunaga E, Brufsky A, Park YH, Xu B, Hegg R, Oliveira M, Fabi A, Vaksman N, Valdez T, Zhang X, Lai C, Tolaney SM; ASCENT-03 Clinical Trial Investigators. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025 Nov 13;393(19):1912-1925.
  • Tolaney SM, Jiang Z, Zhang Q, Barroso-Sousa R, Park YH, Rimawi MF, Saura C, Schneeweiss A, Toi M, Chae YS, Kemal Y, Chaudhari M, Şendur MAN, Yamashita T, Casalnuovo M, Danso MA, Liu J, Shetty J, Herbolsheimer P, Loibl S; DESTINY-Breast09 Trial Investigators. Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2025 Oct 29. doi: 10.1056/NEJMoa2508668.
  • Perachino M, Blondeaux E, Delucchi V, Bernstein Molho R, Frank S, Paluch-Shimon S, Linn S, Di Meglio A, Peccatori F, Moore HCF, Parokonnaya A, Renaud T, Rodriguez Wallberg KA, Partridge AH, Pogoda K, Ferrari A, Wildiers H, Toss A, Rousset-Jablonski C, Kim HJ, Varela M, Cordoba O, Tanase Damian C, Marhold M, Fabi A, Graff SL, Rodriguez-Hernandez A, Okano M, Duchnowska R, Luna Pais H, Di Rocco R, Azim HA Jr, Mariamidze E, Kourie HR, Arecco L, Carrasco E, Agostinetto E, Balmana J, Saura C, Lambertini M. Safety of having a subsequent pregnancy after prior diagnosis of breast cancer during pregnancy in young BRCA carriers. ESMO Open. 2025 Aug;10(8):105513. doi: 10.1016/j.esmoop.2025.105513.
  • Escrivá-de-Romani S, Cejalvo JM, Alba E, Friedmann J, Rodríguez-Lescure Á, Savard MF, Pezo RC, Gion M, Ruiz-Borrego M, Hamilton E, Pluard T, Webster M, Beeram M, Linden H, Saura C, Shpektor D, Salim B, Harvey P, Hurvitz SA. Zanidatamab plus palbociclib and fulvestrant in previously treated patients with hormone receptor-positive, HER2-positive metastatic breast cancer: primary results from a two-part, multicentre, single-arm, phase 2a study. Lancet Oncol. 2025 Jun;26(6):745-758.

Competitive funding:

  1. Collaboration between Karolinska Institutet and Vall d’Hebron Institute of Oncology: Development of new tumour response markers – proteomics.
  2. Estudio prospectivo observacional multicéntrico para la evaluación del impacto en la decisión clínica de realizar el test HER2DX® en pacientes con cáncer de mama HER2 positivo.
  3. INveStigation of PIK3CA mutaTIONs in healthy breast tissue (INSP3KTION study).
  4. Uso de clasificadores de Machine Learning para la evaluación seriada de marcadores sistémicos de inflamación en pacientes de cáncer de mama (INFLAMMATE).
  5. Toxicitat cardiovascular en el càncer de mama HER 2-positiu precoç: desde l'avaluació del risc fins a la prevenció.
  6. STEPS (Soporte TErapeutico Para Supervivientes)Grupo de Psicoterapia Positiva después del tratamiento de cáncer de mama en tiempos de COVID-19: Eficacia, Viabilidad y Mantenimiento.
  7. Predictive spatial transcriptomics to identify minimal residual disease in ER+ HER2- breast cancer.
  8. Analysis of CDK 4/6 inhibitors + Endocrine therapy outcomes as first line therapy in patients carriers of a germline pathogenic variant in an HRR-related gene and diagnosed with Metastatic Breast Cancer.
  9. Identificación de perfiles metabólicos de riesgo para desarrollar diabetes tipo 2 mediante el studio metabolónico del suero de pacientes que dessarrollan diabetes por inhibición de la vía de señalización de la insulina fosfoinositol 3 quinasa (PI3K).
  10. Clinical and molecular characterization of oligometastatic breast cancer: Revealing and improving the potential benefit of a local treatment on primary or metastatic sites. A multicentric study.
  11. Metastatic cells alter systemic fatty acid metabolism to weaken the anti-tumor immunity.
  12. Understanding CDK4/6i and SERD resistance in metastatic ER+ breast cancer using patient samples and PDXs.
  13. Interpretación del NIPT como marcador indirecto de cáncer de mama durante el embarazo.
  14. Synthetic Data Generation Framework For Integrated Validation Of Use Cases And AI Healthcare Applications (Synthia): Breast Cancer Use Cases.
  15. TRADBI NOVEL HER3 BISPECIFIC ANTIBODY DRUG CONJUGATES FOR THE TREATMENT OF AGRESSIVE TUMOURS.
  16. Targeting and Monitoring Non- genetic Cancer cell Plasticity in Triple-Negative Breast Cancer (TxDxPlasticTNBC).
  17. Re-defining prognosis for early breast cancer patients with Lobular histology.
  18. ADVANTAGE study: ADding ablatiVe therApies to first –liNE CDK4/6 inhibitors plus endocrine treatment in breast cancer patients with oligomeTastases. Any proGnostic bEnefit?
  19. Developing new therapeutic strategies to overcome CDK4/6 resistance in oestrogen receptor positive breast cancerDesarrollo de nuevas estrategias terapéuticas para contrarestar la resistencia a los inhibidores de CDK4/6 en cáncer de mama con expresión del receptor de estrógeno.
  20. SYNTHIA - Synthetic Data Generation Framework For Integrated Validation Of Use Cases And AI Healthcare Applications – Feasibility Study and Pilot Screening Phase.
  21. MINISTERIO DE CIENCIA E INNOVACIÓN.2025-2028. Ensayo clínico de fase Ia/Ib de ONA-255, un ADC firstin-class para pacientes con cáncer de mama HR+HER2−refractario.
  22. Lymphocyte immunodynamics during neoadjuvant treatment in early triple negative breast cancer. FERO.2025-2027.
  23. ctDNA in Breast Milk for Early Detection of Pregnancy Associated Breast Cancer.
  24. 24.Detección del ctADN de la leche materna y análisis del metiloma para el diagnóstico precoz del cáncer de mama asociado alembarazo en poblaciones de alto riesgo: Meth-MMATERNA.
  1. Oliveira M, Ciruelos E, Villacampa G, Morales S, Salvador Bofill J, Quiroga V, Gavilá J, Cortegoso A, Vega E, Henao F, Servitja S, Tolosa P, Chillara S, Bergamino M, Salvador F, Paes Dias M, Ferrero-Cafiero JM, Gonzalez Farre X, Pascual T, Saura C. Addition of ipatasertib to dual anti-HER2 maintenance therapy in HER2-positive metastatic breast tumors with PIK3CA mutations: the phase 1b SOLTI-1507 IPATHER trial. Clin Cancer Res. 2025 Dec 1. doi: 10.1158/1078-0432.CCR-25-2298. Epub ahead of print. PMID: 41324568.
  2. Escudero A, Bellet M, Saura C, Aguilera A, Papakonstantinou A, Tolosa P, García-Sáenz JÁ, Moreno F, López de Sá A, Schettini F, Seguí E, Gonzalez-Rodriguez M, Navarro V, Ferrero-Cafiero JM, González X, Hernando C, Matikas A, Prat A, Oliveira M, Pascual T, Villacampa G. Endocrine-based strategies after CDK4/6 inhibitors in biomarker-selected subgroup of hormone receptor positive advanced breast cancer: A systematic review and network meta-analysis. Cancer Treat Rev. 2026 Jan;142:103063. doi: 10.1016/j.ctrv.2025.103063. Epub 2025 Dec 3. PMID: 41385990.
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  • 2020-0900 BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation. III
  • 2024-0647 Resultados del tratamiento con abemaciclib en la práctica clínica real en pacientes con cáncer de mama en estadios tempranos en España: estudio ABSIDE-S IV
  • 2024-1033 A randomized, controlled, open-label, phase-III trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high risk, HR+/HER2- early breast cancer III
  • 2025-1097 Estudio de fase II multicéntrico, abierto para evaluar la seguridad y la eficacia del tratamiento neoadyuvante con combinaciones de inavolisib en pacientes con cáncer de mama en estadio precoz con mutación PIK3CA, no tratado II
  • 2025-0394 An interventional, open-label, randomized, multicenter phase 3 study of PF-07220060 plus letrozole compared to CDK4/6 inhibitor plus letrozole in participants over 18 years with hormone receptor (HR)-positive, HER2-negative advanced/metastatic breast cancer who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease III
  • 2024-0894 Phase 2 Breast Cancer study and currently looking to identify qualified sites for this study to evaluate the biological activity of highly selective CDK4i (PF-07220060) plus letrozole and other anticancer treatments. II
  • 2024-0489-II AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER II
  • 2025-0930 "A Randomized, open-label, phase 3 study of BL-B01D1 (BMS-986507) versus treatment of physician's choice in patients with previously untreated, locally advanced, recurrent inoperable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for approved anti-PD1/PD-L1 with chemotherapy combination." III
  • 2023-1038 A PHASE III RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY. III
  • 2024-1192 "A Phase IIIB study to evaluate the use of capivasertib in combination with fulvestrant in patients with HR+ / HER2- advanced breast cancer who have relapsed/progressed on ET and CDK4/6 inhibitor reflecting Real World Clinical Practice in Spain." III
  • 2024-1153 A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer. III
  • 2024-1098 A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) in combination with Durvalumab compared with Pembrolizumab in combination with Investigator’s Choice of Chemotherapy (Paclitaxel/Nab-paclitaxel/Gemcitabine+Carboplatin) in Patients with PDL1 positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPIONBreast05) III
  • 2023-1035 A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Switching to AZD9833 (a Next Generation, Oral SERD) vs Continuing Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in patients with HR+/HER2- early breast cancer and an intermediate or high risk of recurrence who have completed definitive locoregional therapy and at least 2 years of adjuvant endocrine therapy without disease recurrence III
  • 2023-0904 A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as adjuvant treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease III
  • 2025-0566 A Multicentre, Open-Label Study Assessing Ophthalmic Safety of Camizestrant in ER+/HER2- Early Breast Cancer Patients Either Initiating Adjuvant Endocrine-Based Therapy (CAMBRIA-2) or Having Been Treated with Standard Adjuvant Endocrine-Based Therapy for At Least 2 Years (CAMBRIA-1). IV
  • 2024-0916 A Randomised, Open-Label, Phase III Study of AZD5305 Plus Camizestrant versus Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy for the First-Line Treatment of BRCA1, BRCA2 or PALB2- mutated Patients with Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer III
  • 2024-0590 An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer (ELECTRA) II
  • 2025-0500 A randomized, open-label, phase II trial comparing neoadjuvant endocrinetherapy in combination with trastuzumab, pertuzumab +/- the PI3K inhibitor inavolisib in patients with HER2-positive, HR-positive, PIK3CA mutant earlybreast cancer- GeparPiPPa II
  • 2024-0559 A retrospective, observational and multicenter study of treatment with Sacituzumab govitecan in patients with locally advanced and/or metastatic triplenegative breast cancer within routine clinical practice in Spain IV
  • 2019-0975 A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer. III
  • 2023-0518 A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence III
  • 2024-0887 A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment III
  • 2023-0830 PHASE II STUDY FOR PIK3CA/PTEN-ALTERED ADVANCED METAPLASTIC BREAST CANCER TREATED WITH MEN1611 MONOTHERAPY OR IN COMBINATION WITH ERIBULIN. II
  • 2025-0072 A randomized phase 3, double-blind, placebo-controlled study of elacestrant plus everolimus versus elacestrant in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced breast cancer progressing to endocrine therapy and CDK4/6 inhibitors III
  • 2024-0719 “Phase II Study of Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-Low Breast Cancer Presenting with Newly Diagnosed or Progressing Brain Metastases.” II
  • 2025-0241 Neoadjuvant phase II study of pembrolizumab and carboplatin plus paclitaxel for stage I triple-negative breast cancer. II
  • 2024-0615 “An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer” III
  • 2024-0643 MK-2870 Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR. Estudio de fase 3, aletorizado y abierto para comparar la eficacia y la seguridad de MK-2870 adyuvante en combinación con pembrolizumab (MK-3475) frente al tratamiento elegido por el médico (TEM) en participantes con cáncer de mama triple negativo (CMTN) que recibieron tratamiento neoadyuvante y no lograron una respuesta completa anatomopatológica (RCap) en la cirugía III
  • 2024-1002 A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK4/6 INHIBITOR THERAPY (OPERA-01) III
  • 2025-0451 "A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER" II
  • 2024-0293 "An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation" III
  • 2019-0689 HER2-PREDICT: TRANSLATIONAL STUDY OF TUMOR SAMPLES FROM DS8201-A-U301 AND DS8201-A-U302 TRIALS. II
  • 2022-0175 Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS). II
  • 2023-0682 Estudio de fase II, multicéntrico, aleatorizado, abierto, de mujeres premenopáusicas con cáncer de mama luminal que investiga el efecto del Elastrant SERD oral con/sin triptorelina en la vía funcional del RE y la proliferación de Ki67. Ensayo preoperatorio II
  • 2023-0862 Prospective biomarker analysis in HR+/HER2- advanced or metastatic breast cancer patients treated with sacituzumab govitecan II
  • 2025-1082 Real-World Efficacy outcomes With Tucatinib for HER2- Positive Advanced Breast Cancer Immediately After Trastuzumab Deruxtecan (DS-8201) IV
  • 2024-0434 Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE) II
  • 2025-0256 “Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT).” III
  • 2022-0848 Treatment of advanced or metastatic triple-negative breast cancer with adoptive therapy of PD1+ tumor-infiltrating lymphocytes (TILS001 trial). II
  • 2024-1168 Adjuvant pembrolizumab or surveillance in Early Triple Negative breAst cancer with high stromal tumor-infiltrating lymphocytes (TILs) score II
  • 2023-1033 A PHASE III, 2 ARM, RANDOMIZED, OPEN-LABEL, MULTICENTER, REGISTRATIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO (+/- ENDOCRINE THERAPY) AFTER INDUCTION CHEMOTHERAPY (PHESGO+TAXANE) IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER III
  • 2023-0831 fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para valorar la eficacia y la seguridad de inavolisib en combinación con Phesgo versus placebo en combinación con Phesgo después de la terapia de inducción de primera línea en participantes con HER2 positivo con mutación en PIK3CA localmente avanzado o cáncer de mama metastásico. III
  • 2025-0268 estudio de fase III para evaluar la eficacia y la seguridad de inavolisib más un inhibidor de CDK4/6 y letrozol frente a placebo más un inhibidor de CDK4/6 y letrozol en pacientes con cáncer de mama avanzado con mutación de PIK3CA, RH+ y HER2- endocrino sensibles. III

Group Leader Eva Muñoz Medical Oncologists and Clinical Investigators Julia Lostes, Giulia Petrelli

Research Groups

Melanoma and Other Cutaneous Tumors Research Group

Summary

The VHIO Melanoma and Other Cutaneous Tumors Research Group is primarily focused on clinical and translational research, with a strong emphasis on the development of novel targeted therapies, immunotherapy-based strategies, and the mechanisms of primary and acquired resistance to current treatments.

Our research activity spans the full spectrum of melanoma subtypes, including cutaneous, mucosal, acral, and uveal melanoma, as well as other skin malignancies such as cutaneous squamous cell carcinoma and basal cell carcinoma. In parallel, we lead and participate in early- and late-phase clinical trials across different disease stages, including metastatic, neoadjuvant, and adjuvant settings.

Over recent years, our Unit has consolidated its position as a national and international reference center for skin cancer management and research. This has been supported by the development of one of the largest therapeutic arsenals in skin oncology, granting patients access to innovative drugs and cutting-edge clinical trials.

Our multidisciplinary and translational research model is a defining strength of the group. The team integrates medical oncologists, dermatologists, pathologists, molecular biologists, translational researchers, and other medical specialists, enabling a seamless bidirectional flow between bench and bedside. This structure has allowed us to coordinate and lead one of the largest melanoma collaborative networks in Spain and Europe, fostering multicenter research initiatives and international collaborations.

Throughout 2025 we have continued to make significant progress by leading, co-leading, and participating in multiple phase I-III clinical trials evaluating innovative therapeutic strategies. These include next-generation immune checkpoint inhibitors, cell-based therapies, targeted therapy combinations, and novel neoadjuvant and adjuvant approaches. In parallel, we actively contribute to translational and biomarker-driven projects, with a particular focus on understanding and overcoming resistance to standard immunotherapies and targeted treatments.

One of our major strategic research lines is the study of immune-related adverse events (irAEs). In close collaboration with multiple departments at Vall d’Hebron University Hospital, including Internal Medicine, Cardiology, Neurology, Nephrology, Hepatology, and Endocrinology, we have consolidated a dedicated Immunotherapy Toxicity Working Group. This multidisciplinary initiative aims to:

  • Improve early identification and management of immune-related toxicities,
  • Harmonize clinical care pathways, and advance clinical and translational research into the biological mechanisms underlying irAEs.

Through this integrated approach, the VHIO Melanoma and Other Cutaneous Tumors Research Group continues to strengthen its commitment to precision oncology, patient-centered innovation, and the translation of scientific discoveries into tangible clinical benefit.

  • Consolidate our Cutaneous Tumors Unit as a national and international reference center for melanoma and other skin cancers by strengthening a well-established referral network, and by continuing to lead, co-lead, and actively participate in large-scale clinical trials, from the earliest stages of trial design, planning, and implementation.
  • Improve clinical outcomes in patients with cutaneous and ocular melanoma, while advancing insights into the biological mechanisms underlying disease initiation, progression, and treatment response.
  • Early clinical drug development focused on the identification and validation of biomarkers of tumor progression, therapeutic response, and resistance, as well as the development of novel therapeutic targets in melanoma and other cutaneous malignancies.
  • Expand and strengthen collaborations with other VHIO research groups, foster integrated translational projects aimed at achieving a more comprehensive understanding of tumor immunology and the molecular biology of skin cancers.
  • Elucidate the molecular and cellular mechanisms driving the development and progression of non-melanoma skin cancers, with particular emphasis on cutaneous squamous cell carcinoma and basal cell carcinoma.
  • Identify and validate actionable molecular targets, including those involved in tumor metabolism, to broaden and diversify the therapeutic arsenal available for patients with skin tumors.
  • Leadership in national and international melanoma research networks.
    We continue to lead one of the largest melanoma research networks in Spain and Europe, positioning our Unit among the most active groups in both metastatic and adjuvant clinical research in melanoma and other cutaneous tumors. Importantly, each clinical trial is systematically integrated with translational research projects led by VHIO investigators, ensuring a robust bench-to-bedside approach that accelerates the clinical application of scientific discoveries.
  • The strengthening of translational and immuno-oncology collaborations.
    During 2025, we have further reinforced our collaborations with VHIO research groups and external investigators focused on skin cancer biology. These efforts are aimed at achieving a deeper understanding of tumor immunology in melanoma, identifying biomarkers of disease progression and treatment response, and validating novel therapeutic targets across melanoma and other cutaneous malignancies.
  • Expansion of biological data and sample repositories.
    We are actively expanding and consolidating our clinical databases and biobanking activities, including the systematic collection, annotation, and storage of biological samples. This strategic effort is designed to support future national and international collaborative projects, facilitate high-quality translational research, and enhance the long-term scientific impact of our clinical programs.
  • Sustain and enhance the quality of patient care and clinical research at our Cutaneous Tumors Unit, consolidating its position as a center of excellence at both national and European levels.
  • Further strengthen leadership in skin cancer research by fostering new strategic collaborations and launching innovative clinical and translational research projects in melanoma and other cutaneous malignancies.
  • Clearly define the structure, roles, and responsibilities of each member of the Skin Tumors Unit within the Oncology Department, promoting efficiency, accountability, and multidisciplinary integration.
  • Continue to actively contribute to the education and training of healthcare professionals, with a particular focus on skin tumors and the prevention, early detection, and management of immune-mediated toxicities, while advancing best clinical practices.
  • Optimize patient recruitment across phase I - IV clinical trials, ensuring equitable access to innovative therapies and strengthening the Unit’s role in early drug development.
  • Promote and expand translational research programs, particularly in immunotherapy and targeted therapies, through close collaboration with VHIO investigators and the development of robust national and international partnerships.
  • Consolidate and expand a sustainable biorepository (SEROTECA) to support future collaborative research initiatives, guaranteeing high-quality, well-annotated biological samples for translational and biomarker-driven studies.
  • Robert C, Kicinski M, Dutriaux C, Routier É, Govaerts AS, Bührer E, Neidhardt EM, Durando X, Baroudjian B, Saiag P, Gaudy-Marqueste C, Ascierto PA, Arance A, Russillo M, Perrot JL, Mortier L, Aubin F, Dalle S, Grange F, Muñoz-Couselo E, Mary-Prey S, Amini-Adle M, Mansard S, Lebbe C, Funck-Brentano E, Monestier S, Eggermont AMM, Oppong F, Wijnen L, Schilling B, MandalÁ M, Lorigan P, van Akkooi ACJ. Combination of encorafenib and binimetinib followed by ipilimumab and nivolumab versus ipilimumab and nivolumab in patients with advanced melanoma with BRAFV600E or BRAFV600K mutations (EBIN): an international, open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2025 Jun;26(6):781-794.
  • Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Muñoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med. 2025 Dec;31(12):4301-4309.
  • Long GV, Nair N, Marbach D, Scolyer RA, Wilson S, Cotting D, Staedler N, Amaria RN, Ascierto PA, Tarhini AA, Robert C, Hamid O, Gaudy-Marqueste C, Lebbe C, Munoz-Couselo E, Menzies AM, C, Curigliano G, Mandala M, Jessop N, Bader U, Perdicchio M, Teichgräber V, Muecke M, Markert C, Blank C. Neoadjuvant PD-1 and LAG-3-targeting bispecific antibody and other immune checkpoint inhibitor combinations in resectable melanoma: the randomized phase 1b/2 Morpheus-Melanoma trial. Nat Med. 2025 Nov;31(11):3700-3712.
  • Dummer R, Sandhu S, Miller WH Jr, Butler MO, Taylor MH, Heinzerling L, Blank CU, Muñoz-Couselo E, Burris HA 3rd, Postow MA, Chmielowski B, Middleton MR, Berking C, Hassel JC, Gesierich AH, Mauch C, Kleha JF, Polli A, Harney AS, di Pietro A, Ascierto PA. Longitudinal Genomic Analysis to Fine-tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with BRAFV600-Mutant Metastatic Melanoma. Clin Cancer Res. 2025 Jun 3;31(11):2097-2107.

Although no formal awards were granted in 2025, the scientific leadership and international recognition of the Melanoma and Other Cutaneous Tumors Research Group continued to be reflected through multiple indicators of academic and clinical impact:

  • Leadership in high-impact international clinical trials, including phase I–III studies in metastatic, neoadjuvant, and adjuvant melanoma, results of which have been published in top-tier journals including Nature Medicine, The Lancet Oncology, Journal of Clinical Oncology, and Clinical Cancer Research.
  • Active participation and leadership in international consortia and collaborative networks including European and global melanoma research initiatives, reinforcing VHIO’s position as a reference in skin cancer research.
  • Invited speaker roles and scientific contributions at major national and international oncology and melanoma meetings, reflecting recognition by the scientific community of the group’s expertise in immunotherapy, targeted therapies, and translational research.
  • Key opinion leadership in clinical practice–changing studies, contributing to the development of new standards of care and evidence-based treatment strategies in melanoma and other cutaneous tumors.
  • Institutional recognition through multidisciplinary collaboration, particularly in the consolidation of the Immunotherapy Toxicity Working Group at Vall d’Hebrón University Hospital, highlighting the group’s role in improving patient safety and quality of care

Public and Competitive Funding:

  1. TANGERINE Project Project title: Artificial intelligence for the prediction of response to cancer immunotherapy. Funding body: Instituto de Salud Carlos III (ISCIII) Duration: 01/01/2023 – 01/01/2025 Role: Principal Investigator This project focuses on the application of artificial intelligence tools to improve prediction of response to immunotherapy, contributing to precision oncology strategies.
  2. SEOM Translational Research Grant 2024 (Immuno-Oncology) Project title: Ultrasensitive liquid biopsy as a biomarker of minimal residual disease and risk of recurrence in patients with operable melanoma. Funding body: Sociedad Española de Oncología Médica (SEOM) Award date: October 17, 2024 (Madrid) Role: Principal Investigator This translational project aims to validate high-sensitivity ctDNA approaches for minimal residual disease detection and relapse risk stratification in resectable melanoma.

Industry-Sponsored Competitive Research Projects:

  1. Grantor: Roche Farma S.A. Project title: Observational cross-sectional study evaluating the sociodemographic and clinical characteristics of patients with metastatic melanoma harboring a BRAF V600 mutation who achieve response (CR/PR) after at least one year of treatment with cobimetinib plus vemurafenib in routine clinical practice. Duration: 28/04/2017 – 31/12/2025 Principal Investigator: Eva Muñoz
  2. Grantor: Merck Sharp & Dohme de España, S.A. Project title: Support for research projects in the field of melanoma and cutaneous tumors. Duration: 21/11/2019 – 31/12/2025 Principal Investigator: Eva Muñoz
  3. Grantor: Bristol-Myers Squibb International Corporation (BMSIC) Project title: Phase II study comparing early detection of asymptomatic brain metastases versus standard follow-up on overall survival and symptomatic brain metastasis–free survival in patients with previously untreated unresectable or metastatic melanoma. Duration: 10/12/2019 – 31/12/2025 Principal Investigator: Eva Muñoz
  1. Sergio Martinez-Recio1,2; Maria Alejandra Molina1, Eva Muñoz-Couselo3, Alberto R Sevillano-Tripero4, Francisco Aya5, Ana Arance5, Mayra Orrillo6, Juan Martin-Liberal6, Luis Fernandez-Morales7, Rocio Lesta8, Maria Quindos-Varela8, Maria Nieva9, Joana Vidal9, Daniel Martinez-Perez10, Andres Barba1 and Margarita Majem Adjuvant immunotherapy after resected melanoma: survival outcomes, prognostic factors and patterns of relapse. Cancers 2025, 17,143. https://doi.org/10.3390/cancers17010143
  2. Ainara Soria; Juan José Serrano Domingo; Pedro Sanchez Mauriño; Regina García Galindo; Silvia Sequero; Lourdes Gutiérrez Sanz; Guillermo Crespo; Roberto Díaz-Beveridge; Teresa Puértolas; Pedro López; Joaquín Fra Rodríguez; Rafael López Castro; Cristina Aguayo; Javier Valdivia; Alberto Jacobo Cunquero-Tomás; Gretel Benítez; Pablo Ayala de Miguel; Enrique Espinosa; Eva Muñoz-Couselo; Begoña Campos; Lourdes García Sánchez; Pablo Cerezuela. Real Life evidence of encorafenib plus binimetinib in patients with unresectable advanced or metastatic BRAFV600-mutant melanoma in Spain: the BECARE (GEM-2002) trial. Frontiers in Oncology. Volume 15 - 2025 | doi: 10.3389/fonc.2025.1466185
  3. Axel Hauschild¹, Paolo Antonio Ascierto², Ana Arance³ ⁴⁰, Nethanel Asher⁴, Kirill Baryshnikov⁵, Miguel-Angel Berciano-Guerrero⁶, Carola Berking⁷, Christian U. Blank⁸, Matteo S. Carlino⁹, Nina Dabelić¹⁰, Diwakar Davar¹¹, Lev Demidov⁵, Brigitte Dreno¹², Caroline Dutriaux¹³, Alexander Eggermont¹⁴ ⁷², Enrique Espinosa¹⁵, Andrea Forschner¹⁶ ⁸⁵, Ana-Maria Forsea¹⁷ ⁵⁵, Olivier Gaide¹⁸, Caroline Gaudy-Marqueste¹⁹, Iva Gavrilova²⁰, Christoffer Gebhardt²¹, Stephan Grabbe²², Ralf Gutzmer²³, Christine Hafner²⁴, Omid Hamid²⁵, Jessica Hassel²⁶, Christoph Hoeller²⁷, Celine Jacobs²⁸, Sekwon Jang²⁹, Katharina C. Kähler¹, Lidija Kandolf³⁰, Roland Kaufmann³¹, Helmut Kehrer³², John M. Kirkwood¹¹, Peter Koelblinger³⁴, Celeste Lebbé³⁵, Ulrike Leiter¹⁶, Evan J. Lipson³⁶, Elisabeth Livingstone³⁷, Georgina V. Long⁹ ³⁸, Jason J. Luke¹¹, Marcus Maia³⁹, Josep Malvehy³ ⁴⁰, Mario Mandalà⁴¹, Joanna Mangana⁴², Jasmina Marić Brozić¹⁰, Ivan Marquez Rodas⁴³, Salvador Martin-Algarra⁴⁴, Lara Valeska Maul⁴⁵, Laura Mazilu⁴⁶, Grant McArthur⁴⁷, Inderjit Mehmi²⁵, Friedegund Meier³³ ⁴⁸, Tanja Mesti⁴⁹, Tara C. Mitchell⁵⁰, Peter Mohr⁵¹, Justin Moyers²⁵, Eva Muñoz Couselo⁵², Yana G Najjar¹¹, Yasuhiro Nakamura⁵³, Bart Neyns⁵⁴, Janja Ocvirk⁴⁹, Kristina Orlova⁵, Bogdan Catalin Popescu⁵⁵, Aleksandar Popovic⁵⁶, Christian Posch⁵⁷, Paola Queirolo⁵⁸, Egle Ramelyte⁴², Erika Richtig⁵⁹, Caroline Robert⁶⁰, Rachel Roberts-Thomson⁶¹, Andrée Rorive⁶², Christina H. Ruhlmann⁶³, Annemie Rutten⁶⁴, April K. S. Salama⁶⁵, Igor Samoylenko⁵, Dirk Schadendorf³⁷, Bastian Schilling⁶⁶, Richard Scolyer³⁸, Gergana Shalamanova-Deleva⁶⁷, Marco Siano⁶⁸, James W. Smithy⁶⁹, Vernon K. Sondak⁷⁰, Philipp Stelzhammer²⁴, Eggert Stockfleth⁷¹, Karijn Suijkerbuijk¹⁴, Amina J. Suljevic⁸⁶, Patrick Terheyden⁷³, Alessandro A. E. Testori⁷⁴, Pawel Teterycz⁷⁵, Julia K. Tietze⁷⁶, Vincas Urbonas⁷⁷, Igor Utyashev⁷⁸, Astrid A. M. van der Veldt⁷⁹, Marcia Venter⁸⁰, Rupert Wegher⁸¹, Michael Weichenthal¹, Alberto Weinstein⁸², Hassane M. Zarour¹¹, Lisa Zimmer³⁷, Grigorii Zinovev⁸³, Paolo Nuti⁸⁴, Claus Garbe⁸⁵. Neoadjuvant or perioperative therapy for melanoma metastasis in clinical practice: an international survey. Lancet Oncol 2025 Jan;26(1):12-14. doi: 10.1016/S1470-2045(24)00627-2.
  4. Eva Muñoz Couselo, Carola Berking, Jean François Baurain, Serena Martelli, Ramon Arntz, Paola Savoia. Secondary resistance to sonidegib is rare in locally advanced basal cell carcinoma. Journal of the American Academy of Dermatology 2025; http://doi.org/10.1111/jdv.20629
  5. Paolo A. Ascierto1,a, Hao Tang2,a, Sonia Dolfi2, Marta Nyakas3, Marie Inge Svane4, Eva Muñoz-Couselo5, Jean Jacques Grob6, Carlos Alberto GomezRoca7, Vanna Chiarion Sileni8, Katriina Peltola9, James Larkin10, Ignacio Melero11, Margaret Callahan12, Reinhard Dummer13, Patrick Djidel14, Deepti Warad2, Diane Reusser-Wolf14, Evan Lipson15,b, Charlie GarnettBenson2,b. Effect of prior treatment on baseline immune biomarkers and modulation of the tumor microenvironment in response to nivolumab + relatlimab therapy in patients with melanoma from RELATIVITY-020. Journal of ImmunoTherapy of Cancer (JITC) 2025, volume 13; DOI 1136/jitc-2024-009773
  6. Rebecca Dent,1 Javier Cortés,2,3,4 Yeon Hee Park,5 Eva Muñoz-Couselo,2,6 Sung-Bae Kim,7 Joohyuk Sohn,8 Seock-Ah Im,9 Esther Holgado,10 Theodoros Foukakis,11 Sherko Kümmel,12 Jennifer Yearley,13 Anran Wang,13 Michael Nebozhyn,13 Lingkang Huang,13 Razvan Cristescu,13 Petar Jelinic,13 Vassiliki Karantza,13 Peter Schmid. Molecular determinants of response to neoadjuvant pembrolizumab plus chemotherapy in patients with high-risk, early-stage, triple-negative breast cancer: exploratory analysis of the open-label, multicohort phase 1b KEYNOTE-173 study. Breast Cancer Research (2025) 27:35; https://doi.org/10.1186/s13058-024-01946-y
  7. Eva Muñoz Couselo1, Ainara Soria Rivas2, Shahneen Sandhu3, Georgina V Long4, Miguel Fernández de Sanmamed Gutiérrez5, Anna Spreafico6, Wilson H Miller7, Elizabeth Buchbinder8, Mario Sznol9, Hans Prenen10, Alexander Fedenko11, Mohammed Milhem12, Ana María Arance Fernández13, Jean-Jacques Grob14, Lev Demidov15, Caroline Robert16, Svetlana Protsenko17, Christin Habigt18, Stefan Evers19, §, Nassim Sleiman19, David Dejardin19, Caroline Ardeshir20, Nicole Martin21, Christophe Bötsch19, Jehad Charo21, Volker Teichgräber19, Anton Kraxner19, Nino Keshelava21, Oliver Bechter22. Phase 1b study of the immunocytokine simlukafusp alfa (FAP-IL2v), in combination with pembrolizumab as treatment of advanced and/or metastatic melanoma. Cancer Res Commun. 2025 Feb 1;5(2): 358-368.doi: 10.1158/2767-9764.CRC-24-0601
  8. Reinhard Dummer1, Shahneen Sandhu2, Wilson H. Miller3, Marcus O. Butler4, Matthew R.J. Taylor5, Lucie Heinzerling6, Christian U. Blank7, Eva Muñoz Couselo8, Howard A. Burris 3rd9, Michael A. Postow10, Bartosz Chmielowski11, Mark R. Middleton12, Carola Berking13, Jessica C. Hassel14, Anja Heike Gesierich15, Cornelia Mauch16, Joseph F Kleha17, Anna Polli18, Allison S. Harney19, Alessandra di Pietro18, Paolo Ascierto20. Longitudinal Genomic Analysis to Fine-Tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with BRAF V600-Mutant Metastatic Melanoma. Clin Cancer Res (2025) https://doi.org/10.1158/1078-0432.CCR-24-0254
  9. Juan José Serrano Domingo 1, Pedro Sanchez Mauriño 2, Regina García Galindo 3, Silvia Sequero 4, Lourdes Gutiérrez Sanz 5, Guillermo Crespo 6, Roberto Díaz-Beveridge 7, Teresa Puértolas 8, Pedro López 9, Joaquín Fra Rodríguez 10, Rafael López Castro 11, Cristina Aguayo 12, Javier Valdivia 13, Alberto Cunquero-Tomás 14, Gretel Benítez 15, Pablo Ayala de Miguel 16, Enrique Espinosa 17, Eva Muñoz-Couselo 18, Begoña Campos 19, Pablo Cerezuela-Fuentes 20. Real Life evidence of encorafenib plus binimetinib in patients with unresectable advanced or metastatic BRAFV600-mutant melanoma in Spain: the BECARE (GEM-2002) trial. Oncol.Sec. Skin Cancer Volume 15 - 2025 | doi: 10.3389/fonc.2025.1466185
  10. Pablo Cerezuela7; Maria Gonzalez-Cao1; Teresa Puertolas2; Jose Luis Manzano3; Cayetana Maldonado4; Oriol Yelamos5; Miguel A Berciano-Guerrero6; Juan Martin-Liberal8; Eva Muñoz-Couselo9; Enrique Espinosa10-11; Ana Drozdowskyj1; Alfonso Berrocal12; Ainara Soria13; Ivan Marquez-Rodas14; Salvador Martin-Algarra15; Maria Quindos16; Susana Puig11,17 for the Spanish Melanoma Group (GEM). Access to systemic treatment of Non-Melanoma Skin Cancer in Spain: A Survey Analysis. Frontiers of oncology Volume 27,  386–391, (2025)
  11. Kimberley McGrail, 1 Paula Granado-Martínez, 1 Roberto Orsenigo, 2 Ginevra Caratù,3 Paula Nieto, 2 Holger Heyn, 3 Berta Ferrer, 3 Javier Hernández-Losa, 4 Eva Muñoz-Couselo, 14 5 Vicenç García-Patos and 1 15 *Juan A. Recio. Transcriptional reprogramming induced by neonatal UV radiation prevents BRAFV600E 5 -induced growth arrest in melanocytes. Oncogene 2025; https://doi.org/10.1038/s41388-025-03339-7
  12. Martín-Lluesma1,2*, U. Dafni3,4*, †, K. Vervita5, D. Karlis6, G. Dimopoulou5, Z. Tsourti5, E. Politi5, G. Villacampa1, V. Galvao1, J. Lostes1, E. Muñoz-Couselo1, M. Rotxés1, X. Villalobos1, S. Muñoz1, J.B.A.G. Haanen7,8,9, I.M. Svane10, J.M. Piulats11, J.M. Liberal11, A. Gros1, G. Coukos12, E. Garralda1. Safety of adoptive therapy with tumor-infiltrating lymphocytes and high-dose recombinant interleukin-2 in advanced cutaneous melanoma: a systematic review and meta-analysis. Annals of Oncology, 2025; DOI: 10.1016/j.annonc.2025.04.001
  13. Michael Weichenthal a, Eva Ellebaek b, Joanna Mangana c, Nethanel Asher d, Iva Gavrilova e, Lidija Kandolf f, Selma Ugurel g, Axel Hausschild a, Friedegund Meier h, Ulrike Leiter i, Elisabeth Livingstone g, Christoffer Gebhardt j, Ralf Gutzmer k, ChristinaH. Ruhlmann l, Louise MahnckeGuldbrandt m, CharlotteA. Haslund n, Sylwia Kopec o, Paweł Teterycz p, Marc Bender q, Wilfried Poudroux r, Eva MuñozCouselo s, MiguelAngel BercianoGuerrero t, Gergana Shalamanova u, DanielleK. DePalo v, JasminaMarić Brozić w, Vanna ChiarionSileni x, Anna Arance y, Dimitrios Ziogas z, Caroline Robert aa, AnthonieObik vandeVelde ab, AwaAminata Gassama ac, Ronnie Shapira ad, Guy BenBetzalel ad, Shirly Grynberg ad, Egle Ramelyte c, Fabio Bertoldo c, Valerio DelPrete c, Caroline GaudyMarqueste ae, Peter Mohr af, Reinhard Dummer c, PaoloA. Ascierto ag, Helen Gogas z, Enrique Espinosa ah, Celeste Lebbé ai, Piotr Rutkowski o, John Haanen aj, Dirk Schadendorf g, IngeMarie Svane b, EUMelaReg Consortium Members 1. Immune Checkpoint Inhibition in Metastatic or Non-resectable Melanoma after Failure of Adjuvant anti-PD1 treatment. A EUMelaReg Real-world Evidence study. European Journal of cancer Volume 220, 2 May 2025, 115339
  14. Reinhard Dummer, Shahneen Sandhu, Wilson Miller, Marcus Butler, Matthew Taylor, Lucie Heinzerling, Christian Blank, Eva Muñoz-Couselo, Howard Burris, Michael Postow, Bartosz Chmielowski, Mark Middleton, Carola Berking, Jessica Hassel, Anja Gesierich, Cornelia Mauch, Joseph Kleha, Anna Polli, Allison Harney, Alessandra di Pietro, and Paolo Ascierto.  Longitudinal Genomic Analysis to Fine-Tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with BRAF V600-Mutant Metastatic Melanoma. Clinical Cancer Research 2025; https://doi.org/10.1158/1078-0432.CCR-24-0254
  15. Caroline Robert, Michal Kicinski, Caroline Dutriaux, Émilie Routier, Anne-Sophie Govaerts, Emanuel Bührer, Eve-Marie Neidhardt, Xavier Durando, Barouyr Baroudjian, Philippe Saiag, Caroline Gaudy-Marqueste, Paolo A. Ascierto, Ana Arance, Michelangelo Russillo, Jean-Luc Perrot, Laurent Mortier, Francois Aubin, Stéphane Dalle, Florent Grange, Eva Muñoz-Couselo, Bordeaux second author, Centre Léon Bérard second author, Auvergne second author, Céleste Lebbe, Boulogne second author, Alexander M.M. Eggermont, Felix Oppong, Leen Wijnen, Bastian Schilling, Mario Mandalà*, Paul Lorigan*, Alexander C.J. van Akkooi*. Combination of encorafenib and binimetinib followed by ipilimumab and nivolumab versus ipilimumab and nivolumab in patients with advanced BRAF-V600E/K melanoma (EBIN): an international randomized phase II study. Lancet Oncology 2025, Volume 26, Issue 6, June 2025, 781-794. https://doi.org/10.1016/S1470-2045(25)00133-0
  16. Mario Mandalà1*, Teresa Amaral2*, Piotr Rutkowski3*, Maria Chiara Sergi4, Marie-Lena Rasch 2, Naima Benannoune5, Patricio Serra6, Maria Grazia Vitale7, Diana Giannarelli8, Ana Maria Arance9, Eva Munoz Couselo10, Bart Neyns11, Marco Tucci12, Michele Guida13, Francesco Spagnolo14, Ernesto Rossi15, Paola Queirolo16, Pietro Quaglino17, Roberta Depenni18, Joanna Placzke3, Anna Maria Di Giacomo19, Michele del Vecchio20, Alice Indini20, Ines Pires da Silva21, Alexander M. Menzies22, Angela Hong23, Paul Lorigan6 , Georgina V. Long22, Caroline Robert24§, Paolo A. Ascierto7§. Combined immunotherapy with nivolumab and ipilimumab with and without sequential or concomitant stereotactic radiotherapy in patients with melanoma brain metastasis: an international retrospective study. European Journal of cancer 2025
  17. Michael K. Wong, M.D., Ph.D., F.R.C.P.C,1*, †, Mohammed M. Milhem, M.B., B.S.2*, Joseph J. Sacco, Ph.D., F.R.C.P.3, Judith Michels, M.D., Ph.D.4, Gino K. In, M.D.5, Eva Muñoz Couselo, M.D., Ph.D.6, Dirk Schadendorf, M.D.7, Georgia M. Beasley, M.D.8, Jiaxin Niu, M.D., Ph.D.9, Bartosz Chmielowski, M.D., Ph.D.10, Trisha M. Wise-Draper, M.D., Ph.D.11, Tawnya Lynn Bowles, M.D.12, Katy K. Tsai, M.D.13, Céleste Lebbé, M.D., Ph.D.14, Caroline Gaudy-Marqueste, M.D., Ph.D.15, Mark R. Middleton, M.D.16, Adel Samson, Ph.D.17, Jason A. Chesney, M.D., Ph.D.18, Ari M. VanderWalde, M.D.19, Yousef Zakharia, M.D.2, Kevin J. Harrington, Ph.D.20, Elizabeth Appleton20, Praveen K. Bommareddy, Ph.D.21, Junhong Zhu, Ph.D.21, Marcus Viana, M.D.21, Jeannie W. Hou, M.D.21, Robert S. Coffin, Ph.D.21, Caroline Robert, M.D., Ph.D.22 RP1 Combined With Nivolumab in Advanced Anti–PD-1–Failed Melanoma. Journal of Clinical Oncology (JCO) 0, 10.1200/JCO-25-01346 2025; https://doi.org/10.1200/JCO-25-01346
  18. Eva Muñoz Couselo, Carola Berking, Jean François Baurain, Serena Martelli, Ramon Arntz, Paola Savoia. Secondary resistance to sonidegib is rare in locally advanced basal cell carcinoma.  J Eur Acad Dermatol Venereol, 39: e788-e790. https://doi.org/10.1111/jdv.20629
  19. Georgina Long1–3,*, Nitya Nair4,*, Daniel Marbach4, Richard Scolyer1,2,5, Sabine Wilson6, Denise Cotting4, Nicolas Staedler4, Rodabe Amaria7, Paolo Ascierto8, Ahmed Tarhini9, Caroline Robert10, Omid Hamid11, Caroline Gaudy12, Celeste Lebbe13, Eva Munoz-Couselo14, Alex Menzies1–3, Cecile 15, Giuseppe Curigliano16, Mario Mandala17, Nikki Jessop4, Uwe Bader4, Maurizio Perdicchio4, Volker Teichgraeber4, Merlind Muecke4, Christian Blank18,†, Christoph Markert19,†. Neoadjuvant PD-1 and LAG-3-targeting bispecific antibody alone and other immune checkpoint inhibitor combinations in resectable melanoma: the randomized phase Ib/II Morpheus-Melanoma trial. Nat Med(2025). https://doi.org/10.1038/s41591-025-03967-2
  20. Clara Mayo de las Casas1,2*, Eloisa Jantus-Lewintre3*, Sebastian Ortiz Reina5, Ana Drozdowskyj1, Pablo Cerezuela6, Jose Luis Manzano7, Pablo Ayala de Miguel8, Ana Arance Fernandez9, Miguel Angel Berciano Guerrero10, Almudena Garcia Castano11, Teresa Puertolas12, Guillermo Crespo13, Maria Quindos-Varela14, Juan Francisco Rodriguez-Moreno15, Alfonso Berrocal16, Eva Muñoz-Couselo17, Enrique Espinosa18, Silvia Calabuig-Fariñas4, Miguel Angel Molina1,2, Rafael Rosell1,2, Joan Anton Puig-Butille4**, Maria Gonzalez-Cao1** , on behalf of the Spanish Melanoma Group (GEM). Cross-method comparison for BRAF p.V600 Mutation cfDNA Testing in Melanoma: BRAFI study. EJD skin cancer 2025; https://doi.org/10.1016/j.ejcskn.2025.100738
  21. Pablo Cerezuela-Fuentes, Carlos Aguado de la Rosa; Guillermo Crespo; Miguel-Ángel Berciano-Guerrero; Ainara Soria; Eva Muñoz-Couselo; Rafael López Castro; Margarita Majem; Pablo Ayala de Miguel; José Luis Manzano; Lorena Bellido; Mª José Lecumberri; Mónica Corral Subias; José Carlos Villa Guzmán; Berta Hernández; Enrique Espinosa; Teresa Puértolas; Lourdes Gutiérrez Sanz; Javier Medina Martínez; Vicente Palomar Abril; Salvador Martín Algarra; Iván Márquez-Rodas. Treatment outcomes in patients with advanced mucosal melanoma in Spain: results from the real-world GEM1801 study. Melanoma Research 2025 sep 3; PMID: 40901826; DOI: 1097/CMR.0000000000001062
  22. Georgina Long1–3,*, Nitya Nair4, *, Daniel Marbach4, Richard Scolyer1,2,5, Sabine Wilson6, Denise Cotting4, Nicolas Staedler4, Rodabe Amaria7, Paolo Ascierto8, Ahmed Tarhini9, Caroline Robert10, Omid Hamid11, Caroline Gaudy12, Celeste Lebbe13, Eva Munoz-Couselo14, Alex Menzies1–3, Cecile 15, Giuseppe Curigliano16, Mario Mandala17, Nikki Jessop4, Uwe Bader4, Maurizio Perdicchio4, Volker Teichgraeber4, Merlind Muecke4, Christian Blank18,†, Christoph Markert19,†. Neoadjuvant PD-1 and LAG-3-targeting bispecific antibody alone and other immune checkpoint inhibitor combinations in resectable melanoma: the randomized phase Ib/II Morpheus-Melanoma trial. Nat Med(2025). https://doi.org/10.1038/s41591-025-03967-2
  23. Rodrigo Dienstmann1,2, Ana Vivancos1, Paolo Nuciforo1, Susana Aguilar1, Fiorella Ruiz-Pace1, Cristina Viaplana1, Jenifer Gonzalez1, Benet Fite1, Anna Pedrola1, Elena Elez3, Cristina Saura3, Enriqueta Felip3, Teresa Macarulla3, Jaume Capdevila3, Ana Oaknin3, Joan Carles3, Joaquin Mateo1,3, Eva Muñoz-Couselo3, Judith Balmaña3, Irene Braña3, Elena Garralda3, Josep Tabernero1,2,3,4,5. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO open 2025; https://doi.org/10.1016/j.esmoop.2025.105888
  24. Enrique Espinosa1, Miguel-Ángel Berciano-Guerrero2, Eva Muñoz-Couselo3, Teresa Puértolas4, José Luis Manzano5, Ainara Soria6, Pablo Ayala de Miguel7, Guillermo Crespo8, Lourdes Gutiérrez Sanz9, Pablo Cerezuela-Fuentes10, Carlos Aguado de la Rosa11, Margarita Majem12, Almudena García Castaño13, Alfonso Berrocal14, Francisco Ramon García Arroyo15, María Rodríguez de la Borbolla16, Lorena Bellido17, Javier Medina Martínez18, Luis Antonio Fernández19, Alfonso Martin Carnicero20, Rafael López Castro21, Aida Bujosa Rodríguez22, Mª José Lecumberri23, José Carlos Villa Guzmán24, Begoña Campos Balea25, Joaquín Fra Rodríguez26, Javier Valdivia Bautista27, Victor Navarro Pérez28, Karmele Mujika29, Mónica Corral Subias30, Berta Hernández31, Salvador Martín Algarra32, Iván Márquez-Rodas33. Response rate and long-term survival in patients with advanced melanoma: data from the prospective cohort study GEM-1801. Clinical and Translational Oncology 2025, https://doi.org/10.1007/s12094-025-04098-3
  25. Georgina V. Long, Charlie Garnett-Benson, Sonia Dolfi, Paolo Ascierto, Jun Guo, Ahmed Tarhini, Sunandana Chandra, Eva Munoz-Couselo, Michele Del Vecchio, Andreia Cristina de Meio, Margaret Callahan, Helen Gogas, Reinhard Dummer, Dirk Schadendorf, Peter Koelblinger, Gaelle Quereaux, Ioannis Thomas, Annie Yu, Andrew Fisher, Patrick Djidel, Armand Chouzy, Mark Semaan, Bohang Chen, Alicia Cheong, Bonnie Wang, Hussein Tawbi. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med(2025).; https://doi.org/10.1038/s41591-025-04032-8
  26. Elena Garralda , Dr charles Abbott , Alma Calahorro , Oriol Mirallas , Jason Pugh , Ms Ana Moreno , Dr Kathleen Keough , Vladimir Galvao , Dr Guzman Alonso , Armando Olano , Maria Vieito , Arjun Oberoi , Julia Lostes Bardaji , Alberto Hernando-Calvo , Dr Irene Braña , Giulia Pretelli , Belen Ortega , Ms Carlota Arenillas , Natalia Czerniak , Fabio Navarro , Bailiang Li , Dr Rachel Pyke , Neeraja Ravi , Christina Zatse , Francesco Grussu , Marta Sanz , Cristina Viaplana , Kira Raskina , Mr Jose Jimenez , Roberta Fasani , Patricia Casbas-Hernandez , Ezoglin Oflazoglu , Darren Hodgson , Jorge Reis-Filho , Enriqueta Felip , Dr Elena Elez , Eva Muñoz-Couselo , Dr Rodrigo Dienstmann , Professor Josep Tabernero , Dr Raquel Perez , Paolo Nuciforo , Dr Richard Chen , Sean Michael Boyle. Broad utility of ultrasensitive analysis of ctDNA dynamics across solid tumors treated with immunotherapy. Clin Cancer Res2025, OF1–OF17. https://doi.org/10.1158/1078-0432.CCR-25-2312
  27. Pablo Cerezuela-Fuentes 1#*, Antonio Piñero-Madrona 2#, Eva Muñoz-Couselo 3, José Luis Manzano 4, Miguel-Ángel Berciano-Guerrero 5, Margarita Majem 6, Enrique Espinosa 7, Ainara Soria 8, Pablo Ayala de Miguel 9, Almudena García Castaño 10, Guillermo Crespo 11, Lourdes Gutiérrez Sanz 12, Carlos Aguado de la Rosa 13, Luis Antonio Fernández-Morales 14, Teresa Puértolas 15, Joaquín Fra Rodríguez 16, María Rodríguez de la Borbolla 17, Lorena Bellido 18, Rafael López Castro 19, Eduardo Castañón 20, Victor Navarro Pérez 21, Francisco Ramon García Arroyo 22, José Carlos Villa Guzmán 23, Begoña Campos Balea 24, Berta Hernández 25, Salvador Martín Algarra 20, Iván Márquez-Rodas 26. Characterization of Melanoma of Unknown Primary in the Era of Immunotherapy and Targeted Therapy in Spain: Results from the Prospective Real World Study GEM 1801. Clin Transl Oncol. 2025 Dec 20. doi: 10.1007/s12094-025-04164-w.
  • PRISM-MEL-301: A Phase III Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A02:01–Positive Participants with Previously Untreated Advanced Melanoma. *
  • SEACRAFT-2 (Protocol ERAS-254-02): A Randomized, Open-Label Phase III Study in Patients with Previously Treated Unresectable or Metastatic NRAS-Mutant Cutaneous Melanoma Comparing Naporafenib Plus Trametinib Versus Physician’s Choice of Therapy (Dacarbazine, Temozolomide, or Trametinib Monotherapy), Including Dose-Optimization Lead-In.
  • BI-1607 Trial: An Open-Label, Multicenter Phase Ib/IIa Clinical Trial of BI-1607, an Fc-Engineered Monoclonal Antibody Targeting FcγRIIb (CD32B), in Combination with Ipilimumab and Pembrolizumab in Participants with Unresectable or Metastatic Melanoma.
  • R3767-ONC-2208: A Phase II Perioperative Trial of Fianlimab and Cemiplimab Compared with Pembrolizumab in Patients with Resectable Stage III and IV Melanoma.
  • Enfortumab Vedotin + Pembrolizumab (Phase II): An Open-Label, Multicenter, Non-Randomized Phase II Study Evaluating the Efficacy and Safety of Enfortumab Vedotin in Combination with Pembrolizumab in Previously Treated Advanced Melanoma.
  • Brain Metastases Study: A Phase II, Single-Arm, Multicenter Clinical Trial to Evaluate the Activity of Encorafenib Plus Binimetinib Followed by Cemiplimab and Fianlimab in Patients with BRAF-Mutant Melanoma and Symptomatic Brain Metastases.
  • EIK1001-006: A Multicenter, Randomized, Double-Blind, Active Comparator–Controlled, Adaptive Phase II/III Study to Evaluate the Safety and Efficacy of EIK1001 Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma.
  • C5901001 (PF-08046031): An Open-Label Phase I Study to Investigate PF-08046031 in Adults with Advanced Melanoma and Other Solid Tumors.
  • INTerpath-012 (V940 / mRNA-4157): A Phase II, Randomized, Double-Blind, Placebo- and Active Comparator–Controlled Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants with First-Line Advanced Melanoma.

