Thoracic Tumors Group

Early Clinical Drug Development Group

Gynecological Malignancies Group

Breast Cancer Group

Melanoma and Other Cutaneous Tumors Group

Experimental Hematology Group

Prostate Cancer Group

Hereditary Cancer Genetics Group

Head and Neck Cancer Group

Radiation Oncology Group

Upper Gastrointestinal and Endocrine Tumors Group

Colorectal Cancer 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 2024

Hematology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2024

Group Leader Enriqueta Felip Medical Oncologists and Clinical Fellows Susana Cedres, Patricia Iranzo, Alexandre Martinez, Nuria Pardo, Ilaria Priano, Pedro Rocha, Augusto Valdivia Senior Researcher Ramon Amat Post-Doctoral Fellows Caterina Carbonell, Rocio Caro Bioinformatics Support Gerard Romero Clinical Nurse Specialist Mireia Soleda Data Entry Aina Arbusà

Research Groups

Thoracic Tumors Group

Summary

VHIO’s Thoracic Tumors 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.

Immune-based strategies have a key role in the treatment algorithm for the management of non-small cell lung cancer (NSCLC). A number of protocols are ongoing at our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch led by Elena Garralda. Additionally, we contribute to VHIO’s early clinical drug development efforts. We also manage other less common thoracic malignancies including small cell lung cancer, mesothelioma, thymoma and neuroendocrine tumors.