Group Leader Pere Barba Senior Scientists Jana de Sostoa, Martí Farrera-Sal Hematologist and Clinical Investigators Cecilia Carpio, Samantha Feijoo, Gloria Iacoboni, Alfredo Rivas, Mario Sánchez Salinas Master’s Students Sara Delucchi, Carmen Megías

Research Groups

Cell Engineering and Hematologic Immunotherapy Group

Summary

Cellular immunotherapy has transformed the therapeutic landscape of hematologic malignancies, with chimeric antigen receptor (CAR) T-cell therapy achieving durable remissions in selected patient populations. Despite these advances, important clinical challenges remain, including disease relapse, antigen escape, limited persistence of engineered cells, and treatment-related toxicities. Moreover, many hematologic diseases still lack effective cellular therapy approaches.

The Cell Engineering and Hematologic Immunotherapy Group focuses on addressing these limitations through an integrated clinical and translational research strategy. Our team brings together hematologists and preclinical scientists working at the interface of clinical hematology, synthetic biology, and cell engineering, enabling the rapid translation of clinically driven questions into innovative therapeutic solutions. Clinical observations directly inform our research priorities, while engineering strategies are developed with a clear path toward clinical implementation.

Our research is centered on the development of next-generation CAR T-cell therapies designed to improve specificity, safety, and durability of response. We pursue multiple complementary strategies, including combinatorial antigen targeting, receptor architecture optimization, and genome-editing approaches aimed at enhancing T-cell function. Through systematic engineering and functional screening approaches, we seek to generate more effective and reliable cellular therapies for patients with hematologic malignancies.

In parallel with our cell engineering programs, the clinical arm of our lab focuses on improving each stage of the CAR T-cell therapeutic pathway. Our clinical research efforts aim to optimize lymphodepletion regimens, T-cell fitness at leukapheresis, and the identification of biomarkers predictive of response and treatment-related toxicity. We also investigate the influence of prior treatment exposures on CAR T-cell outcomes and explore rational combination strategies designed to enhance the efficacy and durability of cellular therapies. By integrating clinical data with longitudinal biological samples and mechanistic studies, these initiatives seek to refine CAR T-cell treatment strategies and maximize clinical benefit for patients with hematologic malignancies.

Our research group is embedded within the Vall d’Hebron campus and closely integrated with the Hematology Department and the Advanced Therapies Unit at Vall d’Hebron University Hospital. Approximately 70 patients receive CAR T-cell therapy annually, providing a unique translational environment that connects clinical practice with laboratory research. This setting has enabled the establishment of a longitudinal biobank containing more than 400 samples from CAR T-treated patients, offering an invaluable resource to investigate mechanisms of resistance and relapse, identify molecular determinants of response, and discover predictive biomarkers that may guide patient selection and treatment optimization.

Through this integrated clinical-preclinical framework, our lab aims to develop next-generation cellular immunotherapies capable of delivering more durable responses and expanding the therapeutic potential of engineered immune cells for hematologic malignancies.

  • Advance the development of next-generation CAR T-cell therapies with improved specificity, safety, and persistence through innovative cell engineering approaches.
  • Strengthen the integration between clinical hematology and translational research, leveraging clinical observations and patient-derived samples to guide therapeutic innovation.
  • Expand our cell engineering platforms, including modular CAR design and genome-editing strategies aimed at enhancing T-cell functionality.
  • Identify and validate novel therapeutic targets in hematologic malignancies through collaboration with genomic and molecular profiling initiatives within VHIO.
  • Consolidate and expand the CAR T longitudinal biobank to support translational studies aimed at understanding resistance, relapse, and treatment-related toxicities.
  • Foster strategic collaborations with academic groups and industry partners to accelerate the development of innovative cellular immunotherapy approaches.
  • Promote the translation of discoveries into early-phase clinical trials, enabling the clinical evaluation of novel cell engineering strategies developed within the laboratory.
  • Foundation of the Cell Engineering and Hematologic Immunotherapy Group.
  • Kick-off Research Grant – European Hematology Association.
  • Advance the development of novel CAR engineering platforms capable of systematically optimizing receptor architecture and improving T-cell performance.
  • Translate insights from patient-derived samples and clinical data into new strategies to overcome resistance and improve CAR T-cell durability.
  • Expand our group’s research into next-generation genome editing approaches to enhance T-cell persistence, fitness, and anti-tumor activity.
  • Strengthen collaborations within VHIO and international research networks to accelerate the clinical translation of innovative cellular therapies.
  • Promote the development of first-in-human clinical trials evaluating novel cell engineering strategies emerging from ourAs research.
  • Continue expanding the CAR T patient biobank and translational research infrastructure, enabling deeper mechanistic studies of treatment response and toxicity.
  • Iacoboni G, Rejeski K, Navarro V, van Meerten T, Rampotas A, Martín-López AÁ, Bastos M, Benzaquén A, Reguera-Ortega JL, Carpio C, Roddie C, López-Corral L, Delgado-Serrano J, Landwehr M, Stock S, Silva de Tena P, Abrisqueta P, de Boer J, Martin Garcia-Sancho A, Hernani R, Kwon M, Subklewe M, O'Reilly M, Barba P. Site-specific analysis of extranodal involvement in large B-cell lymphoma reveals distinct efficacy with chimeric antigen receptor T-cell therapy. Leukemia. 2025 May;39(5):1196-1205.
  • Camacho-Arteaga L, Iacoboni G, Kwon M, Bailén R, Hernani R, Benzaquén A, López-Corral L, Pérez-López E, Leguízamo-Martínez LM, Calvo-Orteu M, Guerreiro M, Balaguer-Rosello A, Alonso-Martínez C, Vidal X, Barba P, Agustí A. Late Adverse Events After Chimeric Antigen Receptor T-Cell Therapy for Patients With Aggressive B-Cell Non-Hodgkin Lymphoma. JAMA Netw Open. 2025 Feb 3;8(2):e2461683.
  • Bastos-Oreiro M, Iacoboni G, Garcés VN, Caballero AC, Martínez N, Delgado J, Balaguer A, Kwon M, Gonzalez de Villambrosia S, Hernani R, Jimenez-Ubieto A, Bailen R, Zaberio I, Martín García-Sancho A, Barba P. Chimeric antigen receptor T-cell therapy outcomes in T cell/histiocyte-rich large B-cell lymphoma and subsequent treatment strategies after disease progression: A GELTAMO/GETH study. Hemasphere. 2025 Feb 4;9(2):e70077.
  • Iacoboni G, Morschhauser F. Building the future management of follicular lymphoma with T-cell-redirecting strategies. Blood. 2025 Jan 9;145(2):170-175.
  • Gloria Iacoboni received the 2025 Young Investigator Prize from the Catalan Institute of Health.
  • Pere Barga and Gloria Iacoboni both delivered an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting, December 6-9, Orlando, Florida.

For a full listing of clinical trials in hematology with active recruitment at some time in the year in 2025 click here.

Group Leader Pau Abrisqueta Translational Research Coordinator Marta Crespo Postdoctoral Scientists Pamela Acha (geneticist), Rubén Chazarra (bioinformatician), Iñaki Salvador (immunologist) PhD Students Maite Ergüin, Patricia Fernández, Sofía Mallorquí Technician Marina Corominas Clinical Data Manager Laura Campi Hematologists Marc Bosch, Cecilia Carpio, Inmaculada Fernández, Cristina García, Merche Gironella, Gloria Iacoboni, Ana Marín, Teresa Quiñones, Ángel Serna

Research Groups

Lymphoid Malignancies Group

Summary

Our research group has focused on improving the management of patients with lymphoid malignancies. These diseases are clinically and biologically heterogeneous, and patients who relapse often face limited therapeutic options and poor prognosis. Through a combination of clinical trials, national and international collaborative studies, real-world analyses, and translational studies, we have contributed to advancing more effective and personalized treatment strategies.

From the clinical standpoint, we have participated in 72 clinical trials, including 35 early-phase studies, evaluating novel treatment strategies in patients with lymphoid malignancies.

A central focus of our research has been the integration of innovative immunotherapies into clinical practice. We have contributed to clinical trials assessing bispecific antibodies in heavily pretreated patients, and more recently as a front-line treatment for patients, including patients with both aggressive and indolent lymphomas. Additionally, we have analyzed the outcomes of these treatments outside of clinical trials, showing that these therapies are feasible and effective in real-world populations, including patients with high-risk clinical features. This work has helped validate the broader applicability of immunotherapy and supported its incorporation into routine care for patients with relapsed/refractory lymphomas. By incorporating translational analyses, we have highlighted the importance of biological characterization in identifying patients most likely to benefit from immunotherapeutic approaches. Our translational studies have also contributed to identifying new biomarkers of progression as well as understanding how standard of care targeted therapies can immunomodulate the tumoral microenvironment and how this can be leveraged to propose new combinations of targeted and immunotherapy. In this sense, another focus of our work has been the study of immune evasion mechanisms in primary central nervous system lymphoma (PCNSL), with particular emphasis on the dynamic interaction between macrophages and T lymphocytes in the context of immune checkpoint blockade therapies.

Another key contribution has been the evaluation of novel therapeutic strategies in patients with chronic lymphocytic leukemia (CLL). In particular, we have participated in the first study comparing the two main current treatment strategies in CLL: continuous versus fixed-duration treatment strategies. Such data are essential for understanding how to better use novel treatments in everyday practice for patients with CLL.

Overall, our research reflects a commitment to bridging clinical innovation and real-world application. By advancing immunotherapy strategies, contributing robust outcome data, and performing translational research, our work has helped expand therapeutic options and improve the outlook for patients with lymphoid malignancies.

  • Develop preclinical models that mimic the tumor microenvironment using primary cells, transgenic mouse models, PDX models, and 3D ex-vivo cultures to assess new treatment modalities.
  • Translate preclinical research into clinical interventions for the benefit of patients, through promoting early-phase clinical trials and identifying new biomarkers with predictive and prognostic value.
  • Gain a deeper understanding of the crosstalk mechanisms between tumor cells and the microenvironment that guide the development of personalized, more efficient immunotherapies. In particular, evaluate the genetic and immune determinants of the response to T-cell-engaging bispecific antibodies.
  • Evaluate ctDNA dynamics in lymphoma as a biomarker of disease burden and response to treatment.
  • Determine therapeutic vulnerabilities of persistent resistant cells to targeted therapy.
  • We have collaborated in pivotal clinical studies with novel strategies based on immunotherapy for patients with lymphoma, including first-line and R/R clinical settings.
  • We have participated in the first study comparing the two main current treatment strategies in CLL, a continuous treatment strategy versus a fixed-duration treatment.
  • We have expanded our research on the role of the immune system in the development of lymphoid malignancies, including the study of new mouse models in chronic lymphocytic leukemia and central nervous system (CNS) lymphoma.
  • We have advanced insights into the role of immune dynamics in the efficacy of immunotherapy for the treatment of lymphoid malignancies.
  • We have led the publication of the Spanish guidelines for the diagnosis and treatment of patients with chronic lymphocytic leukemia.
  • Expand our research on the role of the immune system in the development of lymphoid malignancies, including the study of new mouse models in chronic lymphocytic leukemia and CNS lymphoma.
  • Achieve deeper insights into the role of genetic alterations and immune dynamics in the efficacy of immunotherapy, particularly bispecific antibodies, for the treatment of lymphoid malignancies.
  • Evaluate the potential of implementing ctDNA assessment in clinical practice to support patient diagnosis and monitoring of treatment response.
  • Al-Sawaf O, Stumpf J, Zhang C, Simon F, Bosch F, Feyzi E, Ghia P, Gregor M, Kater AP, Lindström V, Mattsson M, Niemann CU, Staber PB, Tadmor T, Thornton P, Wendtner CM, Janssens A, Noesslinger T, Bohn JP, da Cunha-Bang C, Poulsen CB, Ranti J, Illmer T, Schoettker B, Böttcher S, Gaska T, Vandenberghe E, Clifford R, Benjamini O, Frustaci AM, Scarfò L, Sportoletti P, Schreurs J, Levin MD, van der Straaten H, van der Klift M, Tran H, de la Serna J, Loscertales J, Lindblad O, Bergendahl Sandstedt A, Goede J, Baumann M, Fink AM, Fischer K, Ritgen M, Kreuzer KA, Schneider C, Tausch E, Stilgenbauer S, Robrecht S, Eichhorst B, Hallek M; CLL17 Trial Investigators. Fixed-Duration versus Continuous Treatment for Chronic Lymphocytic Leukemia. N Engl J Med. 2025 Dec 6. doi: 10.1056/NEJMoa2515458.
  • Hutchings M, Sureda A, Bosch F, Larsen TS, Corradini P, Avigdor A, Terol MJ, Dominguez AR, Pinto A, Skarbnik A, Cordoba R, Jørgensen JM, Zinzani PL, Leung W, Bottos A, Li D, Relf J, Tandon M, Sellam G, Gritti G. Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial. J Clin Oncol. 2025 Dec 20;43(36):3788-3798.
  • Morschhauser F, Salles G, Sehn LH, Herrera AF, Friedberg JW, Trněný M, Lenz G, Sharman JP, Herbaux C, Burke JM, Matasar M, Collins GP, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Pinto A, Rai S, Izutsu K, Greil R, Mykhalska L, Bergua-Burgués JM, Cheung MC, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Jiang Y, McCall B, Chohan S, Sugidono M, Yan M, Batlevi CL, Tilly H, Flowers CR. Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec 10;43(35):3698-3705.
  • Medina-Gil D, Palomo L, Navarro V, Lázaro G, Martín-Mur B, Hernández C, Castells O, Sánchez B, Muñoz-Torres PM, Pagès C, Pujadas G, Esteve-Codina A, Cabirta A, Ferrà C, Alcoceba M, Terol MJ, Andreu R, Martí M, Abrisqueta P, Bosch F, Crespo M. Bruton tyrosine kinase covalent inhibition shapes the immune microenvironment in chronic lymphocytic leukemia. Haematologica. 2025 Aug 1;110(8):1758-1773.
  • Gloria Iacoboni was awarded as the best young investigator at the Institut Català de la Salut - ICS (Catalan Health Institute).

For a full listing of clinical trials in hematology with active recruitment at some time in the year in 2025 click here.

Group Leader David Valcárcel Molecular Genetics and Germline Programs Leader Andrés Jerez Clinical Team Laura Fox, Félix López, Sandra Novoa, Guillem Orti, Ana Pérez, Olga Salamero, María Sola Clinical Trials Physicians Irene Medina, Alba Puyuelo Clinical Laboratory Adoración Blanco, Laura Gallur, Sara Garrido, Gloria Hidalgo, Julia Montoro, Margarita Ortega Senior Postdoctoral Researcher and Translational Research Coordinator Pamela Acha Postdoctoral Researcher Iñaki Salvador LAB Manager Claudia Pellin Geneticist Sara Torres PhD Students Ferran Balbastre, Francisco Beas, María Gabarrós, Carmen Vázquez Data Manager Adriana Oñós

Research Groups

Myeloid Malignancies Research Group

Summary

VHIO’s Myeloid Malignancies Research Group is dedicated to advancing the biological understanding and clinical management of myeloid malignancies, including myelodysplastic neoplasms (MDS), acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and germline predisposition syndromes. We focus on improving disease characterization, refining risk stratification, and developing biologically informed therapeutic strategies that ultimately translate into improved patient outcomes. We also aim to integrate allogeneic hematopoietic stem cell transplantation both as a therapeutic modality and as a biological platform to study immune-mediated control of malignant clones.

Precision medicine is a guiding principle of our work. We integrate longitudinal clinical data with comprehensive molecular profiling and high-resolution immune characterization to define the determinants of clonal emergence and evolution, disease progression, and therapeutic resistance. By identifying molecular drivers, clonal hierarchies and immune dysfunction patterns in individual patients, we aim to establish robust clinicobiological correlations and actionable biomarkers that inform personalized therapeutic decisions and optimize risk-adapted treatment strategies.

The associated clinical unit diagnoses approximately 40 new MDS cases, 50 AML cases, and 25 MPN cases annually, providing a substantial and continuous source of clinically well-characterized patients for translational research. Since the early 2000s, we have maintained a consolidated institutional registry including more than 1,000 patients with MDS, systematically reported to the Spanish MDS Registry (GESMD). In parallel, AML and MPN cases are prospectively captured within the national collaborative registries CETLAM and GEMFIN, respectively, ensuring standardized clinical annotation and longitudinal follow-up.

Our group also established the first dedicated clinical program in Spain focused on patients with germline predisposition to myeloid neoplasms and clonal hematopoiesis, integrating clinical care with genetic counseling and research. Currently, 20 patients with confirmed germline predisposition syndromes are registered within the CATBAL collaborative network.

Comprehensive molecular characterization is available for more than 400 patients through routine cytogenetic and next-generation sequencing analyses. In addition, a clinically and biologically annotated biobank including approximately 250 consented cases provides a robust infrastructure for translational studies, biomarker discovery, and integrative molecular analyses.

This high volume of comprehensively annotated cases enables the generation of biologically grounded hypotheses and provides a unique bridge between real-world clinical complexity and mechanistic investigation. We work within a multidisciplinary framework that connects clinical hematologists, molecular geneticists, immunologists and translational scientists, ensuring a bidirectional flow between bedside observation and experimental modeling.

Through sustained participation in national and international collaborative networks and multicenter clinical trials, we contribute to the integration of innovative therapeutic approaches into the management of myeloid neoplasms. By linking cohort-driven discovery with mechanistic insight and clinical implementation, the group aims to serve as a reference translational hub in myeloid malignancies, advancing precision medicine strategies rooted in biological understanding and clinical impact.

  • Identify novel biological pathways in myeloid neoplasms to uncover actionable therapeutic targets.
  • Define new germline predisposition syndromes and characterize their molecular and mechanistic basis using next-generation technologies.
  • Refine prognostic models by integrating molecular, immunological and clinical variables to improve risk-adapted therapy.
  • Characterize immune dysregulation and bone marrow microenvironment remodeling across the spectrum from clonal hematopoiesis to acute myeloid leukemia.
  • Clarify the clinical impact of clonal hematopoiesis in hematologic malignancies and across other medical disciplines.
  • Establish allogeneic transplantation as a transversal therapeutic platform, both as a curative strategy and as a model of immune-mediated disease control.
  • Leadership of the national working group on germline predisposition to myeloid malignancies.
  • Co-coordination of a Precision Medicine Program for patients with myelodysplastic syndromes.
  • Establishment of the first dedicated Telomere Biology Unit in Spain.
  • Active contribution to national clinical guidelines for myelodysplastic syndromes.
  • Strengthening the integration of clinical and translational research through optimized longitudinal sample collection for genomic and immune profiling.
Biological Discovery and Mechanistic Insight
  • Define the impact of clonal hematopoiesis in cancer patients, particularly its role in treatment-related toxicity and immune dysfunction.
  • Identify molecular drivers of donor cell leukemia following allogeneic stem cell transplantation.
  • Characterize transcriptomic programs of the bone marrow niche and neoplastic cells in MDS and their influence on therapeutic response.
  • Uncover cryptic genomic variants in germline-predisposed myeloid neoplasms through advanced genomic analyses.
Translational Infrastructure and Biobanking
  • Strengthen longitudinal biobanking capacity by expanding DNA/RNA collection, cell cryopreservation and serum repositories to enable future genomic and immune studies.
  • Consolidate integrated clinical–biological datasets to accelerate hypothesis-driven translational research.
Talent Development and Research Capacity
  • Promote structured research career development through PhD training programs across group members.
  • Expand basic and translational research capacity through competitive funding and recruitment of dedicated research personnel.
  • Novoa-Jáuregui S, Huber S, Gabarrós-Subirà M, Chen-Liang TH, Torres-Esquius S, Carrillo-Tornel S, Santiago M, Bernal Del Castillo T, Martín-Castillo I, Hernandez FM, Del Rey M, Liquori A, Tormo M, Cervera J, Bosch F, Valcárcel D, Haferlach C, Díez-Campelo M, Montoro MJ, Haferlach T, Jerez A. Myelodysplastic neoplasms with ring sideroblasts without SF3B1 mutations in adults: enrichment of germline variants in congenital sideroblastic anemia genes. Leukemia. 2025 Jul;39(7):1791-1794.
  • Gurnari C, Makishima H, Durmaz A, Attardi E, Saiki R, Bataller A, Sapinho G, Gondek L, Nannya Y, Best S, Krishnamurthy P, Kong KL, Atsuta Y, Kasahara S, Ohyashiki K, Miyazaki Y, Kanemura N, Hiramoto N, Versino F, Montoro MJ, Torres-Esquius S, Jerez Cayuela A, López-Esteban M, Martínez-Laperche C, Awada H, Visconte V, DiNardo CD, Voso MT, DeZern AE, Garcia-Manero G, Kulasekararaj AG, Maciejewski JP, Ogawa S. DDX41-mutant myeloid neoplasms defy current prognostic schemes and require a dedicated risk scoring system: a multicenter, retrospective study. Leukemia. 2025 Dec 3. doi: 10.1038/s41375-025-02814-0.
  • Ortí G, Peczynski C, Boreland W, O'Reilly M, von Bonin M, Balduzzi A, Besley C, Kalwak K, Ryhänen S, Güngör T, Wynn RF, Bader P, Mielke S, Blaise D, Amrolia P, Yakoub-Agha I, Calkoen F, Schubert ML, Potter V, Pichler H, Kröger N, Kwon M, Sengeloev H, Torrent A, Chalandon Y, van Gorkom G, Koenecke C, Graham C, Schoemans H, Moiseev I, Penack O, Peric Z. Graft-versus-host disease after anti-CD19 chimeric antigen receptor T-cell therapy following allogeneic hematopoietic cell transplantation: a transplant complications and paediatric diseases working parties joint EBMT study. Leukemia. 2025 Feb;39(2):431-437.
  • DeZern AE, Thepot S, de Botton S, Patriarca A, Deeren D, Torregrossa-Diaz JM, Marconi G, Bernal T, Bergua Burgues J, Xicoy B, Jonášová A, Zeidan AM, Dimicoli-Salazar S, Simand C, Valcarcel D, Diez Campelo M, Chai-Ho W, Saini L, Garnier A, Geissler K, Ofran Y, Nagy Z, Krishnamurthy P, Lübbert M, Basak G, Carraway HE, Sallman DA, Borate U, Santini V, Campbell V, Fenaux P, Braun T, Lanza F, Zaucha JM, Roth DA, Paul S, Roy P, Kelly MJ, Volkert A, Chisholm J, Malak TA, Klimek VM, Cluzeau T. Pivotal results of SELECT-MDS-1 phase 3 study of tamibarotene with azacitidine in newly diagnosed higher-risk MDS. Blood Adv. 2025 Aug 26;9(16):4090-4099.
  • 2025 American Society of Hematology Abstract Achievement Award for the following group members as ASH 2025 meeting abstract first authors: dia Pellin, Sara Torres, Sandra Novoa, Francisco Beas, María Gabarrós.

For a full listing of clinical trials in hematology with active recruitment at some time in the year in 2025 click here.

Group Leaders Joaquin Mateo, Joan Carles (until July) Senior Researcher Irene Casanova Staff Researcher Gisela Mir Medical Oncologists Pablo Cresta, Maria Dolores Fenor de la Maza Postdoctoral Fellows Nicolas Anselmino, Richard Norris Clinical Research Fellow Francesca Zacchi PhD Students Julian Brandariz, Youhao Chen, Victor Esquefa, Andrei Salca, Roma Sunder Technicians Teresa Casals, Lara de Llobet, Laura Martinez, Mar More, Anna Oliveira Clinical Data Curator Haitham Alatoom Clinical Research Coordinators Maria del Mar Suanes, Erika Saenz Research Nurses Ana Maria Castañeira, Helena Palma Bionformaticians Daniel Aguilar, Manuel Ramos

Research Groups

Prostate Cancer Group

Summary

The development of new drugs and therapeutic strategies for advanced prostate cancer is the main objective of our Group. We combine clinical trials, molecular correlative studies, and mechanistic studies following a bench-to-bedside-and-back research approach.

We integrate multidisciplinary expertise spanning clinical research, cancer biology, genomics and transcriptomics, bioinformatics, liquid biopsy, and clinical data science to advance precision medicine for patients with prostate cancer. To support this effort, we have established a platform for collecting longitudinal biospecimens and data from patients with advanced prostate cancer. These samples allow us to study the evolving nature of the disease and generate patient-derived laboratory models, which we use to investigate new therapeutic strategies in the lab.

Our clinical trial portfolio spans the entire disease continuum, with a focus on early phase trials of new compounds and biology-driven therapeutic strategies. Investigator-initiated clinical studies are central to our research strategy, providing a platform for correlative studies. We currently serve as the central laboratory for two academic multi-center clinical trials and manage the sample repository for IRONMAN; an international initiative to build a large clinical and biospecimen database from patients with metastatic prostate cancer.

The main lines of research include: 1) understanding how prostate cancers adapt to systemic therapies, with a focus on the cell cycle and DNA damage response regulation; 2) developing novel tissue and liquid biopsy molecular characterization approaches for improved patient stratification; and 3) identifying prognostic and predictive biomarkers to guide more precise treatment decisions. To achieve these goals, we study in-vitro and in-vivo models, including patient-derived xenografts (PDX) from the patients participating in our clinical studies. We study genomics and transcriptomics of clinical biospecimens, with a focus on ctDNA and tumor-derived extracellular vesicles. Additionally, we leverage both in-house and publicly available clinic-genomic databases to advance precision cancer care.

We are also leading the HOPE-Prostate study, a collaborative project with the SOLTI Group and Spanish prostate cancer medical societies to empower patients to undergo molecular testing. As part of this initiative, over 200 patients from across Spain have enrolled in the study and provided data and biospecimens.

We are honored to receive funding support from the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP), the Spanish Ministry of Health, CRIS Cancer Foundation, Asociación Española Contra el Cáncer – AECC (Spanish Association Against Cancer), FERO Foundation, Prostate Cancer Foundation and the ”la Caixa” Foundation. We also have joint projects with biotech and pharmaceutical industry partners for the development of novel therapeutic strategies.

To accelerate progress, we embrace team science. We actively participate in collaborations that pool resources and expertise across multiple research groups worldwide.

  • To understand why some treatments for prostate cancer only work in some patients and not in others, so we can offer each patient the best therapeutic option for their individual case.
  • To test and develop new therapeutic strategies for prostate cancer in clinical trials.
  • Study how prostate cancer adapts to therapy, with a focus on targeting emerging vulnerabilities to delay disease recurrence.
  • Investigate tumor heterogeneity in response to therapy in preclinical and patient-derived xenograft models (PDX), as well as by interrogating patient biopsies.
  • Develop new liquid biopsy tools that can be used to monitor tumor evolution.
  • Development of academic clinical trials to validate our laboratory results in the clinic and leveraging patient biopsies for correlative studies.
  • Publication of original studies from our research lab in Cell Reports Medicine, Molecular Cancer Research, and NPJ Precision Oncology.
  • Results from clinical trials in which our group has actively participated have been published in The Lancet and reported at international conferences.
  • Launch of the IRONseq project, and ancillary biospecimen analysis study from the IRONMAN study.
  • Collaboration in a study identifying the immunogenic potential of hotspot AR mutations linked to therapy resistance (published in Cancer Discovery).
  • Expansion of our medical team, reinforcing our leading role in clinical trials and enabling more robust integration of clinical and laboratory research.
  • Build a platform for collaborative research, integrating clinical and genomics data.
  • Develop genomics and transcriptomics assays, from both tumor tissue and liquid biopsies, to stratify prostate cancer to clinically relevant signatures.
  • Generate laboratory models from patients’ biopsies for the investigation of new therapeutic strategies.
  • Validate genomic and transcriptomics signatures associated with DDR defects in prostate cancer.
  • Arce-Gallego S, Esquefa V, Domenech H, Salca A, Aguilar D, Casals T, Mir G, Simonetti S, Oliveira A, de Llobet L, Neeb A, Brandariz J, Anselmino N, Casanova-Salas I, Herranz N, Serra V, de Bono JS, Mateo J. Combination therapy overcomes secondary PARPi resistance in ATM-deficient prostate cancer. NPJ Precis Oncol. 2025 Nov 26;9(1):407.
  • Brandariz J, de Llobet L, Esquefa V, Aguilar D, Salca A, Arce-Gallego S, Cresta Morgado P, Sole A, Agundez L, Mir G, Castro N, Casals T, Oliveira A, Casanova-Salas I, Malumbres M, Carles J, Morellá-Aucejo Á, Bernardos A, Martínez-Máñez R, Mateo J, Herranz N. Harnessing Senolytics and PARP Inhibition to Expand the Antitumor Activity of CDK4/6 Inhibitors in Prostate Cancer. Mol Cancer Ther. 2025 Dec 2;24(12):1959-1976.
  • Arce-Gallego S, Cresta Morgado P, Delgado-Serrano L, Simonetti S, Gonzalez M, Romero-Lozano P, Marmolejo D, Morales-Barrera R, Arnau GM, Semidey ME, Aguilar D, Cordoba-Terreros S, Mast R, de Albert M, Planas J, Cuadras M, Maldonado X, Suarez C, Casanova-Salas I, Figols M, Cros S, Mas A, Nonell L, Dienstmann R, Nuciforo P, Vivancos A, Llop-Guevara A, Carles J, Serra V, Mateo J. Homologous recombination repair status in metastatic prostate cancer by next-generation sequencing and functional immunofluorescence. Cell Rep Med. 2025 Feb 18;6(2):101937.
  • Gumpert N, Sagie S, Arnedo-Pac C, Babu T, Weller C, Gonzalez-Perez A, Wang Y, Michel Todó L, Levy R, Chen X, Greenberg P, Dayan-Rubinov M, Yakubovich E, Wasserman-Bartov T, Zerbib M, Gong J, Rebernick RJ, Oliveira Tercero A, Agundez Muriel L, Benedek G, Kedmi M, Oren R, Ben-Dor S, Levin Y, Troyanskaya OG, Munzur AD, Wyatt AW, Cieslik MP, Quigley DA, Van Allen EM, Anandasabapathy N, Mateo J, Yang X, Martínez-Jiménez F, Lopez-Bigas N, Samuels Y. Recurrent Immunogenic Neoantigens and Their Cognate T-cell Receptors in Treatment-Resistant Metastatic Prostate Cancer. Cancer Discov. 2025. doi: 10.1158/2159-8290.CD-24-1213.

Judith Balmaña:

  • Irene Casanova-Salas received a European Research Council (ERC) Starting Grant.
  • Richard Norris was awarded an Asociación Española Contra el Cáncer – AECC (Spanish Association Against Cancer) Talent Fellowship.
  • Francesca Zacchi received an AIRC Fellowship.
New in 2025:
  1. A deep learning framework to predict BRCA mutations from digital pathology slides Grantor: AstraZeneca and ISC-III Duration: 2025-2026 PI: Joaquin Mateo and Raquel Perez-Lopez
  2. Computational modelling of tumour evolution and treatment resistance in prostate cancer Grantor: Fundacion AECC Duration: 2025-2028 PI: Richard Norris
Ongoing projects in 2025:
  1. Project title: Integrated analysis of blood circulating tumor signatures to monitor genomic evolution and therapy responses in advanced Prostate Cancer. Grantor: Prostate Cancer Foundation. Duration: 2024-2027. PI: Irene Casanova-Salas.
  2. Project title: ctDNA profiling in metastatic prostate cancer. Grantor: Guardant Health. Duration: 2024-2025. PI: Joaquin Mateo.
  3. Project title: Targeting Resistance: Mechanisms and Modulators of PARP Inhibitor Response in Prostate Cancer. Grantor: Fundación AECC. Duration: 2024-2027. PI: Nicolas Anselmino.
  4. Title: Dissecting mechanisms of resistance and the interaction between PARPi use and AR in men with prostate cancer. Grantor: AstraZeneca. Duration: 2024-2026. PI: Joaquin Mateo.
  5. Project title: Development of NT1, a potent and selective best-in-class drug targeting the Androgen Receptor disordered domain for the treatment of Castration Resistant Prostate Cancer. Grantor: Programa RETOS Colaboracion Publico-Privada, Spanish Ministry of Science. Duration: 2024-2026. PI: Joaquin Mateo.
  6. Project title: Multimodal Biomarkers for Precise Management of Metastatic Prostate Cancer. Grantor: Programa RETOS Colaboracion Publico-Privada, Spanish Ministry of Science. Duration: 2023-2025. Co-PIs: Joaquin Mateo and Raquel Perez Lopez.
  7. Project title: Studying intra-tumor heterogeneity in the evolution of metastatic hormone-naïve prostate cancer to castration-resistance after intensified hormonal therapy. Grantor: Department of Defense CDMRP (United States) 2022 Call. Duration: 2023-2026. PI: Joaquin Mateo.
  8. Project title: Tumoral senescence induced by anti-cancer therapies constitutes a novel prognostic biomarker and a therapeutic target. Grantor: AECC (Fundación Asociación Española contra el Cáncer). Duration: 2022-2026. Co-PIs: Manuel Serrano, Maria Abad, Raquel Perez and Joaquin Mateo
  9. Project title: Prostate Cancer Genomic Evolution and Signatures of DNA Damage Repair Deficiencies. Grantor: CRIS Cancer Foundation. Duration: 2021-2026. PI: Joaquin Mateo.
  1. Arce-Gallego S, Esquefa V, Domenech H, Salca A, Aguilar D, Casals T, Mir G, Simonetti S, Oliveira A, de Llobet L, Neeb A, Brandariz J, Anselmino N, Casanova-Salas I, Herranz N, Serra V, de Bono JS, Mateo J. Combination therapy overcomes secondary PARPi resistance in ATM-deficient prostate cancer. NPJ Precis Oncol. 2025 Nov 26;9(1):407. doi: 10.1038/s41698-025-01179-y. PMID: 41299058; PMCID: PMC12750001.
  2. Grussu F, Grigoriou A, Bernatowicz K, Palombo M, Casanova-Salas I, Navarro-Garcia D, Barba I, Simonetti S, Serna G, Macarro C, Voronova AK, Garay V, Corral JF, Vidorreta M, García-Polo García P, Merino X, Mast R, Rosón N, Escobar M, Vieito M, Toledo R, Nuciforo P, Mateo J, Garralda E, Perez-Lopez R. Clinically feasible liver tumour cell size measurement through histology-informed in vivo diffusion MRI. Commun Med (Lond). 2025 Nov 20;5(1):535. doi: 10.1038/s43856-025-01246-2. PMID: 41266804; PMCID: PMC12749696.
  3. Gumpert N, Sagie S, Arnedo-Pac C, Babu T, Weller C, Gonzalez-Perez A, Wang Y, Michel Todó L, Levy R, Chen X, Greenberg P, Dayan-Rubinov M, Yakubovich E, Wasserman-Bartov T, Zerbib M, Gong J, Rebernick RJ, Oliveira Tercero A, Agundez Muriel L, Benedek G, Kedmi M, Oren R, Ben-Dor S, Levin Y, Troyanskaya OG, Munzur AD, Wyatt AW, Cieslik MP, Quigley DA, Van Allen EM, Anandasabapathy N, Mateo J, Yang X, Martínez-Jiménez F, Lopez-Bigas N, Samuels Y. Recurrent Immunogenic Neoantigens and Their Cognate T-cell Receptors in Treatment-Resistant Metastatic Prostate Cancer. Cancer Discov. 2026 Feb 6;16(2):250-269. doi: 10.1158/2159-8290.CD-24-1213. PMID: 41056506; PMCID: PMC12749549.
  4. Bacca L, Brandariz J, Zacchi F, Zivi A, Mateo J, Labbé DP. Therapy-induced senescence in prostate cancer: mechanisms, therapeutic strategies, and clinical implications. Gene. 2025 Nov 20;972:149774. doi: 10.1016/j.gene.2025.149774. Epub 2025 Sep 22. PMID: 40992550.
  5. Sanchis P, Sabater A, Lechuga J, Rada J, Seniuk R, Pascual G, Gatti M, Bizzotto J, Shepherd PDA, Yang J, Cotignola J, Vazquez E, Mateo J, Valacco P, Labanca E, Logothetis C, Gueron G, Anselmino N. PKA-driven SPP1 activation as a novel mechanism connecting the bone microenvironment to prostate cancer progression. Oncogene. 2025 Oct;44(38):3568-3579. doi: 10.1038/s41388-025-03511-z. Epub 2025 Aug 2. PMID: 40753365; PMCID: PMC12436191.
  6. Zurita AJ, Tidwell RS, Chapin BF, Harris DR, Zhang M, Pisters LL, Aparicio A, Araujo JC, Arce-Gallego S, Zhu K, Lozano ML, Pagliaro L, Mateo J, Logothetis C, Troncoso P, Davis JW. Randomized Phase 2 Trial of Presurgical Androgen Deprivation Therapy With or Without Axitinib in Prostate Cancer Presenting With Lymph Node Metastasis. Eur Urol Oncol. 2025 Aug;8(4):1010-1019. doi: 10.1016/j.euo.2025.04.015. Epub 2025 Jul 12. PMID: 40651932.
  7. Brandariz J, de Llobet L, Esquefa V, Aguilar D, Salca A, Arce-Gallego S, Cresta Morgado P, Sole A, Agundez L, Mir G, Castro N, Casals T, Oliveira A, Casanova-Salas I, Malumbres M, Carles J, Morellá-Aucejo Á, Bernardos A, Martínez-Máñez R, Mateo J, Herranz N. Harnessing Senolytics and PARP Inhibition to Expand the Antitumor Activity of CDK4/6 Inhibitors in Prostate Cancer. Mol Cancer Ther. 2025 Dec 2;24(12):1959-1976. doi: 10.1158/1535-7163.MCT-24-0903. PMID: 40601842.
  8. Martin-Martin N, Garcia-Longarte S, Corres-Mendizabal J, Lazcano U, Astobiza I, Bozal-Basterra L, Herranz N, van Splunder H, Carlevaris O, Pujana-Vaquerizo M, Blasco MT, Aransay AM, Rosino A, Tudela J, Jimenez D, Martinez A, Salca A, Santos-Martín A, Rey S, Ugalde-Olano A, Gonzalo D, Graupera M, Gomis RR, Mateo J, Unda M, Gonzalez-Billalabeitia E, Loizaga-Iriarte A, Mendizabal I, Carracedo A. Transcriptional analysis of metastatic hormone-naïve prostate cancer primary tumor biopsies reveals a relevant role for SOX11 in prostate cancer cell dissemination. Genome Biol. 2025 Jun 3;26(1):154. doi: 10.1186/s13059-025-03623-5. PMID: 40462200; PMCID: PMC12135548.
  9. Balaguer-Montero M, Marcos Morales A, Ligero M, Zatse C, Leiva D, Atlagich LM, Staikoglou N, Viaplana C, Monreal C, Mateo J, Hernando J, García-Álvarez A, Salvà F, Capdevila J, Elez E, Dienstmann R, Garralda E, Perez-Lopez R. A CT-based deep learning-driven tool for automatic liver tumor detection and delineation in patients with cancer. Cell Rep Med. 2025 Apr 15;6(4):102032. doi: 10.1016/j.xcrm.2025.102032. Epub 2025 Mar 20. PMID: 40118052; PMCID: PMC12047525.
  10. Arce-Gallego S, Cresta Morgado P, Delgado-Serrano L, Simonetti S, Gonzalez M, Romero-Lozano P, Marmolejo D, Morales-Barrera R, Arnau GM, Semidey ME, Aguilar D, Cordoba-Terreros S, Mast R, de Albert M, Planas J, Cuadras M, Maldonado X, Suarez C, Casanova-Salas I, Figols M, Cros S, Mas A, Nonell L, Dienstmann R, Nuciforo P, Vivancos A, Llop-Guevara A, Carles J, Serra V, Mateo J. Homologous recombination repair status in metastatic prostate cancer by next-generation sequencing and functional immunofluorescence. Cell Rep Med. 2025 Feb 18;6(2):101937. doi: 10.1016/j.xcrm.2025.101937. Epub 2025 Feb 5. PMID: 39914385; PMCID: PMC11866514.
  11. Naqvi SAA, Riaz IB, Bibi A, Khan MA, Imran M, Khakwani KZR, Raina A, Anjum MU, Cobran EK, Warner JL, Hussain SA, Singh P, Childs DS, Baca SC, Orme JJ, Mateo J, Agarwal N, Gillessen S, Murad MH, Sartor O, Bryce AH. Heterogeneity of the Treatment Effect with PARP Inhibitors in Metastatic Castration-resistant Prostate Cancer: A Living Interactive Systematic Review and Meta-analysis. Eur Urol. 2025 Jun;87(6):626-640. doi: 10.1016/j.eururo.2024.12.007. Epub 2025 Jan 23. PMID: 39848867.
  12. Zacchi F, Abida W, Antonarakis ES, Bryce AH, Castro E, Cheng HH, Shandhu S, Mateo J. Recent and Future Developments in the Use of Poly (ADP-ribose) Polymerase Inhibitors for Prostate Cancer. Eur Urol Oncol. 2025 Jun;8(3):818-828. doi: 10.1016/j.euo.2024.11.011. Epub 2024 Dec 5. PMID: 39638687; PMCID: PMC12797174.
  13. Gillessen S, Turco F, Davis ID, Efstathiou JA, Fizazi K, James ND, Shore N, Small E, Smith M, Sweeney CJ, Tombal B, Zilli T, Agarwal N, Antonarakis ES, Aparicio A, Armstrong AJ, Bastos DA, Attard G, Axcrona K, Ayadi M, Beltran H, Bjartell A, Blanchard P, Bourlon MT, Briganti A, Bulbul M, Buttigliero C, Caffo O, Castellano D, Castro E, Cheng HH, Chi KN, Clarke CS, Clarke N, de Bono JS, De Santis M, Duran I, Efstathiou E, Ekeke ON, El Nahas TIH, Emmett L, Fanti S, Fatiregun OA, Feng FY, Fong PCC, Fonteyne V, Fossati N, George DJ, Gleave ME, Gravis G, Halabi S, Heinrich D, Herrmann K, Hofman MS, Hope TA, Horvath LG, Hussain MHA, Jereczek-Fossa BA, Jones RJ, Joshua AM, Kanesvaran R, Keizman D, Khauli RB, Kramer G, Loeb S, Mahal BA, Maluf FC, Mateo J, Matheson D, Matikainen MP, McDermott R, McKay RR, Mehra N, Merseburger AS, Morgans AK, Morris MJ, Mrabti H, Mukherji D, Murphy DG, Murthy V, Mutambirwa SBA, Nguyen PL, Oh WK, Ost P, O'Sullivan JM, Padhani AR, Parker C, Poon DMC, Pritchard CC, Rabah DM, Rathkopf D, Reiter RE, Renard-Penna R, Ryan CJ, Saad F, Sade JP, Sandhu S, Sartor OA, Schaeffer E, Scher HI, Sharifi N, Skoneczna IA, Soule HR, Spratt DE, Srinivas S, Sternberg CN, Suzuki H, Taplin ME, Thellenberg-Karlsson C, Tilki D, Türkeri LN, Uemura H, Ürün Y, Vale CL, Vapiwala N, Walz J, Yamoah K, Ye D, Yu EY, Zapatero A, Omlin A. Management of Patients with Advanced Prostate Cancer. Report from the 2024 Advanced Prostate Cancer Consensus Conference (APCCC). Eur Urol. 2025 Feb;87(2):157-216. doi: 10.1016/j.eururo.2024.09.017. Epub 2024 Oct 11. PMID: 39394013.
  14. Francini E, Agarwal N, Castro E, Cheng HH, Chi KN, Clarke N, Mateo J, Rathkopf D, Saad F, Tombal B. Intensification Approaches and Treatment Sequencing in Metastatic Castration-resistant Prostate Cancer: A Systematic Review. Eur Urol. 2025 Jan;87(1):29-46. doi: 10.1016/j.eururo.2024.09.008. Epub 2024 Sep 20. PMID: 39306478.
  15. Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschäbitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):447-460. doi: 10.1016/S0140-6736(25)00684-1. Epub 2025 Jul 16. PMID: 40683290.
  16. Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschäbitz S, Oldenburg J, Ye D, Lin X, Kalac M, Douglas Laird A, Kennedy D, Agarwal N. Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):461-474. doi: 10.1016/S0140-6736(25)00683-X. Epub 2025 Jul 16. PMID: 40683287.
  • 2025-0312; Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy; III
  • 2024-0987; Management of Radium-223 in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) in real world clinical practice in Spain.; IV
  • 2023-1059; "Phase III Trial of Docetaxel vs. Docetaxel and Radium‐223 for Metastatic Castration‐Resistant Prostate Cancer (mCRPC)"; III
  • 2025-0452; A Phase 3, Two-stage part, Randomized, Open-label, Adaptive Study Comparing the Efficacy and Safety of BMS-986365 versus a Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC).; III
  • 2025-1221; Estudio de fase II multicéntrico, internacional, aleatorizado, prospectivo, abierto y no comparativo de lutecio [177Lu] vipivotida tetraxetano (AAA617) en monoterapia y lutecio [177Lu] vipivotida tetraxetano (AAA617) en combinación con inhibidores de la vía del receptor androgénico en pacientes con cáncer de próstata resistente a la castración con PET-PSMA positivo  (PSMACare; II
  • 2025-1078; A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adults with PSMA-positive metastatic castration resistant prostate cancer (mCRPC); II
  • 2023-0452; An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of AZD5305 Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy In Men with Newly Diagnosed Prostate Cancer (ASCERTAIN); I
  • 2024-0566; A Randomised, Double-blind, Placebo-Controlled, Phase III Study of AZD5305 in Combination with Physician's Choice New Hormonal Agents in Participants with Metastatic Castration-Sensitive Prostate Cancer with and without HRRm; III
  • 2025-0695; A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC).; III
  • 2016-0802; Ensayo de fase Ib/II de tratamientos combinados con pembrolizumab (MK-3475) en el cáncer de próstata resistente a la castración metastásico (CPRCm) (KEYNOTE-365); II
  • 2024-0675-1-II; Subestudio MK-5684-01A: Subestudio en paraguas de fase 1/2 del protocolo maestro MK-5684-U01 para evaluar la seguridad y la eficacia de combinaciones terapéuticas basadas en MK-5684 o de MK-5684 en monoterapia en participantes con cáncer de próstata resistente a la castración metastásico (CPRCm); II
  • 2022-0991; A randomized phase III trial evaluating the efficacy and safety of androgen deprivation therapy +/- darolutamide in frail men with castration-naïve de novo metastatic prostate cancer from the Prostate Cancer Consortium in Europe (PEACE).; III

Group Leader Judith Balmaña Laboratory Head Sara Gutiérrez-Enríquez Medical Oncologist Alejandra Rezqallah Genetic Counselors Estela Carrasco, Adrià López Fernández, Eduard Pérez Ballestero Associate Investigators Berta Campos, Alejandro Moles Fernández Predoctoral Investigators Setareh Kompanian, Carmen Moreno Aldomà, Laia Peralba Parada Research Coordinator Laura Duran Lozano Study Coordinator Anna Moreno Garcia Data Managers Victor Gonzalez Huici, Júlia Reig Jané

Research Groups

Hereditary Cancer Genetics Group

Summary

Our group addresses the challenges of diagnosing hereditary cancer susceptibility. In partnership with the Hereditary Cancer Program at the Catalan Institute of Oncology (ICO), we investigate the genetic complexity of hereditary cancer by developing novel diagnostic techniques, assessing individualized cancer risk and their actionability in cancer screening and risk reduction, exploring new models for genetic counselling, and testing targeted therapies for patients with germline alterations. Our goal is to translate these research findings into clinical practice.

We have secured funding to study individualized genetic breast cancer risk assessment and risk-adapted approaches, including polygenic risk score (PRS) analysis. This line of research aims to modify breast cancer screening to a risk-adapted strategy and provide more evidence for cancer risk-reducing actions. Additionally, a longitudinal national-based registry of mutation carriers is collecting prospective data to assess phenotypes and health outcomes of surveillance.

We are also involved in the clinical development of PARP inhibitors (PARPi) in early gBRCA1/2 breast cancer, and novel combinations in advanced disease. Our group has identified a functional biomarker for PARPi sensitivity that has been tested preclinically. We are now validating this biomarker in samples from clinical trials.

This year we led a nationwide project (CANGUR) to reach a consensus on pediatric cancer susceptibility genes to be included in genomic newborn screening. This is the first step of a long journey of implementation research.

Led by Sara Gutiérrez-Enríquez, head of our laboratory, we pursue our interest in the genetic epidemiology of hereditary breast and ovarian cancer (HBOC). This research has provided tools to discriminate and interpret variants of uncertain significance (VUS) in BRCA1/2 genes. We also aim to decipher the role of intronic, splicing, and missense variants in major HBOC genes and investigate the yield of whole genome sequencing (WGS) and RNA-seq. In collaboration with Xavier Maldonado, Head of VHIO’s Radiation Oncology Group, Sara Gutiérrez-Enríquez is independently leading research on predictive genetic and cellular markers of susceptibility to radiotherapy-induced side effects.