  • Develop novel drug treatments targeting alterations in oncogenes such as KRAS and EGFR, and immunotherapy combination strategies through clinical trials.
  • Identify 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 burden, and the tumor microenvironment).
  • Establish if somatic copy number alteration (SCNA) burden is a predictive or prognostic biomarker in advanced lung cancer.
  • Demonstrate the clinical utility of liquid biopsy to:
    • – Diagnose patients and monitor response to therapy in metastatic non-small cell lung cancer (NSCLC).
    • – Study disease relapse in patients with early-stage NSCLC.
  • Study intratumor heterogeneity (genomic, transcriptomic) and clinical implications in paired primary lung tumors and metastatic lesions.
  • 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 genomics, molecular biology and clinical data, we aim to advance our understanding of lung cancer pathophysiology and response to therapy.
  • National and international collaborations of excellence.
  • We have expanded our translational research in small-cell lung cancer (SCLC).
  • Expand clinical 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 a medical device using artificial intelligence-based models to predict immunotherapy efficacy in NSCLC patients by integrating multisource data.
  • Apply single-cell technologies for the study of intratumor heterogeneity and biomarker discovery.
  • Develop new in vitro and in vivo models for evaluating response to targeted therapies and immune checkpoint inhibitors (ICIs), with particular focus on patient-derived organoid (PDOs).
  • Felip E, Cho BC, Gutiérrez V, Alip A, Besse B, Lu S, Spira AI, Girard N, Califano R, Gadgeel SM, Yang JC, Yamamoto S, Azuma K, Kim YJ, Lee KH, Danchaivijitr P, Ferreira CG, Cheng Y, Sendur MAN, Chang GC, Wang CC, Prabhash K, Shinno Y, Stroyakovskiy D, Paz-Ares L, Rodriguez-Cid JR, Martin C, Campelo MRG, Hayashi H, Nguyen D, Tomasini P, Gottfried M, Dooms C, Passaro A, Schuler M, Gelatti ACZ, Owen S, Perdrizet K, Ou SI, Curtin JC, Zhang J, Gormley M, Sun T, Panchal A, Ennis M, Fennema E, Daksh M, Sethi S, Bauml JM, Lee SH. Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA. Ann Oncol. 2024 Sep;35(9):805-816.
  • Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourão Dias J, Besse B, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Yang JC, 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, Passaro A, Kim SW, Gadgeel SM, Xie J, Sun T, Martinez M, Ennis M, Fennema E, Daksh M, Millington D, Leconte I, Iwasawa R, Lorenzini P, Baig M, Shah S, Bauml JM, Shreeve SM, Sethi S, Knoblauch RE, Hayashi H; MARIPOSA Investigators. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024 Oct 24;391(16):1486-1498.
  • Smit EF, Felip E, Uprety D, Nagasaka M, Nakagawa K, Paz-Ares Rodríguez L, Pacheco JM, Li BT, Planchard D, Baik C, Goto Y, Murakami H, Saltos A, Pereira K, Taguchi A, Cheng Y, Yan Q, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol. 2024 Apr;25(4):439-454.
  • Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655.
  • The 2024 Heine H. Hansen Award (International Association for the Study of Lung Cancer - IASLC and the European Society for Medical Oncology – ESMO), was bestowed to Enriqueta Felip.