Figure I: Box-plots showing the distribution of lifetime (20-80 years old) breast cancer risk estimation (%) by gene. Color-shaded areas denote average (<17%), moderate (17–29%), and high (≥30%) risk NICE thresholds. Risk estimates were calculated using the CanRisk tool implementing the BOADICEA algorithm, incorporating mammographic density and a polygenic score composed of 268 SNPs (PRISMA-268). This figure was generated within the framework of the PRISMA II project.
Figure II: Personalized Radiotherapy Optimization Using a Predictive Model Integrating Baseline Blood microRNA Profiles, Clinical, and Dosimetric Data, with a Visualization Tool to Support Medical Decision-Making.
  • Investigate genetic susceptibility to hereditary breast/ovarian cancer (HBOC), from molecular diagnosis to clinical impact.
  • The clinical development of targeted therapies in HBOC.
  • Develop and validate the RAD51 test as a biomarker of homologous recombination deficiency among non-BRCA1/2 mutation carriers and patients with variants of uncertain significance (VUS).
  • Identify cellular and genomic biomarkers as predictors of radiotherapy outcomes.
  • Develop new pathways to promote cancer germline predictive testing.
  • We are investigating the feasibility of personalized breast cancer risk assessment and early detection through the quantification of genetic and non-genetic risk factors, including the analysis of single nucleotide polymorphisms (SNPs).
  • We led a nationwide consensus of pediatric cancer susceptibility genes candidates for inclusion in genomic newborn screening.
  • We are clinically validating the RAD51predict assay as a functional biomarker of homologous recombination repair deficiency and a predictor of PARPi resistance.
  • We are participating in a European project to evaluate the cost-effectivenes of prevention of rare hereditary tumor risk syndromes (PREVENTABLE).
  • In collaboration with the international ENIGMA consortium, we have demonstrated that the application of the recently developed BRCA1/BRCA2 Variant Curation Expert Panel specifications reduced the rate of VUS in the BRCA1 exon 18 from 45.7% to 8.5%. Importantly, experimental mRNA profiling was crucial in solving around 10% of variant uncertainty.
  • We have shown that RAD51 foci can serve as reliable tumour-derived evidence for classifying BRCA1/2 or PALB2 germline variants.
  • We have started to participate in the TETRIS project. Funded by European Atomic Energy Community, this project aims to develop innovative tools by integrating genomics, transcriptomics, radiomics and artificial intelligence, to reduce the risks and effects of ionizing radiation after completing radiation.
  • We hosted the 2025 annual meeting of the Radiogenomics Consortium and the TETRIS European project.
  • Analysis of PRS to improve breast cancer risk estimation in women with pathogenic variants in HBOC genes and prospective validation of comprehensive breast cancer risk estimation at 5 and 10 years
  • Clinical development of novel PARPi as monotherapy or in combination.
  • Assess the challenges and barriers for promotion of hereditary cancer predictive testing
  • Characterize the spliceogenic effect and clinical classification of genetic variants leading to an increase of in-frame delta 11q in the exon 11 of BRCA1, through an ENIGMA and Catalan Institute of Oncology collaborative project.
  • Test the value of whole genome and RNA sequencing in the genetic diagnosis of HBOC.
  • Investigate the utility of patient-derived cells’ phenotype in variant classification.
  • Decipher the genetic susceptibility underlying the radiotherapy-induced side effects and the radiotherapy efficacy for tumor control.
  • Aguado-Flor E, Reyes VM, Navarro V, Mollà M, Aguado-Barrera ME, Altabas M, Azria D, Baten A, Bourgier C, Bultijnck R, Chang-Claude J, De Santis MC, Dunning AM, Duran-Lozano L, Elliott RM, Farcy Jacquet MP, Giandini C, Giraldo A, Green S, Lambrecht M, Lopez-Pleguezuelos C, Monten C, Rancati T, Rattay T, Rosenstein BS, De Ruysscher D, Diez O, Seibold P, Sperk E, Symonds RP, Stobart H, Vega A, Veldeman L, Villacampa G, Webb AJ, Weltens C, Zunino P, Talbot CJ, West CM, Giralt J, Gutiérrez-Enríquez S; REQUITE consortium. Integrating genetic polymorphisms and clinical data to develop predictive models for skin toxicity in breast cancer radiation therapy. Breast. 2025 Aug;82:104506.
  • López-Fernández A, Duran-Lozano L, Villacampa G, Pardo M, Pérez E, Darder E, Vallmajó A, Alfonso R, Cruellas M, Roqué A, Cartró M, Bareas A, Carrasco E, Rezqallah A, Jimenez-Macedo AR, Torres-Esquius S, Torres M, Lopez C, Espinosa M, Teulé A, Munté E, Tuset N, Diez O, Feliubadaló L, Lázaro C, Llort G, Carver T, Ficorella L, Mavaddat N, Mercadé A, Antoniou AC, Brunet J, Ramon Y Cajal T, Balmaña J. A randomized study of 2 risk assessment models for individualized breast cancer risk estimation. J Natl Cancer Inst. 2025 Aug 1;117(8):1593-1604.
  • Turnbull C, Achatz MI, Balmaña J, Castro E, Curigliano G, Cybulski C, Domchek SM, Evans DG, Hanson H, Hoogerbrugge N, James PA, Krause A, Nathanson KL, Ngeow Yuen Yie J, Robson M, Tischkowitz M, Westphalen B, Foulkes WD. Breast cancer germline multigene panel testing in mainstream oncology based on clinical-public health utility: ESMO Precision Oncology Working Group recommendations. Ann Oncol. 2025 Aug;36(8):853-865.
  • Lambertini M, Blondeaux E, Tomasello LM, Agostinetto E, Hamy AS, Kim HJ, Franzoi MA, Bernstein-Molho R, Hilbers F, Pogoda K, Wildiers H, Bajpai J, Ignatiadis M, Moore HCF, Partridge AH, Phillips KA, Toss A, Rousset-Jablonski C, Criscitiello C, Renaud T, Ferrari A, Paluch-Shimon S, Fruscio R, Cui W, Wong SM, Vernieri C, Ruddy KJ, Dieci MV, Matikas A, Rozenblit M, Villarreal-Garza C, De Marchis L, Puglisi F, Rodriguez-Wallberg KA, Duhoux FP, Livraghi L, Bruzzone M, Boni L, Balmaña J. Clinical Behavior of Breast Cancer in Young BRCA Carriers and Prediagnostic Awareness of Germline BRCA Status. J Clin Oncol. 2025 May 10;43(14):1706-1719.
    SARA GUTIÉRREZ-ENRÍQUEZ
    • Selected to give an elevator pitch at an investor day with the project RADiMiRS, Personalized Radiotherapy: Predicting Side Effects Through RNA Signatures.
    • Invited speaker  at the 14th Centro Nacional de Análisis Genómico (CNAG) Symposium on Genome Research in Cancer Genomics, 16 December, Barcelona, Spain.
    • Member of Scientific Organizing Committee, the 9th Variant Effect Prediction Training Course, Human Genome Organisation (HUGO), 28 September - 01 October, Porto, Portugal.
    • Expert Panel Membership,  Evidence-based Network for the Interpretation of Germline Mutation Alleles (ENIGMA) BRCA1 and BRCA2 Variant Curation Expert Panel (VECP), ClinGen.
    • Chair of the Splicing Working Group, ENIGMA international Consortium.
    JUDITH BALMAÑA
    • Catalonia Oncology Master Plan (2022–Present): Member of the Advisory Council.
    • Grant Evaluation: Reviewer for Cancer Research UK (CRUK), MINEO, FERO Foundation, and Gustave Roussy.
    • Scientific Committees: Member of the Scientific Committee of the European Society for Medical Oncology (ESMO) Annual Congress 2025, 17-21 October, Berlin, Germany,   2025 American Society of Clinical Oncology (ASCO) Annual Meeting 30 May – 03 June, Chicago, USA,  Genetic Tumour Risk Syndromes (GENTURIS) International Conference.
    • Cancer Core Europe (CCE): Co-founder of the -4th Pillar: Cancer Prevention and Early Detection.
    • ESMO EDEPT Task Force: Member of the Early Detection and Prevention Task Force.
    • Steering Committee:Steering Committee Member for the EVO-PARP1-BC clinical trial.
    • Invited speaker:invited Speaker at the European Reference Networks (ERN) GENTURIS online conference 2025, and the 10th International Symposium on Hereditary Breast and Ovarian Cancer (HBOC), 06-09 May, Montreal, Canada.
Funded Projects:
    New in 2025:
    Ongoing projects in 2025:
    1. Project title: Whole genome sequencing as a first-tier test to improve hereditary breast/ovarian genetic diagnosis. PI22/01200. PI: Sara Gutiérrez-Enríquez. Funding agency: Instituto de Salud Carlos III (ISCIII). Duration: 2023-2025.
    2. Project title: Feasibility analysis of implementing whole-genome sequencing for breast cancer genetic diagnosis and risk stratification. PI: Judith Balmaña. Funding agency The Breast Cancer Research Foundation (BCRF). Duration: 2023-2024, 2024-2025, 2025-2026
    3. Project title: TETRIS Risk assessment Tools for severe side Effects after breasT Radiotherapy: radiation safety through biological extended models and dIgital twinS. PI: Sara Gutiérrez-Enríquez. Project 101166699. Funding agency: HORIZON-EURATOM-2023-NRT-01 EURATOM-IA. Duration: 2024-2027
    4. Project title: Personalized Radiotherapy: Predicting Side Effects Through RNA Signatures. 2024 LLAV 00133. PI: Sara Gutiérrez-Enríquez. Funding agency: Agencia de Gestio d’Ajuts Universitaris i de Recerca. Llavor. Duration: 2024-2025.
    5. Project title: PREVENTABLE (GRANT 101095483, HORIZON-HEALTH-2022-CARE-08): Cancer Prevention vs cancer treatment, the rare tumor risk syndromes battle. PI Carla Oliveira. Duration 2023-2026.
    6. Project title: PRISMA-II: Breast and ovarian cancer risk stratification with the use of PRS. Validation in mutation carriers, prospective cohort and feasibility of genome sequencing. PI23/01047. Funding agency: ISCIII. PI: Judith Balmaña. Duration: 2024-2026.
    7. Project Title: GENCareSim: Simulation-Based Education for Hereditary Cancer Survivorship. Funding agency: European Health and Digital Executive Agency. PI: Judith Balmaña Coordinator: Bruno Silva (NOVA Medical School | Universidade Nova de Lisboa) Duration: 2025-2026
    8. Project Title: JA PCM: Joint Action Personalised Cancer Medicine. Funding agency: European Health and Digital Executive Agency. Coordinator: Marc Van Den Bulke (Sciensano). Colaborator in Arm 1 at VHIO: Judith Balmaña. Duration: 2025-2029
    9. Project Title: Clinical outcomes of CDK4/6 inhibitor + endocrine therapy in HRR-mutated metastatic breast cancer. Funding agency: Asociación de Cáncer de Mama Metastásico. PI: Judith Balmaña. Duration: 2024-2026
  1. Jaikuna T, Wilson F, Anandadas C, Azria D, Chang-Claude J, De Santis MC, Gutiérrez-Enríquez S, van Herk M, Hoskin P, Kotzki L, Lambrecht M, Lingard Z, Seibold P, Seoane A, Sperk E, Symonds RP, Talbot CJ, Rancati T, Rattay T, Reyes V, Rosenstein BS, de Ruysscher D, Vega A, Veldeman L, Webb A, West CML, Vasquez Osorio E, Aznar MC. Breast composition and dose deposition to fat and fibroglandular tissues are associated with breast side effects after radiation therapy. Breast. 2026 Jan 7;85:104694. doi: 10.1016/j.breast.2026.104694. Epub ahead of print. PMID: 41547330; PMCID: PMC12830329.
  2. Jaikuna T, Wilson F, Anandadas C, Azria D, Chang-Claude J, De Santis MC, Gutiérrez-Enríquez S, van Herk M, Hoskin P, Kotzki L, Lambrecht M, Lingard Z, Seibold P, Seoane A, Sperk E, Symonds R, Talbot CJ, Rancati T, Rattay T, Reyes V, Rosenstein BS, de Ruysscher D, Vega A, Veldeman L, Webb A, West CM, Vasquez Osorio E, Aznar MC. Unveiling regions associated with acute and late breast side-effects from breast radiotherapy using voxel-wise image-based data mining analysis. Radiother Oncol. 2026 Jan;214:111230. doi: 10.1016/j.radonc.2025.111230. Epub 2025 Oct 25. PMID: 41429725.
  3. Aguado-Flor E, Reyes VM, Navarro V, Mollà M, Aguado-Barrera ME, Altabas M, Azria D, Baten A, Bourgier C, Bultijnck R, Chang-Claude J, De Santis MC, Dunning AM, Duran-Lozano L, Elliott RM, Farcy Jacquet MP, Giandini C, Giraldo A, Green S, Lambrecht M, Lopez-Pleguezuelos C, Monten C, Rancati T, Rattay T, Rosenstein BS, De Ruysscher D, Diez O, Seibold P, Sperk E, Symonds RP, Stobart H, Vega A, Veldeman L, Villacampa G, Webb AJ, Weltens C, Zunino P, Talbot CJ, West CM, Giralt J, Gutiérrez-Enríquez S; REQUITE consortium. Integrating genetic polymorphisms and clinical data to develop predictive models for skin toxicity in breast cancer radiation therapy. Breast. 2025 Aug;82:104506. doi:10.1016/j.breast.2025.104506. Epub 2025 May 22. PMID: 40570703; PMCID: PMC12264628.
  4. Li K, Chadha M, Moshier E, Rosenstein BS; REQUITE consortium. Age-stratified analysis of health-related quality of life in patients with early-stage breast cancer receiving adjuvant radiation therapy and endocrine therapy. J Geriatr Oncol. 2025 Mar;16(2):102195. doi: 10.1016/j.jgo.2025.102195. Epub 2025 Feb 6. PMID: 39919652.
  5. McWilliam A, Marshall D, Kerns SL, Barnett GC, Vega A, Kapouranis T, Aguado Barrera ME, Avuzzi B, Azria D, Chang-Claude J, Choudhury A, Coedo Costa C, Dunning A, Farcy-Jacquet MP, Faivre-Finn C, Gutiérrez-Enríquez S, Fuentes-Ríos O, Gómez Caamaño A, Lambrecht M, López Pleguezuelos C, Rancati T, Rattay T, de Ruysscher D, Seibold P, Sperk E, Talbot C, Webb A, Veldeman L, Rosenstein BS, West CML; REQUITE Consortium. Association of radiation-induced normal tissue toxicity with a high genetic risk for rheumatoid arthritis. J Natl Cancer Inst. 2025 May 1;117(5):1018-1026. doi: 10.1093/jnci/djae349. PMID: 39761002; PMCID: PMC12058264.
  6. Aguado-Barrera ME, Lopez-Pleguezuelos C, Gómez-Caamaño A, Calvo-Crespo P, Taboada-Valladares B, Azria D, Boisselier P, Briers E, Chan C, Chang-Claude J, Coedo-Costa C, Crujeiras-González A, Cuaron JJ, Defraene G, Elliott RM, Faivre-Finn C, Franceschini M, Fuentes-Rios O, Galego-Carro J, Gutiérrez-Enríquez S, Heumann P, Higginson DS, Johnson K, Lambrecht M, Lang P, Lievens Y, Mollà M, Ramos M, Rancati T, Rattay T, Rimner A, Rosenstein BS, Sangalli C, Seibold P, Sperk E, Stobart H, Symonds P, Talbot CJ, Vandecasteele K, Veldeman L, Ward T, Webb A, Woolf D, de Ruysscher D, West CML, Vega A; REQUITE Consortium. Professional-patient discrepancies in assessing lung cancer radiotherapy symptoms: An international multicentre study. Lung Cancer. 2025 Jan;199:108072. doi: 10.1016/j.lungcan.2024.108072. Epub 2024 Dec 27. PMID: 39740425. 7. Giuntini F, González-Larreategui Í, Herencia-Ropero A, Casacuberta-Serra S, Zacarías-Fluck MF, Arnal M, Pedretti F, Martínez-Martín S, Thabussot H, Cano VC, Grueso J, Foradada L, Serrano E, López-Estévez S, Rodriguez O, Guzman M, Rodriguez-Hernandez A, Brasó-Maristany F, Llop-Guevara A, Balmaña J, Nonell L, Prat A, Serra V, Beaulieu ME, Whitfield JR, Massó-Vallés D, Soucek L. MYC inhibition by Omomyc causes DNA damage and overcomes PARPi resistance in breast cancer. Cell Rep. 2025 Dec 23;44(12):116604. doi: 10.1016/j.celrep.2025.116604. Epub 2025 Nov 21. PMID: 41273720; PMCID: PMC12727680.
  7. Barnes DR, Tyrer JP, Dennis J, Leslie G, Bolla MK, Lush M, Aeilts AM, Aittomäki K, Andrieu N, Andrulis IL, Anton-Culver H, Arason A, Arun BK, Balmaña J, Bandera EV, Barkardottir RB, Berger LPV, Berrington de Gonzalez A, Berthet P, Białkowska K, Bjørge L, Blanco AM, Blok MJ, Bobolis KA, Bogdanova NV, Brenton JD, Butz H, Buys SS, Caligo MA, Campbell I, Castillo C, Claes KBM, Colonna SV, Cook LS, Daly MB, Dansonka-Mieszkowska A, de la Hoya M, deFazio A, DePersia A, Ding YC, Doherty JA, Domchek SM, Dörk T, Einbeigi Z, Engel C, Evans DG, Foretova L, Fortner RT, Fostira F, Foti MC, Friedman E, Frone MN, Ganz PA, Gentry-Maharaj A, Glendon G, Godwin AK, González-Neira A, Greene MH, Gronwald J, Guerrieri-Gonzaga A, Hamann U, Hansen TVO, Harris HR, Hauke J, Heitz F, Hogervorst FBL, Hooning MJ, Hopper JL, Huff CD, Huntsman DG, Imyanitov EN, Izatt L, Jakubowska A, James PA, Janavicius R, John EM, Kar S, Karlan BY, Kennedy CJ, Kiemeney LALM, Konstantopoulou I, Kupryjanczyk J, Laitman Y, Lavie O, Lawrenson K, Lester J, Lesueur F, Lopez-Pleguezuelos C, Mai PL, Manoukian S, May T, McNeish IA, Menon U, Milne RL, Modugno F, Mongiovi JM, Montagna M, Moysich KB, Neuhausen SL, Nielsen FC, Noguès C, Oláh E, Olopade OI, Osorio A, Papi L, Pathak H, Pearce CL, Pedersen IS, Peixoto A, Pejovic T, Peng PC, Peshkin BN, Peterlongo P, Powell CB, Prokofyeva D, Pujana MA, Radice P, Rashid MU, Rennert G, Richenberg G, Sandler DP, Sasamoto N, Setiawan VW, Sharma P, Sieh W, Singer CF, Snape K, Sokolenko AP, Soucy P, Southey MC, Stoppa-Lyonnet D, Sutphen R, Sutter C, Tan YY, Teixeira MR, Terry KL, Thomsen LCV, Tischkowitz M, Toland AE, Van Gorp T, Vega A, Velez Edwards DR, Webb PM, Weitzel JN, Wentzensen N, Whittemore AS, Winham SJ, Wu AH, Yadav S, Yu Y, Ziogas A, Berchuck A, Couch FJ, Goode EL, Goodman MT, Monteiro AN, Offit K, Ramus SJ, Risch HA, Schildkraut JM, Thomassen M, Simard J, Easton DF, Jones MR, Chenevix-Trench G, Gayther SA, Antoniou AC, Pharoah PDP. Genome-wide association study of 398,238 women unveils seven loci associated with high-grade serous ovarian cancer. NPJ Genom Med. 2025 Nov 20;10(1):73. doi: 10.1038/s41525-025-00529-w. PMID: 41266372; PMCID: PMC12635163.
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Group Leader Irene Braña Medical Oncologists and Clinical Investigators Ilaria Mascagni, Gaspar Molina, Katerin Rojas

Research Groups

Head and Neck Cancer Group

Summary

Our group focuses on translational and clinical and research in head and neck cancers including head and neck squamous cell carcinoma (HNSCC) which accounts for around 90% of these tumor types. We also study rare malignancies including salivary gland, nasopharyngeal, and sinonasal cancers, and NUT carcinoma.

We have collaborated in the development of anti-PD1 therapies for patients with head and neck squamous cell carcinoma from early clinical trial to the pivotal study which led to the approval as 1st line in recurrent-metastatic HNSCC (KEYNOTE-048 study, Burtness et al. 2022). Our group was a key contributor to the study leading to the approval of perioperative anti‑PD‑1 in resectable HNSCC (Uppaluri R. et al 2025). This strong multidisciplinary involvement has laid the foundation for an expanded research line exploring innovative perioperative combination approaches.

We are committed to developing biomarkers of drug sensitivity or resistance to immunotherapy and evaluating novel combinations that might overcome primary or secondary resistance to anti-PD1 therapies.

In close collaboration with VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, we aim to identify and develop novel agents to treat patients with head and neck cancers, and improve patient outcomes through personalized medicine.

We are proud to have received a grant from the Spanish Association Against Cancer (AECC), supporting clinical studies in oncology (Ayuda Estudios Clínicos). This funding has enabled us to initiate the EORTC-sponsored study entitled: PROLoNg: Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck: a randomized phase III study, in Spain. Support received from AECC also allows us to conduct the translational part of this study, evaluating the VIGex gene expression signature developed in-house by VHIO (Hernando-Calvo et al. 2023), as well as other tissue-based and circulating tumor biomarkers.

Building on our interest in rare cancers, our group has initiated an ISCIII‑funded project in collaboration with the Growth Factors Group, to investigate the role of p95HER2 in malignant salivary gland cancers.Our Group Leader, Irene Braña, is an active member of several leading professional societies and associations in oncology. She serves as a member of the European Society for Medical Oncology (ESMO) Congress Head and Neck Cancer Track (since 2020), the European Organisation for Research and Treatment of Cancer (EORTC) Head and Neck Group, Cancer Core Europe, the American Society of Clinical Oncology (ASCO), and the Spanish Group of Head and Neck Cancer Treatment (TTCC). Her expertise significantly contributes to shaping precision oncology in the field of head and neck cancer.

  • Develop immune-based therapies for the treatment of head and neck cancers, and identify biomarkers of drug sensitivity or resistance.
  • Clinical development of novel therapies for head and neck squamous cell carcinomas as well as rare malignancies including salivary gland cancers, nasopharyngeal, sinonasal, and NUT carcinoma.
  • Multidisciplinary collaboration enabling the development of an innovative perioperative combination research program in resectable HNSCC.
  • Molecular characterization of head and neck tumors for the personalized treatment of individual patients.
  • We have pioneered the development of bi-specific antibodies targeting EGFR in head and neck cancers.
  • Evaluation of potential biomarkers of sensitivity/resistance to immunotherapy in head and neck cancers.
  • The advancement of precision oncology in head and neck cancers.
  • We have been awarded with a grant to evaluate the role of p95HER2 in HER2 positive salivary gland cancer.
  • Our collaboration in clinical studies has enabled us to provide selected patients with access to innovative therapies.
  • The initiation of the European Organisation for Research and Treatment of Cancer (EORTC)-sponsored PROLoNg study in Spain. As the national coordinator of this clinical trial, we are evaluating predictive biomarkers of response in patients (supported by funding received from the Spanish Association Against Cancer - AECC).
  • Evaluate the role of the gene expression ViGex as potential biomarker in patients with recurrent/metastatic head and neck squamous cell carcinoma, receiving anti-PD1 therapy to improve patient selection.
  • Create a nationwide project to characterize salivary gland cancers with the overarching goal of finding novel therapies and understanding the mechanisms of sensitivity or resistance to standard of care treatment.
  • Collaboration with immunogenomics group to evaluate factors of sensitivity or resistance to immunotherapy in resectable HNSCC.
  • Start a new research line on cancer prevention and create an education program for the community to promote healthy lifestyle and decrease risk factors associated with head and neck cancers.
  • Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Braña I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50.
  1. Project title: PROLoNg: Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and neck. Funding entity: Estudios Clínicos AECC- NATIONAL CONSORTIUM. Coordinator VHIO: Irene Braña.
  2. Project title: Evaluación del rol de p95HER2 en la evolución de tumores malignos de glándula salival malignos y como posible diana terapéutica. Funding entity: Instituto de Salud Carlos III. Coordinator: Irene Brana.
  3. Project title: tL-CHANCER: Unveiling the Role of T-Lymphocyte Clonal Hematopoiesis in Antitumor Immunity to Transform Cancer Immunotherapy. Coordinator: Francisco Martinez. Collaborator: Irene Brana.
  1. Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Braña I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50. doi: 10.1056/NEJMoa2415434. Epub 2025 Jun 18. PMID: 40532178.
  2. Tahara M, Greil R, Rischin D, Harrington KJ, Burtness B, de Castro G, Psyrri A, Braña I, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesía R, Ngamphaiboon N, Rordorf T, Ishak WZW, Lin J, Gumuscu B, Lerman N, Soulières D. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study. Eur J Cancer. 2025 May 15;221:115395. doi: 10.1016/j.ejca.2025.115395. Epub 2025 Apr 4. PMID: 40262400.
  3. Even C, Harrington KJ, Massarelli E, Laban S, Fayette J, Oliva M, Klein Hesselink M, Visscher S, Fury MG, Wiekmeijer AS, Licitra L, Melichar B, Devriese LA, Braña I, Jankowska P, Posner M, Glisson B, Kong A, Hooftman L, Melief CJM MD,, Ferrarotto R. Randomized clinical efficacy and safety study of peltopepimut-S plus cemiplimab compared to cemiplimab alone in patients with recurrent/metastatic HPV16-positive head and neck cancer. J Immunother Cancer. 2025 Sep 8;13(9):e012555. doi: 10.1136/jitc-2025-012555. PMID: 40921630; PMCID: PMC12421166.
  4. Jiménez-Labaig P, Aymerich C, Rullan A, Cacicedo J, Braña I, Nutting C, Newbold K, Harrington KJ, Catalan A. Prevalence of depressive and anxiety symptoms in patients with head and neck cancer undergoing radiotherapy: A systematic review and meta-analysis of longitudinal studies. Radiother Oncol. 2025 Jan;202:110649. doi: 10.1016/j.radonc.2024.110649. Epub 2024 Nov 24. PMID: 39586358.
Active recruitment:
  • Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck : a randomized phase III study (PROLoNg). Sponsor: EORTC. Funding: AECC.
  • A phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma. MCLA-158-CL03/LiGeR-HN1.
  • A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator’s Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients. MCLA-158-CL03/LiGeR-HN2.
  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ficlatuzumab (HGF/cMET MAb) in Combination with Cetuximab in Patients with Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (HNSCC). FIERCE-HN.
  • A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE).
  • A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC).
Recruitment completed:
  • A Phase 1b/2, non-randomized, multi-arm, multicenter study evaluating the efficacy and safety of subcutaneous amivantamab as monotherapy or in combination with pembrolizumab, paclitaxel, or pembrolizumab plus carboplatin in patients with recurrent or metastatic head and neck squamous cell carcinoma (ORIGAMI‑4).
  • A Phase Ib/II, non-randomized, non-comparative, two-cohort study of niraparib and dostarlimab plus (chemo)radiotherapy in locally advanced head and neck squamous cell carcinoma (RADIAN)” TTCC-2022-01. Sponsor: TTCC-2022-01.

Group Leader Xavier Maldonado Radiation Oncologists Manel Altabas, Sergio Benavente, Josep Garre, André Geng, Alexandra Giraldo, Raquel Granado, Soraya Mico, Begoña Navalpotro, Monica Ramos, Enar Recalde, Victoria Reyes Research Physicist Laia Humbert Translational Biomedical Scientist Esperanza Medina

Research Groups

Radiation Oncology Group

Summary

The VHIO Radiation Oncology Group is a high-technology, internationally connected team dedicated to improving multidisciplinary cancer care through research, innovation, and advanced clinical practice. The department comprises 16 physicians, 40 radiotherapists, and specialized nursing staff, and operates with ISO 9001:2015 and UNE 17009 quality and safety certifications. Equipped with four linear accelerators and a dual-energy CT scanner, the team treats a high volume of complex cases, including more than 80% of pediatric patients in Catalonia requiring radiotherapy, as well as referrals from other Spanish regions and abroad.

The group is strongly integrated into national and international research networks, including EORTC, GETUG, SIOP, Eurocare, IRAD, and the Radiogenomics Consortium, and maintains strategic collaborations with ICMAB-CSIC, UAB, and the Karolinska Proton Center. Within VHIO and VHIR, the team works closely with multiple groups in genetics, prostate cancer, radiomics, and head and neck cancer, supporting both clinical and translational research. In 2025 alone, the group co-authored 30 publications and participated in over 40 clinical trials.

Clinically, the department leads innovation in precision and personalized radiotherapy, implementing respiratory-controlled treatments, deep inspiration breath-hold for breast cancer, image-guided tracking in prostate cancer, adaptive radiotherapy for several tumor sites, stereotactic techniques for oncology and non-oncological indications, and hippocampal-sparing whole-brain irradiation. These approaches aim to maximize tumor control while minimizing toxicity. Internally, we are members of Task Forces focused on various pathologies to help promote research under the VHIR-VHIO umbrella.

Intramurally, we collaborate closely with several VHIO groups, including the Hereditary Cancer Genetics Group led by Judith Balmaña to decipher the genetic causes of underlying normal tissue toxicity after radiotherapy, and with VHIO's Prostate Cancer Group directed by Joaquin Mateo, also previously co-directed by Joan Carles until July 2025), to study the transcriptomic and protein expression markers influenced by androgen deprivation. We are also expanding our research with VHIO's Radiomics Group led by Raquel Perez-Lopez. Together with investigators at the MD Anderson Cancer Center, we are working on a patient-reported outcome measures (PROMs) project in head and neck cancer.

In 2025, the Radiation Oncology research group consolidated its international visibility through high-impact publications and active participation in major consortia such as REQUITE, VALIDATE, ARTFORCE, and PREDMORN. Research focuses include adaptive radiotherapy, dose painting, radiogenomics, NTCP modelling, toxicity prediction, and AI-driven projects such as RADGEN-HNC. The group has demonstrated strong competitiveness in funding and has expanded its team with new investigators and PhD projects.

Overall, the Hospital Vall d’Hebron Radiation Oncology Department and VHIO’s Radiation Oncology Group present a coherent and ambitious program that integrates physics, biology, imaging, and clinical oncology, with a clear strategic orientation toward precision, data-driven, and personalized radiotherapy.

Figure: A 3-dimensional representation of teeth-based jaw segments and the radiation dose distribution overlayed on a CT image, as displayed by the RADMAP (RADiation dose MAPping) tool (van Dijk et al, 2025), a semi-automated tool for segmenting tooth-based jaw regions, enabling patient- and tooth-specific radiation dose mapping to improve dental dose reporting and osteoradionecrosis (ORN) risk assessment in patients with head and neck cancer treated with radiotherapy.
  • Translate new mechanistic insights into personalized radiation therapy and biomarker-driven strategies tailored to each patient's clinical and molecular features.
  • Increase and strengthen our participation into projects supported through competitive grants. Recruiting talent through a pre doctoral program.
  • Advance in clinical research in radiogenomics, predictive models, nanoparticles, polymorphisms, proton therapy and radioimmunotherapy (RIT), and expand our research in collaboration with VHIO's Groups and international research networks.
  • Continue upgrading our equipment to implement cutting-edge radiation oncology techniques, including rotational radiotherapy with volumetric modulated arc therapy (VMAT), radiosurgery (SRS), stereoatactic body radiation therapy (SBRT), respiratory control radiotherapy (RT4D), image-guided radiotherapy (IGRT), autocontouring programs and surface guided radiation therapy (SGRT).
  • Mantain the excellence in quality and safety by ISO 9001/2015 and UNE 17009:2013 certified accreditation program for radiation oncology, and the accreditation by the Organisation of European Cancer Institutes (OECI) for our onco-hematology program at the Vall d'Hebron University Hospital.
  • Develop digital health solutions and web-based/mobile phone applications for investigators, care providers, and patients.
  • Collaborate with our Clinical Research Support Unit (CRSU) in the design and implementation of investigator-initiated clinical trials (IITs) and registries, and provide support for electronic data capture and statistical analysis.
  • Strong integration into national and international research networks, including the European Organisation for Research and Treatment of Cancer (EORTC), Urogenital Tumors Study Group (GETUG), International Society of Paediatric Oncology (SIOP), Eurocare, Instituto de Investigación en Oncología Radioterápica (IRAD), and the Radiogenomics Consortium, and maintains strategic collaborations with the Institute of Materials Science of Barcelona (ICMAB-CSIC), Universitat Autònoma de Barcelona (UAB), and the Karolinska Proton Center.
  • Supported through a VHIO VIDA La Caixa Fellowship Post Doc Grant (2025-2028) Laia Humbert joined our group to pursue the RADGEN-HNC project: Radiogenomic profiling and AI-based spatiotemporal modelling for early detection of radiation-induced multi-organ toxicity in patients with head and neck cancer.
  • Agreement with the ICMAB-CSIC for developing nanomaterials research and its behaviour upon radiotherapy in murine models. The Gold Radiosensitizers for Advanced Proton thErapy (GRAPE) has been awarded with an ERC Proof of Concept Lump Sum Grant 2025 (ERC-2025-PoC). IPs: Gerard Tobias, Esperanza Medina.
  • We exercise leadership in the Spanish Society of Radiation Oncology’s (SEOR) Paediatric Radiation Oncology Group and continue to serve as national representatives of radiation oncology at SIOP through the contribution of Monica Ramos.
  • Our group has started a research line focused on proton therapy with two projects: the PIANOFORTE-EMPATHY EU proton project which is assessing dose distribution in adaptive proton therapy networking with the Hospital Clínic, U.Dresden and U.Leuven and with the Karolinska Institute and the Vall d’Hebron University Hospital’s Physics Department (Marta Beltran) estimating the risk of developing a second cancer in pediatric patients receiving craniospinal proton beam radiotherapy treatment.
  • We are also active members of the European Society for Paediatric Oncology (SIOP Europe) and EORTC QUARTET project that supports the delivery of high-quality radiotherapy for children and adolescents with cancer across Europe in clinical trials.
  • Radiomics and radiogenomics form the foundation of data-driven precision radiotherapy. By combining imaging, genomics, and artificial intelligence, they allow clinicians to predict outcomes more accurately, optimize treatment strategies, reduce side effects, and ultimately improve tumor control and patient quality of life.
  • Two Units of proton therapy are being installed in Barcelona in 2027. The Vall d’Hebron University Hospital is one of the main participants in the Barcelona Proton Consortium. This scenario will enable us to develop a research package with these particles. We have already established networking with the Karolinska Institute and the Uppsala Proton Therapy Center and VHIO’s Hereditary Cancer Genetics Group to start a research program focused on the study genetic susceptibility underlining the radiotherapy-induced normal tissue toxicity.
  • Stereotactic ablative radiotherapy/stereotactic body radiotherapy (SABR/SBRT) is a very focused radiation treatment approach that delivers a high radiation dose concentrated on the tumor, with a sharp fall-off of the dose to the surrounding normal tissue. The use of immune checkpoint inhibitors combined with radiotherapy could be a gamechanger in cancer treatment.
  • A way to obtain a radiation supra-synergistic effect is with the nanoparticles. Our group is working with the ICMAB-CSIC lab. from the UAB (Universitat Autònoma de Barcelona, PI: Gerard Tobias).
  • Our group aims to develop resources and collaborate with stakeholders to gain access to this rapidly evolving AI-driven technology.
  • Aguado-Flor E, Reyes VM, Navarro V, Mollà M, Aguado-Barrera ME, Altabas M, Azria D, Baten A, Bourgier C, Bultijnck R, Chang-Claude J, De Santis MC, Dunning AM, Duran-Lozano L, Elliott RM, Farcy Jacquet MP, Giandini C, Giraldo A, Green S, Lambrecht M, Lopez-Pleguezuelos C, Monten C, Rancati T, Rattay T, Rosenstein BS, De Ruysscher D, Diez O, Seibold P, Sperk E, Symonds RP, Stobart H, Vega A, Veldeman L, Villacampa G, Webb AJ, Weltens C, Zunino P, Talbot CJ, West CM, Giralt J, Gutiérrez-Enríquez S; REQUITE consortium. Integrating genetic polymorphisms and clinical data to develop predictive models for skin toxicity in breast cancer radiation therapy. Breast. 2025 Aug;82:104506.
  • Roubaud G, Kostine M, McDermott RS, Bernard-Tessier A, Maldonado X, Silva M, Fléchon A, Berthold DR, Ronchin P, Tombal BF, Mourey L, Gravis G, Escande A, Abadie-Lacourtoisie S, Maurina T, Climent MA, Ribault H, Bossi A, Foulon S, Fizazi K. Assessment of bone mineral density in men with de novo metastatic castration-sensitive prostate cancer treated with or without abiraterone acetate plus prednisone in the PEACE-1 phase 3 trial. Eur J Cancer. 2025 Mar 11;218:115293.
  • de Leeuw ALMP, Hoebers FJP, Giralt J, Tao Y, Terhaard CHJ, Lee LW, Friesland S, Steenbakkers RJHM, Tans L, Kayembe MT, van Kranen SR, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O. Comparing adaptive and dose redistributed radiotherapy to conventional radiotherapy in head and neck cancer - Quality of life results from the phase III ARTFORCE trial. Radiother Oncol. 2025 Sep;210:111044.
  • Rousseau A, Karimi M, Michiels S, Roubaud G, Maldonado X, Supiot S, McDermott R, Flechon A, Tombal B, Ronchin P, Berthold D, Berdah JF, Kacso G, Gravis G, Calabro F, Tartas S, Muracciole X, Ribault H, Fizazi K, Foulon S. Adjusting for abiraterone-prednisone cross-over in de novo metastatic castration-sensitive prostate cancer: a post-hoc analysis of the PEACE-1 trial.Eur J Cancer. 2025 Nov 17;230:116024.
  • Laia Humbert was awarded a VHIO VIDA La Caixa Fellowship Post Doc Grant (2025-2028) for the RADGEN-HNC project: Radiogenomic profiling and AI-based spatiotemporal modelling for early detection of radiation-induced multi-organ toxicity in patients with head and neck cancer.
  • GRAPE - 101292396 - GAP-101292396. Gold Radiosensitizers for Advanced Proton thErapy (GRAPE) ERC Proof of Concept Lump Sum Grant 2025 (ERC-2025-PoC) PIs: Gerard Tobias, Esperanza Medina.
    Funded Projects:
    1. RADGEN-HNC: Radiogenomic profiling and AI-based spatiotemporal modelling for early detection of radiation-induced multi-organ toxicity in patients with head and neck cancer. PI: L. Humbert. 2025-2028.
    2. GRAPE - 101292396 - GAP-101292396. Gold Radiosensitizers for Advanced Proton thErapy (GRAPE) ERC Proof of Concept Lump Sum Grant 2025 (ERC-2025-PoC). PIs: Gerard Tobias, Esperanza Medina.
    3. FIS PI24/00527 Assessement of the clinical and biological factors associated with the risk of relapse in localized intermediate and high risk prostate cancer subjected to androgen deprivation and combined radiotherapy. PI: X. Maldonado. 2024-2027.
    4. CAT_Clin_ART EU4H_2023_PJ_05:. Organisation of Clinical audit Campaigns as a tool to improve Quality and Safety of medical applications of ionising radiation. EU4Health 2024 Work Programme. European Commission. Team member PI WP4: X. Maldonado. 2024-2027.
    5. IRAD_FEOR funding. The role of circulating exosomes as a biomarker for risk stratification and treatment personalization in patients with prostate cancer after radical prostatectomy. IRAD_FEOR funding in cooperation with the Universidad de Navarra. PI: X. Maldonado. 2024-2027.
    6. EPA (AG) 69/2018 (5413) IRONMAN-ES: Prospective observational study of clinical parameters and biomarkers in advanced prostate cancer in hospitals in Spain. PI: J. Mateo. Ongoing.
    7. ENCANT - 101189443 - GAP-101189443. The ENCANT project, led by Gerard Tobías-Rossell (ICMAB-CSIC), focuses on increasing the effectiveness of cancer radiotherapy through the use of nanoparticles. PI: M. Altabas. 2022-2025.
    8. RAdiogenomics Biorepository and Databank (RBD) PAR-11-167 Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (UM1). PI:  S. Gutiérrez, SI:  V. Reyes. Ongoing.
    9. FIS Detection of ctDNA from breast milk and methylome analysis for early diagnosis of breast cancer associated with pregnancy in high-risk populations: Meth-MMATERNA. SI: V. Reyes. 2024-2027.
    10. TV3-Marato grant :33 / 102 entitled: Deciphering the progression of ductal carcinoma in situ to avoid overtreatment of patients and improve the impact on sexual and reproductive health. SI: V. Reyes. 2024-2026.
    11. Risk assessment Tools for severe side Effects after breasT Radiotherapy: radiation safety through biological extended models and dIgital twinS-TETRIS. SI: V. Reyes. Ref: 101166699. Funding Agency: European Commission. 1/10/2024-30/09/2027.
    12. UMBRELLA SIOP-RTSG 2016 protocol. Registry of the treatment of all pediatric kidney tumors. Ongoing.
    13. 2021-2023. FIS PI20/556. New therapeutic approaches in head and neck cancer. Co-PI:  S. Benavente. Fundació Institut de Recerca de l'Hospital Univ. Vall d'Hebron. Extended 2025.
    14. PIANOFORTE-EMPATHY proton project on assessing dose distribution in adaptive proton therapy. Co-PI:  X. Maldonado. 2024-2027.
    Non-Funded Projects:
    1. Validation of a biomarker from prostate biopsies based on multimodal artificial intelligence and use of digital pathology. Secondary analysis of phase III clinical trial DART 01/5 TYPE: Research Project (LIB 14/2007) CODE: DART-AI. Co-PI: X. Maldonado. 2025-2026.
    2. PR(AG)451/2024 Estimation of the risk of developing a second cancer in pediatric patients receiving craniospinal proton beam radiotherapy treatment. PI: M. Beltran, SI: Maldonado. 2025-2027.
    3. EURAMED rocc-n-roll EURopeAn MEDical application and Radiation prOteCtion Concept: strategic research agenda aNd ROadmap interLinking to heaLth and digitisation aspects -. EU Horizon 2020 research and innovation programme. Grant agreement no: 899995. Co-PI: J. Giralt. 2020-2025.
    4. QUARTET; program for the quality control of pediatric treatments. It is a program subsidized by the SIOP (International Society of Pediatric Oncology) and with the technical support of the EORTC. Team member: M. Ramos. 2023-2028.
    5. COGNITO: Evaluation of long-term cognitive effects in childhood cancer survivors. Reference: PR(AMI)389/2017. EU project 899995 – EURAMED. PI: M.Ramos. 2017-2025.
    6. EORTC Study 1811 E²-RADIatE: European Radiotherapy Infrastructure of EORTC-ESTRO" Cohort: OligoCare 1822- Pragmatic observational study to evaluate radical radiotherapy in patients with oligo-metastatic cancer.  Team member: S. Benavente. 2024-2029.
    7. RADIOGENOMICS Biorepository and Databank (RBD) PAR-11-167 Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (UM1). In addition to DNA isolated from blood collected epidemiological data / records of patient outcomes related to the treatment. Co-PI: V. Reyes. 2022- ongoing.
    8. EORTC Research Project 2011. E2RADIatE – ReCare. A prospective observational cohort on high-dose re-irradiation. ReCare Consortiu Team member: S. Benavente. 2024-2029.
    9. Validation of the MD Anderson Toxicity and QoL questionnaires (MDASI) in Head and Neck tumors treated with radiotherapy in the HU Vall d’Hebron. S. Benavente, R. Granado. 2025-2028.
    10. CPP BATEA-VHIO-FIDIS-FIHM. Preclinical development and clinical proofof-concept of GlioHook, an implantable medical device for the treatment of glioblastoma. Proyectos de Colaboración Público-Privada. PIs: F. Martínez Ricarte, M. Vieito, X. Maldonado. 2025-2028.
  1. Araujo-Castro M, Álvarez-Escola C, Casteràs A, Carmona-Bayonas A, Chiara MD, Hanzu FA, Hernando J, Vercher-Conejero JL, Rodríguez-Fraile M, Gómez Dos Santos V, Jimenez-Fonseca P, Giraldo A, Valdés N, Vidal O, Del Olmo-García M, Capdevila J. Spanish consensus on the diagnosis and management of adrenocortical carcinoma. Endocr Relat Cancer. 2025 Apr 24;32(5):e250034. doi:10.1530/ERC-25-0034. PMID:40215284.
  2. Aguado-Flor E, Reyes VM, Navarro V, Mollà M, Aguado-Barrera ME, Altabas M, Azria D, Baten A, Bourgier C, Bultijnck R, Chang-Claude J, De Santis MC, Dunning AM, Duran-Lozano L, Elliott RM, Farcy Jacquet MP, Giandini C, Giraldo A, Green S, Lambrecht M, Lopez-Pleguezuelos C, Monten C, Rancati T, Rattay T, Rosenstein BS, De Ruysscher D, Diez O, Seibold P, Sperk E, Symonds RP, Stobart H, Vega A, Veldeman L, Villacampa G, Webb AJ, Weltens C, Zunino P, Talbot CJ, West CM, Giralt J, Gutiérrez-Enríquez S; REQUITE consortium. Integrating genetic polymorphisms and clinical data to develop predictive models for skin toxicity in breast cancer radiation therapy. Breast. 2025 Aug;82:104506. doi:10.1016/j.breast.2025.104506. PMID:40570703.
  3. Ciérvide R, Manchón R, Ángel D, Quiles B, Rodríguez G, Veiras M, Blanco J, Diaz FM, Del Portillo EG, Monroy JL, Larrea L, Expósito J, Aristu J, Benavente S, Corrales-García E, Prieto C, García ME, Payano S, Perez MJ, Miguel IS, De la Pinta C, Díaz L, Mascias VM, Villarreal CLM, López M, Martínez FJ, Peña M, García R. Stereotactic radiosurgery practice patterns for brain metastases: a survey by the SRS_SBRT_SEOR Working Group. Rep Pract Oncol Radiother. 2025 Oct 1;30(4):513-522. doi:10.5603/rpor.107739. PMID:41195103.
  4. de Leeuw ALMP, Giralt J, Tao Y, Benavente S, Nguyen TF, Hoebers FJP, Hoeben A, Terhaard CHJ, Lee LW, Friesland S, Steenbakkers RJHM, Tans L, van Kranen SR, van de Kamer JB, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O. Protocol compliance in a multicentric phase III trial investigating scheduled adaptive radiotherapy and dose painting in head and neck cancer. Radiother Oncol. 2025 Jan;202:110612. doi:10.1016/j.radonc.2024.110612. PMID:39522824.
  5. de Leeuw ALMP, Hoebers FJP, Giralt J, Tao Y, Terhaard CHJ, Lee LW, Friesland S, Steenbakkers RJHM, Tans L, Kayembe MT, van Kranen SR, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O.Comparing adaptive and dose redistributed radiotherapy to conventional radiotherapy in head and neck cancer - Quality of life results from the phase III ARTFORCE trial. Radiother Oncol. 2025 Sep;210:111044.doi: 10.1016/j.radonc.2025.111044. Epub 2025 Jul 10.PMID: 40651596.
  6. Alyamani N, Abrunhosa-Branquinho A, Corning C, Sharabiani M, Castadot P, Giralt J, Kazmierska J, Grant W, Christiaens M, Tomsej M, Bar-Deroma R, Monti AF, Stelmes JJ, Clementel E, Fortpied C, Collette S, Hurkmans CW, Grégoire V, Overgaard J, Weber DC, Andratschke N. Radiotherapy quality assurance of the prospective randomised EORTC-1219/DAHANCA-29 trial: an individual case review analysis. Radiother Oncol. 2025 Dec;213:111141. doi: 10.1016/j.radonc.2025.111141. Epub 2025 Sep 21.PMID: 40987385
  7. Ludwig R, Pérez-Haas Y, Benavente S, Balermpas P, Unkelbach J. A probabilistic model of bilateral lymphatic spread in head and neck cancer. Sci Rep. 2025 May 25;15(1):18152. doi:10.1038/s41598-025-99978-7. PMID:40415030.
  8. Benavente S, Ludwig R, Balermpas P, Unkelbach J. Updating “A dataset on patient-individual lymph node involvement in oropharyngeal squamous cell carcinoma” with an additional dataset from a second institution. Data Brief. 2025 Apr 10;60:111546. doi:10.1016/j.dib.2025.111546. PMID:40534725.
  9. Li K, Chadha M, Moshier E, Rosenstein BS; REQUITE consortium. Age-stratified analysis of health-related quality of life in patients with early-stage breast cancer receiving adjuvant radiation therapy and endocrine therapy. J Geriatr Oncol. 2025 Mar;16(2):102195. doi:10.1016/j.jgo.2025.102195.
  10. de Haan-Bosch M, Morell-Daniel M, Recalde-Vizcay E, Sánchez-Montañez A, Gros-Subias L, Ramos-Albiac M, Llort-Sales A. Spinal cord compression in pediatric oncology: the importance of early recognition and optimal management. Academia Oncology. 2025;2(2). doi:10.20935/AcadOnco7783.
  11. Recalde Vizcay E, Navalpotro Yagüe B, Ferrandiz-Pulido C, Hernando Cubero J, Capdevila J, Peregrin Pastor B, Granado Carrasco R. Merkel cell carcinoma: long-term outcomes after radiotherapy treatment. Clin Transl Oncol. 2026 Jan;28(1):366-373. doi: 10.1007/s12094-025-04012-x. Epub 2025 Jul 31.
  12. Najjari-Jamal D, Cordoba S, Gimeno-Morales M, Guevara D, Majercakova K, Sanchez M, Garcia-Cabezas S, Mico S, Tejedor N, Navarro C, Cerron F, Pino F, Muñoz T, Berenguer MA, Matute R, Rovirosa A. Spanish Society for Radiation Oncology and Spanish Society of Medical Physicists recommendations on reirradiation in gynecological cancer: reirradiation techniques, survival outcomes, dose, and toxicity. Clin Transl Oncol. 2026 Jan;28(1):86-104. doi: 10.1007/s12094-025-03957-3. Epub 2025 Jun 30.
  13. González San Segundo C, López-Campos F, Gómez Iturriaga A, Santos M, Ocanto A, Montezuma L, Boladeras-Inglada AM, Glaria L, Guardado S, Rodríguez A, Henríquez I, Olivera J, Duque-Santana V, Garre J, Moreno S, Valero J, Conde AJ, Doval A, Sancho G, Martin Nieto P, Castaño Cantos A, García N, Fernández Alonso S, García García R, Díaz Gavela A, Buchser D, Maldonado X, Mases J, Hernando Requejo O, Sanmamed N, Martínez Salamanca JI, Couñago F. Duration of androgen deprivation therapy with salvage radiotherapy in patients with prostate cancer and biochemical recurrence after surgery: initial recruitment data in the phase III URONCOR 06-24 trial. Actas Urol Esp (Engl Ed). 2025 Sep;49(7):501823. doi:10.1016/j.acuroe.2025.501823.
  14. Rousseau A, Karimi M, Michiels S, Roubaud G, Maldonado X, Supiot S, McDermott R, Flechon A, Tombal B, Ronchin P, Berthold D, Berdah JF, Kacso G, Gravis G, Calabro F, Tartas S, Muracciole X, Ribault H, Fizazi K, Foulon S. Adjusting for abiraterone-prednisone cross-over in de novo metastatic castration-sensitive prostate cancer: a post-hoc analysis of the PEACE-1 trial. Eur J Cancer. 2025 Nov 17;230:116024. doi:10.1016/j.ejca.2025.116024.
  15. Palomino Escobar LC, Díaz-Mejía N, Maldonado X, Semidey ME, Mast R, Trilla E, Morales R, Carles J. Combined neuroendocrine carcinoma of the penis: clinical, pathological and therapeutic insights. BMJ Case Rep. 2025 Jul 1;18(7):e265257. doi:10.1136/bcr-2025-265257.
  16. Mena Ayala MB, Maldonado X. The therapeutic futility paradox: insights from oncological drug litigation in Ecuador. Front Med (Lausanne). 2025 Mar 14;12:1434524. doi:10.3389/fmed.2025.1434524.
  17. Roubaud G, Kostine M, McDermott RS, Bernard-Tessier A, Maldonado X, Silva M, Fléchon A, Berthold DR, Ronchin P, Tombal BF, Mourey L, Gravis G, Escande A, Abadie-Lacourtoisie S, Maurina T, Climent MA, Ribault H, Bossi A, Foulon S, Fizazi K. Assessment of bone mineral density in men with de novo metastatic castration-sensitive prostate cancer treated with or without abiraterone acetate plus prednisone in the PEACE-1 phase 3 trial. Eur J Cancer. 2025 Mar 11;218:115293. doi:10.1016/j.ejca.2025.115293.
  18. Arce-Gallego S, Cresta Morgado P, Delgado-Serrano L, Simonetti S, Gonzalez M, Romero-Lozano P, Marmolejo D, Morales-Barrera R, Arnau GM, Semidey ME, Aguilar D, Cordoba-Terreros S, Mast R, de Albert M, Planas J, Cuadras M, Maldonado X, Suarez C, Casanova-Salas I, Figols M, Cros S, Mas A, Nonell L, Dienstmann R, Nuciforo P, Vivancos A, Llop-Guevara A, Carles J, Serra V, Mateo J. Homologous recombination repair status in metastatic prostate cancer by next-generation sequencing and functional immunofluorescence. Cell Rep Med. 2025 Feb 18;6(2):101937. doi:10.1016/j.xcrm.2025.101937.
  19. Maldonado X, Boladeras A, Gaya JM, Muñoz J, Planas J, Sancho G, Suárez JF. Controversies in the use of next-generation imaging for evaluation and treatment decision-making in patients with prostate cancer after biochemical recurrence: views from a Spanish expert panel. Clin Transl Oncol. 2025 Jul;27(7):2876-2888. doi:10.1007/s12094-024-03833-6.
  20. Fidalgo AP, Alonso P, Andión M, Cañete A, Collado E, Colino CG, Codina JG, Carrasco XD, Sanz RG, Expósito SH, Lopez-Fernandez T, Medin G, Molinés A, Vega AM, Ramos M, Miguel IS, García JS, Santolaya F. Management of late toxicities and specific follow-up needs of adolescent and young adult cancer survivors: recommendations from scientific societies in Spain. Clin Transl Oncol. 2025 Sep 4. doi:10.1007/s12094-025-04047-0. PMID:40908428.
  21. Aguado-Barrera ME, Lopez-Pleguezuelos C, Gómez-Caamaño A, Calvo-Crespo P, Taboada-Valladares B, Azria D, Boisselier P, Briers E, Chan C, Chang-Claude J, Coedo-Costa C, Crujeiras-González A, Cuaron JJ, Defraene G, Elliott RM, Faivre-Finn C, Franceschini M, Fuentes-Rios O, Galego-Carro J, Gutiérrez-Enríquez S, Heumann P, Higginson DS, Johnson K, Lambrecht M, Lang P, Lievens Y, Mollà M, Ramos M, Rancati T, Rattay T, Rimner A, Rosenstein BS, Sangalli C, Seibold P, Sperk E, Stobart H, Symonds P, Talbot CJ, Vandecasteele K, Veldeman L, Ward T, Webb A, Woolf D, de Ruysscher D, West CML, Vega A; REQUITE Consortium. Professional-patient discrepancies in assessing lung cancer radiotherapy symptoms: an international multicentre study. Lung Cancer. 2025 Jan;199:108072. doi:10.1016/j.lungcan.2024.108072.
  22. Humbert-Vidan L, Hansen CR, Petit S, Muñoz-Montplet C, Mohamed ASR, Saunders DP, Patel V, Verduijni GM, Heemsbergen WD, van der Schaaf A, Witjes M, de Vette S, Khan AA, Marruecos Querol J, Oliveras Cancio I, Oliver M, Reich P, Santi SA, Pearce AG, Lai SY, King AP, Langendijk JA, Johansen J, Moreno AC, Fuller CD, van Dijk LV, Guerrero Urbano T, et al. Multi-institutional Normal Tissue Complication Probability (NTCP) Prediction Model for Mandibular Osteoradionecrosis: Results from the PREDMORN Study. Int J Radiat Oncol Biol Phys. 2025; [Epub ahead of print]. doi:10.1016/j.ijrobp.2025.12.044
  23. de Pablo Garcia-Cuenca, A.; Rofin-Fontanet, P.; Lorente-Guerrero, J.; Balmana-Gelpi, J.; Carrasco-Lopez, E.; Temprana-Salvador, J.; Granado- Carrasco, R.; Brana-Garcia, I.; Vaquero Martinez, P.; Pujol-Pina, R.; et al. Head and Neck Cancer in Fanconi Anemia: Report of 11 Cases and a Systematic Review. Cancers. 2025, 17, 349. https://doi.org/10.3390/ cancers17030349
  24. Serra-Aracil X, Pericay C, Cidoncha A, Badia-Closa J, Golda T, Kreisler E, Hernández P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Espín-Bassany E, Caro-Tarrago A, Gallego-Plazas J, Pascual M, Álvarez-Laso C, Guadalajara-Labajo H, Otero A, Biondo S; TAUTEM Collaborative Group. Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):783-793. doi: 10.1001/jamasurg.2025.1398. PMID: 40434784
  25. Max D Tanaka , Bengt Glimelius , Geke A P Hospers , Elma Meershoek-Klein Kranenbarg , Corrie A M Marijnen , Hein Putter , Annet G H Roodvoets , Cornelis J H van de Velde , Boudewijn van Etten , Per J Nilsson , Alice M Couwenberg.  Acute and Late Radiation-Related Toxicity After Treatment of Locally Advanced Rectal Cancer With Intensity Modulated Radiation Therapy Compared With 3-Dimensional Conformal Radiation Therapy in the RAPIDO Trial. Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):470-482. Epub 2025 May 10. PMID: 40354950 DOI: 10.1016/j.ijrobp.2025.04.035
  26. ICO-ICS PRAXIS para el tratamiento médico-quirúrgico y con irradiación de los tumores cutáneos. Actualización junio de 2025ISBN: 978-84-128170-5-8 ISBN: 978-84-128170-4-1 http://hdl.handle.net/11351/13729.
  • A randomized Phase III trial with a factorial design evaluating the efficacy and safety of darolutamide and stereotactic dose escalated radiotherapy in patients with localized prostate cancer and high-risk features of relapse, from the Prostate Cancer Consortium in Europe (PEACE 7). PI: X. Maldonado.
  • A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab  With or Without MK-2870 in  Participants With Resectable Stage  II to IIIB (N2) NSCLC not Achieving  pCR After Receiving Neoadjuvant  Pembrolizumab With Platinumbased Doublet Chemotherapy  Followed by Surgery  (MK-2870-019). SI: A. Giraldo.
  • International Clinical Research Programme to Improve Outcomes in  Newly Diagnosed Ewing Sarcoma – Trial 1 INTER-EWING-1. SI: M.Ramos/A.Giraldo.
  • BAY 1841788 / 21492A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate càncer. PI: X. Maldonado.
  • GETUG-AFU 43/PEACE 8 Combination of darolutamide and stereotactic body radiation therapy in patients with castration resistant prostate cancer and oligometastases on functional imaging. PI:  X. Maldonado.
  •  URONCOR 06-24/GICOR-SEOR 1-21: Short- or long-term androgen deprivation therapy in combination with rescue radiotherapy in patients with prostate cancer with biochemical recurence after surgery: a randomized, controlled, phase III trial. PI: X. Maldonado.
  •  A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy Protocol 56021927PCR3003; Phase 3. PI: X. Maldonado.
  • A Randomized, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localized High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02). PI: X. Maldonado.
  • A Phase 2, randomized, open-Label, dose-finding study of Debio 4228, an extended-release formulation of gonadotropin-releasing hormone antagonist in participants with locally advanced/metastatic prostate cancer. PI: X. Maldonado.
  • PR(AG)283/2021 Randomized phase III trial of adjuvant radiotherapy versus observation after breast-conserving surgery and endocrine therapy in patients with early-stage breast cancer molecularly characterized as luminal A. PI: V. Reyes.
  • Expert Trial (breast): Phase III adjuvant radiotherapy versus observation after breast-conserving surgery and endocrine therapy in patients with early-stage breast cancer molecularly characterized as luminal A. SI: R. Granado.
  • Randomized Phase II study of Cisplatin plus radiotherapy versus Durvalumab plus radiotherapy followed by adjuvant Durvalumab versus Durvalumab plus radiotherapy followed by adjuvant Tremelimumab and durvalumab in intermediate risk HPV-positive locoregionally advanced oropharyngeal squamous cell cancer (LA-OSCC). PI:  R. Granado.
  • A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). SI: R. Granado.
  • A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess the safety and efficacy of xevinapant in combination with cetuximab and radiotherapy compared to placebo in combination with cetuximab and radiotherapy to demonstrate improvement of event free survival in participants with locally advanced squamous cellcarcinoma of the head and neck, who are ineligible for cisplatin. SI: R. Granado.
  • Nanoray -312 (head and neck: Phase III Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma. PI: J. Giralt.
  • Head and neck PROMs project: Prospective evaluation of the relationship between different head and neck questionnaires measuring radiation-induced side-effect. Co-PI:  R. Granado.
  • RADIAN Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head and Neck squamous cell carcinoma. SI: R. Granado.
  • High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) (HR-NBL2). Co-PI:  S. Micó.
  • PR(AG)602/2023.RAPIDO (Rectal cancer And Pre-operative Induction therapy followed by Dedicated Operation). PI: B. Navalpotro.
  • PR(AG)223/2019 hCCA-LT. Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study. SI: B. Navalpotro.
  • TTCC 2022 01 RADIAN. Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head and Neck squamous cell carcinoma (RADIAN). PI: I. Braña, SI: S. Benavente.
  • EORTC-2014-HNCG. Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck : a randomized phase III study. PI: I. Braña, SI: S. Benavente.
  • EORTC Research Project 2011. E2-RADIatE – ReCare A prospective observational cohort on high-dose re-irradiation. PI: S. Benavente.
  • Prospective observational study on radioresistance mediated by S100A9 in patients with brain metastases. National Network of Brain Metastasis (RENACER). PI:  S.Benavente.
  • Prospective evaluation of the relation between different head and neck questionnaires measuring radiation-induced side-effect. Co-PI: S. Benavente.
  • PROLoNg: Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck: a randomized phase III study. SI: S. Benavente.
  • SACRO: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease. PI:  A. Giraldo.
  • PACIFIC 9: A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. SI: A. Giraldo.
  • GEIS 75: Ensayo clínico Fase II multicohorte de trabectedina y radioterapia a bajas dosis en sarcomas avanzados/metastásicos. SI: A. Giraldo.
  •  MK7684A-006: Pembrolizumab/Vibostolimab in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer. SI:  A. Giraldo.
  • Phase Ib study of the combination of regorafenib with conventional chemotherapy for the treatment of newly diagnosed patients with multimetastatic Ewing sarcoma. SI:  A. Giraldo.
  • ETOP 21-21 BOUNCE A multicentre, randomised, phase II trial of brigatinib consolidation versus observation or durvalumab in patients with unresectable stage III NSCLC and ALK-rearrangement, after definitive chemo-radiotherapy. SI:  A. Giraldo.
  • Debio 0123-GBM-105 A Phase 1/2 open-label study of Debio 0123 in combination with temozolomide in adult participants with recurrent or progressive glioblastoma and of Debio 0123 in combination with temozolomide and radiotherapy in adult participants with newly diagnosed glioblastoma. PI: M. Vieito, SI:  X. Maldonado.
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).  PI: M. Vieito, SI: X. Maldonado.
  • Multicentre phase II clinical trial to evaluate the activity of encorafenib and binimetinib before local treatment in patients with BRAF mutated melanoma with metastasis to the brain. Protocol Number: GEM-1802 EudraCT: 2018-002530-20. SI: B.Navalpotro.
  • KEYNOTE-630 . Phase 3 study of adjuvant pembrolizumab versus placebo in patients with high-risk, locally advanced cutaneous squamous cell carcinoma. SI: B.Navalpotro.
  • GEMCAD 2201 Circulating tumor DNA as complementary tool to assess response to neoadjuvant therapy in locally advanced rectal cancer. GEMCAD-REVEAL STUDY. SI: B. Navalpotro.