  • Enriqueta Felip was recognized as a Highly Cited Researcher 2024 (Clarivate) under the category of Clinical Medicine.
  1. 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.
  2. 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.
  3. Project title: Dissecting the role of copy number alterations as a molecular biomarker in advanced NSCLC.
    Funding entity: Instituto de Salud Carlos III.
    PI: Ramon Amat.
    Duration: 01/01/2023 – 31/12/2025.
  4. 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: 2021-2023.
  5. Project title: PREDICT-Meso: PRE-malignant Drivers Combined with Target-Drug validation in Mesothelioma.
    Funding entity: CRUK/ AECC.
    PIs: Susana Cedrés, Enriqueta Felip.
    Duration: 01/01/2019 – 31/12/2022.
  6. 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 (FIS – ISCIII).
    Duration: 2022–2024.
  1. Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourão Dias J, Besse B, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Yang JC, 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, Passaro A, Kim SW, Gadgeel SM, Xie J, Sun T, Martinez M, Ennis M, Fennema E, Daksh M, Millington D, Leconte I, Iwasawa R, Lorenzini P, Baig M, Shah S, Bauml JM, Shreeve SM, Sethi S, Knoblauch RE, Hayashi H; MARIPOSA Investigators. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024 Oct 24;391(16):1486-1498. doi: 10.1056/NEJMoa2403614.
  2. Cheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, Zenke Y, Lee KH, Wang Q, Navarro A, Bernabe R, Buchmeier EL, Chang JW, Shiraishi Y, Sezgin Goksu S, Badzio A, Shi A, Daniel DB, Hoa NTT, Zemanova M, Mann H, Gowda H, Jiang H, Senan S; ADRIATIC Investigators. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327. doi: 10.1056/NEJMoa2404873.
  3. Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. doi: 10.1056/NEJMoa2302299.
  4. Passaro A, Wang J, Wang Y, Lee SH, Melosky B, Shih JY, Wang J, Azuma K, Juan-Vidal O, Cobo M, Felip E, Girard N, Cortot AB, Califano R, Cappuzzo F, Owen S, Popat S, Tan JL, Salinas J, Tomasini P, Gentzler RD, William WN Jr, Reckamp KL, Takahashi T, Ganguly S, Kowalski DM, Bearz A, MacKean M, Barala P, Bourla AB, Girvin A, Greger J, Millington D, Withelder M, Xie J, Sun T, Shah S, Diorio B, Knoblauch RE, Bauml JM, Campelo RG, Cho BC; MARIPOSA-2 Investigators. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Ann Oncol. 2024 Jan;35(1):77-90. doi: 10.1016/j.annonc.2023.10.117.
  5. Felip E, Cho BC, Gutiérrez V, Alip A, Besse B, Lu S, Spira AI, Girard N, Califano R, Gadgeel SM, Yang JC, Yamamoto S, Azuma K, Kim YJ, Lee KH, Danchaivijitr P, Ferreira CG, Cheng Y, Sendur MAN, Chang GC, Wang CC, Prabhash K, Shinno Y, Stroyakovskiy D, Paz-Ares L, Rodriguez-Cid JR, Martin C, Campelo MRG, Hayashi H, Nguyen D, Tomasini P, Gottfried M, Dooms C, Passaro A, Schuler M, Gelatti ACZ, Owen S, Perdrizet K, Ou SI, Curtin JC, Zhang J, Gormley M, Sun T, Panchal A, Ennis M, Fennema E, Daksh M, Sethi S, Bauml JM, Lee SH. Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA. Ann Oncol. 2024 Sep;35(9):805-816. doi: 10.1016/j.annonc.2024.05.541.
  6. Peters S, Loi S, André F, Chandarlapaty S, Felip E, Finn SP, Jänne PA, Kerr KM, Munzone E, Passaro A, Pérol M, Smit EF, Swanton C, Viale G, Stahel RA. Antibody-drug conjugates in lung and breast cancer: current evidence and future directions-a position statement from the ETOP IBCSG Partners Foundation. Ann Oncol. 2024 Jul;35(7):607-629. doi: 10.1016/j.annonc.2024.04.002.
  7. Meyer ML, Peters S, Mok TS, Lam S, Yang PC, Aggarwal C, Brahmer J, Dziadziuszko R, Felip E, Ferris A, Forde PM, Gray J, Gros L, Halmos B, Herbst R, Jänne PA, Johnson BE, Kelly K, Leighl NB, Liu S, Lowy I, Marron TU, Paz-Ares L, Rizvi N, Rudin CM, Shum E, Stahel R, Trunova N, Bunn PA, Hirsch FR. Lung cancer research and treatment: global perspectives and strategic calls to action. Ann Oncol. 2024 Dec;35(12):1088-1104. doi: 10.1016/j.annonc.2024.10.006.
  8. Yu HA, Baik C, Kim DW, Johnson ML, Hayashi H, Nishio M, Yang JC, Su WC, Gold KA, Koczywas M, Smit EF, Steuer CE, Felip E, Murakami H, Kim SW, Su X, Sato S, Fan PD, Fujimura M, Tanaka Y, Patel P, Sternberg DW, Sellami D, Jänne PA. Translational insights and overall survival in the U31402-A-U102 study of patritumab deruxtecan (HER3-DXd) in EGFR-mutated NSCLC. Ann Oncol. 2024 May;35(5):437-447. doi: 10.1016/j.annonc.2024.02.003.
  9. Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655. doi: 10.1038/s41586-024-07121-9. Epub 2024 Feb 28. Erratum in: Nature. 2024 Mar;627(8005):E11. doi: 10.1038/s41586-024-07280-9. Erratum in: Nature. 2024 Jun;630(8016):E9. doi: 10.1038/s41586-024-07562-2. Erratum in: Nature. 2024 Sep;633(8030):E1. doi: 10.1038/s41586-024-07956-2.
  10. Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980.
  11. Solomon BJ, Liu G, Felip E, Mok TSK, Soo RA, Mazieres J, Shaw AT, de Marinis F, Goto Y, Wu YL, Kim DW, Martini JF, Messina R, Paolini J, Polli A, Thomaidou D, Toffalorio F, Bauer TM. Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study. J Clin Oncol. 2024 Oct 10;42(29):3400-3409. doi: 10.1200/JCO.24.00581.
  12. Spigel DR, Dowlati A, Chen Y, Navarro A, Yang JC, Stojanovic G, Jove M, Rich P, Andric ZG, Wu YL, Rudin CM, Chen H, Zhang L, Yeung S, Benzaghou F, Paz-Ares L, Bunn PA; RESILIENT Trial Investigators. RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 1;42(19):2317-2326. doi: 10.1200/JCO.23.02110.
  13. Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733.
  14. Rudin CM, Liu SV, Soo RA, Lu S, Hong MH, Lee JS, Bryl M, Dumoulin DW, Rittmeyer A, Chiu CH, Ozyilkan O, Johnson M, Navarro A, Novello S, Ozawa Y, Tam SH, Patil NS, Wen X, Huang M, Hoang T, Meng R, Reck M. SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2024 Jan 20;42(3):324-335. doi: 10.1200/JCO.23.01363.
  15. Leighl NB, Akamatsu H, Lim SM, Cheng Y, Minchom AR, Marmarelis ME, Sanborn RE, Chih-Hsin Yang J, Liu B, John T, Massutí B, Spira AI, Lee SH, Wang J, Li J, Liu C, Novello S, Kondo M, Tamiya M, Korbenfeld E, Moskovitz M, Han JY, Alexander M, Joshi R, Felip E, Voon PJ, Danchaivijitr P, Hsu PC, Silva Melo Cruz FJ, Wehler T, Greillier L, Teixeira E, Nguyen D, Sabari JK, Qin A, Kowalski D, Şendur MAN, Xie J, Ghosh D, Alhadab A, Haddish-Berhane N, Clemens PL, Lorenzini P, Verheijen RB, Gamil M, Bauml JM, Baig M, Passaro A; PALOMA-3 Investigators. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605. doi: 10.1200/JCO.24.01001.
  16. Dowlati A, Hummel HD, Champiat S, Olmedo ME, Boyer M, He K, Steeghs N, Izumi H, Johnson ML, Yoshida T, Bouchaab H, Borghaei H, Felip E, Jost PJ, Gadgeel S, Chen X, Yu Y, Martinez P, Parkes A, Paz-Ares L. Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update. J Clin Oncol. 2024 Oct 10;42(29):3392-3399. doi: 10.1200/JCO.24.00553.