Group Leader Jaume Capdevila Medical Oncologists Alejandro Garcia, Jorge Hernando Clinical Fellows Sergio Perez-Fernandez, Jose Maria Ucha, Sharela Vega Clinical Research Oncology Nurses Helena Palma, Alexandre Sierra Data Curators Gloria Castillo, Sandra Martinez
Preclinical and Translational Team
Preclinical and Translational Team Leader Belen Elguero Lab Manager Anna Maria Alcántara Buguñá Project Managers Maria Marin, Paola Pisacane

Research Groups

Hepatobiliary Pancreatic Cancer and Endocrine Tumors Group

Summary

Our Hepatobiliary Pancreatic Cancer and Endocrine Tumors Group, led by Jaume Capdevila, is dedicated to advancing molecular and translational therapies across hepatobiliary, pancreatic, and endocrine malignancies. We drive high-impact research and lead the development of innovative anti-cancer agents through early-phase clinical trials, with the goal of identifying novel biomarkers and therapeutic targets that accelerate precision oncology for patients with pancreatic cancer, biliary tract tumors—including cholangiocarcinoma—and neuroendocrine/endocrine neoplasms.

Our multidisciplinary team integrates medical oncologists, translational and preclinical researchers, dedicated research nurses, specialized laboratory technicians in molecular biology and experimental models, and expert data scientists. We work in close collaboration with VHIO investigators, surgeons, pathologists, radiologists, gastroenterologists, and clinical biologists within a highly interactive and disease-oriented framework.

In 2025, our group played a key role in advancing clinical research across hepatobiliary, pancreatic, and endocrine tumors. Notably, we have participated in the RASolute 302 trial, which is contributing to reshaping therapeutic strategies for patients with pancreatic cancer, and ensures future development of RAS inhibitors in pancreatic cancer in earlies lines and adjuvant therapies. In parallel, we have led academic and pharma-sponsored clinical research in neuroendocrine tumors, including reporting the results of the COMPETE study, under the leadership of Capdevila. We have also continued to expand and consolidate our research in cholangiocarcinoma, with a particular focus on neoadjuvant strategies and targeted therapies.

A major milestone has been the establishment of the NET-VHIO Lab, a dedicated research laboratory focused on endocrine and neuroendocrine tumors, representing a unique platform at the national level. This initiative strengthens our ability to generate disease-specific biological insights and accelerate translational applications.

Our translational research program continues to advance liquid biopsy technologies and biomarker discovery, enabling more precise monitoring of disease evolution. Additionally, our robust collection of patient-derived models and preclinical platforms supports the identification of novel actionable mechanisms and therapeutic vulnerabilities across our tumor spectrum.

Collectively, these efforts position our group as a leading reference in hepatobiliary, pancreatic, and endocrine malignancies, as reflected by our strong presence in international scientific forums and high-impact publications.

  • Molecular characterization and biomarker discovery in hepatobiliary, pancreatic, and endocrine malignancies, including pancreatic cancer, biliary tract tumors, and neuroendocrine neoplasms.
  • Implementation of liquid biopsy approaches to monitor disease evolution and treatment response.
  • Development of advanced preclinical models (organoids, PDXs, transgenic systems) to study mechanisms of resistance and identify therapeutic targets.
  • Design and leadership of early-phase clinical trials and investigator-initiated studies.
  • Participation in and coordination of late-phase clinical trials to evaluate clinical benefit and identify predictive biomarkers.
  • Expansion and consolidation of research programs in cholangiocarcinoma and pancreatic cancers (focused on neoadjuvant and targeted strategies) and neuroendocrine/endocrine tumors and increase the relevance in hepatocellular carcinomas.
  • Our research portfolio includes more than 20 active translational projects focused on hepatobiliary, pancreatic, and endocrine malignancies, supported by strong national and international collaborations.
  • We have significantly expanded our research in cholangiocarcinoma, particularly in the neoadjuvant setting and in the development of targeted therapies for advanced stages.
  • In pancreatic cancer, we have contributed to the RAS inhibition drug development, helping to advance new therapeutic approaches for this disease. Additionally, new targeted agents are starting to be assessed in early clinical trials in pancreatic cancer, such as PRMT5 inhibitors, new immunotherapies and modern combinations to give our patients the best systemic treatment otpions.
  • In neuroendocrine tumors, we have led academic clinical research initiatives and reported key results from the COMPETE study, reinforcing our leadership in this field. Additionally, new approaches for alfa emitters are being explored in early clinical trials.
  • We have established the NET-VHIO Lab, a unique national research platform dedicated to endocrine and neuroendocrine tumors.
  • We have strengthened strategic academic–industry partnerships with several companies, including AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, or Jazz Pharmaceuticals, enabling comprehensive research efforts across all tumor types within our scope.
  • Jimenez C, Andreassen M, Durand A, Moog S, Hendifar A, Welin S, Spada F, Sharma R, Wolin E, Ruether J, Garcia-Carbonero R, Fassnacht M, Capdevila J, Del Rivero J, Iliopoulos O, Huillard O, Jang R, Mai K, Artamonova E, Hallqvist A, Else T, Odeleye-Ajakaye A, Gozman A, Naik GS, Berruti A; LITESPARK-015 Investigators. Belzutifan for Advanced Pheochromocytoma or Paraganglioma. N Engl J Med. 2025 Nov 20;393(20):2012-2022.
  • Capdevila J, Hernando J, Molina-Cerrillo J, Benavent Viñuales M, Garcia-Carbonero R, Teulé A, Custodio A, Jimenez-Fonseca P, López C, Hierro C, Carmona-Bayonas A, Alonso V, Llanos M, Sevilla I, García-Álvarez A, Alonso-Gordoa T, Gallego Jiménez I, Antón-Pascual B, Modrego Sánchez A, Grande E. Cabozantinib plus Atezolizumab in Advanced, Progressive Endocrine Malignancies: A Multicohort, Basket, Phase II Trial (CABATEN/GETNE-T1914). Clin Cancer Res. 2025 Nov 14;31(22):4655-4663.
  • Tissera NS, Balconi F, García-Álvarez A, Cubero JH, O'Connor JM, Chacón M, Capdevila J. Maintenance therapy after first-line platinum-based chemotherapy in gastroenteropancreatic neuroendocrine carcinomas: A literature review. Cancer Treat Rev. 2025 Jan;132:102863.
  • Capdevila J, Tafuto S, Krogh M, Teulé A, Garcia-Carbonero R, Klümpen HJ, Cremer B, Sevilla I, Eriksson B, Tabaksblat E, Metges JP, Reed NS, Schrader J, Navarro V, Valentí V, Hernando J, Colao AM, Vestermark L, Carnaghi C, Knigge UP, Jimenez-Fonseca P, Benavent M, de Vos-Geelen J, Venerito M, Von Werder A, Jann H, Rinke A, Smith D, Hörsch D, Starling N, Ruszniewski P, Baudin E, Caroli-Bosc FX, Manzano JL, Martín M, Scarpa A, Lawlor RT, Ragulan C, Ps H, Sadanandam A, Carmona-Bayonas A, Salazar R. Streptozotocin plus 5-fluorouracil followed by everolimus or the reverse sequence in patients with advanced pancreatic neuroendocrine tumors (SEQTOR-GETNE phase III study): a randomized clinical trial. ESMO Open. 2025 Dec;10(12):105922.
  • Jaume Capdevila: Chair of the ESMO Congress and current Chair of the Spanish Task Force for Neuroendocrine Tumors (Grupo Español de Tumores Neuroendocrinos, GETNE).
  1. Project title: NAPAN Study – A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy. Principal investigator: Teresa Macarulla. Funding entity: AMC Medical Research BV. Duration: 10/09/2020 – 31/12/2025.
  2. Project title: Boehringer translational project Principal investigator: Teresa Macarulla. Funding entity: Boehringer Duration: 09/10/2023 - 31/12/2025.
  3. Project title: Perfil clínico y manejo terapéutico de los pacientes con cáncer de páncreas; Registro en los Servicios Hospitalarios de Oncología Médica de España. Principal investigator: Teresa Macarulla. Funding entity: PIVOTAL Duration: 21/08/2015 - 31/12/2025.
  4. Project title: GRANT-ESP-110 - Exosomal Molecular Profiling to Develop Signatures of response to Treatment with nab-paclitaxel plus gemcitabine in Pancreatic Cancer Patients. Principal investigator: Teresa Macarulla. Funding entity: CELGENE Duration: 12/12/2017 - 31/12/2025.
  5. Project title: Exploring the feasibility of predictive and pharmacodynamic biomarkers of immunotherapy in solid tumors (Immune4ALL) Principal investigator: Teresa Macarulla, Sub-aim PI: Tian Tian, Funding entity: ISCIII Duration: 01/01/2023 -31/01/2026.
  6. Project title: Tratamiento innovador con ABTL0812 para el cáncer pancreático metastático: acortando los tiempos para su aprobación – INNOPANC Principal investigator: Teresa Macarulla. Funding entity: Ministerio de Ciencia e innovación RETOS 2022-2025 Duration: 10/02/2022 – 31/01/2025.
  7. Project title: AstraZeneca translational biomarker discovery Principal investigator: Teresa Macarulla. Funding entity: AstraZeneca Duration: 09/09/2021 - 31/12/2025.
  8. Project title: Ajuts de Suport a la Recerca. Principal investigator: Teresa Macarulla. Funding entity: AGAUR Duration: 01/01/2022 - 30/06/2025.
  9. Project title: A patient-derived tumor tissue culture (PDTTC) platform for immunotherapeutics’ testing and prediction of clinical response. Principal investigator: Teresa Macarulla. Funding entity: J-BID Duration: 14/06/2022 - 13/06/2026.
  10. Project title: Aztrazeneca translational project Principal investigator: Teresa Macarulla, Tian Tian Funding entity: AstraZeneca Duration: 09/06/2024 - 31/12/2027.
  11. Project title: Deciphering epigenetic features hidden in the plasma of cholangiocarcinoma patients. Principal investigator: Tian Tian. Funding entity: FERO Foundation Duration: 01/01/2023 - 31/12/2025.
  12. Project title: Alentis translational research grant Principal investigator: Tian Tian and Teresa Macarulla Funding entity: ALENTIS Therapeutics AG Duration: 01/08/2023 -31/07/2025.
  13. Project title: Programa Talents 2024-2025 Principal investigator: Tian Tian. Funding entity: Pedrera Duration: 21/03/2024 - 20/03/2025.
  14. Project title: Servier translational project. Principal investigator: Tian Tian. Funding entity: Servier Duration: 18/07/2024 - 31/12/2025.
  15. Project title: Análisis de la expresión de RNA mediante tecnología RNA-seq. Principal investigator: Jaume Capdevila. Funding entity: GETNE Duration: 04/06/2015 -31/12/2025.
  16. Project title: Estudio de la microbiota, de fusobacterium nucleatum y de la correlación con las vías de los receptores de toll-like en tumores neuroendocrinos de intestino delgado. Principal investigator: Jaume Capdevila. Funding entity: GETNE Duration: 21/07/2021 - 31/12/2025.
  17. Project title: Pfizer - Uncovering genomic alterations in anaplastic thyroid cancer patients. Principal investigator: Jaume Capdevila. Funding entity: Pfizer Duration: 07/08/2014 - 31/12/2025.
  18. Project title: Ancillary Genetic Biomaker study from the III Decision trial by RNA sequencing. Principal investigator: Jaume Capdevila. Funding entity: Bayer Duration: 05/12/2014 - 31/12/2025.
  19. Project title: Desvelando las alteraciones genómicas en pacientes con cáncer de tiroides. Principal investigator: Jaume Capdevila. Funding entity: Astrazeneca Duration: 13/10/2015 - 31/12/2025.
  20. Project title: Wearables en pacientes con tumores neuroendocrinos gastroenteropancreaticos. Principal investigator: Jaume Capdevila. Funding entity: Netfit Duration: 12/02/2021 - 31/12/2025.
  21. Project title: DLL3 DETERMINATION IN NEUROENDOCRINE NEOPLASMS. Principal investigator: Jaume Capdevila. Funding entity: Amgen Duration: 29/04/2021 -31/12/2025.
  22. Project title: Next generation TIL therapy targeting neoantigens for immune checkpoint blockade-resistant tumors (NK-ACT-BC) - 2021-0821. Principal investigator: Jaume Capdevila. Funding entity: FUNDACIO INSTITUT DE RECERCA HOSPITAL UNIVERSITARI VALL HEBRON -VHIR Duration: 01/01/2025-31/12/2026.
  23. Project title: Estudio de la expresión de antígenos como posibles dianas de conjugados anticuerpo-fármaco en tumores neuroendocrinos. Principal investigator: Jaume Capdevila. Funding entity: Grupo Español de Tumores Neuroendocrinos y Endocrinos Duration: 05/11/2021 - 30/11/2025.
  1. J. Capdevila; S Tafuto; M Krogh; A Teulé; R Garcia-Carbonero; HJ Klümpen; B Cremer; I Sevilla; B Eriksson; E Tabaksblat; JP Metges; FX aroli-Bosc; JL Manzano; M Martín; A Scarpa; RT Lawlor; C Ragulan; H Ps; A Sadanandam; A Carmona-Bayonas; R Salazar. Streptozotocin plus 5 fluorouracil followed by everolimus or the reverse sequence in patients with advanced pancreatic neuroendocrine tumors (SEQTOR-GETNE phase III study): a randomized clinical trial. ESMO Open. 10 - 12, 02/12/2025. DOI: 10.1016/j.esmoop.2025.105922.
  2. R Dienstmann; A Vivancos; S Nuciforo; S Aguilar; F Ruiz-Pace; C Viaplana; J Gonzalez; B Fite; A Pedrola; E Elez; C Saura; E Felip; T Macarulla; J Capdevila; L Fariñas-Madrid; J Carles; J Mateo; E Muñoz-Cosuelo; J Balmaña; I Braña; E Garralda; J Tabernero. Genomic actionability and matched targeted therapy in a decade-long institutional precision medicine program for solid tumors. ESMO Open. 10 - 11, 25/11/2025. DOI: 10.1016/j.esmoop.2025.105888.
  3. M Andreassen; A Durand; S Moog; A Hendifar; S Welin; F Spada; R Sharma; E Wolin; J Ruether; R Garcia-Carbonero; M Fassnacht; J Capdevila; J Del Rivero; O Iliopoulos; O Huillard; R Jang; K Mai; E Artamonova; A Hallqvist; T Else; A Odeleye-Ajakaye; A Gozman; GS Naik; A Berruti. LITESPARK-015 Investigators. Belzutifan for Advanced Pheochromocytoma or Paraganglioma. N Engl J Med. 393 - 20, pp. 2012 - 2022. 20/11/2025. DOI: 10.1056/NEJMoa2504964
  4. J Capdevila; J Hernando; J Molina-Cerrillo; M Benavent Viñuales; R Garcia-Carbonero; A Teulé; A Custodio; P Jimenez-Fonseca; C Lopez; C Hierro; A Carmona-Bayonas; V Alonso; M Llanos; I Sevilla; A García-Álvarez; T Alonso-Gordoa; I Gallego Jiménez; B Antón-Pascual; A Modrego Sánchez; E Grande. Cabozantinib plus Atezolizumab in Advanced, Progressive Endocrine Malignancies: A Multicohort, Basket, Phase II Trial (CABATEN/GETNE-T1914). Clin Cancer Res. 31 - 22, pp. 4655 - 4663. 14/11/2025. DOI: 10.1158/1078-0432.CCR-25-2143.
  5. R Elisei; LJ Wirth; J Capdevila; AO Hoff; M Tahara; EJ Sherman; MI Hu; MH Ge; J Wadsley; F Vaisman; K Kopeckova; J Krajewska; D Olvera; C. Churchill; P Maeda; AM Gilligan; Y Lin; N Payakachat; B Robinson; J Hadoux; MS Brose. Patient-Reported Tolerability of Selpercatinib Compared to Cabozantinib/Vandetanib: A Secondary Analysis of the LIBRETTO-531 Randomized-Controlled Trial in RET-Mutant Medullary Thyroid Cancer. Thyroid. 35 - 10, pp. 1162 - 1172. 01/10/2025. DOI: 10.1177/10507256251367352.
  6. J Capdpevila; N Unger; W Fendler; S Theurer; F Weber; D Fuhrer; H Lahner. Lenvatinib as salvage therapy in advanced and progressive GI-NET. Endocr Relat Cancer. 32 - 8, 20/08/2025. DOI: 10.1530/ERC-25-0165.
  7. A Ryška; J Capdevila; MS Dettmer; R Elisei; D Führer; J Hadoux; B Jarząb; LD Locati; K Newbold; G Tallini; S Uccella; L Wirth; R Singh; IM Simon; P Camacho; L Fugazzola. Molecular predictive biomarker testing in advanced thyroid cancer - a European consensus. Eur Thyroid J. 14 - 4, 07/07/2025. DOI: 10.1530/ETJ-25-0024.
  8. A Cercek; JB Bachet; J Capdevila; N Starling; E Chen; L Salvatore; H Bando; S O'Donnell; L Harfst; Z Szijgyarto; V Heinemann. A Phase Two, Single-Arm, Open-Label Study with Dostarlimab Monotherapy in Participants with Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1). Clin. Colorectal Cancer. 24 - 2, pp. 325 - 330. 01/06/2025. DOI: 10.1016/j.clcc.2025.02.003.
  9. C Arenillas; L Celada; J Ruiz-Cantador; B Calsina; D Datta; E García-Galea; R Fasani; AB Moreno-Cárdenas; JJ Alba-Linares; B Miranda-Barrio; ÁM Martínez-Montes; C Alvarez-Escola; B Lecumberri; A González García; S K Flores; E Esquivel; Y Ding; M Peitzsch; JA Robles-Guirado; RM Regojo Zapata; JJ Pozo-Kreilinger; C Iglesias; T Dwight; CA Muir; A Oleaga; ME Garrido-Lestache Rodríguez-Monte; MJ Del Cerro; I Martínez-Bendayán; E Álvarez-González; T Cubiella; DM Lourenço; MA A Pereira; N Burnichon; A Buffet; C Broberg; PV Dickson; MF Fraga; JL Llorente Pendás; J Rueda Soriano; F Buendía Fuentes; SPA Toledo; R Clifton-Bligh; R Dienstmann; J Villanueva; J Capdevila; AP Gimenez-Roqueplo; J Favier; P Nuciforo; JR Young WF; N Bechmann; AR Opotowsky; A Vaidya; I Bancos; D Weghorn; M Robledo; A Casteràs; L Dos-Subirà; I Adameyko; MD Chiara; PLM Dahia; RA Toledo. Convergent Genetic Adaptation in Human Tumors Developed Under Systemic Hypoxia and in Populations Living at High Altitudes. Cancer Discov. 15 - 5, pp. 1037 - 1062. 02/05/2025. DOI: 10.1158/2159-8290.
  10. M Araujo-Castro; A Casteràs; A Carmona-Bayonas; MD Chiara; FA Hanzu; J Hernando; JL Vercher-Conejero; M Rodríguez-Fraile; V Gómez Dos Santos; P Jimenez-Fonseca; A Giraldo; N Valdés; O Vidal; M Del Olmo-García; J Capdevila. Spanish consensus on the diagnosis and management of adrenocortical carcinoma. Endocr. Relat.Cancer. 32 - 5, pp. e250034. 24/04/2025. DOI: 10.1530/ERC-25-0034.
  11. M Balaguer-Montero; A Marcos Morales; M Ligero; L Zatse; D Leiva; LM Atlagich; N Staikoglou; C Viaplana; C Monreal; J Mateo; J Hernando; A García-Álvarez; F Salva; J Capdevila; E Elez; R Dienstmann; E Garralda; R Perez-Lopez. A CT-based deep learning-driven tool for automatic liver tumor detection and delineation in patients with cancer. Cell Rep Med. 6 - 4, 15/04/2025. DOI: 10.1016/j.xcrm.2025.102032.
  12. J Capdevila; V Pubul; U Anido; T Walter; J Molina-Cerrillo; T Alonso-Gordoa; R Garcia-Carbonero; M San-Roman-Gil; B Llana; P Jimenez-Fonseca; M Benavent Viñuales; C Ansquer; E Baudin; C Lepage; M Del Olmo-García; JC Ruffinelli; A Beron; M Haissaguerre; E Deshayes; D Taïeb; S Baldari; M Sansovini; S Cingarlini; A Filice; F Panzuto; R Álvarez-Álvarez; L Lousberg; F Aboubakar Nana; J Hernando; A García-Álvarez; A García-Burillo; G Villacampa; T Vandamme; N Fazio; A Durand. A Randomized clinical trial evaluating the impact on survival and quality of life of 177Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217). BMC Cancer. 25 - 1, pp. 613. 04/04/2025. DOI: 10.1186/s12885-025-13941-3.
  13. Rodriguez-Lloveras, Helena; Zafon, Carles; Iglesias, Carmela; Marcos-Ruiz, Jennifer; Gil, Joan; Rueda-Pujol, Anna; Gonzalez, Lorena; Mayor, Regina; Klein Hesselink, Esther N.; van Hemel, Bettien M.; Carrato, Cristina; Perello-Fabregat, Cecilia; Hernandez-Losa, Javier; Somoza, Rosa; Pluvinet, Raquel; Sanchez-Herrero, Jose F.; Sumoy, Lauro; Seoane, Joan; Riesco-Eizaguirre, Garcilaso; Montero-Conde, Cristina; Robledo, Mercedes; Hernando, Jorge; Capdevila, Jaume; Reverter, Jordi L.; Puig-Domingo, Manel; Links, Thera P.; Jorda, Mireia. DNA Methylation Dynamics and Prognostic Implications in Metastatic Differentiated Thyroid Cancer. THYROID. MARY ANN LIEBERT, INC, 06/03/2025. ISSN 1557-9077. DOI: 10.1089/thy.2024.0303.
  14. M Del Olmo-García; L Hernandez-Rienda; R Garcia-Carbonero; J Hernando; A Custodio; B Anton-Pascual; M Gomez; S Palma Milla; L Suarez; M Bellver; V Alonso; R Serrano; N Valdés; M Melian; B Febrero; MA Sampedro-Nuñez; J Biarnes; JÁ Díaz-Pérez; J Molina-Cerrillo; C Lopez; MA Martínez Olmos; JF Merino-Torres; J Capdevila; M Argente Pla. Nutritional status and quality of life of patients with advanced gastroenteropancreatic neuroendocrine neoplasms in Spain: the NUTRIGETNE (GETNE-S2109) study. Oncologist. 30 - 2, 06/02/2025. DOI: 10.1093/oncolo/oyae343.
  15. S Gil-Bernabé; L García-DeLaFuente; A García-Álvarez; G García-Rostán; J Capdevila; J Hernando. Genomics Review of Selective RET Inhibitors Sensitivity in Thyroid Cancer Clinical Trials. Am J Med Genet C Semin Med Genet. e32127, 04/01/2025. DOI: 10.1002/ajmg.c.32127
  16. F Balconi; A García-Álvarez; JH Cubero; JM O'Connor; M Chacón; J Capdevila. Maintenance therapy after first-line platinum-based chemotherapy in gastroenteropancreatic neuroendocrine carcinomas: A literature review. Cancer Treat Rev. 132, 01/2025. DOI: 10.1016/j.ctrv.2024.102863.
Protocol Code Abreviated Title Study Title PI Tumor Type
RAPIDO RAPIDO RAPIDO " Estudio aleatorizado multicéntrico en fase III de radioterapia de corta duración seguida de quimioterapia preoperatoria de larga duración y cirugía en el cáncer rectal primario de alto riesgo en comparación con quimiorradioterapia convencional y cirugía y óptima quimioterapia adyuvante. CAPDEVILA CASTILLON, JAUME [O/RT] [GI CRC] - RECTO
WO39608 WO39608 (MORPHEO 1) A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (MORPHEUS-PANCREATIC CANCER). MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
VHIO16001 - EORTC 1604 VHIO16001 - EORTC 1604 (MOTRICOLOR CT3) A phase II open-label study with the anti-PD-L1 Atezolizumab monoclonal antibody in combination with Bevacizumab in patients with advanced chemotherapy resistant colorectal cancer and MSI-like molecular signature. TABERNERO CATURLA, JOSEP [O/RT] [GI CRC] - COLORRECTAL
EF-27 EF-27 (PANOVA-3) PANOVA-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
XL184-311 XL184-311(COSMIC) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy. CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - TIROIDES
INCB 54828-302 INCB 54828-302 (FIGHT 302) A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302). MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - COLANGIOCARCINOMA
ITM-LET-01 ITM-LET-01 (COMPETE) A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somato-statin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
GEMCAD 1703 GEMCAD 1703 (DUREC) Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial). CAPDEVILA CASTILLON, JAUME [O/RT] [GI CRC] - RECTO
STEMNESS-PANC STEMNESS-PANC A Phase II/III Randomized, Open-Label Clinical Study of Napabucasin in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
CAAA601A22301 CAAA601A22301 (NETTER-2) A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in patients with Grade 2 and Grade 3 advanced GEP-NET. CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
EOADR1-19 EOADR1-19 (SPENCER)-II A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma. CAPDEVILA CASTILLON, JAUME [O/RT] [GI+N] - DIGESTIVO
EOADR1-19 EOADR1-19 (SPENCER) A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma. CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - HEPATOCARCINOMA
J2G-MC-JZJB J2G-MC-JZJB A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing LOXO-292 to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer LIBRETTO-531). CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - TIROIDES
Nocanther NOCANTHER A feasibility clinical investigation of intratumoral injection of magnetic nanoparticles associated to hyperthermia treatment in locally advanced pancreatic cancer. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
INCMGA0012-303 INCMGA0012-303 (POD1UM-303) A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2). CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - ANAL
BP42675 BP42675 AN OPEN LABEL, MULTICENTER, PHASE IB STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI TUMOR ACTIVITY OF CIBISATAMAB IN COMBINATION WITH RO7122290, A FIBROBLAST ACTIVATION PROTEIN A (FAP) TARGETED 4 1BB LIGAND (CD137L), WITH OBINUTUZUMAB PRE TREATMENT, IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC, MICROSATELLITE-STABLE COLORECTAL ADENOCARCINOMA WITH HIGH CEACAM5 EXPRESSION. TABERNERO CATURLA, JOSEP [O/RT] [GI CRC] - COLORRECTAL
849-010 849-010 (KRYSTAL-010) A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy TABERNERO CATURLA, JOSEP [O/RT] [GI CRC] - COLORRECTAL
AMCMEDONC17-010 AMCMEDONC17-010 (NAPAN) A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5 fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
NLM-2020-01 NLM-2020-01(NELUM-NLM) Phase Ib/IIa Study to evaluate safety and efficacy of Priming Treatment with the Hedgehog Inhibitor NLM-001 Prior to Chemotherapy (Gemcitabine and Nab-Paclitaxel) plus AGEN 1884 as First Line treatment in Patients with Advanced Pancreatic Cancer. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
CNIS793E12201 CNIS793E12201 A randomized, open-label, three-arm phase II study of NIS793 with or without spartalizumab in combination with standard of care anti-cancer therapy for the second line treatment of metastatic colorectal cancer. TABERNERO CATURLA, JOSEP [O/RT] [GI CRC] - COLORRECTAL
MK-6482-015 MK-6482-015 A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, formerly PT2977) Monotherapy in Participants with Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumor (pNET). CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
CL-SBP-101-04 CL-SBP-101-04 A Phase 3, Randomized, Double-blind, Placebo-controlled Study of SOC with or without IMP in Subjects with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
DP-1111-02CT DP-1111-02CT (COMPOSE) A prospective, randomised, Controlled, Open-label, Multicentre study to evaluate efficacy, safety and Patient Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to best Standard of care in patients with well-differentiated aggressive Grade 2 and Grade 3, somatostatin receptor positive (SSTR+), neuroendocrine tumours of gastroEnteric or pancreatic origin CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
HS-19-657 HS-19-657 (CAMURUS) Estudio de fase III, aleatorizado, multicéntrico, controlado con tratamiento activo y abierto para evaluar la eficacia y seguridad de CAM2029 (octreótido depot S.C. ) vs. Octreótido LAR o Lanreótido ATG en pacientes con tumores neuroendocrinos gastro-pancreáticos. CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
D8151C00001 D8151C00001 A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination with Durvalumab and Chemotherapy in Subjects with Locally Advanced or Metastatic Solid Tumors. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
D-FR-60010-015 D-FR-60010-015 (SIRACUSA) A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination with Anti-Cancer Agents in Adult Participants with Metastatic Pancreatic Adenocarcinoma. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
A-20-1013-C-03 A-20-1013-C-03 (OPTIMIZE-1) An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
TTD-20-04 TTD-20-04 (OLADURVA) Olaparib and durvalumab (MEDI4736) in patients with metastatic pancreatic cancer and DNA Damage Repair genes alterations HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - PANCREAS
RYZ101-301 RYZ101-301 (ACTION-1) Phase 1b/3 Clinical Study of RYZ101 in advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that express somatostatin receptors (SSTR) RYZ101-301 CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
P-VCNA-003 P-VCNA-003 A phase IIb, open-label, randomized study of Gemcitabine and NabPaclitaxel plus/VCN-01 in Patients with Metastatic Pancreas Cancer MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
8951-CL-5201 8951-CL-5201 A Phase 2, Open-label. Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line treatment in subjects with Claudin 18.2 (CLDN 18.2) Positive, Metastatic Pancreatic Adenocarcinoma MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
C4221026/C4221009C C4221026 SUBSTUDY C4221009C "AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE C4221009 (ARRAY-818-302, BEACON) AND W00090 GE 2 01 (ANCHOR CRC) ENCORAFENIB BINIMETINIB AND CETUXIMAB STUDIES" TABERNERO CATURLA, JOSEP [O/RT] [GI CRC] - COLORRECTAL
ONCO01P04 ONCO01P04 (TRIPP-FFX) ONCOSIL An open label, multi centre, randomized study of OncoSil™ in addition to FOLFIRINOX chemotherapy versus FOLFIRINOX chemotherapy alone in patients with unresectable locally advanced pancreatic adenocarcinoma HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - PANCREAS
1403-0011 1403-0011 A Phase II/III, open-label, single-arm, multi-centre study of BI 907828 for treatment of patients with locally advanced / metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma (cohort 1) and other selected MDM2 amplified, TP53 wild-type solid tumours MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
GEMCAD 2103 GEMCAD 2103 / MO44170 TIRANUS "Estudio de fase II de atezolizumab más tiragolumab en combinación con quimio-radioterapia en carcinoma de células escamosas localizado del canal anal." CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - ANAL
D4191C00140 D4191C00140 (TOURMALINE) A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers GARCÍA ÁLVAREZ, ALEJANDRO [O/RT] [GI non CRC] - PANCREAS
DIM-95031-002 DIM-95031-002 (ProvIDHe) An open-label early access phase 3b study of Ivosidenib in patients with a pretreated locally advanced or metastatic cholangiocarcinoma HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - PANCREAS
219369 219369 (AZUR-1) PH2 Open label study evaluating Dostarlimab in the Neoadjuvant Treatment of locally advanced (la) dMMR/MSI-H rectal cancer (RC) CAPDEVILA CASTILLON, JAUME [O/RT] [GI CRC] - RECTO
2020-9610 2020-9610 SPRINT-RET An observational, multi-country, retrospective chart review study to describe the characteristics, treatment patterns and clinical outcomes of patients receiving selpercatinib in real-world clinical practice in Europe HERNANDO CUBERO, JORGE [O/RT] [NET] - TIROIDES
GEMCAD 2201 GEMCAD 2201 (REVEAL) Circulating tumor DNA as complementary tool to assess response to neoadjuvant therapy in locally advanced rectal cancer. GEMCAD-REVEAL STUDY GARCÍA ÁLVAREZ, ALEJANDRO [O/RT] [GI CRC] - RECTO
Actuate 1801/ACT1801 Actuate 1801 SUBSTUDY/ACT1801 randomized phase II clinical study evaluating 9-ING-41 (“Elraglusib”, a Glycogen synthase kinase 3β inhibitor) in combination with Gemcitabine-Abraxane, in 1st line metastatic PDAC patients. MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
EF-39 EF-39 PANOVA-4 "Pilot, Single arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) " HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - PANCREAS
GO44479 GO44479 A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS mFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS
GETNE-T2216 GETNE-T2216 (CABOTHYROID) Biomarker Phase II Study Of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer HERNANDO CUBERO, JORGE [O/RT] [NET] - TIROIDES
M24-147 M24-147 A Phase 2, Randomized Open-Label Study to Evaluate the Optimized Dose, Safety, and Efficacy of ABBV-151/Livmoniplimab (GARP-TGFβ1) in Combination with Budigalimab (anti–PD-1) for locally advanced or Metastatic Hepatocellular Carcinoma (HCC) patients who have progressed after an approved immune checkpoint inhibitor containing regimen in 1L HCC. HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - HEPATOCARCINOMA
2021-10496 2021-10496 (SPRINT-RET) "An observational, retrospective chart review study in patients with RET-altered locally advanced or metastatic lung, thyroid or other solid tumours: a real-world contextual comparator to selpercatinib-treated patients in LIBRETTO-001" HERNANDO CUBERO, JORGE [O/RT] [NET] - TIROIDES
TAS-120-205 TAS-120-205 Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements GARCÍA ÁLVAREZ, ALEJANDRO [O/RT] [GI non CRC] - COLANGIOCARCINOMA
OMO-103-02 OMO-103-02 A Phase 1b Study to evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 administered intravenously in combination with different drugs in Patients with advanced Solid Tumors (OMO-103-02) HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - PANCREAS
GETNE-T2217 GETNE-T2217  LEVEL Efficacy, safety and patient-reported outcomes of peptide receptor radionuclide therapy with 177Lu-edotreotide compared to everolimus in somatostatin receptor positive neuroendocrine tumors of the lung and thymus. The LEVEL Trial CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
TT420C2308 TT420C2308 (FIRST-308) A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician’s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308). MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - COLANGIOCARCINOMA
M24-052 M24-052 (LIVIGNO-2) A Phase 2/3, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in subjects with Locally Advanced or Metastatic  Hepatocellular Carcinoma (HCC) who have not previously received systemic treatment CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - HEPATOCARCINOMA
TTX-030-003 TTX-030-003 A Phase 2, open-label, 3-arm randomized study to evaluate the efficacy and safety of TTX-030 with or without budigalimab, and in combination with chemotherapy for the treatment of locally advanced, unresectable, or metastatic pancreatic ductal adenocarcinoma CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS
D9800C00001 D9800C00001 (CLARITY PAN TUMOR 01) An Open Label, Phase 2a Study of AZD0901 as Monotherapy or in Combination with Anti-cancer Agents in Participants with advanced or metastatic solid tumors expressing Claudin 18.2 GARCÍA ÁLVAREZ, ALEJANDRO [O/RT] [GI non CRC] - PANCREAS
GETNE-T2318 GETNE-T2318 (SETHY) Estudio de fase II, multicéntrico, abierto, de dos cohortes, de un solo brazo, para evaluar la eficacia y la seguridad del anticuerpo-fármaco conjugado anti-TROP2 sacituzumab govitecan en pacientes con neoplasias tiroideas anaplásicas y diferenciadas avanzadas. GARCÍA ÁLVAREZ, ALEJANDRO [O/RT] [NET] - TIROIDES
JZP598-302 JZP598-302 HERIZON-BTC-01 An open-label randomized trial of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2‑positive biliary tract cancer (BTC) MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
PANT-SP-2023-01 SP-PANT-2023-01 (Pantheia) "Estudio de factores pronósticos y predictivos de respuesta a tratamiento quimioterápico en pacientes diagnosticados de cáncer de páncreas avanzado" HERNANDO CUBERO, JORGE [O/RT] [GI non CRC] - PANCREAS
CT-01-CD-1 CT-01-CD-1 (CAPTOR) A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-01 as Monotherapy and Combination Therapy in Subjects with Intermediate or Advanced Hepatocellular Carcinoma (BCLC Stage B or C) with Preserved Liver Function (Child-Pugh Class A) MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - HEPATOCARCINOMA
D781PC00001 D781PC00001 (DESTINY-Biliary Tract Cancer-01) A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care gemcitabine, cisplatin, and durvalumab for first line locally advanced or metastatic HER2-expressing Biliary Tract Cancer CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - COLANGIOCARCINOMA
BAY-LAR-2022-01 BAY-LAR-2022-01 (ON-TRK) ON-TRK: Estudio prOspectivo No intervencionista en pacientes con cáncer de fusión TRK localmente avanzado o metastásico tratados con larotrectinib GARCÍA ÁLVAREZ, ALEJANDRO [O/RT] [NET] - NET
CRUKD/24/002 CRUKD/24/002 "A CANCER RESEARCH UK PHASE II OPEN LABEL TRIAL IN PARTICIPANTS WITH METASTATIC  PANCREATIC DUCTAL ADENOCARCINOMA OF GINISORTAMAB GIVEN INTRAVENOUSLY I) WITH FIRST-LINE STANDARD OF CARE NAB-PACLITAXEL AND GEMCITABINE, OR II) IN COMBINATION WITH MEK INHIBITOR MAINTENANCE THERAPY " MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
PRISM-1 PRISM-1 A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma Not Previously Treated in the Metastatic Setting MACARULLA MERCADE, TERESA [O/RT] [GI non CRC] - PANCREAS
S095031-210 S095031-210 A Phase 1b/2, Safety Lead-in and Dose Expansion, Open label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - COLANGIOCARCINOMA
MK-1022-011 MK-1022-011 A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers HERNANDO CUBERO, JORGE [O/RT] [GI+N] - DIGESTIVO
RMC-6236-302 RMC-6236-302 (RASolute 302) RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS
GETNE T2420 GETNE T2420 (EVNEC) un estudio Fase II, multicéntrico, abierto, de un solo brazo para evaluar la eficacia y seguridad de Enfortumab Vedotina como agente único en pacientes con tumores neuroendocrinos G3 o carcinomas neuroendocrinos avanzados, refractarios o no elegibles para quimioterapia con platino, cuyo inicio está previsto en diciembre de 2024. CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
VESPA VESPA "“Randomized phase 2 study of Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients (The VESPA trial)" CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS
D419CR00035 D419CR00035 (LIVER-R) An Observational Multi-center study to Evaluate Real-World Treatment Outcomes of Durvalumab-based Regimens in Hepatobiliary Cancers VEGA CANO, KREINA SHARELA [O/RT] [GI non CRC] - HEPATOCARCINOMA
CRN00808-12 CRN00808-12 (CAREFNDR) A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults with Carcinoid Syndrome due to Well-Differentiated Neuroendocrine Tumors HERNANDO CUBERO, JORGE [O/RT] [NET] - NET
GETNE T2421 RLTTio2023 GETNE T2421 RLTTio2023 (RIALTO) Randomized Interval Assessment trial of Lu177-Dotatate every 8 versus every 16 weeks in slowly progressive G1-2 advanced midgut neuroendocrine tumors (NETs) to Lower Toxicity CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
TTD-24-01 TTD-24-01-PANSOTO Sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma with KRAS p.G12C mutation CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS
GETNE T2419 GETNE T2419 (GETNE-RAGNAR) Phase II Study Of Tarlatamab Alone Or in Combination With Chemotherapy In Advanced Neuroendocrine Carcinomas Of The Digestive System Or Unknown Primary Origin CAPDEVILA CASTILLON, JAUME [O/RT] [NET] - NET
GETNE S2411 GETNE S2411 (SPAINTRK) Análisis retrospectivo de la experiencia con Larotrectinib en pacientes con neoplasias sólidas con fusión NTRK en España (SPAINTRK) HERNANDO CUBERO, JORGE [O/RT] [NET] - NET
CAAA601A62301 CAAA601A62301 (NETTER-3) A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET (NETTER-3) HERNANDO CUBERO, JORGE [O/RT] [NET] - NET
C3651032 C3651032 A Low-Interventional Study to Assess Physical Activity using Digital Health Technology in Adult Participants with Cachexia and Receiving or will be Receiving First-Line Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS
OMTX705-006 OMTX705-006 Phase 1b Dose Escalation Trial of OMTX705, an Anti‐Fibroblast  Activation  Protein  Antibody‐Drug  Conjugate,  in  ombination  with Gemcitabine/Nab‐Paclitaxel  and  Tislelizumab  in  Patients  with  Advanced/Metastatic Pancreatic Adenocarcinoma CAPDEVILA CASTILLON, JAUME [O/RT] [GI non CRC] - PANCREAS

Group Leader Elena Élez Medical Oncologists and Clinical Investigators (colorectal cancer): Iosune Baraibar, Marta Rodríguez, Francisco Javier Ros, Francesc Salvà, Clara Salvà, Nadia Saoudí Medical Oncologists and Clinical Investigators (gastroesophageal cancer): Daniel Acosta, Eduardo Terán Research Oncology Nurse Ariadna García Nutritionist Adriana Alcaraz Colon Task Force Manager Mireia Sanchis Sample Manager Ines Suárez

Research Groups

Gastrointestinal Tract Tumors Group

Summary

VHIO’s Gastrointestinal Tract Tumors Group, led by Elena Élez, brings together extensive expertise in both colorectal and gastroesophageal malignancies, integrating clinical and translational research to advance patient care. Our work focuses on identifying novel prognostic and predictive biomarkers, understanding mechanisms of drug resistance, and developing innovative therapeutic strategies across disease stages.

In colorectal cancer (CRC), the group is internationally recognized for its leadership in BRAF-mutated disease, a subtype associated with aggressive clinicopathological features. Our investigators have contributed to landmark studies such as the phase III BREAKWATER trial, supporting the approval of encorafenib in combination with cetuximab and chemotherapy in the first-line setting, and we continue to expand therapeutic options through investigator-initiated trials exploring novel combinations. We have also played a key role in the development and approval of multiple therapies in metastatic CRC, including immune checkpoint inhibitors for MSI-H tumors and targeted agents in refractory disease. In parallel, we are expanding research efforts in early-onset CRC, aiming to elucidate the role of environmental exposures, microbiota, and host immunity in tumorigenesis.

The microbiome represents a central cross-cutting research priority, with studies exploring its role in cancer development, treatment response, and toxicity. These efforts are supported by multidisciplinary approaches integrating biological sample analysis and dietary assessments, including the development of a validated food frequency questionnaire to study nutrition–microbiome interactions in the Spanish population. In rectal cancer, our research is focused on optimizing perioperative strategies in localized disease, including clinical trials such as the DUREC study evaluating the addition of immunotherapy to standard chemoradiotherapy, alongside translational projects investigating microbiota influences on treatment efficacy.