  17. Provencio M, Nadal E, Insa A, García Campelo R, Casal J, Dómine M, Massuti B, Majem M, Rodríguez-Abreu D, Martínez-Martí A, de Castro J, Gómez de Antonio D, Macia I, Figueroa S, Fernández Vago L, Calvo V, Palmero R, Sierra-Rodero B, Martínez-Toledo C, Molina-Alejandre M, Serna-Blasco R, Romero A, Cruz-Bermúdez A. Perioperative chemotherapy and nivolumab in non-small-cell lung cancer (NADIM): 5-year clinical outcomes from a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Nov;25(11):1453-1464. doi: 10.1016/S1470-2045(24)00498-4. Epub 2024 Oct 14. Erratum in: Lancet Oncol. 2024 Nov;25(11):e542. doi: 10.1016/S1470-2045(24)00593-X.
  18. Smit EF, Felip E, Uprety D, Nagasaka M, Nakagawa K, Paz-Ares Rodríguez L, Pacheco JM, Li BT, Planchard D, Baik C, Goto Y, Murakami H, Saltos A, Pereira K, Taguchi A, Cheng Y, Yan Q, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol. 2024 Apr;25(4):439-454. doi: 10.1016/S1470-2045(24)00064-0.
  19. Usset J, Rosendahl Huber A, Andrianova MA, Batlle E, Carles J, Cuppen E, Elez E, Felip E, Gómez-Rey M, Lo Giacco D, Martinez-Jimenez F, Muñoz-Couselo E, Siu LL, Tabernero J, Vivancos A, Muiños F, Gonzalez-Perez A, Lopez-Bigas N. Five latent factors underlie response to immunotherapy. Nat Genet. 2024 Oct;56(10):2112-2120. doi: 10.1038/s41588-024-01899-0.
  20. Lin JJ, Horan JC, Tangpeerachaikul A, Swalduz A, Valdivia A, Johnson ML, Besse B, Camidge DR, Fujino T, Yoda S, Nguyen-Phuong L, Mizuta H, Bigot L, Nobre C, Lee JB, Yu MR, Mente S, Sun Y, Kohl NE, Porter JR, Shair MD, Zhu VW, Felip E, Cho BC, Friboulet L, Hata AN, Pelish HE, Drilon A. NVL-655 Is a Selective and Brain-Penetrant Inhibitor of Diverse ALK-Mutant Oncoproteins, Including Lorlatinib-Resistant Compound Mutations. Cancer Discov. 2024 Dec 2;14(12):2367-2386. doi: 10.1158/2159-8290.CD-24-0231.
  21. Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Özgüroğlu M, Dols MC, Sullivan R, Kowalski DM, Andric Z, Lee DH, Sezer A, Hu P, Wang X, von Heydebreck A, Jacob N, Mehr KT, Park K. Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. J Thorac Oncol. 2024 Feb;19(2):297-313. doi: 10.1016/j.jtho.2023.09.1445.
  22. Vokes EE, Mornex F, Sezer A, Cheng Y, Fang J, Baz DV, Cil T, Adjei AA, Ahn MJ, Barlesi F, Felip E, Garon EB, Audhuy F, Ito R, Sato M, Eggleton SP, Martin CM, Reck M, Robinson CG, Paz-Ares L. Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study. J Thorac Oncol. 2024 Feb;19(2):285-296. doi: 10.1016/j.jtho.2023.09.1452.
  23. Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Herraez-Baranda LA, Shearer-Kang E, Liu X, Tosti N, Williams P, Castro Sanchez AY, Zanghi J, Felip E. Brief Report: Updated Data From IMscin001 Part 2, a Randomized Phase III Study of Subcutaneous Versus Intravenous Atezolizumab in Patients With Locally Advanced or Metastatic NSCLC. J Thorac Oncol. 2024 Oct;19(10):1460-1466. doi: 10.1016/j.jtho.2024.05.005.
  24. Spicer JD, Cascone T, Wynes MW, Ahn MJ, Dacic S, Felip E, Forde PM, Higgins KA, Kris MG, Mitsudomi T, Provencio M, Senan S, Solomon BJ, Tsao MS, Tsuboi M, Wakelee HA, Wu YL, Chih-Hsin Yang J, Zhou C, Harpole DH, Kelly KL. Neoadjuvant and Adjuvant Treatments for Early Stage Resectable NSCLC: Consensus Recommendations From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2024 Oct;19(10):1373-1414. doi: 10.1016/j.jtho.2024.06.010.
  25. Mirallas O, Martin-Cullell B, Navarro V, Vega KS, Recuero-Borau J, Gómez-Puerto D, López-Valbuena D, Salva de Torres C, Andurell L, Pedrola A, Berché R, Palmas F, Ucha JM, Villacampa G, Rezqallah A, Sanz-Beltran J, Bach R, Bueno S, Viaplana C, Molina G, Hernando-Calvo A, Aguilar-Company J, Roca M, Muñoz-Couselo E, Martínez-Martí A, Alonso A, Eremiev S, Macarulla T, Oaknin A, Saura C, Élez E, Felip E, Peñuelas Á, Burgos R, Pardo PG, Garralda E, Tabernero J, Serradell S, Servitja S, Paez D, Dienstmann R, Carles J. Development of a prognostic model to predict 90-day mortality in hospitalised cancer patients (PROMISE tool): a prospective observational study. Lancet Reg Health Eur. 2024 Oct 9;46:101063. doi: 10.1016/j.lanepe.2024.101063.
  26. Petracci E, Pasini L, Urbini M, Felip E, Stella F, Davoli F, Salvi M, Beau-Faller M, Tebaldi M, Azzali I, Canale M, Solli P, Lai G, Amat R, Carbonell C, Falcoz PE, Martinez-Marti A, Pencreach E, Delmonte A, Crinò L, Ulivi P. Circulating cell-free and extracellular vesicles-derived microRNA as prognostic biomarkers in patients with early-stage NSCLC: results from RESTING study. J Exp Clin Cancer Res. 2024 Aug 22;43(1):241. doi: 10.1186/s13046-024-03156-y.
  27. Carbone DP, Ciuleanu TE, Schenker M, Cobo M, Bordenave S, Juan-Vidal O, Menezes J, Reinmuth N, Richardet E, Cheng Y, Mizutani H, Felip E, Zurawski B, Alexandru A, Paz-Ares L, Lu S, John T, Zhang X, Mahmood J, Hu N, De T, Santi I, Penrod JR, Yuan Y, Lee A, Reck M. Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial. J Immunother Cancer. 2024 Feb 12;12(2):e008189. doi: 10.1136/jitc-2023-008189.
  28. Ciardiello F, Hirsch FR, Pirker R, Felip E, Valencia C, Smit EF. The role of anti-EGFR therapies in EGFR-TKI-resistant advanced non-small cell lung cancer. Cancer Treat Rev. 2024 Jan;122:102664. doi: 10.1016/j.ctrv.2023.102664.
  29. Thunold S, Hernes E, Farooqi S, Öjlert ÅK, Francis RJ, Nowak AK, Szejniuk WM, Nielsen SS, Cedres S, Perdigo MS, Sørensen JB, Meltzer C, Mikalsen LTG, Helland Å, Malinen E, Haakensen VD. Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):693-707. doi: 10.1007/s00259-024-06853-0. Epub 2024 Aug 12.
  30. Felip E, Metro G, Soo RA, Wolf J, Solomon BJ, Tan DS, Ardizzoni A, Lee DH, Sequist LV, Barlesi F, Ponce-Aix S, Abreu DR, Campelo MRG, Sprauten M, Djentuh LO, Smith N, Jary A, Belli R, Glaser S, Zou M, Cui X, Giovannini M, Yang JC. Capmatinib plus nazartinib in patients with EGFR-mutated non-small cell lung cancer. Eur J Cancer. 2024 Sep;208:114182. doi: 10.1016/j.ejca.2024.114182.
  31. Reck M, Ciuleanu TE, Schenker M, Bordenave S, Cobo M, Juan-Vidal O, Reinmuth N, Richardet E, Felip E, Menezes J, Cheng Y, Mizutani H, Zurawski B, Alexandru A, Carbone DP, Lu S, John T, Aoyama T, Grootendorst DJ, Hu N, Eccles LJ, Paz-Ares LG. Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial. Eur J Cancer. 2024 Nov;211:114296. doi: 10.1016/j.ejca.2024.114296.
  32. Van Cutsem E, Mahé I, Felip E, Agnelli G, Awada A, Cohen A, Falanga A, Mandala M, Peeters M, Tsoukalas N, Verhamme P, Ay C. Treating cancer-associated venous thromboembolism: A practical approach. Eur J Cancer. 2024 Sep;209:114263. doi: 10.1016/j.ejca.2024.114263.