In gastroesophageal cancers (GE), the program is dedicated to improving outcomes in esophageal, gastroesophageal junction, and gastric malignancies through therapeutic innovation and precision medicine. We have contributed to pivotal trials such as MATTERHORN, supporting the integration of immunotherapy in the perioperative setting, and DESTINY-Gastric04, establishing trastuzumab deruxtecan as standard second-line therapy in HER2-positive disease. Our research also focuses on emerging targets such as CLDN18.2, building on our role in the development of zolbetuximab and advancing next-generation agents in early-phase trials.

Translational research efforts in gastroesophageal cancer include the identification of predictive biomarkers for immunotherapy response, such as the VIGex gene expression signature, as well as the study of tumor microenvironment heterogeneity and biomarker overlap to refine treatment prioritization. A cornerstone of our strategy is the development of investigator-initiated trials, including the RILVE phase II study evaluating rilvegostomig, a novel PD-1/TIGIT bispecific antibody, in advanced gastric cancer.

Across both disease areas, we place particular emphasis on addressing treatment resistance and unmet clinical needs in advanced stages. Additional research lines include the study of cancer-associated cachexia and sarcopenia using radiomic approaches within immunotherapy-treated populations. Through this comprehensive and integrated approach—spanning biomarker discovery, microbiome research, perioperative optimization, and novel drug development—our group is well positioned to define emerging standards of care and drive next-generation therapeutic strategies in gastrointestinal cancers.

  • Drive drug development in gastrointestinal cancers through participation in international clinical trials and leadership of investigator-initiated and early-phase studies, including innovative trial designs such as window-of-opportunity approaches.
  • Advance precision oncology by integrating biomarker discovery, validation, and implementation with multi-omics and liquid biopsy approaches to optimize patient selection and monitor disease evolution.
  • Elucidate mechanisms of primary and acquired resistance to anticancer therapies, with a focus on BRAF-mutated colorectal cancer and refractory gastroesophageal malignancies, to identify new therapeutic vulnerabilities.
  • Develop and optimize targeted and immune-based therapeutic strategies for molecularly defined subgroups in GE (e.g., HER2, CLDN18.2), including the integration of novel agents and combinations, and incorporate these approaches into perioperative and advanced disease settings.
  • Investigate early-onset colorectal cancer (EO-CRC) as a central research priority, focusing on underlying biological mechanisms and the role of environmental exposures in tumorigenesis.
  • Characterize the role of the microbiome and environmental factors in cancer, including their impact on tumor development, treatment response, and toxicity, and assess nutrition–microbiome interactions through validated dietary tools.
  • Characterize disease biology across stages, including metastatic progression (e.g., colorectal liver metastases) and tumor microenvironment dynamics, to refine prognostic stratification and treatment prioritization.
  • Characterize disease biology across stages, including metastatic progression (e.g., colorectal liver metastases) and tumor microenvironment dynamics, to refine prognostic stratification and treatment prioritization.
  • Investigate cancer-associated cachexia and sarcopenia, particularly in gastroesophageal cancer and immunotherapy-treated populations, to improve patient outcomes and quality of life
  • In colorectal cancer (CRC), the team is leading the REFISH trial (VHIO23004), a phase II study using circulating tumor DNA (ctDNA) to guide treatment decisions. This trial evaluates rechallenge with targeted therapy (encorafenib plus cetuximab) in selected patients with BRAFV600E-mutated metastatic CRC, representing a key step toward more personalized treatment strategies.
  • Our investigators contributed to the landmark phase III BREAKWATER study, which led to the approval of a new first-line treatment combination for patients with BRAFV600E-mutated CRC.
  • The STELLAR-303 phase III trial demonstrated improved survival with a chemotherapy-free, immunotherapy-based regimen in heavily pretreated metastatic CRC patients, offering a new option for this difficult-to-treat population.
  • In early-stage colon cancer, we participated in the design of the FOxTROT8 phase III trial, evaluating biomarker-driven neoadjuvant treatment strategies. A comprehensive translational program linked to this study integrates advanced technologies (including liquid biopsy and multi-omics) to improve patient selection and outcomes.
  • In 2025, we initiated and completed the safety lead-in phase of the BRAVE trial, exploring a novel combination strategy in BRAFV600E-mutated metastatic CRC aimed at delaying treatment resistance and improving therapeutic efficacy.
  • The BeLIVER project, funded by ISCIII and the European Union, focuses on understanding how the tumor microenvironment contributes to immune resistance in liver metastases and aims to identify new therapeutic strategies.
  • We have strengthened internal collaboration through the consolidation of CRC Working Groups, enhancing coordination between clinicians, researchers, and other key stakeholders.
  • Our research has also highlighted the role of environmental factors (the exposome) in early-onset CRC, identifying both known risk factors and new potential contributors in younger patients.
  • In gastroesophageal cancer, we contributed to the phase III MATTERHORN trial (published in the New England Journal of Medicine), which showed that adding immunotherapy to standard perioperative chemotherapy improves outcomes in resectable disease.
  • We also participated in the DESTINY-Gastric04 trial, whose 2025 results established a new standard second-line treatment for patients with HER2-positive advanced gastric cancer.
  • We launched the RILVE Project, an investigator-initiated phase II study exploring the effects of a novel immunotherapy (rilvegostomig) in advanced gastric cancer.
  • Our group continues to expand treatment options targeting CLDN18.2, including participation in the phase III LUCERNA trial and the development of next-generation therapies.
  • Overall, our program combines clinical trials and translational research to accelerate the development of more effective and personalized treatments for patients with gastrointestinal cancers.
  • In the CRC field, we are developing a new interdisciplinary research line exploring the relationship between cancer, depression, and the microbiome, building on emerging evidence linking the gut–brain axis and immunotherapy outcomes. This initiative, in collaboration with the Oncology and Mental Health Departments at Vall d’Hebron University Hospital, will lead to the launch of a joint research project in 2026.
  • We have completed the validation of a food frequency questionnaire (FFQ) designed to assess dietary patterns in the Spanish population and their impact on the intestinal microbiota, enabling future large-scale studies on diet–microbiome interactions in cancer.
  • Using multi-omics approaches, we aim to generate comprehensive datasets to better understand the biological and environmental factors underlying the increasing incidence of early-onset colorectal cancer (<50 years) in Spain.
  • We will continue to advance precision medicine approaches through the implementation of liquid biopsy in localized disease, including its integration into Master Observational Trials for real-time disease monitoring.
  • We aim to expand our cohort of patients with BRAFV600E-mutated colorectal cancer through the investigator-initiated BRAVE trial (funded by ISCIII), evaluating the combination of encorafenib, cetuximab, and bevacizumab to improve treatment outcomes.
  • In the GE field, in the perioperative setting, we will advance precision oncology strategies to predict response to immunotherapy and other systemic treatments in localized disease, with the goal of personalizing neoadjuvant and adjuvant approaches and addressing early treatment resistance.
  • We will further investigate the biology of CLDN18.2, including its interaction with the tumor microenvironment and its role as a therapeutic target, with particular emphasis on combination strategies with immunotherapy and treatment prioritization in biomarker-overlapping populations.
  • We will deepen our understanding of treatment-refractory gastroesophageal cancer by characterizing its molecular heterogeneity and studying the impact of cachexia and sarcopenia through integrated clinical and tumor profiling approaches, with the aim of identifying new therapeutic vulnerabilities.
  • Elez E, Yoshino T, Shen L, Lonardi S, Van Cutsem E, Eng C, Kim TW, Wasan HS, Desai J, Ciardiello F, Yaeger R, Maughan TS, Morris VK, Wu C, Usari T, Laliberte R, Dychter SS, Zhang X, Tabernero J, Kopetz S; BREAKWATER Trial Investigators. Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer. N Engl J Med. 2025 Jun 26;392(24):2425-2437.
  • Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, Tabernero J; MATTERHORN Investigators. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jul 17;393(3):217-230.
  • Elez E. Nonoperative Management of dMMR Tumors - A Patient-Centered Approach. N Engl J Med. 2025 Jun 19;392(23):2380-2382.
  • Elez E, Siena S, Sartore-Bianchi A, Ros J, Ciardello F, Martinelli E, Steeghs N, Huijberts S, Cervantes A, Roselló S, Tejpar S, Wilmsen B, Salazar R, Santos C, de Schaetzen G, Muñoz S, Bernards R, Moreno V, García-Galera E, Alemany R, Gros A, Bardelli A, Arena S, Piris A, Chavarría E, Dienstmann R, Tabernero J. Efficacy and safety of atezolizumab plus bevacizumab in MSI-like metastatic colorectal cancer: a multicenter, single-arm, phase II, open-label clinical trial. ESMO Open. 2025 Dec;10(12):105892.
  • Highly Cited Researcher 2025 Clarivate Elena Élez.
  • Premio Extraordinario a la Excelencia e Innovación en Investigación en Tumores Digestivos al Grupo de Cáncer Colorrectal del Vall d’Hebron Institute of Oncology (VHIO). XIII Edición de los Premios Fundación ECO. Fundación ECO. Elena Élez.
  • VHIO MD-PhD fellowship in 2025. Fundació Catalunya La Pedrera. Clara Salvà de Torres.
  • Beca SEOM 2025. Proyectos de Impacto en cáncer metastásico utilizando la Inteligencia Artificial. Sociedad Española de Oncología Médica. Iosune Baraibar.
  • Visiting Fellowship de estancia en centros de referencia financiada. Sociedad Española de Oncología Médica. Javier Ros.
  • Premio SEOM Tesis doctoral para Investigadores Jóvenes. Sociedad Española de Oncología Médica. Javier Ros.
  • Appointed coordinator of the Young Group of the Catalan Association of Esophagogastric Tumors. ACTEG-SCBO. Eduardo Terán.
  • Appointed member of the TTD Young Researchers Working Group within the Spanish Cooperative Group for the Treatment of Digestive Tumors. TTD. Eduardo Terán.
  • Recipient of the Award for Best Scientific and Professional Residency Career from the Royal Academy of Medicine of Salamanca. Royal Academy of Medicine of Salamanca. Eduardo Terán.
  • Recipient of the SEOM “Somos Futuro” Award 2025 for Outstanding Resident. SEOM. Eduardo Terán.
  • Best Poster Award, ESMO Congress 2025 (Berlin). “Claudin 18.2 expression in gastroesophageal adenocarcinoma: biomarker overlap and association with immunotherapy outcomes: A multicenter study.” Annals of Oncology 2025;36:S1206. DOI:10.1016/j.annonc.2025.08.2763. ESMO. Eduardo Terán.
  1. Exploring the feasibility of predictive and pharmacodynamics biomarkers of immunotherapy in solid tumours (Immune4ALL). PI: Elena Élez. Grantor: Carlos III Health Institute. Duration: 01/01/2023 - 31/12/2025.
  2. A precision medicine trial leveraging blood-based tumour genomics to optimise treatment in operable stage iii and high-risk stage ii colon cancer patients – the Sagittarius Trial. PI: Elena Élez. Grantor: Horizon Europe. Duration: 01/07/2023 - 30/06/2028.
  3. Multi-target approach including anti-angiogenic agent to overcome treatment resistance in BRAF mutant metastatic colorectal setting. PI: Elena Élez. Grantor: Carlos III Health Institute. Duration: 01/01/2022 - 31/12/2025.
  4. Identification and validation of mechanisms of resistance and response to targeted therapies in patients with metastatic colorectal cancer with BRAFV600E mutation. Grantor: CRIS Cancer Foundation. PI: Elena Élez. Duration:  01/12/2021 - 31/12/2025.
  5. Identification and validation of sensitivity signatures and mechanisms of resistance and response to targeted therapies and immunotherapy in patients with advanced colorectal cancer. Grantor: Carlos III Health Institute. Duration: 01/01/2021 - 30/06/2025.
  6. BioPrinted hydROgel MicrofluIdicS to mimic patient-specific tumour mEtastatic (PROMISE). Grantor: "La Caixa" Foundation. Duration: 01/12/2020 – 30/05/2025.
  7. OPTIMISTICC: OPportunity To Investigate the Microbiome’s Impact on Science and Treatment In Colorectal Cancer. PI: Josep Tabernero. Grantor: Grand Challenge Cancer Research UK. Duration: 01/01/2019 - 30/12/2025.
  8. Identification and Validation of Mechanisms of Resistance and Response to Targeted Therapies in BRAFV600E Metastatic Colorectal Cancer. PI: Elena Élez. Grantor: TTD Duration: 01/03/2022 – 28/02/2025.
  9. Circulating Tumor DNA Based Decision for Adjuvant Treatment in Colon Cancer stage II-III (CIRCULATE-SPAIN). PI: Elena Élez. Grantor: Carlos III Health Institute. Duration: 2021 – 2025.
  10. Single cell characterization of persistent cells upon treatment with durvalumab (MEDI4736) with or without tremelimumab in MSS and MSI colorectal and endometrial tumors: the SERPENTINE clinical trial (Single cEll pRofiling PErsistaNce To ImmuNothErapy). PI: Elena Élez. Grantor: AstraZeneca Farmacéutica Spain, S.A. Duration: 11/01/2022 - 31/03/2026.
  11. Evaluación de las estructuras linfoides terciarias (TLS) como biomarcador en el cáncer colorrectal metastásico tratado con combinaciones de puntos de control inmunitarios. PI: Elena Élez. Grantor: Becas SEOM para Proyectos de Investigación Traslacional en Inmuno-oncología 2024. Duration: 01/12/2023-30/11/2025.
  12. Single-cell resolution of primary CRC microenvironment and matched liver tumor metastasis (LimeCop). PI: Elena Élez. Grantor: MEDIMMUNE LLC. Duration: 09/06/2023 – 31/12/2025.
  13. Biomarker identification in patients with BRAF mutant metastatic colorectal cancer to guide treatment strategy and overcome primary/adquired restances to BRAF Inhibitor-targeted agents – BRAFsistance. PI: Elena Élez. Grantor: CRIS Cancer Foundation. Duration: 01/05/2024 – 30/04/2029.
  14. Identification of T cell receptors targeting hotspot mutations in common driver oncogenes from tumor specimens of mismatch repair proficient colorectal carcinoma patients. PI: Elena Élez. Grantor: AstraZeneca UK Ltd. Duration: 14/11/2024 – 14/11/2026.
  15. Identification and Analysis of Hepatic Transcriptional Regulators in Liver Metastasis of Colorectal Cancer (COHET project). PI: Elena Élez. Grantor: Gilead Sciences. Duration: 2025-2027.
  16. Colorectal cancer – Stratification of Therapies through Adaptive Responses (CRC-STARS). PI: Josep Tabernero. Grantor: Cancer Research UK. Duration: 04/2025-03/2030
  17. EGFR Ligand-Based Patients Hyperselection in Neoadjuvant Therapy: Transforming Treatment Strategies for Localized Colon Cancer through FOxTROT8 clinical trial. PI: Elena Élez. Grantor: Asociación Española Contra el Cáncer (AECC). Duration: 2025-2030
  18. VHIO23004 (REFISH) A Phase 2, Single-Arm study of encorafenib plus cetuximab as rechallenge treatment of BRAF V600E-mutant metastatic colorectal cancer patients after previous therapy with BRAF inhibitors-based combinations: the REFISH trial. PI: Elena Élez. Grantor: VHIO
  19. “Validation of the VIGex gene expression signature as a predictive biomarker for immune checkpoint inhibitors in patients with gastroesophageal adenocarcinoma”. PI: Daniel Acosta. Grantor: SEOM Duration: 2024 – 2026
  20. Local and systemic immune modulation by rilvegostomig in advanced gastric cancer (RILVE Project). PI: Dr. Elena Élez and Dr. Eduardo Terán       | Collaborator: AstraZeneca (Partners of Choice Program). Phase: II (Window-of-opportunity) | Duration: 2024-2026. Investigator-initiated trial evaluating the pharmacodynamic and immunological effects of the PD-1/TIGIT bispecific antibody rilvegostomig in first-line gastric cancer through comprehensive translational endpoints including serial tumor biopsies and peripheral immune monitoring.
  21. INMUNO-CGM: Immunonutritional profile and body composition as predictors of response and toxicity to immunotherapy in metastatic gastric cancer. PR(AG)618/2025. PI: Eduardo Terán and Richard Mast. Duration: 2026-2028.
  22. Expresión de Claudina 18.2 en tumores gastroesofágicos:  solapamiento de biomarcadores y su impacto pronóstico asociado. PR(AG)533/2025. PI: Eduardo Terán. Duration: 2026-2028.
  1. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial. André, Thierry ; ELEZ FERNANDEZ, MARIA ELENA; Lenz, Heinz-Josef ; Jensen, Lars Henrik ; Touchefeu, Yann ; Van Cutsem, Eric ; Garcia-Carbonero, Rocio ; Tougeron, David ; Mendez, Guillermo Ariel ; Schenker, Michael ; de la Fouchardiere, Christelle ; Limon, Maria Luisa ; Yoshino, Takayuki ; Li, Jin ; Manzano Mozo, Jose Luis ; Dahan, Laetitia ; Tortora, Giampaolo ; Chalabi, Myriam ; Goekkurt, Eray ; Braghiroli, Maria Ignez ; Joshi, Rohit ; Cil, Timucin ; Aubin, Francine ; Cela, Elvis ; Chen, Tian ; Lei, Ming ; Jin, Lixian ; Blum, Steven I ; Lonardi, Sara Lancet. 2025 Feb 1;405(10476):383-395. doi: 10.1016/S0140-6736(24)02848-4.
  2. Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer. ELEZ FERNANDEZ, MARIA ELENA; Yoshino, Takayuki ; Shen, Lin ; Lonardi, Sara ; Van Cutsem, Eric ; Eng, Cathy ; Kim, Tae Won ; Wasan, Harpreet Singh ; Desai, Jayesh ; Ciardiello, Fortunato ; Yaeger, Rona ; Maughan, Timothy S ; Morris, Van K ; Wu, Christina ; Usari, Tiziana ; Laliberte, Robert ; Dychter, Samuel S ; Zhang, Xiaosong ; TABERNERO CATURLA, JOSEP; Kopetz, Scott ; BREAKWATER Trial Investigators. N Engl J Med. 2025 Jun 26;392(24):2425-2437. doi: 10.1056/NEJMoa2501912. Epub 2025 May 30.
  3. Pembrolizumab versus chemotherapy in microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer: 5-year follow-up from the randomized phase III KEYNOTE-177 study. André, T ; Shiu, K-K ; Kim, T W ; Jensen, B V ; Jensen, L H ; Punt, C J A ; Smith, D ; Garcia-Carbonero, R ; Alcaide-Garcia, J ; Gibbs, P ; Fouchardiere, C de la ; Rivera, F ; ELEZ FERNANDEZ, MARIA ELENA; Le, D T ; Yoshino, T ; Zuo, Y ; Fogelman, D ; Adelberg, D ; Diaz, L A Jr. Ann Oncol. 2025 Mar;36(3):277-284. doi: 10.1016/j.annonc.2024.11.012. Epub 2024 Dec 2.
  4. The molecular and functional landscape of resistance to FOLFIRI chemotherapy in metastatic colorectal cancer. Avolio, Marco ; Leto, Simonetta M ; Sassi, Francesco ; Lupo, Barbara ; Grassi, Elena ; Catalano, Irene ; Zanella, Eugenia R ; Vurchio, Valentina ; Cottino, Francesca ; Tsantoulis, Petros K ; Lazzari, Luca ; Luraghi, Paolo ; Ferri, Martina ; Galimi, Francesco ; Berrino, Enrico ; Bellomo, Sara E ; Viviani, Marco ; Sogari, Alberto ; Mauri, Gianluca ; Tosi, Federica ; Cruciani, Federica ; Sartore-Bianchi, Andrea ; Siena, Salvatore ; Borghi, Felice ; Torri, Valter ; ELEZ FERNANDEZ, MARIA ELENA; TABERNERO CATURLA, JOSEP; Nieva, Maria ; Montagut, Clara ; Tarazona, Noelia ; Cervantes, Andres ; Tejpar, Sabine ; Bardelli, Alberto ; Marchiò, Caterina ; Marsoni, Silvia ; Bertotti, Andrea ; Trusolino, Livio. Cancer Discov. 2026 Feb 6;16(2):270-295. doi: 10.1158/2159-8290.CD-24-0556.
  5. A Phase Two, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1). Andrea Cercek, Jean-Baptiste Bachet, Jaume Capdevila, Naureen Starling, Eric Chen, Lisa Salvatore, Hideaki Bando, Sean O'Donnell, Lauren Harfst, Zsolt Szijgyarto, Volker Heinemann. Clin Colorectal Cancer. 2025 Jun;24(2):325-330. doi: 10.1016/j.clcc.2025.02.003. Epub 2025 Feb 21.
  6. Sex and outcomes of patients with microsatellite instability-high and BRAF V600E mutated metastatic colorectal cancer receiving immune checkpoint inhibitors. Nasca, Vincenzo ; Zhao, Joseph ; ROS MONTAÑA, JAVIER; Lonardi, Sara ; Zwart, Koen ; Cohen, Romain ; Fakih, Marwan ; Jayachandran, Priya ; Roodhart, Jeanine M. L. ; Derksen, Jeroen ; Intini, Rossana ; Bergamo, Francesca ; Mazzoli, Giacomo ; Ghelardi, Filippo ; LIGERO HERNANDEZ, MARTA; Jonnagaddala, Jitendra ; Hawkins, Nicholas ; Ward, Robyn L. ; Wankhede, Durgesh ; Brenner, Hermann ; Hoffmeister, Michael ; Vitellaro, Marco ; Salvatore, Lisa ; Gallois, Claire ; Laurent-Puig, Pierre ; Cremolini, Chiara ; Overman, Michael J. ; Taieb, Julien ; Tougeron, David ; Andre, Thierry ; Kather, Jakob Nikolas ; Sundar, Raghav ; Carmona, Javier ; ELEZ FERNANDEZ, MARIA ELENA; Koopman, Miriam ; Pietrantonio, Filippo. J Immunother Cancer.2025 Feb 10;13(2):e010598. doi: 10.1136/jitc-2024-010598.
  7. Early treatment discontinuation in patients with deficient mismatch repair or microsatellite instability high metastatic colorectal cancer receiving immune checkpoint inhibitors. Taieb, Julien ; Ambrosini, Margherita ; Alouani, Emily ; Lonardi, Sara ; Sinicrope, Frank A ; Decraecker, Marie ; Boileve, Alice ; Hafliger, Emilie ; Mazard, Thibault ; Pernot, Simon ; Parent, Pauline ; ROS MONTAÑA, JAVIER; Overman, Michael J ; Jayachandran, Priya ; Nasca, Vincenzo ; Salvatore, Lisa ; Guimbaud, Rosine ; Cremolini, Chiara ; Tougeron, David ; Pietrantonio, Filippo. J Immunother Cancer.2025 Jan 4;13(1):e010424. doi: 10.1136/jitc-2024-010424.
  8. Prognostic impact of the BRAF V600E mutation in patients with MSI-high metastatic colorectal cancer treated with immune checkpoint inhibitors. Gallois, Claire ; Ambrosini, Margherita ; Lonardi, Sara ; Alouani, Emily ; Guimbaud, Rosine ; Overman, Michael J ; Sinicrope, Frank ; Mazard, Thibault ; Decraecker, Marie ; ROS MONTAÑA, JAVIER; ELEZ FERNANDEZ, MARIA ELENA; Pernot, Simon ; Cremolini, Chiara ; Boilève, Alice ; Parent, Pauline ; Jayachandran, Priya ; Dutherage, Marie ; Mercier, Mathilde ; Flecchia, Clémence ; Fakih, Marwan ; Sclafani, Francesco ; Pietrantonio, Filippo ; Taieb, Julien ; Tougeron, David. Eur J Cancer.2025 Sep 9:227:115645. doi: 10.1016/j.ejca.2025.115645. Epub 2025 Jul 12.
  9. Impact of trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response in refractory metastatic colorectal cancer: analysis of the SUNLIGHT trial. Taieb, Julien; Modest, Dominik P; Fakih, Marwan; Ciardiello, Fortunato; Van Cutsem, Eric; ELEZ FERNANDEZ, MARIA ELENA; Gravalos, Cristina; Bragagnoli, Arinilda Campos; Barboux, Valentine; Roby, Lucas; Amellal, Nadia; Prager, Gerald W. Eur J Cancer. 2025 Sep 9:227:115644. doi: 10.1016/j.ejca.2025.115644. Epub 2025 Jul 12.
  10. Health-related quality of life associated with fruquintinib in patients with metastatic colorectal cancer: Results from the FRESCO-2 study. Sobrero, Alberto ; Dasari, Arvind ; Aquino, Jeneth ; Lonardi, Sara ; Garcia-Carbonero, Rocio ; ELEZ FERNANDEZ, MARIA ELENA; Yoshino, Takayuki ; Yao, James ; Garcia-Alfonso, Pilar ; Kocsis, Judit ; Gracian, Antonio Cubillo ; Sartore-Bianchi, Andrea ; Satoh, Taroh ; Randrian, Violaine ; Tomasek, Jiri ; Chong, Geoff ; Price, Timothy ; Yu, Ziji ; Geiger, Ashley ; Chen, Lucy ; Yang, Zhao ; Schelman, William R ; Kania, Marek ; TABERNERO CATURLA, JOSEP; Eng, Cathy. Eur J Cancer. 2025 Mar 11:218:115268. doi: 10.1016/j.ejca.2025.115268. Epub 2025 Jan 29
  11. Quality-adjusted survival in patients with metastatic colorectal cancer treated with fruquintinib plus best supportive care: results from FRESCO-2. Stintzing, S ; TABERNERO CATURLA, JOSEP; Satoh, T ; Dasari, A ; Lonardi, S ; Eng, C ; Garcia-Carbonero, R ; ELEZ FERNANDEZ, MARIA ELENA; Yoshino, T ; Sobrero, A F ; Yao, J C ; Kasper, S ; Arnold, D ; Basic, E ; Granold, M ; Petschulies, M ; Wu, L ; Chung, Y-C ; Chen, L ; Yang, Z ; Van Cutsem, E. ESMO Open. 2025 Mar;10(3):104297. doi: 10.1016/j.esmoop.2025.104297. Epub 2025 Feb 21.
  12. Efficacy and safety of atezolizumab plus bevacizumab in MSI-like metastatic colorectal cancer: a multicenter, single-arm, phase II, open-label clinical trial. ELEZ FERNANDEZ, MARIA ELENA; Siena, S ; Sartore-Bianchi, A ; ROS MONTAÑA, JAVIER; Ciardello, F; Martinelli, E ; Steeghs, N; Huijberts, S; Cervantes, A; Roselló, S; Tejpar, S; Wilmsen, B; Salazar, R; Santos, C; de Schaetzen, G; MUÑOZ TABERNERO, SUSANA; Bernards, R; Moreno, V; García-Galera, E; Alemany, R; GROS VIDAL, ALENA; Bardelli, A; Arena, S; PIRIS GIMENEZ, ALEJANDRO; CHAVARRIA MIRAS, ELENA; DIENSTMANN, RODRIGO; TABERNERO CATURLA, JOSEP. ESMO Open.2025 Dec;10(12):105892. doi: 10.1016/j.esmoop.2025.105892. Epub 2025 Dec 2.
  13. Differentiating low tumor burden from oligometastatic disease in colorectal cancer: a call for individualized therapeutic approaches. de Grandis, M C ; BARAIBAR ARGOTA, IOSUNE; Prior, O ; Balaguer-Montero, M ; SALVA BALLABRERA, FRANCESC; ROS MONTAÑA, JAVIER; RODRIGUEZ CASTELLS, MARTA; TABERNERO CATURLA, JOSEP; Lonardi, S ; PEREZ LOPEZ, RAQUEL; ELEZ FERNANDEZ, MARIA ELENA. ESMO Open.2025 Aug;10(8):105520. doi: 10.1016/j.esmoop.2025.105520. Epub 2025 Aug 12.
  14. Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study. Martelli, V ; Vidal, J ; Gibert, J ; Fernández-Rodríguez, M C ; Linares, J ; García-Alfonso, P ; Páez, D ; Alonso, V ; Gomez-España, M A ; Guix, M ; Santos, C ; Duran, G ; ELEZ FERNANDEZ, MARIA ELENA; Garcia-Carbonero, R ; Ferreiro, R ; Pineda, E ; Sastre, J ; Cano, M T ; Manzano, J L ; Losa, F ; Aranda, E ; Rivera, F ; Sibilio, A ; DE ALMEIDA TOLEDO, RODRIGO; TABERNERO CATURLA, JOSEP; Salazar, R ; Bellosillo, B ; Montagut, C ; Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). ESMO Open. 2025 Sep;10(9):105760. doi: 10.1016/j.esmoop.2025.105760. Epub 2025 Sep 3.
  15. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2. Eng, Cathy ; Dasari, Arvind ; Lonardi, Sara ; Garcia-Carbonero, Rocio ; ELEZ FERNANDEZ, MARIA ELENA; Yoshino, Takayuki ; Sobrero, Alberto ; Yao, James ; Garcia-Alfonso, Pilar ; Kocsis, Judit ; Gracian, Antonio Cubillo ; Sartore-Bianchi, Andrea ; Satoh, Taroh ; Randrian, Violaine ; Tomasek, Jiri ; Chong, Geoff ; Yang, Zhao ; Guevara, Ferdinand ; Schelman, William ; Pallai, Rajash ; TABERNERO CATURLA, JOSEP. Lancet. 2023 Jul 1;402(10395):41-53. doi: 10.1016/S0140-6736(23)00772-9. Epub 2023 Jun 15.
  16. First-line PD-1 +/- CTLA-4 blockade in patients with deficient mismatch repair and/or microsatellite instability-high metastatic colorectal cancer. Nasca, Vincenzo ; Tine, Gabriele ; Taieb, Julien ; Lonardi, Sara ; Boursi, Ben ; Margalit, Ofer ; Salvatore, Lisa ; Cohen, Romain ; ROS MONTAÑA, JAVIER; Ambrosini, Margherita ; Zwart, Koen ; Roodhart, Jeanine ; Jayachandran, Priya ; Overman, Michael J. ; ELEZ FERNANDEZ, MARIA ELENA; Cremolini, Chiara ; Tougeron, David ; Koopman, Miriam ; Andre, Thierry ; Miceli, Rosalba ; Pietrantonio, Filippo. Oncologist. 2025 Sep 1;30(9):oyaf255. doi: 10.1093/oncolo/oyaf255.
  17. Fertility preservation practices and gastrointestinal oncologist in Europe: a pan-European study. Ben-Aharon, Irit ; Goshen-Lago, Tal ; Puccini, Alberto ; Alsina, Maria ; Arnold, Dirk ; Von-Larhoven, Hanneke ; Elme, Anneli ; Buffart, Tineke ; Fokter-Dovnik, Nina ; Sokop, Tomas ; Obermanova, Radka ; Lordick, Florian ; Papamichael, Demetris ; Sclafani, Francesco ; ELEZ FERNANDEZ, MARIA ELENA; Taieb, Julien. Oncologist. 2025 Nov 11;30(11):oyaf350. doi: 10.1093/oncolo/oyaf350.
  18. A Phase Ia/b study of MEK1/2 inhibitor binimetinib with MET inhibitor crizotinib in patients with RAS mutant advanced colorectal cancer (MErCuRIC). Aroldi, Francesca ; ELEZ FERNANDEZ, MARIA ELENA; André, Thierry ; Perkins, Geraldine ; Prenen, Hans ; Popovici, Vlad ; Gallagher, Peter ; Houlden, Jennifer ; Collins, Linda ; Roberts, Corran ; Rolfo, Christian ; Di Nicolantonio, Federica ; Grayson, Margaret ; Boyd, Ruth ; Bettens, Karolien ; Delfavero, Jurgen ; Coyle, Victoria ; Lawler, Mark ; Khawaja, Hajrah ; Laurent-Puig, Pierre ; Salto-Tellez, Manuel ; Maughan, Tim S ; TABERNERO CATURLA, JOSEP; Adams, Richard ; Jones, Robert ; Hennessy, Bryan T ; Bardelli, Alberto ; Peeters, Marc ; Middleton, Mark R ; Wilson, Richard H ; Van Schaeybroeck, Sandra ; MErCuRIC Trial Consortium. BMC Cancer.2025 Apr 10;25(1):658. doi: 10.1186/s12885-025-14068-1.
  19. BREAKWATER Phase III: results for encorafenib and cetuximab plus mFOLFOX6 in first-line BRAF V600E-mutant metastatic colorectal cancer. Kopetz, Scott ; TABERNERO CATURLA, JOSEP; ELEZ FERNANDEZ, MARIA ELENA. Future Oncol.2025 Dec;21(28):3585-3588. doi: 10.1080/14796694.2025.2579882. Epub 2025 Nov 13.
  20. Predictive factors of efficacy for FTD/TPI plus bevacizumab in refractory metastatic colorectal cancer patients: a subanalysis of the Spanish cohort from the SUNLIGHT phase III trial. Soler, Gemma ; Grávalos, Cristina ; Rivera, Fernando ; Safont, María José ; Virgili, Anna C ; Valladares-Ayerbes, Manuel ; Ferreiro-Monteagudo, Reyes ; Ortiz-Morales, María José ; Polo-Marques, Eduardo ; Kornusova-Bersheva, Irina ; Soustre, Elsa ; Yao, Weiyu ; ELEZ FERNANDEZ, MARIA ELENA. Clin Transl Oncol.2025 Nov;27(11):4203-4213. doi: 10.1007/s12094-025-03907-z. Epub 2025 May 8.
  21. Gender and sex differences in colorectal cancer screening, diagnosis and treatment. González-Flores, Encarnación ; Garcia-Carbonero, Rocio ; ELEZ FERNANDEZ, MARIA ELENA; Redondo-Cerezo, Eduardo ; Safont, María José ; Vera García, Ruth. Clin Transl Oncol.2025 Jul;27(7):2825-2837. doi: 10.1007/s12094-024-03801-0. Epub 2025 Jan 17.
  22. Definition of lines of treatment in metastatic colorectal cancer: a Delphi consensus. García-Alfonso, Pilar ; Alcaide-Garcia, Julia ; Aranda Aguilar, Enrique ; ELEZ FERNANDEZ, MARIA ELENA; Fernández Montes, Ana ; García Escobar, Ignacio ; Grávalos, Cristina ; Matos García, Ignacio ; Montagut Viladot, Clara ; Santos Vivas, Cristina ; Sastre, Javier ; Tarazona, Noelia ; Jimenez-Fonseca, Paula. Clin Transl Oncol.2026 Feb;28(2):617-624. doi: 10.1007/s12094-025-03986-y. Epub 2025 Aug 11.
  23. Surrogate to predict overall survival in patients with BRAF V600E-mutant colorectal cancer treated with BRAF inhibitor combinations. ROS MONTAÑA, JAVIER; NAVARRO GARCES, VICTOR; VILLACAMPA JAVIERRE, GUILLERMO; BARAIBAR ARGOTA, IOSUNE; SALVA BALLABRERA, FRANCESC; RODRIGUEZ CASTELLS, MARTA; Vaghi, C. ; GARCIA RODRIGUEZ, ARIADNA MARIA; Alcaraz, A. ; TABERNERO CATURLA, JOSEP; ELEZ FERNANDEZ, MARIA ELENA; DIENSTMANN, RODRIGO. ESMO Gastrointest Oncol.2025 Aug 18:9:100225. doi: 10.1016/j.esmogo.2025.100225. eCollection 2025 Sep.
  24. Retreatment with oxaliplatin-based regimens in refractory metastatic colorectal cancer: characterization of high-response patients. SALVA BALLABRERA, FRANCESC; Catani, G. ; Saoudi, N. ; BARAIBAR ARGOTA, IOSUNE; ROS MONTAÑA, JAVIER; RODRIGUEZ CASTELLS, MARTA; de Torres, C. Salva ; Alcaraz, A. ; GARCIA RODRIGUEZ, ARIADNA MARIA; COMAS NAVARRO, RAQUEL; RUIZ PACE, FIORELLA DAFNE; REZQALLAH ARON, ALEJANDRA; DIENSTMANN, RODRIGO; TABERNERO CATURLA, JOSEP; ELEZ FERNANDEZ, MARIA ELENA. ESMO Gastrointest Oncol.2025 Aug 26:9:100230. doi: 10.1016/j.esmogo.2025.100230. eCollection 2025 Sep.
  25. Preoperative immunotherapy with atezolizumab and tiragolumab in patients with colorectal liver metastases?the PURPLE trial. Kasper, S. ; ELEZ FERNANDEZ, MARIA ELENA; Neumann, U. ; Lang, S. ; Trampe, A. -K. ; SALVA BALLABRERA, FRANCESC; Dopazo, C. ; Virchow, I. ; Hartmann, S. ; Herrmann, K. ; TABERNERO CATURLA, JOSEP; Westendorf, A. ; Schuler, M. ; Schramm, A. ESMO Gastrointest Oncol.2025 Sep 1:9:100226. doi: 10.1016/j.esmogo.2025.100226. eCollection 2025 Sep.
  26. European screening platform for EORTC clinical trials in advanced colorectal cancer ‘SPECTAcolor’. Folprecht, G. ; Morfouace, M. ; Collienne, M. ; Salazar, R. ; Stein, A. ; ELEZ FERNANDEZ, MARIA ELENA; Wagner, A. D. ; Arnold, D. ; Kohne, C. H. ; Ducreux, M. ; Lordick, F. ; Borelli, B. ; Stevovic, A. ; Gorlia, T. ; Fontana, E. ; Aust, D. ; Golfinopoulos, V. ; Moehler, M. ; Tejpar, S. ESMO Gastrointest Oncol.2025 Apr 9:8:100168. doi: 10.1016/j.esmogo.2025.100168. eCollection 2025 Jun.
  27. Association between neutropenia and efficacy in patients with refractory mCRC receiving trifluridine/tipiracil. Prager, G. W. ; ELEZ FERNANDEZ, MARIA ELENA; Fakih, M. ; Ciardiello, F. ; Van Cutsem, E. ; Roby, L. ; Yao, W. ; Choucair, E. ; Taieb, J. ESMO Gastrointest Oncol.2025 Dec doi: 10.1016/j.esmogo.2025.100234 eCollection 2025 Sept.
  28. Analysis of fruquintinib in patients with metastatic colorectal cancer who were enrolled in Spain: results from the global FRESCO-2 study. Garcia-Carbonero, R. ; ELEZ FERNANDEZ, MARIA ELENA; Garcia-Alfonso, P. ; Gracian, A. Cubillo ; Lopez, R. Lopez ; Jimenez-Fonseca, P. ; Miron, M. L. Limon ; Dasari, A. ; Lonardi, S. ; Zhu, H. ; Chen, L. ; Yang, Z. ; Schelman, W. R. ; TABERNERO CATURLA, JOSEP. ESMO Gastrointest Oncol. 2025 Jul 15:9:100205. doi: 10.1016/j.esmogo.2025.100205. eCollection 2025 Sep.
  29. Value contribution of trifluridine/tipiracil with bevacizumab for the treatment of metastatic colorectal cancer in Catalonia using a multicriteria decision analysis. Calle, Candela ; ELEZ FERNANDEZ, MARIA ELENA; Manzano, Jose Luis ; Moreno-Martinez, Maria-Estela ; Pericay, Carles ; Graefenhain, Ruth ; Ariznavarreta, Asis ; Lizan, Luis. J Pharm Policy Pract. 2025 Oct 13;18(1):2567970. doi: 10.1080/20523211.2025.2567970. eCollection 2025.
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  40. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, TABERNERO J; MATTERHORN Investigators. N Engl J Med. 2025 Jul 17;393(3):217-230. doi: 10.1056/NEJMoa2503701.
  41. Lenvatinib Plus Pembrolizumab and Chemotherapy Versus Chemotherapy in Advanced Metastatic Gastroesophageal Adenocarcinoma: The Phase III, Randomized LEAP-015 Study. Shitara K, Lorenzen S, Li J, Bai Y, Fernández MG, Aguilar M, Shoji H, Reyes-Cosmelli F, Peña YR, Corrales L, Wyrwicz L, EYZAGUIRRE DA, Pan Y, Ryu MH, Cohen DJ, Wainberg ZA, Ku G, TABERNERO J, Van Cutsem E, Qin SK, Oh DY, Xu J, Liang LW, Bordia S, Bhagia P, Rha SY; LEAP-015 Investigators. J Clin Oncol. 2025 Aug;43(22):2502-2514. doi: 10.1200/JCO-25-00748.
  42. Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers. Hurvitz S, Simonelli M, Yarza R, Berz D, Kitano S, Del Conte G, ACOSTA EYZAGUIRRE D, Doger de Speville Uribe BG, Maier D, Erzen D, Aykut Yazgili S, Curigliano G, Deng T, Yan M, Zhang Q, Wang X, Nakayama I, Shitara K. Future Oncol. 2025 Nov;21(26):3385-3393. doi: 10.1080/14796694.2025.2569553.
  43. Does perioperative FLOT increase cure rates in resectable esophageal adenocarcinoma? A mixture cure model analysis. Mateos L, Jiménez-Fonseca P, Gallego J, Lecumberri A, Custodio A, Martínez de Castro E, Hernández San Gil R, Fernández Montes A, Limón ML, Vidal-Tocino R, Cano JM, López Robles J, Gil M, ACOSTA EYZAGUIRRE D, Marín Zafra G, Mérida-García AJ, Francisco Fernández A, Ribera Fernández P, Hierro C, Riesco MC, García Araque M, Ruiz Martín M, Pimentel P, Visa L, Cerdá P, Granja M, Rupérez Blanco AB, Gutiérrez L, Carmona-Bayonas A. Br J Cancer. 2026 Feb;134(3):414-427. doi: 10.1038/s41416-025-03264-2.
  44. Evolving treatment strategies for resectable gastric cancer: Bridging Asia-West disparities toward personalized and integrated therapy. Zhao X, Hao Q, Alsina M, ACOSTA D, Castet F, TERÁN E, CANO KV, Saurí T, Macías I, Yoshikawa T, Castro S, Shoji H, Lordick F, Shen Z, Tian TV, Macarulla T. Cancer Treat Rev. 2025 Dec;141:103041. doi: 10.1016/j.ctrv.2025.103041.
  45. Ivosidenib for IDH1-Mutant Intrahepatic Cholangiocarcinoma: Insights From a Multicenter Real-World Study. Niger M, Rimini M, Castet F, Melzer A, Rizzato MD, Pressiani T, Lavacchi D, Aprile G, Angela T, Saladino T, Silvia N, Cito P, Pastorino A, TERÁN-BRAGE E, Sciortino C, Camera S, Pircher C, Persano M, Mazzaferro V, Foti S, VEGA KS, Ettrich TJ, Antonuzzo L, Rimassa L, Lonardi S, Perkhofer L, Macarulla T, Pietrantonio F, Casadei-Gardini A. Liver Int. 2025 Sep;45(9):e70295. doi: 10.1111/liv.70295
  • MK-3475-158.  Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158). PI: ELENA ELEZ FERNANDEZ
  • TTD-18-01.       Phase III randomized sequential open-label study to evaluate the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in  ntreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer: The CRSEQUENCE. PI: ELENA ELEZ FERNANDEZ.
  • CA209-8HW.     A Phase 3b Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or an Investigator’s Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer.  PI: ELENA ELEZ FERNANDEZ.
  • CADPT01C12101.         A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select drug combinations in adult patients with advanced or metastatic BRAF V600 colorectal cancer.    PI: ELENA ELEZ FERNANDEZ.
  • IFOM-CPT005/2019/PO004.      POST-SURGICAL LIQUID BIOPSY - GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS.  PI: ELENA ELEZ FERNANDEZ.
  • STEMNESS-CRC.            A Phase III, Randomized, Clinical Study of Napabucasin in Combination with FOLFIRI and Best Supportive Care (BSC). PI: ELENA ELEZ FERNANDEZ.
  • C4221015. An open-label, multicenter, randomized phase 3 study of first-line encorafenib plus cetuximab with or without chemotherapy versus standard of care therapy with a safety lead-in of encorafenib and cetuximab plus chemotherapy in participants with metastatic BRAFV600E-mutant colorectal cancer (BREAKWATER). PI: ELENA ELEZ FERNANDEZ.
  • BNT122-01. A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection. PI:          ELENA ELEZ FERNANDEZ.
  • MK-1308A-008.            Estudio de fase 2, multicéntrico y de varios grupos para evaluar pembrolizumab (MK-3475) o MK-1308A (coformulación de quavonlimab (MK-1308)/ pembrolizumab) en participantes con cáncer colorrectal en estadio IV con inestabilidad de microsatélites alta (MSI-H) o con defectos en la reparación de los errores de emparejamiento (dMMR): (MK-1308A-008). PI: ELENA ELEZ FERNANDEZ.
  • WO42758.        A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC).   PI: ELENA ELEZ FERNANDEZ.
  • BNT000-001.    Epidemiological study to determine the prevalence of ctDNA positivity in participants with Stage II (high risk) or Stage III CRC after surgery with curative (R0) intent and subsequent adjuvant chemotherapy with monitoring of ctDNA during.  PI: ELENA ELEZ FERNANDEZ.
  • SCO101-001_CORIST.    An open-label phase II prospective clinical trial to investigate safety, tolerability, maximum tolerated dose and anti-tumor effect for SCO-101 in combination with FOLFIRI as a safe and efficient treatment modality in metastatic or advanced colorectal cancer (mCRC) patients with acquired FOLFIRI resistant cancer disease.         PI: ELENA ELEZ FERNANDEZ.
  • SGNTUC-029.    An Open Label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus Chemotherapy as First Line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer.          PI: ELENA ELEZ FERNANDEZ.
  • C4221022.        A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI-H/DMMR METASTATIC COLORECTAL CANCER. PI: ELENA ELEZ FERNANDEZ.
  • ESR 21-21165.  Single cell characterization of persistent cells upon treatment with durvalumab (MEDI4736) with or without Tremelimumab in MSS and MSI colorectal and endometrial tumors: the SERPENTINE clinical trial. PI:     ELENA ELEZ FERNANDEZ.
  • GEMCAD 2102. Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC) - PEMBROLA.            PI: ELENA ELEZ FERNANDEZ.
  • 61186372GIC2002.       A Phase 1b/2, open-label, study of amivantamab monotherapy and in combination with chemotherapy in patients with advance metastatic colorectal cancer.     PI: ELENA ELEZ FERNANDEZ.
  • CA224-123.      Phase 3, Randomized, Open-label (Sponsor Blinded) Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal Cancer (RELATIVITY-123). PI:          ELENA ELEZ FERNANDEZ.
  • EOCRC2-22.      A global multicenter phase 1/2 trial of EO4010, a novel microbial Derived peptide Therapeutic vaccine, in combination with nivolumab, for Treatment of patients with previously treated metastatic colorectal carcinoma (the “AUDREY” study).    PI: ELENA ELEZ FERNANDEZ.
  • NOUS-209-01.  Multicentre, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumours.           PI: ELENA ELEZ FERNANDEZ.
  • 219606 A. Phase 3, Open-Label and Randomized Study of Perioperative Dostarlimab Monotherapy versus standard of care in Participants with Untreated Stage II/III dMMR/MSI-H Locally Advanced Colon Cancer.        PI: ELENA ELEZ FERNANDEZ.
  • XL092-303.       A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer.           PI: ELENA ELEZ FERNANDEZ.
  • RGX-202-002.   A randomized Phase 2 Study of RGX-202-01 versus placebo in combination with FOLFIRI plus bevacizumab in patients with previously treated RAS mutant advanced or metastatic colorectal cancer.   PI: ELENA ELEZ FERNANDEZ.
  • Z0011001.        PHASE 1/2, OPEN-LABEL, MULTI-CENTER STUDY OF ZN-c3 ADMINISTERED IN COMBINATION WITH ENCORAFENIB AND CETUXIMAB IN ADULTS WITH METASTATIC COLORECTAL CANCER.          PI: ELENA ELEZ FERNANDEZ.
  • C-800-25. A Randomized, Open-label, Phase 2 study of Botensilimab (AGEN1181) as Monotherapy and in Combination with Balstilimab (AGEN2034) or Investigator’s Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer. PI: ELENA ELEZ FERNANDEZ.
  • BP44474.  A Phase I, open-label study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7589831 in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR). PI: ELENA ELEZ FERNANDEZ.
  • ART0380C001. A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors. PI: ELENA ELEZ FERNANDEZ.
  • 61186372COR3001 (ORIGAMI-2). A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With RAS/RAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer. PI: ELENA ELEZ FERNANDEZ.
  • 61186372COR3002 (ORIGAMI-3). Amivantamab añadido a la quimioterapia de referencia frente a los tratamientos estándar más la quimioterapia de referencia en pacientes con CCRm. PI: ELENA ELEZ FERNANDEZ.
  • 222892 (AZUR 4) Phase 2, open label, randomized study of neoadjuvant dostarlimab plus CAPEOX versus CAPEOX in participants with previously untreated T4N0 or Stage III MMRp/ MSS colon cancer. ELENA ELEZ FERNANDEZ
  • 20210081 (CodeBreak301). A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus Investigator’s Choice Chemotherapy (FOLFOX or FOLFIRI) with or without Bevacizumab-awwb for Treatment-naïve Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation. PI: ELENA ELEZ FERNANDEZ.
  • 89402638GIC1001. A Phase I Study of JNJ-89402638, a T-cell Redirecting Agent Targeting GUCY2C, for Advanced Stage Colorectal Cancer. PI: ELENA ELEZ FERNANDEZ.
  • C-145-04. A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma. PI: ELENA ELEZ FERNANDEZ.
  • Ph1 INBRX-109. An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors, Including Sarcomas. PI: ELENA ELEZ FERNANDEZ.
  • MK-4280A-007. A Phase 3 study of MK-4280A Co-formulated favezelimab (MK-4280) plus pembrolizumab (MK-3475) versus Standard of Care in Previously Treated Metastatic PDL1 positive Colorectal Cancer. PI: ELENA ELEZ FERNANDEZ.
  • D798VC00001 (CANTOR). A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants with Colorectal Cancer. PI: ELENA ELEZ FERNANDEZ.
  • VHIO23004. A Phase 2, Single-Arm study of encorafenib plus cetuximab as rechallenge treatment of BRAF V600E-mutant metastatic colorectal cancer patients after previous therapy with BRAF inhibitors-based combinations: the RefIsh trial. PI: ELENA ELEZ FERNANDEZ.
  • A Phase1b/2, multicenter, randomized, open-label study to evaluate the efficacy and safety of GSK5764227 alone and in combination in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors. PI: ELENA ELEZ FERNANDEZ.
  • MK-1084-012. A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012). PI: ELENA ELEZ FERNANDEZ.
  • CITRIC. Multicenter, open-label, randomized, 2-arm, phase II study to evaluate the efficacy and safety of cetuximab plus irinotecan rechallenge compared with investigator's choice of therapy in the third-line setting in ctDNA genomically selected patients with metastatic colorectal cancer (CITRIC Study). PI: ELENA ELEZ FERNANDEZ.
  • M24-311. A Phase 2, Randomized Study to Evaluate the Safety, Efficacy and Optimal dose of ADC drug in Combination with Fluorouracil (5-FU), Folinic Acid and Bevacizumab in Previously Treated Subjects with unresectable Metastatic Colorectal Cancer (mCRC). PI: IOSUNE BARAIBAR ARGOTA.
  • LCB 2301 001. A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF NILK-2301, A BISPECIFIC CEACAM5 x CD3 ENGAGING NTIBODY, IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC LOW TUMOR VOLUME COLORECTAL CANCER. PI: IOSUNE BARAIBAR ARGOTA.M24-533. A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with ABBV-400 in Subjects with Metastatic Colorectal Cancer. PI: IOSUNE BARAIBAR ARGOTA.
  • VHIO23001. Bevacizumab plus encoRAfenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial. PI: FRANCISCO JAVIER ROS MONTAÑÁ.
  • TTD-21-02. Multicenter Phase 2 study to evaluate the efficacy and safety of Cetuximab in combination with Encorafenib plus Binimetinib as induction treatment in BRAF (V600E) mutated MSS, initially resectable or potentially resectable advanced colorectal cancer: CEBBRA study. PI: FRANCISCO JAVIER ROS MONTAÑÁ.
  • TTD 24-09. Observational retrospective study to evaluate real world effectiveness, safety and tolerability of Fruquintinib for treatment of advanced colorectal cancer in Spain – FrESP Study. PI: FRANCISCO JAVIER ROS MONTAÑÁ.
  • CAPRI-3 study: Phase 3 clinical study to evaluate the use of continuing cetuximab treatment beyond first line progression in molecular selected metastatic colorectal cancer patients. PI: FRANCESC SALVA BALLABRERA.
  • RAPIDO.           Estudio aleatorizado multicéntrico en fase III de radioterapia de corta duración seguida de quimioterapia preoperatoria de larga duración y cirugía en el cáncer rectal primario de alto riesgo en comparación con quimiorradioterapia convencional y cirugía y óptima quimioterapia adyuvante.    PI: JAUME CAPDEVILA CASTILLON.
  • GEMCAD 1703. Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial).      PI: JAUME CAPDEVILA CASTILLON.
  • INCMGA0012-303.       A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With System. PI:    JAUME CAPDEVILA CASTILLON.
  • GEMCAD 2103. Estudio de fase II de atezolizumab más tiragolumab en combinación con quimio-radioterapia en carcinoma de células escamosas localizado del canal anal. PI:   JAUME CAPDEVILA CASTILLON.219369 PH2. Open label study evaluating Dostarlimab in the Neoadjuvant Treatment of locally advanced (la) dMMR/MSI-H rectal cancer (RC). PI:          JAUME CAPDEVILA CASTILLON.

Group Leader Joan Carles (until July), Cristina Suárez (since August) Senior Investigator Joan Carles (since August) Medical Oncologists and Clinical Fellows Carlo Cicala, Diego Gómez, Macarena González, David Marmolejo, Rafael Morales Barrera, César Serrano, Claudia Valverde, María Vieito Clinical Nurse Specialist Helena Palma

Research Groups

Genitourinary (non-prostate), Central Nervous System Tumors (CNS), Sarcomas, and Tumors of Unknown Origin Group

Summary

Over recent years, major advances have transformed the management of genitourinary (GU) malignancies, particularly through immunotherapy, antibody–drug conjugates (ADCs), targeted therapies, and radioligand approaches. Our group has played a central role in shaping these developments across bladder, kidney, prostate, and rare GU cancers through early-phase clinical trials, biomarker-driven strategies, and translational research.

In kidney cancer, we have contributed to the clinical development of immune-based combinations and HIF2α inhibitors, exploring novel combinations, earlier disease settings, and predictive biomarkers in collaboration with international partners. In bladder cancer, we are actively involved in phase I studies targeting FGFR and Nectin-4, innovative intravesical delivery strategies aimed at bladder preservation, and first-line combination approaches integrating multiple ADCs and immunotherapy. We also made a major contribution to IMvigor011, supporting the clinical integration of circulating tumor DNA as a precision oncology biomarker.

Beyond GU tumors, we have consolidated leadership in sarcoma, CNS tumors, and cancers of unknown primary (CUP), with investigator-initiated trials, national and European consortia, and real-world genomic and radiomic initiatives. Notable efforts include liquid biopsy–guided trials in GIST, first-in-class therapies for rare sarcomas, academic trials in glioblastoma, and AI-enabled imaging tools to support surgical and radiotherapy decision-making.

Our program is strongly patient-centered, integrating translational research, quality-of-life initiatives, survivorship, and dedicated care for adolescents and young adults (AYAs). Through national leadership roles, European projects, and sustained international collaboration, we continue to advance precision medicine approaches that improve outcomes across multiple cancer types.

  • Design and conduct investigator-initiated and collaborative clinical trials across GU cancers, sarcoma, CNS tumors, and CUP, spanning early and advanced disease stages.
  • Advance biomarker-driven precision oncology, including liquid biopsy, genomics, and imaging-based decision tools.
  • Strengthen translational platforms in kidney cancer, sarcoma/GIST, and CNS tumors through multidisciplinary task forces and biobanking.
  • Expand national and European clinical and research networks (CSUR, EURACAN, ACCELERATE) to improve access to innovative therapies.
  • Integrate patient-reported outcomes, survivorship, and quality-of-life research into clinical trial design and routine care.
  • Foster collaboration between academia, industry, and patient advocacy groups, and develop educational resources to empower patients and families.
  • Our team played a major role in the IMvigor011 clinical trial, supporting ctDNA as a clinically actionable biomarker in urothelial carcinoma.
  • In 2025, we expanded and consolidated our Serum Bank to include well-annotated collections of samples across several tumor types, including kidney cancer, sarcoma and GIST tumors and urothelial carcinoma, strengthening our translational research capabilities.
  • Continued integration of multidisciplinary care teams, including surgeons, oncologists, radiologists, pathologists, and support care specialists, to enhance personalized treatment strategies for patients at all stages. We are also implementing a strategic and personalized approach for the treatment of patients with genitourinary tumors and cancers of unknown primary (CUP), utilizing biomarkers and genetic sequencing techniques to guide therapeutic decision making and improve clinical outcomes.
  • We have expanded our phase I program by including additional tumor types and are also collaborating in phase I studies led by the Urology Department at the Vall d'Hebron University Hospital (HUVH). We actively participate in clinical studies involving intravesical devices to offer bladder preservation options for patients with bladder cancer.
  • Launch of OSTEOMYC, a VHIO-promoted phase II trial evaluating MYC inhibition in osteosarcoma, including correlative biomarker analyses and AYA-focused initiatives.
  • Development of PRESARC, an AI-driven radiomics platform to improve management of retroperitoneal sarcoma.
  • Consolidation of the AYA Unit, with over 80 patients treated and new digital and AI-enabled survivorship projects supported by SEOM and Horizon Europe funding.
  • Leadership in national and European precision oncology programs, including IMPaCT-GENóMICA (CUP) and CARE1 (metastatic kidney cancer).
  • Activation and funding of multiple investigator-initiated trials, including TUVASTRAT, co-led by VHIO to evaluate ataxia telangiectasia and Rad3-related protein (ATR) inhibition in patients with I isocitrate dehydrogenase (IDH)-mutant grade 3 gliomas, and other academic phase I–II studies in sarcoma and GU cancers.
  • We will continue to develop radioligand therapy to treat tumor types under our scope (kidney cancers, sarcomas).
  • In close collaboration with the Urology Department at Vall d’Hebron, we will continue to extend new treatments under development to non-muscle invasive bladder cancer.
  • Expand the tumor bank to include all genitourinary tumors, cancers of unknown primary origin and all sarcomas.
  • Participation in research projects focused on the mechanisms of resistance to antibody-drug conjugates (ADCs), with the goal of identifying new therapeutic strategies and enhancing the efficacy of these innovative treatments.
  • Expand the development of clinical studies involving next-generation therapies targeting FGFR3 offers a promising approach for select populations with pathogenic FGFR3 mutations, potentially reversing secondary resistance to first-generation FGFR3-directed treatments.
  • Collaboration with multidisciplinary teams and international research networks will be crucial to remain at the forefront of CUP management, ensuring that patients receive the most innovative and evidence-based care available
  • Generate laboratory models from patients’ biopsies for the investigation of new therapeutic strategies.
  • Expand our AYAs Unit to other tumors including lymphomas, leukemia etc., and also develop a long-term follow-up for those patients treated with chemotherapy during their childhood.
  • Promote the integration radiomics to help guide treatment decision making for sarcoma patients.
  • We aim to further incorporate patient perspectives in regular practice and research.
  • Increase and establish new collaborations with other VHIO research groups.
  • Powles T, Kann AG, Castellano D, Gross-Goupil M, Nishiyama H, Bracarda S, Bjerggaard Jensen J, Makaroff L, Jiang S, Ku JH, Park SH, Reig Torras O, Ye D, Maruzzo M, Necchi A, Morales-Barrera R, Giunta EF, Lee JL, Tortora G, Ürün Y, Dolowy L, Erdem D, Pinto A, Grando F, Zou W, Assaf ZJ, Vuky J, Degaonkar V, Steinberg EE, Bellmunt J, Gschwend JE; IMvigor011 Investigators. ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer. N Engl J Med. 2025 Dec 18;393(24):2395-2408.
  • Suarez C, Rojas C, Shin SJ, Yanez Weber P, Albiges L, Motzer R, Hammers H, Peer A, Lee JL, Miller WH, Waddell T, Neiman V, Keizman D, Zwenger Kloster A, Weickhardt A, Dziadziuszko R, Suttner L, Sharma M, Burgents JE, Powles T. Novel pembrolizumab-based treatments as first-line therapy in advanced clear-cell renal cell carcinoma: substudy 03A of the open-label, umbrella platform, phase I/II KEYMAKER-U03 trial. Ann Oncol. 2025 Oct 18. doi: 10.1016/j.annonc.2025.10.010.
  • Palmerini E, Meazza C, Tamburini A, Márquez-Vega C, Bisogno G, Fagioli F, Ferraresi V, Milano GM, Coccoli L, Rubio-San-Simón A, Gallego O, Llinares Riestra ME, Manzitti C, Mora J, Vaz-Salgado MÁ, Luksch R, Mata C, Pierini M, Carretta E, Cesari M, Paioli A, Marrari A, Scotlandi K, Serra M, Asaftei SD, Gambarotti M, Picci P, Ferrari S, Valverde C, Ibrahim T, Broto JM. Is There a Role for Mifamurtide in Nonmetastatic High-Grade Osteosarcoma? Results From the Italian Sarcoma Group (ISG/OS-2) and Spanish Sarcoma Group (GEIS-33) Trials. J Clin Oncol. 2025 Oct;43(28):3113-3122.
  • Serrano C, Bauer S, Blay JY, Casali PG, Cicala CM, Dei Tos AP, Digklia A, Gelderblom H, Italiano A, Jones RL, Kasper B, Kyriazoglou A, Le Loarer F, Martín-Broto J, Napolitano A, Rutkowski P, Stacchiotti S, Tap W, Thomas D, Thway K, Valverde C, van der Graaf WTA, Wardelmann E, Bovée JVMG. Guidelines for Next-Generation Sequencing in Sarcoma Diagnosis and Treatment: A Consensus Review. JAMA Oncol. 2025 Dec 1;11(12):1527-1537.
  • Rafael Morales was awarded through the 3rd Ideas Competition on Research in Genitourinary Oncology by the Spanish Oncology Genito-Urinary Group (SOGUG) for the project titled: Optimization of Systemic Therapy in Metastatic Urothelial Carcinoma: Liquid Biopsy vs. Tissue Biopsy (OPTIMUS-LT).
  • Cristina Suárez was awarded with a Fondo de Investigación Sanitaria - FIS (Health Research Fund) grant for the project titled: Biomarcadores Predictivos en Terapia Neoadyuvante para Carcinoma de Células Renales (CCR) del estudio MOONLANDING.
  • César Serrano was the Scientific Coordinator of the 2025 Spanish Society of Medical Oncology’s (SEOM) Annual Congress (SEOM2025), 11-14 November, Madrid, Spain.
  • María Vieito was elected as the next President of the Spanish Group of Research in Neuro-Oncology (GEINO) for the 2026-2028 term.
  • Diego Gómez received a Best Poster Award at SEOM2025.
  1. Efficacy and safety of treatment of disseminated germ cell tumors with the BEP chemotherapy regimen (bleomycin, etoposide, cisplatin) in patients aged ≥ 40 years compared with efficacy and safety in patients aged ≤ 39 years.
  2. Metastatic tropism in urothelial carcinoma and histological subtypes. Characteristics, Treatments, and Outcomes of Patients with Oligometastatic Urothelial Carcinoma.
  3. Systematic Characterization of the Distinct Immunogenomic Features of Cancers of Unknown Primary (CUPs) to Identify New Therapeutic Opportunities.
  4. IMPaCT-Genomica CUP.
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  55. de Torres CS, Trallero-Araguas E, Marmolejo D, Hermida JMU, Mejía ND, Baselga PM, Geng-Cahuayme AAA, Catalan L, González M, Morales-Barrera R, Carles J, Gallardo E, Suárez C. Balancing risks and benefits of immune checkpoint inhibitors in patients with pre-existing immune-mediated inflammatory diseases: A comprehensive review. Crit Rev Oncol Hematol. 2025 Dec;216:105000. doi: 10.1016/j.critrevonc.2025.105000. Epub 2025 Oct 30. PMID: 41176078.
  • 2024-146-1; "PREDICTING OUTCOME OF RENAL CELL CARCINOMA PATIENTS BASED ON CLINICAL, MOLECULAR, RADIOLOGIC, AND HISTOLOGICAL CHARACTERISTICS"; IV
  • 2022-0460; Observational study evaluating the long-term safety and efficacy of avapritinib in the first-line treatment of patients with platelet-derived growth factor receptor alpha (PDGFRA) D842V mutated gastrointestinal stromal tumour (GIST); IV
  • 2024-0713; ESTUDIO MULTICÉNTRICO ALEATORIZADO FASE II, DOBLE CIEGO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE AUTOGENE CEVUMERAN MÁS NIVOLUMAB FRENTE A NIVOLUMAB COMO TRATAMIENTO ADYUVANTE EN PACIENTES CON CARCINOMA UROTELIAL MÚSCULO INVASIVO DE ALTO RIESGO; II
  • VHIO-0021; "ESTUDIO OBSERVACIONAL, MULTICÉNTRICO, RETROSPECTIVO Y PROSPECTIVO, PARA EVALUAR LA EFECTIVIDAD Y SEGURIDAD DE LA INMUNOTERAPIA EN PACIENTES CON CÁNCER Y ENFERMEDADES INFLAMATORIAS INMUNOMEDIADAS"; IV
  • 2025-0284; A phase 3, multicenter, double blind, randomized, placebo[1]controlled study of ivosidenib in subjects ≥ 18 years of age with unresectable or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 prior systemic treatment regimen; III
  • 2021-0957; A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA).; III
  • 2023-0538; “An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT)”; III
  • 2022-0758; A randomised phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cáncer; II
  • 2025-0883; “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma,”; PRODUCTO SANITARIO
  • 2025-0712; 177Lu-DOTATATE for recurrent MENingioma: a randomized phase II study; II
  • 2021-0658; Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”).; II
  • 2025-053-1; EUonQoL; IV
  • 2022-0674; Exploración de reordenamiento génico NTRK 1/2/3 en GIST y sarcoma de hueso. GIBOTREK; IV
  • VHIO-0024; Estudio observacional para la exploración de reordenamiento de genes NTRK1/2/3 en Sarcomas de Partes Blandas localmente avanzados o metastásicos; IV
  • 2021-0551; Phase II multicohort trial of trabectedin and low-dose radiation therapy in advanced/metastatic sarcomas (SYNERGIAS).; II
  • 2024-0934; A Multicenter, Randomized, Phase III Study to Assess the Efficacy and Safety of Intratumorally Administered INT230-6 (VINblastine, CIsplatin) compared with Standard of Care in Adult SuBjects with Locally REcurrent, Inoperable or Metastatic Soft Tissue Sarcomas – (The INVINCIBLE-3 Trial); III
  • 2025-0309; A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma; III
  • 2024-1189; A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination with Budigalimab Versus Chemotherapy in Subjects with Metastatic Urothelial Carcinoma; II
  • 2025-0194; A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma; II
  • 2022-1133; A Phase 3 study for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma; III
  • 2022-0219; A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma.; II
  • 2022-0365; A phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma; III
  • 2024-0187; Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma; II
  • 2024-0621; A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) in Subjects with HER2-Expressing Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma; II
  • 2021-0677; An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma.; II
  • 2015-0407; An international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma.; II
  • 2024-0651; Randomised, open-label, multicentric, pivotal trial of SonoCloud-9 combined with carboplatin and nab-paclitaxel vs Standard of Care (SoC) lomustine (CCNU) or temozolomide (TMZ) in patients with first recurrence/progressive glioblastoma; II
  • 2021-0292-II; Phase I/II randomized clinical trial of selinexor plus gemcitabine in selected advanced soft-tissue sarcomas; II
  • 2024-1144; Multicenter, Open-Label Phase II Trial of Cirtuvivint as a Second-Line Therapy in Selected Advanced Soft-Tissue Sarcomas; II
  • 2024-0718; An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater); III
  • 2025-0552; Estudio observacional retrospectivo multicéntrico de vida real de Tivozanib en primera línea de tratamiento de cáncer renal de células claras metastásico; IV
  • 2024-0709; Estudio observacional de efectividad de medicamentos financiados por el Sistema Nacional de Salud para tumores genitourinarios; IV
  • 2014-0623-II; Ensayo clinico Fase I-II, abierto, prospectivo y muticéntrico, que explora la combinación de Trabectedina y Radioterapia en pacientes con Sarcoma de tejidos Blandos; II
  • 2024-0206; A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma; II
  • 2024-0064; A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-Risk Muscle-Invasive Urothelial Carcinoma Post-Radical Resection; II
  • 2023-0824; A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma; III
Transversal Clinical Trials Services and Units

Clinical Trials at a Glance

In 2025, we managed a total of 1,091 active clinical trials and studies at some point of the year across oncology, hematology and radiotherapy.

1 Multiphase clinical trials with active recruitment in phase I and phase II Basket in 2025.
10 Master phase I trial sub-studies with active recruitment in 2025.
5 Master phase II Basket trial sub-studies with active recruitment in 2025.
3 Master phase II STT trial sub-studies with active recruitment in 2025.
In 2025, our Clinical Trials Office also managed 1 phase I trial and 5 phase III trials in radiotherapy with active recruitment at some point in 2025, these studies included at total of 13 patients.


Developed by VHIO’s Oncology Data Science (OdysSey) Group, the Onco Trials Track platform empowers healthcare providers in the difficult and time-consuming task of identifying the most suitable clinical trial for cancer patients based on molecular data. This resource provides a user-friendly interface with an up-to-date catalogue of molecularly and semantically tagged clinical trials: https://oncotrialstrack.vhio.net/.

OncoTrialsTrack has receiveds funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 825835 - EUCANCan

Director, Clinical Trials Office Cristina Pérez Head, Start-Up Unit and Clinical Trials Liaison Núria Farràs Coordinator, Start-Up Unit Paula Chiquillo Head, Data Entries Ignacio Carcela Head, Phase I Clinical Trials Office Ana Matres Head, Hematology Laura Segura Lead Study Coordinators Eulalia Aliende, Aitana Almodóvar, Eva Banús, Laia Catalan, Natalia Écija, Danis Fernández, Magda Masana, Alba Meire, Olga Padrós, Laura Saucedo Lead Data Entries Gloria García, Eva Lázaro, Eva Puerma, Alberto Rojo, Judith Serrano Study Coordinators Ester Aguado, Gisela Andrés, Jorge Bardina, Paula Barranco, Laia Benítez, Laura Blanco, Taiana Cristina Burgin, Cristina Calderón, Júlia Caparrós, Gregorio Casas, Gemma Comas, Paula Cruz, Nuria Durá, Anna Falcón, Carlos Fernandez, Neus Figa, Alba Galiana, Natàlia Gallardo, Alexia Garcia, Beatriz García, Daniel García, Isaac Gimenez, Sara Herbera, Cristina Hernández, Montserrat Hernández, Silvia Hurtado, Bàrbara Juanmiquel, Esther Llaudet Planas, Maria Lloret, Nura Lutfi, Marc Majo, Marc Martí, Patricia Martín, Carmen Martínez, Sonia Martinez, Mireia Mira, Antonio Molina, Daniel Muñoz, Gemma Mur, Marco Neves, Alicia Nogueroles, Inés Ortuño, Mario Panisello, Anna Peñalver, Jordi Perera, Eva Maria Plana, Gemma Pujadas, Marta Quintero, Olga Reyes, Maria Rion, Maria Teresa Romero, Cristina Rosales, Marta Rotxés, Álvaro Rueda, Laura Sancho, Júlia Sedó, Júlia Sellés Altés, Samira Serhir, Anna Serradell, Pol Sisó, Alex Subias, Albert Texidor, Júlia Toledo, Alejandro Torres, Laia Vila, Anna Viñals Data Entries Judit Abós, Annalisa Aiti, Mariona Alegre, Laura Arias, María Artero, Nestor Babon, Samanta Bascuas, Raul Bonilla, Julia Capo, Helena Carbonero, Anna Casas, Monica Cepeda, Marta Chavero, Ana Cos, Alejandro del Río, David Díaz, Marta Díaz, Ruben Díaz, Sandra Diez, Carlos Domínguez, Esther Domínguez, Claudia Fernández, Dídac Fernández, Marta García, Eulàlia Gómez, Ada González, Laura González, Silvia Gracia, Cristina Homs, Andrea Illescas, Neus Iserte, Sandra Justicia, Jordina Llavall, Eva Marín, Sílvia Marín, Laura Martínez, Sara Martínez, Sonia Martínez, Mireia Masot, Maria Mateu, Carina Monclús, Andrea Monzo, Cristina Navarro, Ana Nicolas, Paula Núnez, Queralt Olesti, Maria Ortega, Mònica Pascual, Sergio Perez, Nerea Plaza, Laura Pol, Irene Quevedo, Maria Rebollo, Anna Ricart, Laura Roa, Angel Romano, Rosa Romero, Luciana Ruiz, Beatriz Sánchez, Laia Solsona, Hugo Somoza, Marta Urdi, Judit Villamor, Núria Vilaplana, Elena Vizcaino, Irati Wyatt Clinical Trials Assistants Nuria Carballo, Laura Cruz, Núria Lafuente, Diana Tello, Sara Vázquez

Transversal Clinical Trials Services and Units

Clinical Trials Office

Established in 1997, the Clinical Trials Office is formed by experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, led by VHIO Director Josep Tabernero.Our team brings together a multidisciplinary team of study coordinators, data managers and research support staff, under the direction of Cristina Pérez, Director of the Clinical Trials Office. In close collaboration with VHIO investigators, the team coordinates phase I-IV clinical trials covering all tumour types and also participate in several translational research projects.

In 2025, our team managed a total of 1,091 active clinical trials and studies across oncology, hematology and radiotherapy. These included 1 phase 0 trial, 351 phase I trials, 29 basket trials, 250 phase II trials, 367 phase III clinical trials, 6 medical device trials and 87 post-authorization and rollovers studies

Of these, 731 were actively recruiting patients during the year, including 289 phase I trials, 24 basket trials, 150 phase II trials, 198 phase III clinical trials, and 4 medical device trials. Patient enrolment in our oncology, hematology and radiotherapy clinical trials reached 1,377, while 66 post-authorization and rollover studies enrolled an additional 481 patients.

During 2025, 264 new clinical trials were initiated, including 19 post-authorization trials and rollover studies. In addition, we continue to follow up patients from trials initiated in previous years. A total of 1,005 patients remained on active treatment in Phase 0, I, II, III and medical device trials, with 1,990 additional patients in long-term follow-up.

Clinical Trials in Oncology

Within oncology specifically, the Clinical Trials Office managed 849 active studies during 2025, including 1 phase 0 trial, 296 phase I trials, 26 basket trials, 204 phase II trials, 363 phase III clinical trials, 6 medical device trials and 53 post-authorization and rollover studies. Also in 2025 we managed 242 phase I, 21 basket, 115 phase II, and 137 phase III clinical trials, and 4 medical device trials with active recruitment at some time in the year (Figure I), with patient enrolment totalling at 1,200 (Figure II). We also managed 40 post-authorization and rollover studies with active recruitment at some time in the year. 216 new trials were initiated, including 15 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2025 and are still enrolled and receiving study treatment (815 patients in total, and 1,699 in follow- up) in Phase 0, I, II, III and medical device trials.

Figure I: Annual distribution of oncology clinical trials (Phase 0, I + Basket, II, III, and a medical device) and post- authorization trials with active recruitment at some time in the year.
Figure II: Annual recruitment of patients enrolled in oncology clinical trials (Phase 0, I + Baskets, II, III, medical device), and post-authorization trials.

Over half of our patients included in our phase I clinical trials have been referred to us from other hospitals, which has consequently positioned our Unit as a leading reference in early clinical studies. Reflective of our recognized excellence, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, directed by Elena Garralda, has been re-accredited by the Generalitat de Catalunya (Government of Catalonia) in 2025.

As we continue to render personalized medicine more precise by matching therapies to the specificities of each individual patient, the requirements and selection criteria for inclusion in certain studies are becoming more complex.

We are dedicated to expanding our portfolio of trials to ultimately establish new treatment regimens with highly selective drugs. Our Unit continues to fine-tune patient selection criteria to identify those patients who are most likely to benefit from novel therapies, including emerging immune-based treatments, tailored to individual patients’ molecular features.

Clinical Trials in Hematology

The total number of active clinical trials and studies in hematology active in 2025 was 229, including 55 phase I trials, 3 basket trials, 44 phase II trials, 96 phase III clinical trials, and 31 post-authorization and rollovers studies. In 2025 we managed 47 phase I, 3 basket, 34 phase II and 55 phase III clinical studies with active recruitment at some time in the year (Figure III), with patient enrolment totalling at 147 (Figure IV). We also managed 23 post-authorization and rollover studies with active recruitment at some time in the year. 45 new trials were initiated, including 3 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2025 and are still enrolled and receiving study treatment (185 patients in total, and 237 in follow-up) in Phase I, II and III trials.

Figure III: Annual distribution of hematology clinical trials (Phase I + Basket, II and III) and post-authorization trials with active recruitment at some time in the year.
Figure IV: Annual recruitment of patients enrolled in hematology clinical trials (Phase I + Basket, II and III) and post- authorization trials with active recruitment.

The prestige of HUVH's Medical Oncology Department is recognized by pharmaceutical and biotechnology companies. It has also become a reference program and selected by the industry to carry out complex clinical trials. The number of participating centers in these studies is highly restricted.

Clinical sites are selected on the basis of the highest quality standards and capacity for carrying out state-of-the-art research. We have participated in early phase trials of several drugs, which ultimately allow the pharmaceutical industry to bring new cancer drugs to market.

We participate in clinical trials sponsored by the pharmaceutical industry as well as those we develop in collaboration with other hospitals. In 2025, we have collaborated in about 155 academic trials in oncology.

  • Consolidation as an international reference for clinical trials in oncology and hematology.
  • Contribute to the development of novel anti-cancer therapies.
  • Continuous training of both our teams and the teams with which we collaborate to best manage complex protocols which are becoming increasingly demanding.
  • Supporting patients enrolled in clinical trials in their daily lives throughout their participation and exploring new operational options to facilitate protocol compliance.
  • Ensuring optimal quality and compliance with Good Clinical Practice (GCP) by standardising the clinical trial process.
  • We have maintained a high number of clinical trials open for recruitment to provide patients with the best possible treatment options.
  • Implementation of new digital resources to implement remote monitoring and electronic investigator site file, which will reduce the use of paper and streamline operations.
  • Partnering with new services and creating and adapting new circuits to participate in increasingly complex protocols.

Director Elena Garralda Executive Team Laura Bascuñana, Elena Garralda, Cristina Pérez, Gemma Sala Clinical Head Elena Garralda Associated Investigators, Senior Consultants Judith Balmaña, Irene Braña, Joan Carles, Mª Elena Élez, Enriqueta Felip, Elena Garralda, Teresa Macarulla, Eva Muñoz, Ana Oaknin, Cristina Saura, Josep Tabernero CORE Phase I Investigators Guzmán Alonso, Vladimir Galvao, Alberto Hernando-Calvo, Julia Lostes, Oriol Mirallas, Arjun K. Oberoi, Belén Ortega, Giulia Pretelli, Victoria Sánchez, María Vieito Phase I Investigators Daniel Acosta, Guzmán Alonso, Angeles Arnaldos, Miriam Arumi, Iosune Baraibar, Pere Barba, Meritxell Bellet, Maria Borrell, Francesc Bosch, Jaume Capdevila, Cecilia Carpio, Florian Castet, Susana Cedrés, Carlo Cicala, Mara Cruellas, Nely Merci Díaz, Marc Diez, Santiago Escrivá, Lorena Fariñas, Inmaculada Fernández, Maria Laura Fox, Vladimir Galvao, Alejandro Garcia, Carmen Garcia, Cristina Garcia, Sara Garrido, Mercedes Gironella, Diego Gomez, Nadia Gomez, Patricia Gómez, Macarena González, Alberto Hernando, Jorge Hernando, David Garcia Illescas, Gloria Iacoboni, Patricia Iranzo, Daniel López, Maria Julia Lostes, David Marmolejo, Alexandre Martínez, Joaquín Mateo, Gaspar Molina, Rafael Morales, Arjun Oberoi, Mafalda Oliveira, Roberta Mazzeo, Oriol Mirallas, Belén Ortega, Núria Pardo, Isabel Pimentel, Ilaria Priano, Alba Puyuelo, Maria Teresa Quiñones, Alejandra Rezqallah, Angélica Rodriguez, Marta Rodríguez, Katerin Ingrid Rojas, Francisco Javier Ros, Omar Saavedra, Francesc Salvà, Mario Sanchez, Lucia Sanz, Ángel Serna, César Serrano, Kreina Sharela, Pedro Filipe Simoes, Maria Sola, Cristina Suarez, Eduardo Terán, Augusto Valdivia, Claudia Mª Valverde, Pilar Velarde, María Vieito, Ester Zamora Director, Clinical Trials Office Cristina Pérez Head, Start-Up Unit and Clinical Trials Liaison Núria Farràs Coordinator, Start-Up Unit Paula Chiquillo Head, Data Entries Ignacio Carcela Head, Phase I Clinical Trials Office Ana Matres Head, Hematology Laura Segura Lead Study Coordinators Eulalia Aliende, Aitana Almodóvar, Eva Banús, Laia Catalan, Natalia Écija, Danis Fernández, Magda Masana, Alba Meire, Olga Padrós, Laura Saucedo Lead Data Entries Gloria García, Eva Lázaro, Eva Puerma, Alberto Rojo, Judith Serrano Study Coordinators Ester Aguado, Gisela Andrés, Jorge Bardina, Paula Barranco, Laia Benítez, Laura Blanco, Taiana Cristina Burgin, Cristina Calderón, Júlia Caparrós, Gregorio Casas, Gemma Comas, Paula Cruz, Nuria Durá, Anna Falcón, Carlos Fernandez, Neus Figa, Alba Galiana, Natàlia Gallardo, Alexia Garcia, Beatriz García, Daniel García, Isaac Gimenez, Sara Herbera, Cristina Hernández, Montserrat Hernández, Silvia Hurtado, Bàrbara Juanmiquel, Esther Llaudet Planas, Maria Lloret, Nura Lutfi, Marc Majo, Marc Martí, Patricia Martín, Carmen Martínez, Sonia Martinez, Mireia Mira, Antonio Molina, Daniel Muñoz, Gemma Mur, Marco Neves, Alicia Nogueroles, Inés Ortuño, Mario Panisello, Anna Peñalver, Jordi Perera, Eva Maria Plana, Gemma Pujadas, Marta Quintero, Olga Reyes, Maria Rion, Maria Teresa Romero, Cristina Rosales, Marta Rotxés, Álvaro Rueda, Laura Sancho, Júlia Sedó, Júlia Sellés Altés, Samira Serhir, Anna Serradell, Pol Sisó, Alex Subias, Albert Texidor, Júlia Toledo, Alejandro Torres, Laia Vila, Anna Viñals Data Entries Judit Abós, Annalisa Aiti, Mariona Alegre, Laura Arias, María Artero, Nestor Babon, Samanta Bascuas, Raul Bonilla, Julia Capo, Helena Carbonero, Anna Casas, Monica Cepeda, Marta Chavero, Ana Cos, Alejandro del Río, David Díaz, Marta Díaz, Ruben Díaz, Sandra Diez, Carlos Domínguez, Esther Domínguez, Claudia Fernández, Dídac Fernández, Marta García, Eulàlia Gómez, Ada González, Laura González, Silvia Gracia, Cristina Homs, Andrea Illescas, Neus Iserte, Sandra Justicia, Jordina Llavall, Eva Marín, Sílvia Marín, Laura Martínez, Sara Martínez, Sonia Martínez, Mireia Masot, Maria Mateu, Carina Monclús, Andrea Monzo, Cristina Navarro, Ana Nicolas, Paula Núnez, Queralt Olesti, Maria Ortega, Mònica Pascual, Sergio Perez, Nerea Plaza, Laura Pol, Irene Quevedo, Maria Rebollo, Anna Ricart, Laura Roa, Angel Romano, Rosa Romero, Luciana Ruiz, Beatriz Sánchez, Laia Solsona, Hugo Somoza, Marta Urdi, Judit Villamor, Núria Vilaplana, Elena Vizcaino, Irati Wyatt Clinical Trials Assistants Nuria Carballo, Laura Cruz, Núria Lafuente, Diana Tello, Sara Vázquez Director of Oncology Nursing Mª Ángeles Peñuelas Study Nurse Supervisor Laura Bascuñana Nurse Director's Assistant Juan Manuel Garcia Coordinator Sonia Valverde Nurses Xenia Amigó, Carla Barjola, Yana Baryshchuk, Alejandra Maria Botero, Andrea Caballero, Anguiela Cachique, Carles Caro, Mª Elena de Cabo, Javier Dengra, Julia Deulofeu, Elvira Domingo, Elena Espadas, Mª Luisa Fargas, Rosa Gallardo, Eva Gomez, Julia Gónzalez, Carla Gotor, Margarida Marcos, Marta Mate, Carmen Moína, Mireia Moral, Isabel Muñoz, Carla Sanchez, Tania Sanchez, Carla Solana, Scarlet Squadrito, Adriana Terres, Judit Torres, Lydia Velez Operational Research Nurses Andrea Caballero, Anna Maria Carro, Inés Depares, Andrea Martinez, Alba Silverio, Rubén X. Torres Nursing Assistants Katherine Espinoza, Youssef El Maddahi, Susana Flores, Melania Fornies, Mireia Hernández, Mª Ascension Martin, Marta Marzo, Laura Maza, Lucia Melero, Ana Belen Ortiz, Alba Pardes, Keyla Vasquez Head of the Clinical Research Oncology Pharmacy Unit Anna Farriols Head of the Pharmacy Service Maria Queralt Gorgas Pharmacists Mariona Calvo, Montserrat Carreres, Matilde Casañ, Carla Esteban, Celia Fernández, Lorena García, Patricia García, Pablo González, Ariadna Gracia, Pablo Martínez, Rocío Paucar, Pilar Rovira, Eugenia Serramontmany, Manuel Serrano, Lucia Sopena, Carlota Varon Technicians Marc Acuña, Montserrat Aguilar, Romina Bellini, Esther Carabantes, Bryan Cárdenas, Angélica Cely, Elisabeth Gabilan, Cristina Gullón, Ariadna Javalera, Jennifer Jimenez, Susana Mulet, Isabel Pérez, Sergio Pizarro, Marta Pozo, Dayana Puyas, Madiha Shaheen, Alan Thompson, Silvia Torralba, Noemi Visus Pharmacy Assistant Álex Valle Data Entry Carmen Torres Administrative Assistants Isabel Mª Alerany, Nida Mehmood

Transversal Clinical Trials Services and Units

Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch

Summary

Inaugurated in June 2010, thanks to the support received from the ”la Caixa” Foundation, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch is dedicated to designing and conducting clinical trials in oncology with drugs in early development (phase I and phase II) against novel targets. With a surface area of 1000 m2, our Unit is located within the Vall d’Hebron University Hospital (HUVH), as part of the Vall d’Hebron Barcelona Hospital Campus.

This privileged environment directly connected with patients, coupled with VHIO’s translational approach to research and superb scientific framework, has established our unit as one of the few comprehensive facilities in Europe to rapidly transform the latest discoveries into patient benefit. The UITM – CaixaResearch comprises a multidisciplinary team of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel.

By promoting tight connectivity between oncology care and research, we implement novel treatment modalities with selective drugs, and generate insights to guide the individualized treatment of patients - getting the right therapy to the right patient at the right time.

Our unit participated in 322 active phase I clinical trials in oncology during 2025, 26 of which are Basket trials. Thanks to our multidisciplinary team we have continued to expand our portfolio of phase I and Basket trials, with 645 patients enrolled. This year, we opened 85 new studies, treated over 1,300 patients and performed over 740 first visits. In 2025 we also managed 242 phase I clinical trials and 21 basket trials, with active recruitment at some time in the year.

Directed by Elena Garralda, research carried out at our unit by VHIO’s Early Clinical Drug Development Group focuses on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimens using combinations of new agents with those that already exist.

Reflective of VHIO’s translational model, our studies are also linked to research led by other VHIO groups.

We also participate in VHIO’s Molecular Prescreening Program that performs molecular analyses of patients’ tumors to select the best possible treatment with the experimental therapies available, with the support from Ana Vivancos' Cancer Genomics Group and a broad range of technologies for high-throughput molecular analysis of patient samples.

In addition to our clinical trials in oncology, in 2025 our Unit also participated in 27 phase I, 1 phase II, and 1 phase III active clinical trials in hematology, with 28 patients enrolled. Of those, 24 clinical trials (23 phase I and 1 phase III) had active recruitment at some time in the year.

Optimal patient treatment and care and pioneering research at UITM-CaixaResearch would not be possible without the collaboration of many other teams of oncology professionals. These include our Clinical Research Oncology Nurses, directed by Mª Ángeles Peñuelas and supervised by Laura Bascuñana, pathologists at the Vall d’Hebron University Hospital’s Molecular Pathology Department, radiologists and interventional radiologists at Vall d’Hebron, our Clinical Trials Office directed by Cristina Pérez, this Unit’s Database Managers, VHIO’s Clinical Research Oncology Pharmacy Unit headed by Ana Farriols, our Academic CRO and Quality & Processes Unit directed by Susana Muñoz and Gemma Sala, respectively, as well as many other healthcare specialists including dermatologists, cardiologists, and ophthalmologists.

  • Early clinical drug development and translational research led by our UITM – CaixaResearch clinical investigators and VHIO researchers: expansion of our broad portfolio of promising novel anticancer therapies, across a balanced spectrum of studies. In particular, we focus on first-in-human studies, novel combinations, best-in-class compounds, and new therapeutic modalities.
  • Perform innovative trials, such as basket and umbrella studies, and link clinical research with VHIO's preclinical and translational projects. We also collaborate with various other partners involved in drug development and translational research.
  • Molecularly guided early-phase oncology trials to promote drug development. This includes performing molecular analysis of patients' tumors to select the best experimental therapy available, co-develop bioinformatic pipelines for genomic-based medicine, and integrate new mechanistic insights, anticancer drugs and customized molecular diagnostics.
  • Early drug development of immunotherapies, focusing on new cytokines, bispecifics, immunomodulatory agents, and treatment combinations, as well as conducting translational research in immuno-oncology.
  • We have performed several phase I trials, including on complex molecularly selected patient populations, and immuno-oncology.
  • We have expanded our portfolio of drugs targeting developmental pathways, cell signaling mediators (RAS; ERK, MET, FGFR, RET, NOTCH, NTRK), antibody drug conjugates (ADCs), and immunotherapy including BITEs, bispecifics, T-cell engagers, T-cell receptor (TCR) therapies, and cellular therapy products.
  • We have established alliances with several pharma companies as the preferred site for testing their novel and most relevant therapies, including Roche ImCORE, Astra Zeneca Partners of Choice, Amgen Partners of Choice, Abbvie and Janssen. Additionally, new alliances have been established with Boehringer Ingelheim and Regeneron during 2025.
  • Our investigators have successfully expanded the Basket of Baskets (BoB) clinical trial. This innovative study in precision oncology integrates flexible molecular prescreening of patients with the development of new diagnostic tests based on molecular tumor characterization. This platform study allows for testing novel targeted therapies in patients diagnosed with tumors harboring specific molecular alterations who have a high probability of deriving benefit from matched therapies. This academic study, sponsored by the Cancer Core Europe (CCE) consortium, is co-funded by pharmaceutical companies and has an adaptive design to incorporate new study modules.
  • We have launched an advanced cell-based therapy program and are participating in several pharma sponsored trials to evaluate tumor-infiltrating lymphocyte (TIL) therapy. We are also exploring academic TIL products in collaboration with VHIO’s Tumor Immunology & Immunotherapy Group led by Alena Gros.
  • In collaboration with other VHIO groups, we co-lead our CaixaResearch Advanced Oncology Research Program (2020-2025), also supported by the ”la Caixa” Foundation.

Director of Oncology Nursing Mª Ángeles Peñuelas Study Nurse Supervisor Laura Bascuñana Nurse Director's Assistant Juan Manuel Garcia Coordinator Sonia Valverde Nurses Xenia Amigó, Carla Barjola, Yana Baryshchuk, Alejandra Maria Botero, Andrea Caballero, Anguiela Cachique, Carles Caro, Mª Elena de Cabo, Javier Dengra, Julia Deulofeu, Elvira Domingo, Elena Espadas, Mª Luisa Fargas, Rosa Gallardo, Eva Gomez, Julia Gónzalez, Carla Gotor, Margarida Marcos, Marta Mate, Carmen Moína, Mireia Moral, Isabel Muñoz, Carla Sanchez, Tania Sanchez, Carla Solana, Scarlet Squadrito, Adriana Terres, Judit Torres, Lydia Velez Operational Research Nurses Andrea Caballero, Anna Maria Carro, Inés Depares, Andrea Martinez, Alba Silverio, Rubén X. Torres Nursing Assistants Katherine Espinoza, Youssef El Maddahi, Susana Flores, Melania Fornies, Mireia Hernández, Mª Ascension Martin, Marta Marzo, Laura Maza, Lucia Melero, Ana Belen Ortiz, Alba Pardes, Keyla Vasquez

Transversal Clinical Trials Services and Units

Clinical Research Oncology Nurses

Summary

Clinical trials in oncology are essential for developing novel, more effective targeted therapies against cancer as well as improving survival outcomes, toxicity profiles, and the quality of life of our patients. Optimal, well-coordinated and patient-centred processes in clinical trials drive advances in oncology care and the delivery of more increasingly powerful anti-cancer medicines.

Our expert clinical research oncology nurses assume a central role in clinical studies and work closely with multidisciplinary teams to ensure high-quality patient care. They also contribute to clinical trials by identifying patterns of toxicity associated with anticancer agents, collating samples and quality data for clinical trial validation, optimally managing patient symptoms and providing excellent nursing care, focused on the quality of life of patients.

In addition, our nursing team provides a dedicated Advanced Practice Nursing (APN) consultation specifically designed to support patients participating in clinical trials. This consultation plays a key role in the prevention and early detection of adverse events, the longitudinal follow-up of patients throughout the course of experimental treatments, and the delivery of tailored health education related to clinical trial therapies. Through this advanced nursing practice model, patients receive structured education on treatment administration, potential side effects, self-care strategies, and adherence, thereby enhancing safety, patient empowerment, and the continuity of care.

Our team, led by Laura Bascuñana and is specialized in molecular therapies. We represent an essential element of the multidisciplinary teams involved in the studies carried out and coordinated by VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, and our Clinical Trials Office, led by Elena Garralda and Cristina Pérez, respectively.

Supporting these teams composed of medical oncologists, molecular pathologists, oncology pharmacists, clinical researchers, and study coordinators, VHIO's oncology nurses are key to ensuring the delivery of optimal care for our patients who receive the full range of expertise, guidance, and the necessary follow-up throughout the course of their participation in clinical studies. As importantly is the psychological support that they provide, alongside the other superbly trained oncology care givers and specialists, including psychologists.

Furthermore, our nurses provide patients and their families with clear, accurate information and professional guidance to enable fully informed decision-making regarding treatment options and participation in clinical trials. Our clinical teams also continue to follow up patients recruited prior to 2025 who remain enrolled and are still receiving treatment.

VHIO continues to expand its portfolio of clinical trials to establish novel treatments with highly selective drugs, as well as fine-tune patient selection criteria to identify those patients who are most likely to benefit from them. We can expect a steady increase in patient recruitment across our clinical studies in the future.

Head of the Clinical Research Oncology Pharmacy Unit Anna Farriols Head of the Pharmacy Service Maria Queralt Gorgas Pharmacists Mariona Calvo, Montserrat Carreres, Matilde Casañ, Carla Esteban, Celia Fernández, Lorena García, Patricia García, Pablo González, Ariadna Gracia, Pablo Martínez, Rocío Paucar, Pilar Rovira, Eugenia Serramontmany, Manuel Serrano, Lucia Sopena, Carlota Varon Technicians Marc Acuña, Montserrat Aguilar, Romina Bellini, Esther Carabantes, Bryan Cárdenas, Angélica Cely, Elisabeth Gabilan, Cristina Gullón, Ariadna Javalera, Jennifer Jimenez, Susana Mulet, Isabel Pérez, Sergio Pizarro, Marta Pozo, Dayana Puyas, Madiha Shaheen, Alan Thompson, Silvia Torralba, Noemi Visus Pharmacy Assistant Álex Valle Data Entry Carmen Torres Administrative Assistants Isabel Mª Alerany, Nida Mehmood

Transversal Clinical Trials Services and Units

Clinical Research Oncology Pharmacy Unit

Summary

Our Unit, ISO 9001:2015 certified, forms part of the Medical Oncology Department of the Vall d’Hebron University Hospital (HUVH), within the Vall d’Hebron Barcelona Hospital Campus. Established in 2020 with the support of the ”la Caixa” Foundation, our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch Clinical Research Onco-Hematology Unit provides state-of-the-art infrastructure to ensure excellence in pharmaceutical care and full regulatory compliance in oncology clinical research.

We focus on two main areas of clinical research in oncology:

Oncology Pharmaceutical Care Program

Our specialized oncology and hematology pharmacists, supported by laboratory technicians, oversee the preparation of cytostatics and other investigational parenteral therapies, and provide structured pharmaceutical care to patients enrolled in clinical trials. In 2025, 3,335 patients were seen in consultation, including 1,640 Cycle 1 Day 1 visits and 750 screenings for early-phase studies. Pharmacists review concomitant medications to detect contraindications and interactions, helping to prevent screening failures and enhance treatment safety and efficacy.

Pharmacological Research in Oncology Support Program

This program ensures comprehensive management of investigational medicinal products, including storage, traceability, dispensing, and protocol adherence. In 2025, the Unit managed drugs for 907 active oncology and hematology clinical trials and handled nearly 14,000 investigational product resupply deliveries. A total of 54,137 clinical trial medications were dispensed, including 17,949 cytostatic preparations for infusion.

The Unit operates a robust quality and safety framework, including continuous electronic temperature monitoring, standardized dispensing procedures (234 new active SOPs implemented in 2025, among the more than 1,000 that are active), protocol amendment updates, and validated computerized traceability systems.

In 2025, the team participated in over 3,000 monitoring and site visits and successfully passed sponsor audits and regulatory inspections, including ISO and FDA evaluations. Also, during 2025 our dispensing staff actively participated in 314 pre-study visits, 233 initial visits, 2,459 monitoring visits, 228 close-out visits and successfully passed 18 audits, 1 ISO inspections, and 1 FDA inspections.

  • Ensure excellence, optimal efficacy, efficiency and safety in pharmaceutical management for oncology and hematology clinical trials.
  • Management, dispensing, preparation and administration of clinical study drugs according to protocol specifications. Ensure traceability of the entire circuit new software solutions and digital platforms.
  • Maintain a detailed control of storage conditions of samples and preparations, aligned with ISO certification and regulatory authority requirements.
  • Provision of a pharmaceutical care program for patients enrolled in phase I, II and III studies undergoing treatment with orally administered medicines to improve safety, compliance and efficacy.
  • Deployment and expansion of QuimioProcess–TrialProcess, an integrated traceability software platform covering prescription, validation, dispensing, preparation, and administration of investigational drugs across different pathologies including breast cancer, gynecological cancers and melanoma.
  • Implementation of automated qualitative and quantitative quality control systems for parenteral anticancer preparations, including automated visual verification, barcode systems and automated gravimetric control to guarantee patient safety and protocol compliance.
  • Renewal of ISO9001:2015 certification and successful completion of sponsor audits, regulatory inspections, including the reaccreditation of VHIO’s UITM.

Unit Head Susana Muñoz Clinical Research Managers Pol Barbarroja, Marta González, Darío López, Anna Palazón Clinical Research Associates Lucía Alba, Soraya Alonso de Caso, Raquel Anta, Judith Bautista, Belén Garcé, José María Gómez, Àlex Ossmann Medical Writer Marta Carboneras Clinical Trials Assistant Elena Guzmán

Transversal Clinical Trials Services and Units

Academic CRO

Summary

VHIO's Academic Contract Research Organization (CRO) has extensive experience in conducting sponsored trials and investigator-initiated trials (IITs). We offer the complete range of start-to-end management services required to perform clinical trials and studies. Our multidisciplinary team enables us to operate as a full service CRO in clinical studies from phase I to IV.

We also provide guidance to investigators and sponsors on how to achieve optimal experimental design and offer logistical guidance to help maximize resources. Comprising a team of 14 professionals, we also offer medical writing support, full regulatory activities, as well as monitoring, project management, e-case report form (CRF) creation, statistical support, drug management, insurance management and pharmacovigilance services.

Our highly motivated and qualified team is committed to successful project delivery. We foster individual growth to strengthen our unit further.

In 2025, we continued working with the new Clinical Trials Information System (CTIS) under the clinical trials regulation (EU 536/2014), in effect since January 2022.

  • Provide clinical project management support to awarded R&D projects (European/Pharma funded), and academic oncology clinical studies led by our medical oncologists and clinical investigators at VHIO and the Vall d'Hebron University Hospital (HUVH), Vall d'Hebron Barcelona Hospital Campus.
  • Serve as an Academic CRO for investigator-initiated trials (IITs).
  • Serve as a CRO for pharmaceutical industry sponsored trials involving VHIO investigators.
  • Provide solid experience managing clinical trials with cell therapies.
  • Achieve economic self-sufficiency as a unit.
  • In 2025, we have successfully managed several major projects including SERONCO-1, BRCA-P, BoB, RAMPART, STROBE, NIPU, BRAVE, SAGITTARIUS, Osteomyc, among others. Most of these studies are led by our medical oncologists and clinical investigators at HUVH’s Medical Oncology Department, headed by VHIO’s Director Josep Tabernero. Of particular note, four clinical trials in cell therapy with tumor-infiltrating lymphocytes (TILs) are currently logistically managed by our team: NEXTGEN-TIL-ACT, TILTS-001, ARES and PragmaTIL. Sponsored by VHIO and funded by the European Union, PragmaTIL received regulatory approval in 2024 and has been initiated across three EU sites: Vall d’Hebron University Hospital, Herlev Hospital in Denmark, and the Netherlands Cancer Institute (NKI).
  • We are also managing a clinical trial with CAR-T cells, that has received approval from authorities and will be opened for recruitment in 2026.
  • During 2025, we successfully met the regulatory requirements for all of our trials (first submissions and amendments).
  • Our clinical research associates have monitored more than 200 patients across different hospitals in Spain.
  • We managed clinical trial drug requirements in more than 40 national hospitals.
  • Update our Standard Operating Procedure (SOP) system.
  • Continue to be the CRO partner of choice for all the clinical trials led by our investigators.
  • Increase our portfolio of haemato-oncology clinical trials.
  • Expand our work in cell therapy clinical trials.
  • Gain experience managing clinical trials under the new IVDR (In Vitro Diagnostic Medical Devices Regulation).
  • Incorporate a Regulatory Affairs Manager to increase our capacity in this field while maintaining high quality standards.
  • VHIO20002 (natural killer cells - NKs).
  • VHIO20001 (NEXTGEN-TIL-ACT)
  • TILTS-001
  • VHIO23002 (PragmaTIL)
  • VHIO17002 BOB
  • VHIO19001 MONEO
  • RAMPART
  • ESR-17-13082 DUREC
  • ESR-21-21165 SERPENTINE
  • IRONMAN-ES Registry (EOM)
  • CA209-7H4 NIPU
  • CA209-7J3
  • ABCSG 50 (BRCA-P)
  • CHECKYIMID
  • ESR-22-21756 (MARION)
  • TP53CLL2023
  • VHIO-PBF-999-01
  • IFOM-CPT005/2019/PO004 (Low interventional trial)
  • KILT trial (T-cell Lymphoma)
  • VHIO23001 BRAVE
  • TTD-20-04
  • ESR-20-21103 STROBE
  • LB-208-001 SERONCO-1
  • CT-OST-499-01
  • SAGITTARIUS
  • VHIO23003 (Osteomyc)
  • APACE
  • ARES
  • VHIO23004 REFISH
  • UC-BCG-2213 ETNA

Director Gemma Sala Quality Team: Quality Managers Javier Fonts, Alba Martinez, Melisa Belén Oliva, Mafalda Rodrigues Quality Technicians Miriam Artigas, Vanessa Soriano Head, General and Laboratory Quality Unit Deborah Grazia Lo Giacco Sample Managers Jennifer Alarcón, Marta Chorro, Ana Fernandez, Judith Gonzalez, Gerard Perez, David Vendrell Schedulers Laura Abellan, Christian Damea, Maria Teresa Mendoza, Noelia Moles, Marc Palomar

Transversal Clinical Trials Services and Units

Quality and Processes Unit

Summary

Led by Gemma Sala, VHIO’s Quality and Processes Unit was established in 2020 to further improve quality and standardize processes across all clinical studies conducted at VHIO.

This unit comprises quality and transversal support teams including sample managers and schedulers. We perform various tasks related to clinical trials, develop and implement standardized processes and VHIO’s quality management system at both the institutional and laboratory levels, and ensure quality excellence.