  33. Haakensen VD, Öjlert ÅK, Thunold S, Farooqi S, Nowak AK, Chin WL, Grundberg O, Szejniuk WM, Cedres S, Sørensen JB, Dalen TS, Lund-Iversen M, Bjaanæs M, Helland Å. UV1 telomerase vaccine with ipilimumab and nivolumab as second line treatment for pleural mesothelioma - A phase II randomised trial. Eur J Cancer. 2024 May;202:113973. doi: 10.1016/j.ejca.2024.113973.
  34. Michels S, Massutí B, Vasyliv I, Stratmann J, Frank J, Adams A, Felip E, Grohé C, Rodriguez-Abreu D, Bischoff H, Carcereny I Costa E, Corral J, Pereira E, Fassunke J, Fischer RN, Insa A, Koleczko S, Nogova L, Reck M, Reutter T, Riedel R, Schaufler D, Scheffler M, Weisthoff M, Provencio M, Merkelbach-Bruse S, Hellmich M, Sebastian M, Büttner R, Persigehl T, Rosell R, Wolf J. Overall survival and central nervous system activity of crizotinib in ROS1-rearranged lung cancer-final results of the EUCROSS trial. ESMO Open. 2024 Feb;9(2):102237. doi: 10.1016/j.esmoop.2024.102237.
  35. Riveiro-Barciela M, Barreira-Díaz A, Salcedo MT, Callejo-Pérez A, Muñoz-Couselo E, Iranzo P, Ortiz-Velez C, Cedrés S, Díaz-Mejía N, Ruiz-Cobo JC, Morales R, Aguilar-Company J, Zamora E, Oliveira M, Sanz-Martínez MT, Viladomiu L, Martínez-Gallo M, Felip E, Buti M. An algorithm based on immunotherapy discontinuation and liver biopsy spares corticosteroids in two thirds of cases of severe checkpoint inhibitor-induced liver injury. Aliment Pharmacol Ther. 2024 Apr;59(7):865-876. doi: 10.1111/apt.17898.
  36. Chen J, Bearz A, Kim DW, Mamdani H, Bauman J, Chiari R, Ou SI, Solomon BJ, Soo RA, Felip E, Shaw AT, Thurm H, Clancy JS, Lee K, O'Gorman M, Tanski C, Pithavala YK. Evaluation of the Effect of Lorlatinib on CYP2B6, CYP2C9, UGT, and P-Glycoprotein Substrates in Patients with Advanced Non-Small Cell Lung Cancer. Clin Pharmacokinet. 2024 Feb;63(2):171-182. doi: 10.1007/s40262-023-01309-4.
  37. Planchard D, Wolf J, Solomon B, Sebastian M, Wermke M, Heist RS, Sun JM, Min Kim T, Reguart N, Sanmamed MF, Felip E, Garrido P, Santoro A, Bootle D, Couillebault XM, Gaur A, Mueller C, Poggio T, Yang J, Moschetta M, Dooms C. A phase Ib study of the combination of naporafenib with rineterkib or trametinib in patients with advanced and metastatic KRAS- or BRAF-mutant non-small cell lung cancer. Lung Cancer. 2024 Nov;197:107964. doi: 10.1016/j.lungcan.2024.107964.
  38. Liu G, Mazieres J, Stratmann J, Ou SI, Mok T, Grizzard M, Goto Y, Felip E, Solomon BJ, Bauer TM. A pragmatic guide for management of adverse events associated with lorlatinib. Lung Cancer. 2024 May;191:107535. doi: 10.1016/j.lungcan.2024.107535.
  39. Bar J, Esteban E, Rodríguez-Abreu D, Aix SP, Szalai Z, Felip E, Gottfried M, Provencio M, Robinson A, Fülöp A, Rao SB, Camidge DR, Speranza G, Townson SM, Kobie J, Ayers M, Dettman EJ, Hunkapiller N, McDaniel R, Jung B, Burkhardt D, Mauntz R, Csőszi T. Blood tumor mutational burden and response to pembrolizumab plus chemotherapy in non-small cell lung cancer: KEYNOTE-782. Lung Cancer. 2024 Apr;190:107506. doi: 10.1016/j.lungcan.2024.107506.