Our Quality organizational structure includes two main areas: Clinical Trials Quality and General & Laboratory Quality, each with clearly defined objectives and responsibilities. Our clinical trials support unit consists of schedulers and sample managers teams. All activities comply with Good Clinical Practice (GCP) guidelines and current regulatory requirements, including ISO standards, with the rights, safety and well-being of patients remaining the paramount priority.

  • Implement and maintain VHIO’s clinical quality management system to ensure quality excellence at the institutional and laboratory levels.
  • Provide cross-support and perform clinical trial activities including scheduling, the management of samples and quality assurance, and the standardization of processes.
  • Administrative management of clinical visits, follow-up and treatment of patients participating in clinical trials at VHIO.
  • Standardize and optimize processes and circuits to reduce patient waiting times and provide the best possible service.
  • Establish circuits for the optimal management and processing of clinical trial samples.
  • Renewal of ISO9001 and ISO15189 certification for the establishment and maintenance of effective quality management systems: ISO9001 certification for VHIO’s general quality management system, and ISO15189 certification of VHIO’s Cancer Genomics and Molecular Oncology Laboratories ( 124-126).
  • Collaborate closely with all teams involved in clinical trials at VHIO to identify and resolve any instances of non-conformity across all clinical trial activities as well as VHIO’s general Quality Management system.
  • Conduct periodic quality control and internal audits of documentation, site inspections, circuits and procedures.
  • Obtain renewed certification from the Government of Catalonia of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch.
  • Organization of courses and training sessions in-house including Good Clinical Practice (GCP), assessment of electrocardiogram (ECG), cardiopulmonary resuscitation (CPR).
  • Conduct regular training sessions to review and further reinforce quality-related aspects.
  • Develop and update Standard Operating Procedures (SOPs) to standardize circuits and provide all necessary trainings.
  • In 2025, we have collaborated in more than 900 active clinical trials in oncology and haematology, and have successfully passed 17 external audits, 7 internal audits, 2 U.S. Food and Drug Administration (FDA) inspections, and 1 inspection of the UITM -CaixaResearch by the Government of Catalonia.
  • Continued improvement of circuits, monitoring to identify and resolve any incidents, and the standardization and optimization of processes.
  • We have also participated in the internal training of staff involved in clinical trials.
  • Consolidation of VHIO's Moodle learning platform for internal as well as SOP trainings.
  • Reorganization of VHIO’s Quality Area including the establishment of our General and Laboratory Quality Unit to centralize and standardize quality management at our institution.
  • Compliance of VHIO-developed in vitro diagnostic (IVD) tests with the requirements of the (EU) 2017/746 IVD medical devices regulation and current national regulations.
  • Further improve quality and standardize processes across all clinical studies conducted at VHIO.
  • Promote the use of digital tools to optimize data and process management in clinical trials.
  • Ensure that all teams comply with current regulations to guarantee quality.

Oncology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2025

Code Clinical Trial Title Phase
2022-0759 Observation of Residual Cancer with Liquid biopsy Evaluation (ORACLE). IV
2024-146-1 "PREDICTING OUTCOME OF RENAL CELL CARCINOMA PATIENTS BASED ON CLINICAL, MOLECULAR, RADIOLOGIC, AND HISTOLOGICAL CHARACTERISTICS" IV
2022-0544 “An open-label fixed sequence trial to investigate the potential drug-drug interaction when BI 907828 is co-administered with an OATP1B1 and/or OATP1B3 transporter inhibitor in patients with various solid tumours” I
2020-0295 A First–in-human Phase I, non-randomized, open-label, multicenter dose escalation trial of BI 764532 administered by repeated intravenous infusions in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3. I
2023-0906 An open-label, multicenter Phase II trial, with an initial randomized dose selection part, to evaluate efficacy and safety of repeated intravenous infusions of BI 764532, a DLL3-targeting T cell engager, in patients with Extensive-Stage SCLC who have failed at least two prior lines of therapy II
2023-1067 A Phase I, open-label, dose escalation and expansion trial to investigate safety and tolerability of BI 764532 in combination with standard of care (platinum and etoposide) in first-line treatment of patients with neuroendocrine carcinomas (NEC) I
2021-0772 Phase I dose-finding study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers. I
2024-0386 Beamion LUNG-2: A Phase III, open-label, randomised, active-controlled, multi-centre trial evaluating orally administered BI 1810631 compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non–small cell lung cancer harbouring HER2 tyrosine kinase domain mutations III
2024-0981 "A Phase II, multicenter, open-label study to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumors " I
2024-0758 A Phase Ib dose escalation and Phase II dose optimization, randomized, open-label, multicenter trial of oral zongertinib  (BI 1810631) in combination with intravenous trastuzumab deruxtecan (T-DXd) or in combination with intravenous trastuzumab emtansine (T-DM1) for treatment of patients with advanced HER2+ metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) I
2022-1040 Phase Ia, first in human open-label trial evaluating BI 1703880, a non-CDN STING agonist, in combination with ezabenlimab for treatment of advanced solid tumours I
2023-0326 A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer I
2021-1236 A PHASE 1B, MASTER PROTOCOL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF AMG510 IN SUBJECTS WITH AVANCED SOLID TUMORS WITH KRAS P.G12C MUTATION I
2024-0237 “A Phase 3, Multicenter, Randomized, Open-labelStudy Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)” III
2024-0595 A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination with Durvalumab compared With Durvalumab as Maintenance Therapy in Subjects with Extensive-Stage Small-Cell Lung Cancer (ESSCLC) Following First-Line Induction Therapy with Platinum, Etoposide and Durvalumab III
2023-0392 An observational, multi-country, retrospective chart review study to describe the characteristics, treatment patterns and clinical outcomes of patients receiving selpercatinib in real-world clinical practice in Europe IV
2023-0883 "A Randomized, Double-blind Study to Compare the Efficacy and Safety Between ABP 206 and Nivolumab (OPDIVO®) in Subjects with Unresectable or Metastatic Melanoma" III
2024-0703 A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus Investigator’s Choice Chemotherapy (FOLFOX or FOLFIRI) with or without Bevacizumab-awwb for Treatment-naïve Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutatio III
2022-0695 “Estudio tipo cesta de fase 1b/2, multicéntrico y abierto que evalúa la seguridad y eficacia de bemarituzumab en monoterapia en tumores sólidos con sobreexpresión de FGFR2b (FORTITUDE-301)” II
2023-0464 "An observational, retrospective chart review study in patients with RET-altered locally advanced or metastatic lung, thyroid or other solid tumours: a real-world contextual comparator to selpercatinib-treated patients in LIBRETTO-001" IV
2024-0591 “Primer estudio en humanos de fase 1 que evalúa la seguridad, tolerabilidad, farmacocinética y eficacia de AMG 355 en monoterapia y en combinación con pembrolizumab en sujetos con tumores sólidos avanzados” I
2023-0877 Primer estudio en humanos de fase 1 para evaluar la seguridad, tolerabilidad y farmacocinética de AMG 305 en sujetos con tumores sólidos avanzados I
2024-0756 "A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors Conditions" II
2025-0312 Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy III
2024-0604 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF TARLATAMAB THERAPY IN SUBJECTS WITH LIMITED-STAGE SMALL-CELL LUNG CANCER WHO HAVE NOT PROGRESSED FOLLOWING CONCURRENT CHEMORADIATION THERAPY III
2024-0766 A PHASE 1B/2 STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACO KINETICS, AND EFFICACY OF AMG 193 ALONE OR IN COMBINATION WITH OTHER THERAPIES IN SUBJECTS WITH ADVANCED THORACIC TUMORS WITH HOMOZYGOUS MTAP DELETION I
2024-0877 A Phase 1B/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG193 Alone or in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract or Pancreatic Cancers With Homozygous MTAP Deletion I
2024-0936 A Phase 1B Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Subcutaneous Tarlatamab in Subjects with Extensive-Stage Small Cell Lung Cancer (DELLPHI-308) I
2025-0542 “Estudio de fase 2, aleatorizado, abierto y multicéntrico de las pautas posológicas de tarlatamab en sujetos con cáncer de pulmón microcítico (CPM) (DeLLphi-309)” II
2025-0979 A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer I
2025-0874 “A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small Cell Lung Cancer (DeLLphi-312)” III
2024-0952 A Randomized, Multi-Center, Double-blind, Placebo Controlled, Phase 3 Study to Investigate Safety and Efficacy of GSK4428859A in combination with Dostarlimab compared with Placebo in combination with Pembrolizumab in Participants with Previously Untreated Locally Advanced, Unresectable or Metastatic PD-L1 Selected Non-Small Cell Lung Cancer (NSCLC) III
2022-1054 A Phase 2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated Locally Advanced/Metastatic Programmed Death Ligand 1-Positive Non Small Cell Lung Cancer. II
2025-0916 Phase 1/1b study in Metastatic/Locally Advanced Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma or Pancreatic Adenocarcinoma whose tumors have Claudin (CLDN) 18.2 expression I
2024-0842 A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors I
2024-0731 “An  open‐label,  phase  1,  first‐in‐human,  dose escalation  and expansion  study  to evaluate  the  safety,  tolerability,  maximum  tolerated  or  administered  dose,  pharmacokinetics, pharmacodynamics, and tumor response profile of the diacylglycerol kinase zeta inhibitor (DGKzi) BAY 2965501 as monotherapy, and in combination, in participants with advanced solid tumors” I
2023-0612 A Phase 3, Open-Label and Randomized Study of Perioperative Dostarlimab Monotherapy versus standard of care in Participants with Untreated Stage II/III dMMR/MSI-H Locally Advanced Colon Cancer. III
2023-0943 A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants with Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck II
2024-0448 A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Patients with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma III
2025-0666 A Phase 1/2 Master Protocol to Assess the Safety and Efficacy of DNA-Damage Repair Inhibitors, as Monotherapies or in Combination with Other Anti-Cancer Agents in Adult Participants with Solid Tumors I
2024-0850 An open-label, phase 1, first-in-human, dose escalation and expansion study to evaluate the safety, tolerability, maximum tolerated or administered dose, pharmacokinetics, pharmacodynamics, and tumor response profile of the diacylglycerol kinase alpha inhibitor (DGKai) BAY 2862789 in participants with advanced solid tumors I
2024-0918 A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors I
2025-0237 Phase 2, open label, randomized study of neoadjuvant dostarlimab plus CAPEOX versus CAPEOX in participants with previously untreated T4N0 or Stage III MMRp/ MSS colon cancer. II
2025-0737 "A Phase I Clinical Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in Participants with Advanced Solid Tumors" I
2025-0335 “Estudio de fase I/II, aleatorizado, multicohorte para evaluar la seguridad, tolerabilidad, farmacocinética y actividad clínica de GSK5733584 en combinación con otros tratamientos contra el cáncer en participantes con tumores sólidos avanzados.” I
2025-0775 A Phase1b/2, multicenter, randomized, open-label study to evaluate the efficacy and safety of GSK5764227 alone and in combination in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors I
2024-0987 Management of Radium-223 in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) in real world clinical practice in Spain. IV
2025-0119 AN OPEN-LABEL, MULTICENTRE PHASE 1B/2A CLINICAL TRIAL OF BI-1607, AN FC-ENGINEERED MONOCLONAL ANTIBODY TO FCγRIIB (CD32B), IN COMBINATION WITH IPILIMUMAB AND PEMBROLIZUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA I
2024-1129 A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation I
2025-1073 A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in combination with Standard of Care (SOC) or other agents in Participants with Advanced Solid Tumors I
2024-0974 A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation I
2023-1136 Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumors I
2017-0401 A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors I
2020-0720 A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER). I
2024-1052 61186372COR3001   A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With RAS/RAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer III
2024-1035 2L: Amivantamab añadido a la quimioterapia de referencia frente a los tratamientos estándar más la quimioterapia de referencia en pacientes con CCRm. III
2022-0699 "A Phase 1b/2, open-label, study of amivantamab monotherapy and in combination with chemotherapy in patients with advance metastatic colorectal cancer" I
2024-0593 Ensayo fase 1b/2 con ramas de Amivantamab en monoterapia y en combinación con Paclitaxel o Pembrolizumab. I
2022-1035 A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in multiple regimens in patients with Advanced or Metastatic Solid Tumors including Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer (PALOMA-2) II
2024-0204 A Phase 2, open-label, randomized trial evaluating the impact of enhanced versus standard dermatologic management on selected dermatologic adverse events among patients with first-line locally advanced or metastatic EGFR-mutated NSCLC treated with amivantamab + lazertinib II
2023-1060 A Phase I Study of JNJ-79032421, a T-cell Redirecting Agent Targeting Mesothelin for Advanced Stage Solid Tumors I
2021-0477-III A Phase 3 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation. III
2024-0711 A Randomized Study of Two Dosing Regimens of Adagrasib in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation II
2023-1000 “Estudio en Fase I de JNJ-86974680, un antagonista del receptor A2a, administrado en monoterapia y en combinación con cetrelimab y radioterapia para Cáncer de pulmón de célula no pequeña.” I
2024-0302 A Phase 1 Study of Intratumoral Delivery of JNJ 87704916 in Combination with Systemic Immunotherapies in Patients with Non-Small Cell Lung Cancers I
2024-0210 “Estudio en Fase I de JNJ-87890387, un anticuerpo biespecífico frente al Miembro 3 de la familia de las Ectonucleótido Pirofosfatasas/Fosfodiesterasas (ENPP3) y CD3 en tumores sólidos avanzados.” I
2025-0238 A Phase I Study of JNJ-89402638, a T-cell Redirecting Agent Targeting GUCY2C, for Advanced Stage Colorectal Cancer I
2025-0865 Phase 3, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma study. III
2020-0900 BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation. III
2024-0647 Resultados del tratamiento con abemaciclib en la práctica clínica real en pacientes con cáncer de mama en estadios tempranos en España: estudio ABSIDE-S IV
2025-0757 A Phase I/IIa Open Label Study of ABX-001 Administered With and Without Anti-PD-1 Checkpoint Inhibitor in Participants With Advanced Solid Tumors I
2024-1033 A randomized, controlled, open-label, phase-III trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high risk, HR+/HER2- early breast cancer III
2022-1114 A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors I
2021-1309-II A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR expressing Cancers I
2025-0518 A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment II
2024-0352 A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti Claudin1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti-PD-1 antibody) in Adult Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma I
2025-0548 A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Squamous Solid Tumors I
2021-1232 “A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6” II
2024-0411 A first-in-human, open-label Phase 1/2 study to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with relapsed/refractory advanced solid tumors I
2023-068-1 feasibility of using Accelerometers to measure Physical Activity in Cancer patients on Early phase clinical trials. A feasibility study evaluating the use of accelerometers to capture physical activity levels in cancer patients on early phase clinical trials PRODUCTO SANITARIO
2024-0415 A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors I
2023-0140 IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination with Pembrolizumab or Standard of Care Chemotherapy in Participants Aged 18 Years or Older with Locally Advanced or Metastatic Solid Tumor Malignancies. I
2024-0292 Newly Diagnosed Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma II
2024-0650 A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PHASE 3 STUDY OF FICLATUZUMAB IN COMBINATION WITH CETUXIMAB IN PARTICIPANTS WITH RECURRENT OR METASTATIC (R/M) HPV-NEGATIVE HEAD AND NECK SQUAMOUS CELL CARCINOMA (FIERCE-HN) III
2022-0439 AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES IV
2024-0820 A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations. III
2022-0370 First-in-human study of BAY2927088 in patients with advanced cancer harboring an EGFR and/or HER2 mutation. I
2024-1084 Basket study of BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations I
2024-1107 First-in-human Phase 1 study of the SOS1 inhibitor BAY 3498264 administered alone and in combination with sotorasib in participants with advanced KRASG12C-mutated solid tumors I
2025-1260 BCA101 “A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma” II
2025-0467 Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Antitumor Activity of a Chimeric Degradation Activating Compound (CDAC) Degrading Epidermal Growth Factor Receptor (EGFR), BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) I
2023-0681 “A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors” I
2025-0076 A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor in Patients With Advanced Solid Tumor I
2023-0240 Phase 1b/2a safety and feasibility study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced (stage IIIb) or metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation II
2024-0495 A multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-B01D1 in subjects with metastatic or unresectable NSCLC I
2022-0460 Observational study evaluating the long-term safety and efficacy of avapritinib in the first-line treatment of patients with platelet-derived growth factor receptor alpha (PDGFRA) D842V mutated gastrointestinal stromal tumour (GIST) IV
2021-1087 Epidemiological study to determine the prevalence of ctDNA positivity in participants with Stage II (high risk) or Stage III CRC after surgery with curative (R0) intent and subsequent adjuvant chemotherapy with monitoring of ctDNA during. IV
2022-0506 First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer. I
2021-0172 A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection. II
2022-0445 “First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors” I
2021-0254 TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL. I
2022-0192 A PHASE IIII, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF BIOMARKER- SELECTED PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NONSMALL CELL LUNG CANCER, III
2025-0313 A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF BIOMARKER-SELECTED PATIENTS FOLLOWING CURATIVE INTENT RESECTION FOR NON-SMALL CELL LUNG CANCER . II
2023-0740 A phase Ib/II, open-label, multicenter study evaluating the safety, activity, and pharmacokinetics of GDC-6036 in combination with other anti-cancer therapies in patients with previously untreated advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation I
2024-0714 estudio con Divarasib, el farmaco KRAS de Roche, en comparación con otro fármaco KRAS G12C, en segunda línea tras fallo a IO+CT en pacientes KRAS+. II
2024-0713 ESTUDIO MULTICÉNTRICO ALEATORIZADO FASE II, DOBLE CIEGO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE AUTOGENE CEVUMERAN MÁS NIVOLUMAB FRENTE A NIVOLUMAB COMO TRATAMIENTO ADYUVANTE EN PACIENTES CON CARCINOMA UROTELIAL MÚSCULO INVASIVO DE ALTO RIESGO II
2025-1097 Estudio de fase II multicéntrico, abierto para evaluar la seguridad y la eficacia del tratamiento neoadyuvante con combinaciones de inavolisib en pacientes con cáncer de mama en estadio precoz con mutación PIK3CA, no tratado II
2023-1068 AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF RO7616789 IN PARTICIPANTS WITH ADVANCED SMALL CELL LUNG CANCER AND OTHER NEUROENDOCRINE CARCINOMAS I
2023-1030 A Phase I, open-label study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7589831 in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) I
2024-0979 AN OPEN-LABEL, MULTICENTER, DOSEESCALATION, RANDOMIZED, PHASE I STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF RO7567132 AS SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS I
2021-0708 Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression. I
2021-0261 Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies. I
2023-1059 "Phase III Trial of Docetaxel vs. Docetaxel and Radium‐223 for Metastatic Castration‐Resistant Prostate Cancer (mCRPC)" III
2018-0975 A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL). I
2025-1154 A Low-Interventional Study to Assess Physical Activity using Digital Health Technology in Adult Participants with Cachexia and Receiving or will be Receiving First-Line Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma PRODUCTO SANITARIO
2022-0795 "AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE C4221009 (ARRAY-818-302, BEACON) AND W00090 GE 2 01 (ANCHOR CRC) ENCORAFENIB BINIMETINIB AND CETUXIMAB STUDIES" IV
2025-0394 An interventional, open-label, randomized, multicenter phase 3 study of PF-07220060 plus letrozole compared to CDK4/6 inhibitor plus letrozole in participants over 18 years with hormone receptor (HR)-positive, HER2-negative advanced/metastatic breast cancer who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease III
2024-0894 Phase 2 Breast Cancer study and currently looking to identify qualified sites for this study to evaluate the biological activity of highly selective CDK4i (PF-07220060) plus letrozole and other anticancer treatments. II
2024-0489-II AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER II
2024-0503 "A randomized, phase 3, open-label study to evaluate SGN-B6A compared with docetaxel in adult subjects with previously treated non-small cell lung cancer with or without actionable genomic alterations" III
2025-0755 A Study to Learn About the Study Medicine Called Sigvotatug Vedotin in People with Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer with High Levels of PD-L1 III
2025-0535 AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS I
2025-0412 AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046032 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES I
2023-0512 A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab in Participants with Advanced Solid Tumors I
2025-0452 A Phase 3, Two-stage part, Randomized, Open-label, Adaptive Study Comparing the Efficacy and Safety of BMS-986365 versus a Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC). III
2023-1137 Randomized, Open-label, Multicenter Phase III Trial to Compare the Efficacy and Safety of Repotrectinib and Crizotinib in Participants with Locally Advanced or Metastatic TKInaïve ROS1 Positive NSCLC III
2020-0957 Pan Tumor Study for Long Term Follow-up of Cancer Survivors who have participated in Trials investigating Nivolumab. IV
2024-1063 A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Stage IV or Recurrent Non-squamous Non-small Cell Lung Cancer III
2025-0519 A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Non‐squamous Histology and KRAS G12C Mutation III
2025-0854 A Phase 2 Trial of BMS-986504 in Participants with Advanced and or Metastatic Non-Small Cell Lung Cancer with Homozygous MTAP Deletion After Progression on Prior Therapies II
2025-0310 A Phase 1/2a, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BMS-986507-01 (BL-B01D1) combinations in adult participants with advanced lung cancers I
2025-0930 "A Randomized, open-label, phase 3 study of BL-B01D1 (BMS-986507) versus treatment of physician's choice in patients with previously untreated, locally advanced, recurrent inoperable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for approved anti-PD1/PD-L1 with chemotherapy combination." III
2022-0237 A Phase Ib Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide and Tislelizumab in Induction and with Tislelizumab in Maintenance Treatment Phase. I
2022-0241 A Phase Ib Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Radiotherapy with or without Temozolomide and in Recurrent Glioblastoma as Single Agent. I
2025-0941 A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET (NETTER-3) III
2022-0337 A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Whole-body Distribution, Radiation Dosimetry and Anti-tumor Activity of [177Lu]-NeoB Administered in Patients With Advanced Solid Tumors Known to Overexpress Gastrin-releasing Peptide Receptor (GRPR). I
2025-0525 “Estudio de fase Ib de búsqueda de dosis en el que se evalúan la seguridad y la actividad de [177Lu]Lu-NeoB en combinación con ribociclib y fulvestrant en participantes con cáncer de mama avanzado receptor de estrógenos positivo, receptor 2 del factor de crecimiento epidérmico humano negativo y receptor del péptido liberador de gastrina positivo que hayan presentado una recidiva temprana con la terapia endocrina (neo)adyuvante o que hayan progresado con la terapia endocrina en combinación co I
2025-1221 Estudio de fase II multicéntrico, internacional, aleatorizado, prospectivo, abierto y no comparativo de lutecio [177Lu] vipivotida tetraxetano (AAA617) en monoterapia y lutecio [177Lu] vipivotida tetraxetano (AAA617) en combinación con inhibidores de la vía del receptor androgénico en pacientes con cáncer de próstata resistente a la castración con PET-PSMA positivo  (PSMACare II
2025-1124 CAPRI-3 study: Phase 3 clinical study to evaluate the use of continuing cetuximab treatment beyond first line progression in molecular selected metastatic colorectal cancer patients II
2024-1116 Phase 1, Modular, First-in-Human Study to Assess the Safety, Tolerability and Antitumor Activity of CDR404 in HLA-A*02:01+ Participants with MAGE-A4 Positive Solid Tumors I
2017-0857 An open label, multi-center roll-over study to assess longterm safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment. IV
2025-1050 Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/​HER2- Breast Cancer and Other Advanced Solid Tumors I
2023-1021 A Phase 1/2 Open-Label, Multicenter, Global Trial to Characterize the Safety, Tolerability and Preliminary Efficacy of CFT1946 as Monotherapy and in Combination with Trametinib in Subjects with BRAF-V600 Mutant Solid Tumors. I
2024-0282 A randomized, double-blind, parallel-group study to compare pharmacokinetics of GME751 (proposed pembrolizumab biosimilar) and US-licensed and EU-authorized Keytruda® in participants with stage II and III melanoma requiring adjuvant treatment with pembrolizumab I
2024-0720 A randomized, double-blind, parallel-group study of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda® in adult participants with untreated unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). III
2025-1094 An open-label, multi-center, single arm, rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies IV
VHIO-0021 "ESTUDIO OBSERVACIONAL, MULTICÉNTRICO, RETROSPECTIVO Y PROSPECTIVO, PARA EVALUAR LA EFECTIVIDAD Y SEGURIDAD DE LA INMUNOTERAPIA EN PACIENTES CON CÁNCER Y ENFERMEDADES INFLAMATORIAS INMUNOMEDIADAS" IV
2023-0699 “Estudio de fase I/Ib, multicéntrico, abierto y de búsqueda y expansión de dosis de HRO761, en monoterapia y en combinación, en pacientes con tumores sólidos avanzados con inestabilidad de microsatélites alta o con alteración del sistema de reparación de errores de replicación” I
2021-0833 “Estudio de fase I, multicéntrico y abierto de IAG933 oral en pacientes adultos con mesotelioma avanzado y otros tumores sólidos” I
2022-0253 Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA. II
2025-1078 A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adults with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) II
2023-0662 A phase I, open-label, multi-center study of KFA115 as a single agent and in combination with tislelizumab in patients with select advanced cancers I
2024-0839 "Phase 1b/2 trial of S095029 and pembrolizumab in MSI-H/dMMR locally advanced unresectable or metastatic CRC and S095029, pembrolizumab and trastuzumab in HER2- positive locally advanced unresectable or metastatic GEJ and GA" I
2025-1156 Fase I/II para evaluar la seguridad, tolerancia, farmacocinética y actividad preliminar de S95035 (un inhibidor de MTA2A) en monoterapia y también en combinación con taxanos en pacientes previamente tratados con tumores sólidos avanzados o metastásicos con supresión homocigota MTAP y/o falta de expresión de MTAP. I
2025-0284 A phase 3, multicenter, double blind, randomized, placebo[1]controlled study of ivosidenib in subjects ≥ 18 years of age with unresectable or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 prior systemic treatment regimen III
2025-0806 ESTUDIO DESCRIPTIVO DE LA EVOLUCIÓN EN EL DIAGNÓSTICO Y TRATAMIENTO DE PACIENTES CON CÁNCER MICROCÍTICO DE PULMÓN EN ESPAÑA IV
2024-0410 An open-label, phase I/IIa first-in-human, dose escalation and cohort expansion study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and anti-tumour activity of ERK1/2 inhibitor IPN01194 as single agent in participants with advanced solid tumours I
2025-0327 “An open‐label, phase I/II  first‐in‐human, dose escalation and confirmation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic  and  anti‐tumour  activity  of  IPN01195  as  single  agent  in  adult participants with advanced solid tumours” I
2022-0493 Estudio de fase I, abierto, de escalada de dosis y expansión de MGY825 en pacientes adultos con cáncer de pulmón de células no pequeñas en estadio avanzado I
2018-0398 "A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE NEGATIVE BREAST CANCER (MORPHEUS TNBC)" I
2021-0596 "A PHASE IB, OPEN-LABEL, DOSE-ESCALATION AND DOSEEXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF INAVOLISIB IN COMBINATION WITH PACLITAXEL AND WITH OR WITHOUT TARGETED THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS". I
2021-0317 Phase 1b/II umbrella, adaptive design study The first cohort of the new Breast Cancer study will target 2L or 3L metastatic or inoperable locally advanced ER+ Breast Cancer patients who had disease progression during or following treatment with a CDK4/6i. I
2023-1038 A PHASE III RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY. III
2022-0865 A multicenter, Phase II, open label, randomized trial evaluating the efficacy of Tedopi plus docetaxel or Tedopi plus nivolumab as second-line therapy in metastatic non-small-cell lung cancer progressing after first-line chemo-immunotherapy (Combi-TED) II
2025-0619 "A Phase 2 Study of Relacorilant in Combination with Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (BELLA)" II
2019-0678 An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments. IV
2024-0914 A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that are Antigen-rich (START-001) I
2024-1193 “A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients with Advanced Solid Tumors” I
2025-0786 A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults with Carcinoid Syndrome due to Well-Differentiated Neuroendocrine Tumors II
2025-0288 "A CANCER RESEARCH UK PHASE II OPEN LABEL TRIAL IN PARTICIPANTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA OF GINISORTAMAB GIVEN INTRAVENOUSLY I) WITH FIRST-LINE STANDARD OF CARE NAB-PACLITAXEL AND GEMCITABINE, OR II) IN COMBINATION WITH MEK INHIBITOR MAINTENANCE THERAPY " II
2024-1065 A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-01 as Monotherapy and Combination Therapy in Subjects with Intermediate or Advanced Hepatocellular Carcinoma (BCLC Stage B or C) with Preserved Liver Function (Child-Pugh Class A) I
2023-1079 “A Phase 1b/2 Open-label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer” I
2021-1149 A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF FADRACICLIB (CYC065), AN ORAL CDK2/9 INHIBITOR, IN SUBJECTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA. I
2024-1192 "A Phase IIIB study to evaluate the use of capivasertib in combination with fulvestrant in patients with HR+ / HER2- advanced breast cancer who have relapsed/progressed on ET and CDK4/6 inhibitor reflecting Real World Clinical Practice in Spain." III
2024-1153 A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer. III
2024-1106 "A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation" I
2023-1111 A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers III
2025-0421 An Observational Multi-center study to Evaluate Real-World Treatment Outcomes of Durvalumab-based Regimens in Hepatobiliary Cancers IV
2025-0876 "A phase IIIb study of durvalumab as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent or sequential chemoradiation therapy in Spain" III
2022-0668 A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON) III
2024-0372 A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies I
2021-1305 A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer. I
2024-0463 A Phase III, Randomized, Double-Blind, Placebo-Controlled, International Study of AZD2936 in combination with Physicians' Choice of Chemotherapy as Adjuvant Treatment for Biliary Tract Cancer (ARTEMIDE-Biliary) III
2025-0483 A Randomized, Phase 3 Study of Trastuzumab Deruxtecan in Combination with Fluoropyrimidine and Rilvegostomig versus Trastuzumab, Chemotherapy and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer III
2025-0239 A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 III
2025-0207 “Estudio fase III aleatorizado, doble ciego, multicéntrico, internacional de rilvegostomig o pembrolizumab en combinación con quimioterapia basada en platino para el tratamiento en primera línea de cáncer de pulmón no microcítico no escamoso metastásico con expresión de PD-L1” (ARTEMIDE-Lung 03)” III
2025-0565 A Phase I/IIa Multi-Center Global Open-Label Modular Dose Exploration, Optimization and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD0022 as Monotherapy and in Combination with Anti-cancer Agents in Participants Harbouring a KRASG12D Mutation I
2024-1098 A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) in combination with Durvalumab compared with Pembrolizumab in combination with Investigator’s Choice of Chemotherapy (Paclitaxel/Nab-paclitaxel/Gemcitabine+Carboplatin) in Patients with PDL1 positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPIONBreast05) III
2025-0436 A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women with High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy III
2023-0416 An Open-Label, Multi-Drug, Multi-Centre, Phase II Platform Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma II
2024-0451 A Phase III, Open-label, Randomised Study of MEDI 5752 in combination with Platinum-Pemetrexed Chemotherapy Versus Investigator’s Choice of Platinum-Pemetrexed Chemotherapy or Nivolumab + Ipilimumab in Unresectable Malignant Pleural Mesothelioma III
2024-0818 A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced-Head and Neck Squamous Cell Carcinoma Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC) III
2025-0481 A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants with Colorectal Cancer (CANTOR) II
2022-0706 "A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)" I
2024-0377 A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants with Selected Advanced or Metastatic Solid Tumors (CYCAD-1) I
2023-1035 A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Switching to AZD9833 (a Next Generation, Oral SERD) vs Continuing Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in patients with HR+/HER2- early breast cancer and an intermediate or high risk of recurrence who have completed definitive locoregional therapy and at least 2 years of adjuvant endocrine therapy without disease recurrence III
2023-0904 A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as adjuvant treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease III
2025-0566 A Multicentre, Open-Label Study Assessing Ophthalmic Safety of Camizestrant in ER+/HER2- Early Breast Cancer Patients Either Initiating Adjuvant Endocrine-Based Therapy (CAMBRIA-2) or Having Been Treated with Standard Adjuvant Endocrine-Based Therapy for At Least 2 Years (CAMBRIA-1). IV
2024-0405 A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors I
2022-0707 "Phase 2 open-label trial of neoadjuvant and adjuvant treatment in Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer." II
2022-0345 A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9) III
2021-0957 A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA). III
2022-1010-6 A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03) I
2022-1010-1 A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03) I
2022-1010-2 A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03) I
2022-1010-4 A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03) I
2022-1010-3 A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03) I
2025-0289 “Estudio de fase IIIb para evaluar el uso de durvalumab en combinación con quimioterapia basada en platino seguido de durvalumab con olaparib como tratamiento de primera línea en pacientes con cáncer de endometrio avanzado de nuevo diagnóstico o recurrente con estado de MMR competente en España” III
2023-0649 A Modular Phase 1, Open-label, Dose-escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Tumors I
2021-0542 A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, anti-TIM-3 and anti PD-1 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors . I
2020-0714 A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Doseexpansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2-Overexpressing Gastric Cancer (DESTINY-Gastric03). I
2020-0714-II A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Doseexpansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2-Overexpressing Gastric Cancer (DESTINY-Gastric03). I
2021-0136 Phase 2, Multicentre, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors . I
2021-0093 A Modular Phase I/IIa, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5305 monotherapy and in combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies. I
2023-0452 An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of AZD5305 Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy In Men with Newly Diagnosed Prostate Cancer (ASCERTAIN) I
2024-0916 A Randomised, Open-Label, Phase III Study of AZD5305 Plus Camizestrant versus Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy for the First-Line Treatment of BRCA1, BRCA2 or PALB2- mutated Patients with Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer III
2024-0566 A Randomised, Double-blind, Placebo-Controlled, Phase III Study of AZD5305 in Combination with Physician's Choice New Hormonal Agents in Participants with Metastatic Castration-Sensitive Prostate Cancer with and without HRRm III
2025-0710 A Phase I/II Study Master Protocol to Investigate Biomarker-Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants with Advanced/Metastatic Ovarian Cancer (Ovarian Platform) I
2024-0959 An Open Label, Phase 2a Study of AZD0901 as Monotherapy or in Combination with Anti-cancer Agents in Participants with advanced or metastatic solid tumors expressing Claudin 18.2 II
2025-0449 A Randomized, Multicenter, Registrational Phase 3 Study of AZD0901 monotherapy vs SOC in subjects with 2L+ advanced or metastatic gastric or gastroesophageal junction cancer expressing CLDN18.2 III
2025-1068 A Master Protocol for an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Novel Combinations as Neoadjuvant and Adjuvant Treatment in Participants with Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma" II
2024-0526 A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours That are MTAP Deficient I
2024-0397 A Phase 1 Open-Label Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a Sensitive CYP3A Probe Substrate (Midazolam) in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) I
2023-0538 “An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT)” III
2020-0504 A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors. I
2024-0242 Phase 1 dose expansion study of Debio 0123, a highly selective and potent Wee1 inhibitor, as monotherapy in patients with advanced solid tumors who have previously been treated with standard therapy or for which standard of care therapy is not suitable. I
2023-0333 Multi-center, open-label, non-randomized, uncontrolled, dose-escalation study of Debio 0123 in combination with carboplatin and etoposide in adult participants with small cell lung cancer that recurred or progressed after previous standard platinum-based therapy, followed by an expansion in adult participants with small cell lung cancer that recurred or progressed after previous standard platinum-based therapy. I
2023-0462 A phase 1/2 open label study of Debio 0123 in combination with temozolomide in adult participants with recurrent glioblastoma, and Debio 0123 in combination with temozolomide and radiotherapy in adult participants with newly diagnosed glioblastoma I
VHIO-0025 "Decision for or against Anti-PD-1 Treatment In Adjuvant Setting of Patients across Europe with Resected Stage IIB/IIC Melanoma" IV
2021-1019 A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications I
2022-0758 A randomised phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cáncer II
2022-0892 A prospective, randomised, Controlled, Open-label, Multicentre study to evaluate efficacy, safety and Patient Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to best Standard of care in patients with well-differentiated aggressive Grade 2 and Grade 3, somatostatin receptor positive (SSTR+), neuroendocrine tumours of gastroEnteric or pancreatic origin III
2023-0597 A Randomized  Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung07) III
2022-0495 A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-Small Cell Lung Cancer without Actionable Genomic Alterations (Tropion-LUNG08) III
2024-0070 A PHASE 1, 2-PART, MULTICENTER,  FIRST-IN-HUMAN DOSE-ESCALATION AND DOSE-EXPANSION STUDY OF DS-1103A COMBINATION THERAPY IN SUBJECTS WITH ADVANCED SOLID TUMORS (DS-1103A COMBINATION THERAPY FIRST-INHUMAN STUDY) I
2025-0864 A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination with Deruxtecan Antibody-drug Conjugates in Subjects with Solid Tumors I
2025-0320 PHASE 1/2, OPEN-LABEL, MULTICENTER, FIRST-IN HUMAN STUDY OF DS-3939a IN SUBJECTS WITH  ADVANCED SOLID TUMORS I
2025-0130 A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants with Advanced/Metastatic Solid Tumors. I
2024-0961 A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice (TPC) in Subjects with Relapsed Small Cell Lung Cancer (SCLC) (IDeate-2) III
2024-1096 A PHASE 1B/2, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD), A B7-H3 ANTIBODY DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER (ES SCLC) II
2025-0629 A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH PRETREATED UNRESECTABLE/METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) III
2025-0290 A PHASE 2 PAN-TUMOR, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH RECURRENT OR METASTATIC SOLID TUMORS I
2025-1085 A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF TRASTUZUMAB DERUXTECAN (ENHERTU®) PLUS CHEMOTHERAPY PLUS OR MINUS PEMBROLIZUMAB VERSUS CHEMOTHERAPY PLUS TRASTUZUMAB PLUS OR MINUS PEMBROLIZUMAB AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) CANCER (DESTINY-GASTRIC05) (TRIAL OF TRASTUZUMAB DERUXTECAN (ENHERTU®) PLUS CHEMOTHERAPY PLUS OR MINUS PEMBROLIZUMAB VERSUS  CHEMOTHERAPY PLUS TRASTUZU III
2025-0958 A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy as First line Maintenance Therapy in HER2 Expressing Ovarian Cancer III
2024-0941 Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy or in Combination with Anti-Cancer Agents in Participants with Advanced Malignancies I
2023-0259 A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation. III
2025-0409 An Open-Label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors (EXPANSION COHORT ONLY) II
2025-0883 “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma,” PRODUCTO SANITARIO
2024-1034 “FIRST-IN-HUMAN PHASE 1/2 TRIAL OF EGL-001 IN ADULT PATIENTS WITH SELECTED ADVANCED AND/OR METASTATIC SOLID TUMORS” I
2025-0536 A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma II
2025-0466 “A first in-human, Phase 1/2, open￾label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, as monotherapy and in combination in patients with advanced solid tumors” I
2024-0590 An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer (ELECTRA) II
2024-0230 "A Phase 1a/1b Study of ELVN-002 for the Treatment of HER2 mutant or HER2 amplified solid tumors" I
2024-0679 "A Phase 1a/1b Study of ELVN-002 Combined with Trastuzumab in Advanced Stage HER2+ Solid tumors, and ELVN-002 Combined with Trastuzumab and Chemotherapy in Advanced Stage HER2+ Breast Cancer or Colorectal Cancer" I
2025-0247 “Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck : a randomized phase III study (PROLoNg)” III
2025-0712 177Lu-DOTATATE for recurrent MENingioma: a randomized phase II study II
2022-1050 A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies I
2024-1102 A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer I
2025-0851 Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 monotherapy in Subjects with Advanced Solid Tumors I
2024-1167 A randomized, open-label Phase III study in patients with previously treated unresectable or metastatic NRAS mutant cutaneous melanoma comparing the combination of naporafenib + trametinib to physician’s choice of therapy (dacarbazine, temozolomide or trametinib monotherapy) with a dose optimization lead-in III
2022-0603 Single cell characterization of persistent cells upon treatment with durvalumab (MEDI4736) with or without Tremelimumab in MSS and MSI colorectal and endometrial tumors: the SERPENTINE clinical trial I
2023-0153 Non‐Randomized, Open‐Label, Prospective Phase II Trial to Better Characterize the Status of HRD leading to a Benefit from Olaparib in Combination with Bevacizumab in Patients with Advanced FIGO Stage III‐IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer After Standard First‐Line Treatment II
2021-0233 A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy and stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the primary tumour, in patients with synchronous oligo-etastatic nonsmall cell lung cancer. II
VHIO-0023 A multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligo-symptomatic brain metastases III
VHIO-0029 ETOP LUNGSCOPE IV
2021-0658 Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”). II
2025-053-1 EUonQoL IV
2024-0865 "First-In-Human Phase 1/2 open-label trial to assess safety and efficacy of STX-241 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) resistant to third generation EGFR tyrosine kinase inhibitors (TKIs)" I
2024-0432 F8394-201"A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF class 1 and class 2 alterations, in participants with cancer harboring BRAF alterations • Sub Protocol A: Solid tumors with BRAF fusion (excluding colorectal cancer or pancreatic ductal adenocarcinoma) • Sub Protocol B: High-grade gliomas with BRAF fusions or V600 mutation • Sub Protocol C: Colorectal Cancer with V600 or Class 2 mutations in combination with an EGFRi Ab • Sub Protocol D: c I
2020-0851 A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects with Advanced Malignancies. I
2023-0532 A global, phase 3, randomized, multicenter, open-label study to investigate the efficacy  and safety of furmonertinib compared to  platinum-based chemotherapy as first-line  treatment for patients with locally  advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations III
2025-0500 A randomized, open-label, phase II trial comparing neoadjuvant endocrinetherapy in combination with trastuzumab, pertuzumab +/- the PI3K inhibitor inavolisib in patients with HER2-positive, HR-positive, PIK3CA mutant earlybreast cancer- GeparPiPPa II
2025-0414 A Prospective, Open-label, Randomized, Parallel-group, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06) III
2024-0478 First-In-Human, Open-Label, Dose Escalation Trial with Expansion Cohorts to  Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy With a PD-1 Inhibitor in Subjects With Malignant Solid Tumors I
2025-0077 “A First-In-Human, Open-Label, Dose Escalation Trial to Evaluate the Safety and Preliminary Efficacy of GEN1057 in Subjects with Malignant Solid Tumors I
2025-0162 First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1078 in subjects with malignant solid tumors I
2022-1056 A Phase II study of pembrolizumab, lenvatinib and chemotherapy combination in first line extensive-stage small cell lung cancer (ES-SCLC) II
2022-0284 PHASE II CLINICAL TRIAL OF AMG510 (SOTORASIB) IN STAGE III UNRESECTABLE NSCLC KRAS p.G12C PATIENTS AND MEDICALLY INELIGIBLE FOR CONCURRENT CHEMO-RADIOTHERAPY II
VHIO-0015 Study of ctDNA as prognostic factor on resectable stage IIIA NSCLC patients treated with neoadjuvant treatment in real world IV
2025-0468 Phase II clinical trial with an adaptive design according to response to cemiplimab monotherapy using ctDNA and subsequent treatment with chemotherapy (CT) and cemiplimab or cemiplimab monotherapy in first line advanced NSCLC patients II
2023-0334 Phase II clinical trial of Neo-adjuvant chemo/immunotherapy followed by adjuvant treatment depending on the resection status for the treatment of NSCLC patients diagnosed with pancoast tumor. A multicenter exploratory study II
2025-0655 Phase II clinical trial of chemotherapy +Atezolizumab + Tiragolumab for stage IIIA and IIIB non-small cell lung cancer followed by Atezolizumab + Tiragolumab treatment after surgery or chemoradiotherapy II
2024-1044 "A PHASE III CLINICAL TRIAL OF ADJUVANT TREATMENT WITH SACITUZUMAB AND ZIMBERELIMAB FOR STAGE IB-IIIA-IIIB(N2) PREVIOUSLY RESECTED (R0) NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS THAT DID NOT ACHIEVE PATHOLOGICAL COMPLETE RESPONSE AFTER NEOADJUVANT TREATMENT" III
2024-0955 Study of antitumor immune response generated after concurrent chemo-radiotherapy (cCRT) and IO treatment in non-resectable stage IIIA/B and IIIC NSCLC patients treated in real world IV
2022-0674 Exploración de reordenamiento génico NTRK 1/2/3 en GIST y sarcoma de hueso. GIBOTREK IV
VHIO-0024 Estudio observacional para la exploración de reordenamiento de genes NTRK1/2/3 en Sarcomas de Partes Blandas localmente avanzados o metastásicos IV
2021-0551 Phase II multicohort trial of trabectedin and low-dose radiation therapy in advanced/metastatic sarcomas (SYNERGIAS). II
2022-0637 Phase Ib/II multicohort trial of different schemes of PM14 in monotherapy and in combination with radiotherapy in soft tissue sarcomas and other solid tumors. I
2021-1256 Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma treated in real life in Spain: a multi-centric, retrospective and non-interventional study. (BECARE). IV
2018-0566 ESTUDIO OBSERVACIONAL DESCRIPTIVO SOBRE LAS CARACTERÍSTICAS DEL MELANOMA AVANZADO Y METASTÁSICO EN ESPAÑA. IV
2025-0480 ENcorafenib and BINImetinib followed by Cemiplimad and FiAnLimab in patients with BRAF mutant melanOma and symptomatic brain metastasies II
2025-0445 A PHASE II, OPEN-LABEL, MULTICENTER, NON-RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB PREVIOUSLY TREATED ADVANCED MELANOMA II
2022-0693 Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC) - PEMBROLA II
2024-1194 Análisis retrospectivo de la experiencia con Larotrectinib en pacientes con neoplasias sólidas con fusión NTRK en España (SPAINTRK) IV
2025-0255 un estudio Fase II, multicéntrico, abierto, de un solo brazo para evaluar la eficacia y seguridad de Enfortumab Vedotina como agente único en pacientes con tumores neuroendocrinos G3 o carcinomas neuroendocrinos avanzados, refractarios o no elegibles para quimioterapia con platino, cuyo inicio está previsto en diciembre de 2024. II
2025-0520 Randomized Interval Assessment trial of Lu177-Dotatate every 8 versus every 16 weeks in slowly progressive G1-2 advanced midgut neuroendocrine tumors (NETs) to Lower Toxicity II
2023-0634 Efficacy, safety and patient-reported outcomes of peptide receptor radionuclide therapy with 177Lu-edotreotide compared to everolimus in somatostatin receptor positive neuroendocrine tumors of the lung and thymus. The LEVEL Trial III
2024-0269 Estudio de fase II, multicéntrico, abierto, de dos cohortes, de un solo brazo, para evaluar la eficacia y la seguridad del anticuerpo-fármaco conjugado anti-TROP2 sacituzumab govitecan en pacientes con neoplasias tiroideas anaplásicas y diferenciadas avanzadas. II
2023-0291 A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS I
2024-0690 A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS mFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA II
2023-0843 A PHASE I, OPEN-LABEL, MULTICENTER, DOSEESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7656594 IN PATIENTS WITH ADVANCED OR METASTATIC PROSTATE CANCER I
2025-0372 Ph1a/b open-label, multicenter, dose escalation/expansion study in solid tumors evaluating RO7759065 as a single agent and in combination with atezolizumab I
2025-0267 A PHASE I/II DOSE-ESCALATION AND DOSE-EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC 7035 IN PATIENTS WITH ADVANCED SOLID TUMORS WITH A KRAS G12D MUTATION I
2020-1010 A phase III randomized trial of post-operative adjuvant nivolumab and concomitant chemo-radiotherapy in high-risk patients with resected squamous cell carcinoma of head and neck (SCCHN). III
2023-1032 “A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination with Anticancer Treatments in Patients with Solid Malignancies” I
2024-0559 A retrospective, observational and multicenter study of treatment with Sacituzumab govitecan in patients with locally advanced and/or metastatic triplenegative breast cancer within routine clinical practice in Spain IV
2024-0449 A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti–PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors I
2025-0807 Estudio internacional, multicéntrico, aleatorizado, abierto, de fase III de sacituzumab govitecan frente al tratamiento estándar en participantes con cáncer de pulmón de células pequeñas en estadio extendido (CPCP-ES) previamente tratado. III
2023-0680 "A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination with an Anti-PD-1 Monoclonal Antibody in Adults with Advanced Solid Tumors" I
2022-1166 "A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations" III
2022-0346 A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients with Advanced Solid Tumors. I
2025-0939 “A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations” I
2019-0975 A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer. III
2019-1012 A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study). I
2023-0679 "An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors" I
2023-0223 FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST) I
2023-0769 "A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers" I
2024-0589 A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA A*02:01-Positive Participants With Previously Untreated Advanced Melanoma III
2024-0205 “Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)" II
2024-1005 A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC P115 C as a Single Agent and in Combination with Standard of Care Agents in HLA A*02:01 Positive Participants with Advanced PRAME Positive Cancers I
2024-0471 A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants with Selected Advanced PIWIL1-Positive Cancers I
2025-0124 "A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (anti-FRα antibody-drug conjugate) in Adult Patients with Recurrent Endometrial Cancer and Recurrent, High-Grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers" I
2023-0914 Randomized, multicenter, open-label, phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second line platinum-based chemotherapy plus bevacizumab III
2024-1145 A randomized Phase 2 study of ocular toxicity evalutation and mitigation during treatment wiht Mirvetuximab Soravtansine in patients with recurrent ovarian cancer with high Folate Receptor-Alpha Expression II
2025-0595 A randomized Phase 2, open-label study of mirvetuximab soravtansine in patients with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression testing 2 schedules of administration for dose optimization, with a separate cohort to determine starting dose in patients with moderate hepatic impairment. II
2023-0161-I A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer -cohorte 7 I
2023-0844 A Phase 1, Open-Label, Multicenter Study of INCA033890 as Monotherapy in Participants With advanced or metastatic Solid Tumors I
2024-0913 Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors with KRAS G12D Mutation. I
2022-0676 A phase I trial evaluating the safety, tolerability and pharmacokinetic profile of INP12 in patients with advanced solid tumors I
2024-0290 Phase 3, multicenter, randomized, open-label, parallel group treatment study to assess the efficacy and safety of lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma. III
2024-0934 A Multicenter, Randomized, Phase III Study to Assess the Efficacy and Safety of Intratumorally Administered INT230-6 (VINblastine, CIsplatin) compared with Standard of Care in Adult SuBjects with Locally REcurrent, Inoperable or Metastatic Soft Tissue Sarcomas – (The INVINCIBLE-3 Trial) III
2022-1098 A Phase I/Ib, Open-label, Multicentre, Multiple Ascending Doses Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral ITF3756 as Monotherapy and in Combination with an Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Agent in Patients with Advanced Solid Tumors I
2025-0309 A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma III
2021-0818 A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC. III
2023-0518 A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence III
2024-0310 Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression III
2025-0362 "A Phase 3, Multi-center, Double-blind, 2-part Study in Participants with KRAS G12C-Mutant, Non-Small Cell Lung Cancer Comparing the Efficacy and Safety of Olomorasib in Combination with Standard of Care to Placebo in Combination with Standard of Care as Adjuvant Treatment after Platinum-based Chemotherapy" III
2024-1108 Phase 1a/1b Study of LY3962673 in Patients with KRAS G12D-Mutant Solid Tumor I
2025-0392 "A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with KRAS Mutant Solid Tumors" I
2025-0766 A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants with Selected Advanced Solid Tumors I
2024-1091 A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients with Unresectable Locally Advanced or Metastatic Cancer I
2022-0489 "A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein targeting CTLA-4, in Patients with Unresectable Locally Advanced or Metastatic Cancer" I
2025-0393 A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy III
2024-0712 An open-label randomized trial of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2‑positive biliary tract cancer (BTC) III
2024-0887 A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment III
2025-0196 Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients with Advanced Solid Tumors I
2025-0159 A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Malignancies I
2024-0699 “Phase I, first-in human, open-label, dose escalation and cohort expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumour activity of LB-208 (HTR1B antagonist) in adult patients with relapsed or refractory solid tumours and lymphoma” I
2024-0067 A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF NILK-2301, A BISPECIFIC CEACAM5 x CD3 ENGAGING NTIBODY, IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC LOW TUMOR VOLUME COLORECTAL CANCER I
2025-0733 “A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF NI-1801, A BISPECIFIC MESOTHELIN x CD47 ENGAGING ANTIBODY, AS A SINGLE AGENT, IN COMBINATION WITH ANTI-PD-1 ANTIBODY, AND IN COMBINATION WITH WEEKLY PACLITAXEL (STANDARD OF CARE) IN PATIENTS WITH MESOTHELIN - EXPRESSING OVARIAN, PANCREATIC, NON-SMALL CELL LUNG AND TRIPLE-NEGATIVE BREAST CANCERS” I
2024-0752 A PHASE I STUDY OF THE CEACAM5 x CD47 ANTIBODY NILK2401 AS SINGLE AGENT OR IN COMBINATION WITH ANTI-PD-1 ANTIBODY IN SOLID CANCERS I
2024-0879 “A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants with Recurrent, Advanced or Metastatic Solid Tumors” I
2024-0852 "A first-in-Human, Phase 1a/1b Trial to assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an AntibodyDrug Conjugate T -Expressing Tumor Cells, in Participants with Selected Advanced Solid Tumors" I
2018-0358 "A Phase 1 Study of Oral LOXO-292 in Adult Patients with Advanced Solid Tumors, Including RET-Fusion Non-Small Cell Lung Cancer, Medularry Thyroid Cancer, and Other Tunors with Increased RET Activity". I
2024-0819 Estudio fase 1, el primero en seres humanos, multicéntrico y abierto con escalado de dosis para determinar la seguridad, tolerabilidad, farmacocinética y dosis recomendada para la fase 2 de LIVMONIPLIMAB (ABBV-151) en monoterapia y en combinación con BUDIGALIMAB (ABBV-181) en sujetos con tumores sólidos localmente avanzados o metastásicos I
2023-0366 A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors I
2024-0226 A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors. I
2024-0754 A Randomized, Phase 2/3 Study to Evaluate the Optimized Dose, Safety and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in untreated metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) II
2024-0222 A Phase 2/3, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in subjects with Locally Advanced or Metastatic  Hepatocellular Carcinoma (HCC) who have not previously received systemic treatment II
2024-0745 A Phase 2, Randomized Study to Evaluate the Safety, Efficacy and Optimal dose of ADC drug in Combination with Fluorouracil (5-FU), Folinic Acid and Bevacizumab in Previously Treated Subjects with unresectable Metastatic Colorectal Cancer (mCRC) II
2025-0543 A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with ABBV-400 in Subjects with Metastatic Colorectal Cancer II
2025-0632 A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer I
2024-1189 A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination with Budigalimab Versus Chemotherapy in Subjects with Metastatic Urothelial Carcinoma II
2022-0496 “Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors” I
2018-0267 Phase 1 dose escalation and cohort expansion study evaluating single-agent MCLA-158 in metastatic colorectal cancer and other advanced solid tumors. I
2024-0614 “A phase III open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma.” III
2025-0299 “A phase III randomized, open label study to evaluate the efficacy and safety of Petosemtamab plus Pembrolizumab vs. Pembrolizumab in head and neck squamous cell carcinoma in the first line treatment of PD-L1+ (CPS≥1) metastatic/recurrent disease without curative therapy available.” III
2023-0830 PHASE II STUDY FOR PIK3CA/PTEN-ALTERED ADVANCED METAPLASTIC BREAST CANCER TREATED WITH MEN1611 MONOTHERAPY OR IN COMBINATION WITH ERIBULIN. II
2025-0072 A randomized phase 3, double-blind, placebo-controlled study of elacestrant plus everolimus versus elacestrant in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced breast cancer progressing to endocrine therapy and CDK4/6 inhibitors III
2024-0673 "Phase II study to assess the efficacy of niraparib rechallenge treatment after surgery in ovarian cancer patients with oligometastatic progression" II
2024-0719 “Phase II Study of Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-Low Breast Cancer Presenting with Newly Diagnosed or Progressing Brain Metastases.” II
2025-0241 Neoadjuvant phase II study of pembrolizumab and carboplatin plus paclitaxel for stage I triple-negative breast cancer. II
2025-0499 A phase II study assessing the safety and efficacy of Repotrectinib in ROS1-positive non-small cell lung cancer (NSCLC) patients with active brain metastasis (BMs). II
2024-1074 Estudio clínico de fase 1/1b, abierto y multicéntrico, de MK-0472 en monoterapia y en tratamiento combinado, en participantes con tumores sólidos avanzados/metastásicos I
2024-0896 A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers I
2021-1144 Estudio de fase 1, abierto y multicéntrico para evaluar la seguridad, la tolerabilidad, la farmacocinética y la eficacia de MK-1084 en monoterapia y en combinación con pembrolizumab en sujetos con tumores sólidos avanzados con KRASG12C mutado. I
2024-0509 Phase 3 study of MK-1084 in combination with pembrolizumab compared to pembrolizumab monotherapy as first line treatment in patients with KRAS G12C mutant, advanced NSCLC with PD-L1 TPS ≥50%. III
2025-0861 Phase 3 study of 1L MK-1084 with FOLFOX plus Cetuximab in KRAS-G12C mutated mCRC A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012) III
2025-0695 A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC). III
2023-0820 “Phase 3 study of MK-2870 vs. Docetaxel or Pemetrexed in Advanced or Metastatic nsq-NSCLC Patients with EGFR Mutations or Other Genomic Alterations Progressed on Prior TKIs and Platinum-based Therapies” III
2023-1181 " A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy" III
2024-0215 "A Phase 3 Study of MK-2870 in Combination with Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer with PD-L1 TPS ≥ 50%" III
2024-0615 “An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer” III
2024-0643 MK-2870 Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR. Estudio de fase 3, aletorizado y abierto para comparar la eficacia y la seguridad de MK-2870 adyuvante en combinación con pembrolizumab (MK-3475) frente al tratamiento elegido por el médico (TEM) en participantes con cáncer de mama triple negativo (CMTN) que recibieron tratamiento neoadyuvante y no lograron una respuesta completa anatomopatológica (RCap) en la cirugía III
2024-0452 A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician’s Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma) III
2024-0435 A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab with or without MK-2870 in Resectable Stage II to IIIB (N2) NSCLC for Participants not Achieving pCR after Receiving Neoadjuvant Pembrolizumab with Platinum based Doublet Chemotherapy Followed by Surgery III
2024-0801 A Phase 3 Randomized, Active-Controlled, Open-Label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-Line or Third-Line Treatment for Participants with Recurrent or Metastatic Cervical Cancer III
2025-0242 A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of MK-2870 Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer III
2024-0578 A Randomized Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Paclitaxel or Nabpaclitaxel followed by Maintenance Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Participants With Metastatic Squamous Non-small Cell Lung Cancer III
2025-0665 Phase 3 Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumutecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer III
2025-0664 A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03C in Participants with Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy I
2015-0785 Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158) I
2016-0802 Ensayo de fase Ib/II de tratamientos combinados con pembrolizumab (MK-3475) en el cáncer de próstata resistente a la castración metastásico (CPRCm) (KEYNOTE-365) II
2018-0388 A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. IV
2024-0817 A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK 3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS ≥50%” III
2021-0529-II A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Investigational Agents for the Treatment of Participants With PD-1/L1-refactory Extensive Stage Small Cell Lung Cancer in Need of Second-Line Therapy. II
2022-0847 "Estudio adaptativo de ramas tipo paraguas, fase 1/2 y abierto, con fármacos en investigación con o sin pembrolizumab en participantes con carcinoma urotelial localmente avanzado o metastásico resistente a inhibidores de PD-1/L1 (KEYMAKER-U04): Subestudio 04A" MK-3475-U04/MK-3475-04A: Phase 1/2 Umbrella Study of Investigational Agents With or Without Pembrolizumab in PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma. MK-3475-U04/MK-3475-04B: Phase 1/2 Umbrella Study of Pem I
2024-0750 A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) in Combination With Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C I
2024-0675-1 Subestudio MK-5684-01A: Subestudio en paraguas de fase 1/2 del protocolo maestro MK-5684-U01 para evaluar la seguridad y la eficacia de combinaciones terapéuticas basadas en MK-5684 o de MK-5684 en monoterapia en participantes con cáncer de próstata resistente a la castración metastásico (CPRCm) I
2024-0675-1-II Subestudio MK-5684-01A: Subestudio en paraguas de fase 1/2 del protocolo maestro MK-5684-U01 para evaluar la seguridad y la eficacia de combinaciones terapéuticas basadas en MK-5684 o de MK-5684 en monoterapia en participantes con cáncer de próstata resistente a la castración metastásico (CPRCm) II
2025-0285 A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in  Participants with High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy. I
2025-0265 A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Recurrent Extensive-Stage Small Cell Lung Cancer I
2021-0356 A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, formerly PT2977) Monotherapy in Participants with Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumor (pNET). II
2021-0678 An Open-label, Multicenter, Phase 2 Study of Pembrolizumab Plus Lenvatinib in Combination With MK-6482 in Multiple Solid Tumors. I
2022-0380 Open label Phase 3 Study MK7684A (Coformulation of MK-7684 200mg and pembrolizumab 200 mg) in Combination with cCRT Followed by MK7684A Vs cCRT Followed by Durvalumab in Participants with Unresectable, Locally-advanced, Stage III NSCLC (All-comers regardless of PD-L1 status). III
2020-0920 A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pembrolizumab + Lenvatinib with Chemotherapy-Induction Followed by Pembrolizumab + Lenvatinib Compared with Chemotherapy as First-line Intervention in Participants with Metastatic Esophageal Carcinoma. III
2024-0456 A Phase 1/2 Substudy of the MK-9999-U02 Master Protocol to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers I
2025-0209 “A  Phase  1  Study  of MOMA‐313  Given  as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors” I
2023-0567 A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202 a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types. II
2024-1092 An open-label, multicenter, randomized Phase 2 study of the ATR inhibitor M1774 in combination with other DNA damage response inhibitors in participants with BRCA mutant and/or homologous recombination deficiency (HRD)-positive epithelial ovarian cancer that progressed on prior PARP inhibitor therapy II
2022-0576 A Phase I, Two-Part, Multicenter, Open-Label First in Human Study of anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants with Advanced Solid Tumors I
2025-0272-2 PROCEADE PanTumor Substudy NSCLC: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer I
2024-0904 An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination with the ATR Inhibitor Tuvusertib in Participants with Advanced Solid Tumors I
2023-0998 A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Malignancies I
2024-1064 An open-label, phase I/II multicenter clinical trial of NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor therapy in patients with solid tumors I
VHIO-0020 A Time and Motion (T&M) study comparing subcutaneous (SC) pembrolizumab co-formulated with hyaluronidase (MK-3475A) versus intravenous (IV) pembrolizumab in metastatic non-small cell lung cancer (mNSCLC) IV
2023-0021 Multicentre, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumours II
2022-0208 A Phase 1/2 study of the highly selective ROS1 inhibitor NUV-520 in patients with advanced NSCLC and other solid tumors. I
2022-0388-II A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1) I
2023-0499 A Phase 1b Study to evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 administered intravenously in combination with different drugs in Patients with advanced Solid Tumors (OMO-103-02) I
2025-0194 A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma II
2025-1031 Phase 1b Dose Escalation Trial of OMTX705, an Anti‐Fibroblast  Activation  Protein  Antibody‐Drug  Conjugate,  in  ombination  with Gemcitabine/Nab‐Paclitaxel  and  Tislelizumab  in  Patients  with  Advanced/Metastatic Pancreatic Adenocarcinoma I
2024-1043 A Phase I/Ib Dose Escalation and Cohort Expansion Study of OMX-0407 a Salt[1]inducible Kinase inhibitor in patients with previously treated unresectable solid tumour I
2022-1133 A Phase 3 study for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma III
2023-0302 An open label, multi centre, randomized study of OncoSil™ in addition to FOLFIRINOX chemotherapy versus FOLFIRINOX chemotherapy alone in patients with unresectable locally advanced pancreatic adenocarcinoma PRODUCTO SANITARIO
2024-1002 A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK4/6 INHIBITOR THERAPY (OPERA-01) III
2024-1187 "An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration" I
2024-1137 "An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer" I
2024-1069 A randomized, open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non- Small Cell Lung Cancer (NSCLC) and secondary resistance to Immune Checkpoint Inhibitor (ICI)- ARTEMIA study III
2024-0672 "Estudio de factores pronósticos y predictivos de respuesta a tratamiento quimioterápico en pacientes diagnosticados de cáncer de páncreas avanzado" IV
2025-0361 "An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors, Including Sarcomas" I
2022-0219 A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma. II
2022-1095 An open-label, randomized, controlled multi-center Study of the efficacy of Daromun (L19IL2+L19TNF) neoadjuvant intratumoral treatment followed by surgery and adjuvant therapy versus surgery and adjuvant therapy in clinical stage IIIB/C melanoma patients. III
2022-0365 A phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma III
2025-0788 An Open-Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring IV
2024-0558 Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer (PolyDamas) II
2024-0187 Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma II
2017-0546 Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors I
2024-0572 A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Advanced Solid Tumors Harboring a p53 Y220C Mutation I
2025-0071 A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma Not Previously Treated in the Metastatic Setting III
2024-0960 A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation I
2025-0236 A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT7732 in Participants with Select Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation I
2025-0390 Maintenance Pembrolizumab at Usual or Low doSE in nonsquamous lung cancer: a non-inferiority study III
2025-0451 "A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER" II
2023-0328 A phase IIb, open-label, randomized study of Gemcitabine and NabPaclitaxel plus/VCN-01 in Patients with Metastatic Pancreas Cancer II
2023-0867 A Phase 1, First-in-Human, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Subjects with Advanced Solid Tumors I
2023-0706 Phase 3 Trial of Fianlimab (Anti-Lag-3) And Cemiplimab Versus Pembrolizumab in the Adjuvant Setting In Patients With Completely Resected High-Risk Melanoma III
2024-1142 A PHASE 2 AND PHASE 3 PERI-OPERATIVE TRIAL OF FIANLIMAB AND CEMIPLIMAB COMPARED WITH ANTI-PD1 ALONE IN PATIENTS WITH RESECTABLE STAGE III AND IV MELANOMA II
2024-0755 A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 antibody) in Combination with Cemiplimab (Anti-PD-1 antibody) versus Cemiplimab Monotherapy in First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with Tumors Expressing PD-L1 ≥50% II
2024-0621 A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) in Subjects with HER2-Expressing Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma II
2023-0139 A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer I
2021-0677 An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma. II
2015-0407 An international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma. II
2022-0698 A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer I
2025-1162 Phase 3 Study of RMC-6236 in Previously Treated Patients with RAS-Mutant NSCLC III
2025-0498 RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) III
2024-0995 A Phase 1b/2 Open-Label, Multicenter Study of RMC-6291 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with KRASG12C-Mutated Solid Tumors – Subprotocol A I
2024-1014 A Phase 1b/2 Open-Label, Multicenter Study of RMC-6236 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with RAS-Mutated Solid Tumors – Subprotocol B I
2025-0915 Open-Label, Multicenter Study of Zoldonrasib (RMC-9805) in Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC) II
2024-0296 “A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)” IV
2025-0657 Phase 1b/3 Clinical Study of RYZ101 in advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that express somatostatin receptors (SSTR) RYZ101-301 III
2025-0356 A Phase 1b/2, Safety Lead-in and Dose Expansion, Open label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation I
2025-0307 Fase Ib/II de Vorasidenib en combinación con Temozolomida en pacientes con diagnóstico nuevo de Astrocitoma IDH1 o  IDH2 mutado grado 4. I
2024-1097 "A PRECISION MEDICINE TRIAL LEVERAGING BLOOD-BASED TUMOR GENOMICS TO OPTIMIZE TREATMENT IN OPERABLE STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS" III
2024-0603 A multicenter, open-label, phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced/metastatic solid tumors I
2024-0651 Randomised, open-label, multicentric, pivotal trial of SonoCloud-9 combined with carboplatin and nab-paclitaxel vs Standard of Care (SoC) lomustine (CCNU) or temozolomide (TMZ) in patients with first recurrence/progressive glioblastoma II
2021-0292-II Phase I/II randomized clinical trial of selinexor plus gemcitabine in selected advanced soft-tissue sarcomas II
2024-1144 Multicenter, Open-Label Phase II Trial of Cirtuvivint as a Second-Line Therapy in Selected Advanced Soft-Tissue Sarcomas II
2020-0902 A Phase 1 Study of SGN-B6A in Advanced Solid Tumors. I
2022-0234 A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors. I
2024-0718 An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater) III
2024-0757 "A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors" I
2024-0769 A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2. I
2022-0291 A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors I
2022-0398 An Open Label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus Chemotherapy as First Line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer. III
2024-1128 A Phase II Study of SKB264 Monotherapy or in Combination with Pembrolizumab with or without Chemotherapy in Patients with Advanced or Metastatic Non-small Cell Lung Cancer II
2023-0622 An Open-Label, Phase 1B Study of SL-172154 (SIRPα-Fc-CD40L) Administered With Pegylated Liposomal Doxorubicin or Paclitaxel to Subjects With Platinum-Resistant Gynecological Cancers I
2024-0214 A randomized, controlled, multiregional Phase 3 study of ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy for the first-line treatment of metastatic squamous NSCLC III
2024-0293 "An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation" III
2025-0789 A PHASE 1, OPEN-LABEL DOSE ESCALATION AND EXPANSION STUDY OF SNV1521 IN PARTICIPANTS WITH ADVANCED SOLID TUMORS I
2025-0552 Estudio observacional retrospectivo multicéntrico de vida real de Tivozanib en primera línea de tratamiento de cáncer renal de células claras metastásico IV
2024-0709 Estudio observacional de efectividad de medicamentos financiados por el Sistema Nacional de Salud para tumores genitourinarios IV
2019-0689 HER2-PREDICT: TRANSLATIONAL STUDY OF TUMOR SAMPLES FROM DS8201-A-U301 AND DS8201-A-U302 TRIALS. II
2022-0175 Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS). II
2023-0682 Estudio de fase II, multicéntrico, aleatorizado, abierto, de mujeres premenopáusicas con cáncer de mama luminal que investiga el efecto del Elastrant SERD oral con/sin triptorelina en la vía funcional del RE y la proliferación de Ki67. Ensayo preoperatorio II
2023-0862 Prospective biomarker analysis in HR+/HER2- advanced or metastatic breast cancer patients treated with sacituzumab govitecan II
2025-1082 Real-World Efficacy outcomes With Tucatinib for HER2- Positive Advanced Breast Cancer Immediately After Trastuzumab Deruxtecan (DS-8201) IV
2024-0851 A Phase 1b/2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression I
2024-0066 Phase I/II dose expansion study for an EGFRxCD28 costimulatory bispecific antibody in combination with cemiplimab in patients with advanced solid tumors I
2020-0835 A Phase III, Randomized, Clinical Study of Napabucasin in Combination with FOLFIRI and Best Supportive Care (BSC) Versus Napabucasin plus BSC in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC). III
2020-0488 A Phase II/III Randomized, Open-Label Clinical Study of Napabucasin in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure. III
2024-0434 Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE) II
2025-0256 “Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT).” III
2022-0634 A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor alpha (FolRα) Antibody Drug Conjugate (ADC), in Combination with Bevacizumab in Patients with Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers). I
2024-0193 First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor I
2024-0315 First-In-Human Study of STX-721 In Participants With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations I
2023-1115 An open-label, phase I/II study of T3P-Y058-739, a genetically-modified strain of the bacterium Yersinia enterocolitica, in patients with advanced solid tumors. I
2025-0704 Randomized phase 2/3 study in the first-line setting for stageIIIB/C-IV NSCLC patients with positive PD-L1 expression and without EGFR or ALK mutations. The study is exploring a chemotherapy-free combination of a first-in-class antigen-presenting cell (APC) III
2023-0319 AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPENLABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER: SUB-STUDY A-C4891006 (ARV-471 IN COMBINATION WITH ABEMACICLIB) and SUB-STUDY B- C4891023 (ARV-471 IN COMBINATION WITH RIBOCICLIB) I
2024-0270 Phase 1b/2 TACTIVE-U (Umbrella) study to evaluate the safety, efficacy and PK of ARV-471 in combination with other anti-cancer therapies in participants with ER+ Advanced or Metastatic Breast Cancer. I
2024-0470 A Phase 1/2, Firstin-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer I
2023-1145 Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements II
2024-0862 An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study I
2025-0866 Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects with Advanced Solid Tumors I
2023-0823 An open-label, multicenter Phase 1/2 dose escalation and expansion study of THOR-707 as a single agent and as a combination therapy in adult subjects with advanced or metastatic solid tumors I
2023-0759 First-in-human, open-label, multicenter, dose escalation and expansion study for the evaluation of the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activities of SAR445877 administered intravenously as a single agent and in combination with atezolizumab in adult participants with advanced unresectable or metastatic solid tumors. I
2025-0297 A randomized phase I/II trial in patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN) evaluating a mutanome-directed immunotherapy initiated at completion of primary treatment or at time of recurrence II
2025-0705 A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor activity of TH9619 in Subjects with advanced solid tumors I
2022-0848 Treatment of advanced or metastatic triple-negative breast cancer with adoptive therapy of PD1+ tumor-infiltrating lymphocytes (TILS001 trial). II
2024-0772 A phase 2, Multicenter Study of TILs Treatment in Advanced Tumors with Alterations in the SWI/SNF Complex: the TILTS Study. II
2023-0279 A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors I
2024-0335 “A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor, TOS-358, in Adult Subjects with Select Solid Tumors” I
2020-0159 A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements  (TRIDENT-1). II
2014-0623-II Ensayo clinico Fase I-II, abierto, prospectivo y muticéntrico, que explora la combinación de Trabectedina y Radioterapia en pacientes con Sarcoma de tejidos Blandos II
2024-0387 A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician’s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308). III
2023-1167 “Estudio de fase Ib/II, no aleatorizado, no comparativo, de dos cohortes de niraparib y dostarlimab más (quimio)radioterapia en carcinoma de células escamosas de cabeza y cuello localmente avanzado (RADIAN)” I
2023-1169 A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects with Advanced Solid Tumors I
2025-0853 Observational retrospective study to evaluate real￾world effectiveness, safety and tolerability of Fruquintinib for treatment of advanced colorectal cancer in Spain – FrESP Study IV
2021-0489 Estudio epidemiológico observacional multicéntrico descriptivo sobre tumores digestivos. IV
2024-0271 Multicenter Phase 2 study to evaluate the efficacy and safety of Cetuximab in combination with Encorafenib plus Binimetinib as induction treatment in BRAF (V600E) mutated MSS, initially resectable or potentially resectable advanced colorectal cancer: CEBBRA study. II
2025-0410 Sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma with KRAS p.G12C mutation I
2023-187-1 TUBectomy with delayed oophorectomy as Alternative for risk-reducing salpingo-oophorectomy in high-risk Women to assess the Safety of Prevention IV
2023-0508 "A Multicenter, Open-Label Phase 1/2 Study of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors with Activating FGFR3 Gene Alterations" I
2024-0864 “A Phase 2, Multicenter, Multicohort, OpenLabel, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors (HERTHENA-PanTumor01" I
2020-0146 A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF U3-1402 IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER. I
2024-1168 Adjuvant pembrolizumab or surveillance in Early Triple Negative breAst cancer with high stromal tumor-infiltrating lymphocytes (TILs) score II
2022-0991 A randomized phase III trial evaluating the efficacy and safety of androgen deprivation therapy +/- darolutamide in frail men with castration-naïve de novo metastatic prostate cancer from the Prostate Cancer Consortium in Europe (PEACE). III
2023-1131 “A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer. III
2024-0206 A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma II
2024-0064 A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-Risk Muscle-Invasive Urothelial Carcinoma Post-Radical Resection II
2024-0832 "Phase 3 adjuvant pembro with or without V940 after neoadjuvant pembro+chemo in patients with resectable Stages II-IIIB(N2) NSCLC who have not achieved a pCR" III
2025-0669 “Estudio clínico de fase 2, aleatorizado, doble ciego y comparativo con placebo y con un tratamiento activo de V940 (mRNA-4157) más pembrolizumab frente a un placebo más pembrolizumab en participantes con melanoma metastásico en primera línea (INTerpath-012)” II
2025-0413 "“Randomized phase 2 study of Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients (The VESPA trial)" II
2018-0467 Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours. I
2021-0821 A Phase I study to assess the safety and tolerability of ex vivo neoantigen-selected Tumor-infiltrating Lymphocytes (TILs) in advanced epithelial tumors and refractory melanoma. I
2022-0482 PHASE IB STUDY WITH A SAFETY LEAD-IN COHORT AND EXPANSION PHASE, OF THE SAFETY, TOLERABILITY, BIOLOGICAL EFFECT AND EFFICACY OF ALLOGENIC NATURAL KILLER CELLS IN COMBINATION WITH TRASTUZUMAB AND PERTUZUMAB IN ADULT PATIENTS WITH REFRACTORY METASTATIC HER2 POS BREAST CANCER. I
2024-0500 Bevacizumab plus encoRAfenib-cetuximab in BRAF-V600E mutated metastatic colorectal cancer, a phase II study with a safety lead-in cohort, the BRAVE trial II
VHIO-0022 “Phase II randomized study evaluating a Pragmatic approach to Adoptive Cell Therapy (ACT) using an IL2 analog (ANV419) vs High dose IL2 after Tumor Infiltrating Lymphocytes (TIL) Therapy in patients with melanoma, NSCLC and cervical cancer” I
2025-1056 A Phase 2, Single-Arm study of encorafenib plus cetuximab as rechallenge treatment of BRAF V600E-mutant metastatic colorectal cancer patients after previous therapy with BRAF inhibitors-based combinations: the RefIsh trial II
2023-0957 "A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)" I
2022-0947 A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic HER2-Expressing Cancers. I
2024-0715 Un estudio abierto, aleatorizado en fase III del tratamiento combinado con avutometinib más defactinib frente al tratamiento elegido por el investigador en pacientes con cáncer de ovario seroso de bajo grado (COSBG) recurrente (RAMP 301) III
2024-0953 A first-in-human, open label, multicenter study of the NRF2 antagonist VVD-130037 in adult patients with advanced solid tumors I
2024-1151 A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of VVD-130850 as Single Agent and in Combination with Checkpoint Inhibition in Participants with Advanced Solid and Hematologic Tumors I
2019-0383 A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC). I
2021-0554 A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC). I
2023-1033 A PHASE III, 2 ARM, RANDOMIZED, OPEN-LABEL, MULTICENTER, REGISTRATIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO (+/- ENDOCRINE THERAPY) AFTER INDUCTION CHEMOTHERAPY (PHESGO+TAXANE) IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER III
2023-0831 fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para valorar la eficacia y la seguridad de inavolisib en combinación con Phesgo versus placebo en combinación con Phesgo después de la terapia de inducción de primera línea en participantes con HER2 positivo con mutación en PIK3CA localmente avanzado o cáncer de mama metastásico. III
2025-0268 estudio de fase III para evaluar la eficacia y la seguridad de inavolisib más un inhibidor de CDK4/6 y letrozol frente a placebo más un inhibidor de CDK4/6 y letrozol en pacientes con cáncer de mama avanzado con mutación de PIK3CA, RH+ y HER2- endocrino sensibles. III
2022-0225 A PHASE IA/B OPEN-LABEL STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7276389 ALONE AND IN COMBINATION WITH COBIMETINIB IN PARTICIPANTS WITH BRAF-V600 MUTATION-POSITIVE ADVANCED SOLID TUMOR OR BRAF-V600 MUTATION-POSITIVE MELANOMA WITH CENTRAL NERVOUS SYSTEM METASTASES I
2023-0511 A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors I
2023-0824 A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma III
2024-0649 A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer I
2023-0645 A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53 WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA III
2023-0851 A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy with  Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Advanced Solid Tumor Malignancies. I
2024-0976 An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer I
2024-0627 Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors with or without brain metastases. I
2024-1195 A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN‑c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations. II
2021-1034 A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA) III

Hematology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2025

Code Clinical Trial Title Phase
2018-1005 Ensayo clínico de fase I/IIa de BI-1206, un anticuerpo monoclonal contra CD32b (Fc γ RIIB), en combinación con rituximab en personas con linfoma no hodgkiniano de linfocitos B de escasa malignidad que ha recidivado o es resistente al rituximab I
2022-0274 A Phase 3 Open-label, randomized Study comparing blinatumomab with low intensity chemotherapy blocks versus standard of care (SOC) chemotherapy in subjects > 55 years with newly diagnosed Philadelphia (ph)-negative B‑cell Precursor Acute Lymphoblastic Leukemia (ALL) III
2024-0628 A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia. III
2025-0630 A phase 3, randomized, open-label study of Belantamab Mafodotin administered in combination with Lenalidomide and Dexamethasone versus Bortezomib, Lenalidomide, and Dexamethasone in participants with newly diagnosed Multiple Myeloma who are ineligible for Autologous Stem Cell Transplantation (TI-NDMM). III
2025-0497 A Phase 2 Open-label Study to Evaluate Momelotinib in Combination with Luspatercept in Participants with Transfusion Dependent Primary or Secondary Myelofibrosis. II
2025-0796 A Phase 2, Randomized, Open-Label, Study of Momelotinib in Participants with Anemia due to Low-risk Myelodysplastic Syndrome. II
2021-0676 Estudio multicéntrico, aleatorizado, controlado con placebo, doble ciego y adaptativo de FT-4202 oral, un activador de la piruvato cinasa en pacientes con anemia drepanocítica4202 II
2023-1168 Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia. II
2024-0065 A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR), Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR)  versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy. III
2021-0200 A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma II
2023-1128 Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (TalP), Talquetamab in Combination with Teclistamab (TalTec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received an AntiCD38 Antibody and Lenalidomide. III
2021-0680 A First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants with Acute Leukemia. I
2022-0700 A Phase 1b Study of JNJ-75276617 in Combination with AML Directed Therapies for Participants with Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations. I
2025-0594 A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are ineligible for Intensive Chemotherapy. III
2024-0838 A Phase 1 Study of JNJ-80948543 in Combination with Other CD3 T-cell Engagers in Participants with Relapsed/Refractory B-cell Non--Hodgkin Lymphoid Malignancies. I
2023-1132 A Phase 1, First-in-human Study of JNJ-87801493 in Combination with CD3 T-Cell Engagers in Participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs). I
2024-0491 A Phase 1b Multi-Center, OpenLabel Study of C-CAR039, an Autologous CD19/CD20 Bi-Specific CAR-T Cell Therapy in Adult Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Study. I
2021-0324 A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety of oral masitinib to placebo un treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment. III
2025-0517 “A Phase 3, Double‐Blind,  Randomized  Placebo‐Controlled  Trial  of  Quizartinib  Administered  in  Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance  Therapy  in  Adult  Patients  with  Newly  Diagnosed  FLT3‐ITD  Negative Acute  Myeloid  Leukemia  (QuANTUM‐Wild) (QUIZARTINIB  OR  PLACEBO  PLUS CHEMOTHERAPY IN NEWLY DIAGNOSED PATIENTS WITH FLT3‐ITD NEGATIVE AML) ” III
2018-0451 Pyruvate Kinase Deficiency Global Longitudinal Registry IV
2023-0472 A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Double-blind, Randomized, Placebo-Controlled (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes AG946-C-002. II
2016-0922 Estudio retrospectivo para evaluar el uso de agonistas de los receptores de trombopoyetina en pacientes adultos con trombocitopenia inmune primaria en España IV
2020-1069 Estudio de fase III, abierto, aleatorizado y multicéntrico de ravulizumab en pacientes adultos y adolescentes que presentan microangiopatía trombótica (MAT) después de un trasplante de células madre hematopoyéticas (TCMH). III
2024-0499 A Phase 3, multicenter, randomized, double-blind, placebo-control-led, parallel-group study to evaluate the efficacy and safety of abelacimab in high-risk patients with Atrial fibrillation who have been deemed unsuitable for oral antiCoagulation (LILAC). III
2025-0549 A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Lisaftoclax (APG- 2575) in Previously Treated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. III
2025-0667 A Global Multicenter, Double-Blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination with Azacitidine (AZA) in Patients with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4). III
2024-0433 A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). II
2021-0428 An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases I
2020-0557 Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study). III
2025-0074 LONG-TERM FOLLOW-UP OF PATIENTS PREVIOUSLY TREATED WITH AUTOLOGOUS T CELLS GENETICALLY MODIFIED WITH VIRAL VECTORS. II
2022-0792 AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN SEVERE (COAGULATION FACTOR ACTIVITY <1%) HEMOPHILIA A PARTICIPANTS WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS. III
2023-1004 Open Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB 11417 in Patients With Relapsed/Refractory Waldenström’s Macroglobulinemia. II
2023-0578 A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies. I
2022-0499 Estudio abierto, multicéntrico y de extensión a largo plazo con pautas de zanubrutinib (BGB-3111) en pacientes con neoplasias malignas de linfocitos B. III
2021-1050 A PHASE IB OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF MOSUNETUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA. I
2025-0960 A PHASE IB OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF MOSUNETUZUMAB IN COMBINATION WITH PIRTOBRUTINIB IN PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA. I
2019-0326 AN OPEN-LABEL, PHASE I STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF RO7227166 (A CD19 TARGETED 4-1BB LIGAND) IN COMBINATION WITH BINUTUZUMAB AND IN COMBINATION WITH RO7082859 (CD20-TCB) FOLLOWING A PRE-TREATMENT DOSE OF OBINUTUZUMAB ADMINISTERED IN PARTICIPANTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA. I
2023-0571 A first-in-human dose-escalation and expansion study with the SIRPa-directed monoclonal antibody BYON4228 alone and in combination with rituximab to evaluate the safety, pharmacokinetics, harmacodynamics and efficacy in patients with relapsed/refractory CD20 positive B-cell Non-Hodgkin Lymphoma (NHL). I
2024-0654 Phase 3, open-label, single-arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV Spark100-hFIX-R338L) in adult male participants with moderately severe to severe hemophilia B (FIX:C ≤2%) (BeneGene 2). III
2021-1049 An Open-Label, 3-Arm, Multicenter, Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab vs Daratumumab + Pomalidomide + Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma. III
2022-0547 MAGNETISMM-7. A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA WHO ARE MINIMAL RESIDUAL DISEASE POSITIVE AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION. III
2021-0403 Phase 3, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of PF 07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C≤1%) III
2025-0412H AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046032 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES I
2023-0853 A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-486 (Onureg®) in Subjects with Moderate or Severe Hepatic Impairment Compared with Normal Hepatic Function in Adult Subjects with Myeloid Malignancies. I
2023-1011 Estudio de fase 3, abierto y aleatorizado para comparar la eficacia y la seguridad de luspatercept (ACE-536) frente a la epoetina alfa para el tratamiento de la anemia debida al síndrome mielodisplásico (SMD) de riesgo muy bajo, bajo o intermedio según el Sistema Internacional de Puntuación Pronóstica Revisado (IPSS-R) en participantes que no han recibido agentes estimulantes de la eritropoyetina (AEE) y no dependientes de transfusiones (NDT)”. III
2023-1143 A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS with IPSS-R Very Low-, Low- or Intermediate-risk Who Require RBC Transfusions. III
2023-0160 A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM). III
2024-0336 A Phase 1, multi-center, Open-label, Dose-finding Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986458, alone and in combination with antilymphoma agents in Subjects with Relapsed/Refractory non-Hodgkin lymphomas (R/R NHL). I
2024-1183 An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment. IV
2024-1053 Intensificación precoz del tratamiento en pacientes con linfoma de células del manto  de alto riesgo con terapia CAR-T tras una inducción abreviada con rituximab e ibrutinib seguida de mantenimiento con ibrutinib durante 6 meses (Brazo A) en comparación con el estándar de tratamiento en inducción y mantenimiento (Brazo B). II
2015-0109 A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide IV
2021-1068 Estudio Fase I, abierto, de búsqueda de dosis, de CC91633 (BMS-986397) en sujetos con Leucemia Mieloide Aguda en recaída o refractaria, o con Síndromes Mielodisplásicos de alto riesgo en recaída o refractarios I
2018-0915 A PHASE I, MULTI-CENTER, OPEN-LABEL STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF AN ORALLY AVAILABLE SMALL MOLECULE, CC-99282, ALONE AND IN COMBINATION WITH RITUXIMAB IN SUBJECTS WITH RELAPSED OR REFRACTORY NONHODGKIN LYMPHOMAS (R/R NHL) I
2019-0461 Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CAR T-Cell Therapy. II
2023-0783 A randomized, open-label, multicenter phase III trial comparing tisagenlecleucel to standard of care in adult patients with relapsed or refractory follicular lymphoma. III
2021-0566 A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) III
2020-0670 Real-world trends in clinical management of Relapsed/Refractory Multiple Myeloma (RRMM) patients who have received at least 2 prior anti-myeloma regimens: results from exploring electronic health records (EHR) with artificial intelligence (AI) – ‘’MYHRAI study’’ IV
2012-0512 Estudio observacional post-autorización para evaluar la respuesta de la función renal al tratamiento de pacients con mieloma múltiple en recaída y con aclaramiento de creatinina IV
2017-0446 Estudio observacional para valorar la carga de la enfermedad, en términos de Calidad de Vida Relacionada con la Salud y costes sanitarios directos, en pacientes con Mieloma Múltiple de nuevo diagnóstico no candidatos a trasplante autólogo de progenitores hematopoyéticos en España Estudio QoLMMBuS. IV
2024-0980 Pacientes diagnosticados con leucemia mieloide aguda (LMA) con enfermedad residual medible persistente (ERM) o reaparición de ERM después de la quimioterapia de primera línea o antes del trasplante alogénico de células hematopoyéticas (alo-TCH). II
2023-0531 Estudio fase 2 abierto, multicéntrico del perfil de seguridad, eficacia, farmacocinética y farmacodinámica de CGT9486 como agente único en pacientes con mastocitosis sistémica avanzada. II
2023-0509 A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB OR GLOFITAMAB IN COMBINATION WITH CC-220 AND CC-99282 IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA. I
2022-1052 A phase I, open-label, multi-center study of PIT565 in patients with relapsed and/or refractory B-cell malignancies. I
2019-0604 A Phase 2/3, Multicenter, randOmized, Double-blind, placebo-controlled, stUdy to evaLuate the safety and efficacy of Alpha-1 AntiTrypsin for the prEvention of graft-versushost disease in patients receiving hematopoietic cell transplant (MODULAATE Study) III
2023-0018 A phase 3, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia. III
2022-1156 A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoinmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA). III
2020-1021 Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL. I
2025-0308 A Modular Phase I/II, Single-arm, Multicenter, Open-label study to evaluate the Efficacy and Safety of AZD0486 in Subjects with Relapsed/Refractory (R/R) B-cell Non Hodgkin Lymphoma (B-NHL). II
2024-0813 A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia. I
2025-0754 A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AZD2962, an IRAK4 inhibitor, as Monotherapy and in Combination with other Agents, in Participants with Haematologic Neoplasms. I
2025-0709 A single-arm, open-label, multicenter, phase II study of acalabrutinib, in combination with the R-CHOP standard of care, for previously untreated mantle cell lymphoma in Spain. III
2023-0756 Acalabrutinib RWE on 1L CLL in Spain Non-interventional cohort study of patients Previously untreated or firstgeneration BTKi Intolerant with Chronic lymphocytic leukemia describing the first-line use of Acalabrutinib and its Real-world Outcomesin Spain: the PICAROS study. IV
2024-0841 A Modular Phase I/II, Open-label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients with CD123- positive Hematological Malignancies. I
2024-0932 A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T cell-engaging Antibody Targeting CD20 in Subjects with Relapsed or Refractory B-Cell Malignancies (TITANium). I
2024-0320 A single arm, open-label Phase 3b study to describe the safety and tolerability of ivosidenib in combination with azacitidine in adult patients newly diagnosed with mIDH1 acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy. III
2019-0895 Virología e inmunología de la infección por el citomegalovirus (CMV) en el paciente con neoplasias hematológicas en la era de las nuevas bioterapias. IV
2024-0571 A multicenter, open-label, first-in human (FIH), multiple expansion cohort, Phase 1/2 study to evaluate the safety and efficacy of DR-01 in adult subjects with large granular lymphocytic leukemia (LGLL) or cytotoxic lymphomas. I
2024-0194 A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP 5336 in Adult Acute Leukemia Patients with and without Mixed Lineage Leukemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation. I
2021-0232 A global multicenter phaSe 1/2 trial of EO2463, a novel microbial-derived peptIde therapeutic vaccine, as monotherapy, and in combination with lenaliDomide and rituximab, for treatmeNt of patients with indolEnt Non-Hodgkin's LYmphoma (the "SIDNEY" study). I
2021-0263 “A Phase 1b/3 double-blind, randomized, activecontrolled, 3-stage, biomarker adaptive study of tazemetostat or placebo in combination with lenalidomide plus rituximab in subjects with relapsed/refractory follicular lymphoma” I
2018-0986 “Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells”. II
2024-1117 A multicenter, phase 2 randomized, open label study to evaluate zanubrutinib in combination with obinutuzumab in previously untreated patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (GELLC-10-ZANUBIO). II
2024-0646 CHOP PLUS MOSUNETUZUMAB AS FIRST LINE IN PATIENTS WITH RICHTER'S SYNDROME; A PHASE II STUDY OF THE SPANISH GROUP OF CLL II
2014-0423 Estudio observacional prospectivo para identificar los aspectos clínicos que conducen a la toma de decisiones terapéuticas en pacientes con mielofibrosis. IV
2018-0854 Uso práctico de concetrados FVIII de Octafarma en paciente con hemofilia A sin tratamiento previo o mínimamente tratados que se incorporan a un tratamiento clínico rutinario: estudio observacional de la seguridad y eficacia en un entorno real: "Protect Now" IV
2022-0761 AN OPEN-LABEL, MULTICENTER, PHASE Ib TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF CEVOSTAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (CAMMA 1). I
2023-0940 A Phase III, open-label, multicenter randomized study evaluating glofitamab as a single agent versus investigator’s choice in patients with relapsed/refractory MCL. III
2022-0703 Post-Authorization Long Term Safety Surveillance Study of Fostamatinib in Adult Patients with Chronic Immune Thrombocytopenia (cITP) who are Refractory to Previous Treatments. IV
2025-1167 Ensayo clínico fase I-Ib de Seguridad e Inmunobiologia de la Infusión Profiláctica de Linfocitos γδ y Células NK de donante HLA idéntico post Alo-TPH con depleción T. I
2023-0570 Phase 1/2 multicenter, open-label, dose-escalation study of IDP-121 in patients with relapsed/refractory hematologic malignancies. I
2025-0296 Phase 3, interventional, multicentre, open label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ). III
2025-0872 International multicentric phase II trial to evaluate the efficacy and safety of pirtobrutinib in combination with rituximab in patients with indolent clinical forms of Mantle Cell Lymphoma. II
2024-0966 A Phase 3 Study of Axatilimab (INCA034176) and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease. III
2025-0787 A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) who are Unresponsive to JAK inhibitors (HEMA-MED). I
2024-1003 A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment with a Covalent Bruton Tyrosine Kinase Inhibitor. II
2020-0088 Estudio observacional para describir la repercusión de los anticuerpos monoclonales como tratamiento de primera línea frente a otros regímenes estándar en pacientes con mieloma múltiple de nuevo diagnóstico que no sean candidatos a trasplante. Datos de práctica clínica habitual en España. IV
2024-1042 An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination with Glofitamab in Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01). II
2025-0391 A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KER-050 in Adult Participants with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) with Anemia. III
2022-0536 A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS). II
2022-0675 A Phase 2, Open-label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Participants with Myelofibrosis (MF) II
VHIO-0017 A randomized non comparative Phase II study of Lacutamab with GemOx versus GemOx alone in relapsed/refractory patients with peripheral Tcell lymphoma. II
2021-1119 Ensayo de fase I/IIA (primer estudio en seres humanos) del inhibidor KO-539 de menina-MLL (KMT2A) en pacientes afectados de leucemia mieloide aguda recidivante o refractaria I
2024-0933 A Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia. I
2024-0985 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Navtemadlin Plus Ruxolitinib Versus Placebo Plus Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) That Have a Suboptimal Response to Ruxolitinib. III
2020-0467 Real-World Response/Survival and Treatment Patterns among Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma in USA, UK, France, and Spain Oncology Practices. IV
2023-0433 A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma III
2023-0410 An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-23). III
2023-1036 Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells. II
2025-0357 Estudio fase II multicéntrico, abierto, de un solo brazo de tratamiento para evaluar la eficacia de Axicabtagene ciloleucel en pacientes con recaída tardía de Linfoma Difuso de Células B Grandes. II
2023-0224 A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ringsideroblastic phenotype (MDS-RS). III
2024-0867 Ensayo de fase 3, multicéntrico, aleatorizado y abierto para evaluar la seguridad y eficacia de epcoritamab + rituximab y lenalidomida (R2) en comparación con quimio-inmunoterapia en linfoma folicular no tratado previamente (EPCORE™FL-2). III
2022-0543 Phase 1b/2, Open Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents/Immunotherapies in Subjects with Non-Hodgkin Lymphoma. I
2022-0404 Relapsed or Refractory Multiple Myeloma: Dose Escalation and Expansion of ABBV-383 in Combination with Anti-Cancer Regimens I
2024-0878 A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies I
2024-0957 First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies. I
2021-0654 ‘A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)’ III
2021-0171 A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies. I
2023-1017 A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Ibrutinib as 1L+ Therapy in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011). III
2022-0498 A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants with Aggressive and Indolent B-cell Malignancies I
2024-0334 A Phase 3, Randomized, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea. III
2024-0866 A Phase 3, Randomized, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) versus Hydroxyurea in Participants with Previously-Untreated Essential Thrombocythemia. III
2021-0837 ESTUDIO OBSERVACIONAL PARA EVALUAR EL IMPACTO Y LA CARGA DE LA ENFERMEDAD EN HEMOFILIA MODERADA Y GRAVE DESDE LA PERSPECTIVA DE ENFERMERÍA Y DEL PACIENTE (ESTUDIO NURSES-WHO-CARE). IV
2025-0286 A Phase III randomized, openA Phase III randomized, open-label, international, multicenter study evaluating the efficacy and safety of mosunetuzumab plus lenalidomide in comparison to anti-CD20 monoclonal antibody plus chemotherapy in subjects with previously untreated FLIPI 2-5 follicular lymphoma.-label, international, multicent III
2021-0352 “MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial” IV
2024-0413 A multi-center randomized, double blinded phase IIb trial evaluating oral pooled fecal microbiotherapy Maa7033 to prevent allogenic hematopoietic cell transplantation complications. II
2017-0762 ESTUDIO SOBRE LAS COMPLICACIONES CLÍNICAS DIRECTAS E INDIRECTAS DERIVADAS DE LA DETECCIÓN DE LA INFECCIÓN POR CITOMEGALOVIRUS (CMV) EN PACIENTES CON TRASPLANTE ALOGÉNICO DE CÉLULAS PROGENITORAS HEMATOPOYÉTICAS (ALO-TPH). ESTUDIO CMV-ALOTPH IV
2022-0240 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis. III
2022-0408 Open-label study investigating efficacy, safety and pharmacokinetics of concizumab prophylaxis in children below 12 years with haemophilia A or B with or without inhibitors. III
2025-0815 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People with Haemophilia A. I
2025-0126 A global phase 3, randomized, double-blinded and placebo-controlled study evaluating the efficacy and safety of etavopivat among adolescents and adults with sickle cell disease. III
2024-0926 An open-label, multi-centre, rollover study to characterise long-term safety and efficacy of etavopivat in adults, adolescents and children who have sickle cell disease or thalassaemia and have completed a treatment period in an etavopivat study. III
2016-0777 A MULTICENTER, OPEN-LABEL, PHASE I STUDYTO EVALUATE THE SAFETY,  EFFICACY, TOLERABILITY AND PHARMACOKINETICS OF ESCALATING DOSES OF RO7082859 AS A SINGLE AGENT AND IN COMBINATION WITH OBINUTUZUMAB ADMINISTERED AFTER A FIXED, SINGLE DOSE PRE-TREATMENT OF OBINUTUZUMAB (GAZYVA/GAZYVARO) IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA I
2025-0812 An Open-label, Intra-participant Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Immune Thrombocytopenia. II
2024-1197 A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies. I
2025-0921 A multicenter, open-label, randomized, phase 2 study of venetoclax and azacitidine plus cusatuzumab versus venetoclax and azacitidine alone in newly diagnosed AML patients who are not candidates for intensive therapy. II
2023-1095 A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/µL). III
2015-0975 A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study. III
2022-1181 A prospective randomized, double-blind, placebo-controlled, multi-center phase IIb study to evaluate the efficacy and safety of mocravimod in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). II
2025-0881 An Open-Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring. IV
2025-0772 Glofitamab Combined with Pirtobrutinib in Relapsed/Refractory Patients with Mantle Cell Lymphoma Followed by an Extension in Treatment Naïve Patients. II
2023-0282 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP). III
2025-0711 A PHASE 1/2 OPEN-LABEL STUDY OF REGV131LNP1265, A CRISPR/CAS9-BASED COAGULATION FACTOR IX (BEYOND-9) II
2024-0254 A phase 3, open-label, randomized study to compare the safety and efficacy of Odronextamab (REGN1979), an anti-CD20 x anti-CD3 bispecific antibody, versus investigator's choice in previously untreated participants with Follicular lymphoma (OLYMPIA-1). III
2015-0670 Estudio de fase I para evaluar la seguridad y la tolerabilidad del REGN1979, un anticuerpo monoclonal biespecífico contra CD20 y CD3, y el REGN2810, un anticuerpo monoclonal contra la proteína de muerte celular programada 1, en pacientes con neoplasias malignas de linfocitos B. I
2019-0410 “AN OPEN-LABEL STUDY TO ASSESS THE ANTI-TUMOR ACTIVITY AND SAFETY OF REGN1979, AN ANTI-CD20 X ANTI-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA” II
2022-0168-II Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated with Systemic Therapy in a Real-World Assessment (FLORA). IV
2022-1168-I R1979-ONC-2090 Outcomes in Patients with Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated with Systemic Therapy from Real-World Experience (ORCHID). IV
2024-0255 A phase 3, open-label, randomized study to compare the safety and efficacy of Odronextamab combined with Lenalidomide in Relapsed/Refractory indolent lymphoma (OLYMPIA-5). III
2023-0963 PHASE 1B STUDY OF REGN5458 (ANTI-BCMA X ANTICD3 BISPECIFIC ANTIBODY) PLUS OTHER CANCER TREATMENTS FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA. I
2023-1175 A PHASE 1 STUDY TO ASSESS SAFETY AND TOLERABILITY OF REGN5837, AN ANTI-CD22 X ANTI-CD28 COSTIMULATORY BISPECIFIC MONOCLONAL ANTIBODY, IN COMBINATION WITH ODRONEXTAMAB, AN ANTI-CD20 X ANTI-CD3 BISPECIFIC MONOCLONAL ANTIBODY, IN PATIENTS WITH AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMAS (ATHENA-1). I
2024-1185 PHASE 1B OPEN LABEL BASKET STUDY OF RAY121 TO INHIBIT COMPLEMENT CLASSICAL PATHWAY IN IMMUNOLOGICAL DISEASES (RAINBOW TRIAL). I
2025-0541 Response-adaptive to Epcoritamab In FIrst Relapse: A Phase II, response-adaptive, Open-Label, Multicenter Study to Evaluate the Efficacy of Epcoritamab in Patients with Relapse/Refractory Large B Cell Lymphoma. II
2023-0016 A multicenter, randomized, open-label study of dexamethasone plus romiplostim vs dexamethasone in patients with newly diagnosed primary immune thrombocytopenia. III
2025-0078 A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) monotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study). III
2024-0977 A phase 1, open-label study to evaluate SGN-35C in adults with advanced malignancies. I
2025-0406 Phase 1/2 study with an open-label dose escalation phase followed by a randomized, double-blind phase of SLN124 in patients with Polycythemia Vera. II
2024-1186 A 12 months, interventional, open-label phase 4 study in Europe to investigate the course of synovial hypertrophy as detected by joint ultrasound and MRI in patients with haemophilia A on efanesoctocog alfa prophylaxis. IV
2023-0519 Estudio observacional, multicéntrico para evaluar el uso y la eficacia de Doptelet® (Avatrombopag) en pacientes adultos con Trombocitopenia Inmune (PTI). IV
2021-1061 Natural History and Treatment Outcomes of Congenital and Immune Thrombotic Thrombocytopenic Purpura: a Retrospective Chart Review Study IV
2024-1072 A firts-in-human, open-label, Phase 1 study to evaluate the safety, antitumor activity, pharmacokinetics, and pharmacodynamics of subcutaneous SAR446523, an anti-GPRC5D ADCC-enhanced monoclonal antibody, in participants with relapsed/refractory multiple myeloma. I
2024-0414 A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Patients with Chronic Myeloid Leukemia. I
2025-0161 Letermovir (LMV) prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients with CMV seropositive donors: an exploratory study from Spanish GETH/TC Centers. III
2024-0359 Estudio en fase I/III para evaluar la eficacia y la seguridad del selinexor, un inhibidor selectivo de la exportación nuclear, en combinación con ruxolitinib en pacientes con mielofibrosis que no han recibido tratamiento previo. III
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