  40. Provencio M, Robado de Lope L, Serna-Blasco R, Nadal E, Diz Tain P, Massuti B, González-Larriba JL, Insa A, Sánchez-Hernández A, Casal-Rubio J, García-Campelo R, Sequero López S, Rogado J, Martínez-Martí A, Bosch-Barrera J, Bernabé R, Vázquez Estévez S, Ponce S, de Castro J, Coves Sarto J, Reguart N, Dómine M, Aguilar A, Majem M, Estival A, Peña Cabia S, López Martín A, Sala González MÁ, Cobo M, Camps C, Barneto I, Calvo V, Collazo-Lorduy A, Cruz-Bermúdez A, Romero A. BRAF mutational status is associated with survival outcomes in locally advanced resectable and metastatic NSCLC. Lung Cancer. 2024 Aug;194:107865. doi: 10.1016/j.lungcan.2024.107865.
  41. Felip E, Metro G, Tan DSW, Wolf J, Mark M, Boyer M, Hughes BGM, Bearz A, Moro-Sibilot D, Le X, Puente J, Massuti B, Tiedt R, Wang Y, Xu C, Mardjuadi FI, Cobo M. Capmatinib plus nivolumab in pretreated patients with EGFR wild-type advanced non-small cell lung cancer. Lung Cancer. 2024 Jun;192:107820. doi: 10.1016/j.lungcan.2024.107820.
  42. Carreras MJ, Renedo-Miró B, Valdivia C, Tomás-Guillén E, Farriols A, Mañós L, Vidal J, Alcalde M, De la Paz I, Jiménez-Lozano I, Palacio-Lacambra ME, Sabaté N, Felip E, Garralda E, Garau M, Gorgas MQ, Monterde J, Tabernero J. Drug Cost Avoidance Resulting from Participation in Clinical Trials: A 10-Year Retrospective Analysis of Cancer Patients with Solid Tumors. Cancers (Basel). 2024 Apr 17;16(8):1529. doi: 10.3390/cancers16081529.
  43. Peters S, Trigo J, Besse B, Moreno V, Navarro A, Eugenia Olmedo M, Paz-Ares L, Grohé C, Antonio Lopez-Vilariño J, Fernández C, Kahatt C, Alfaro V, Nieto A, Zeaiter A, Subbiah V. Lurbinectedin in patients with small cell lung cancer with chemotherapy-free interval ≥30 days and without central nervous metastases. Lung Cancer. 2024 Feb;188:107448. doi: 10.1016/j.lungcan.2023.107448.
  44. Piedra A, Martínez-Recio S, Hernández A, Morán T, Arriola E, Recuero-Borau J, Cobo M, Cordeiro P, Mosquera J, Fernández M, García-Campelo R, Calles A, Álvarez R, Zapata-García M, Isla D, Callejo A, Iranzo P, Serra-López J, Barba A, Sullivan I, Felip E, Majem M. First-line pembrolizumab in patients with advanced non-small cell lung cancer and high PD-L1 expression: real-world data from a Spanish multicenter study. Front Oncol. 2024 Dec 17;14:1510278. doi: 10.3389/fonc.2024.1510278.
  45. Khasraw M, Yalamanchili P, Santhanagopal A, Wu C, Salas M, Meng J, Karnoub M, Esker S, Felip E. Clinical Management of Patients with Non-Small Cell Lung Cancer, Brain Metastases, and Actionable Genomic Alterations: A Systematic Literature Review. Adv Ther. 2024 May;41(5):1815-1842. doi: 10.1007/s12325-024-02799-9.
  46. Santoro A, Pilar G, Tan DSW, Zugazagoitia J, Shepherd FA, Bearz A, Barlesi F, Kim TM, Overbeck TR, Felip E, Cai C, Eddy S, McCulloch T, Schaefer ES. Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC. BMC Cancer. 2024 Oct 24;24(1):1307. doi: 10.1186/s12885-024-12841-2. Erratum in: BMC Cancer. 2024 Nov 21;24(1):1436. doi: 10.1186/s12885-024-13210-9.
  47. Riely GJ, Smit EF, Ahn MJ, Felip E, Ramalingam SS, Tsao A, Johnson M, Gelsomino F, Esper R, Nadal E, Offin M, Provencio M, Clarke J, Hussein M, Otterson GA, Dagogo-Jack I, Goldman JW, Morgensztern D, Alcasid A, Usari T, Wissel P, Wilner K, Pathan N, Tonkovyd S, Johnson BE. A plain language summary of the PHAROS study: the combination of encorafenib and binimetinib for people with BRAF V600E-mutant metastatic non-small-cell lung cancer. Future Oncol. 2024;20(16):1047-1055. doi: 10.2217/fon-2023-0859.
  48. Solomon BJ, Dagogo-Jack I, Lee SH, Boyer MJ, Ramalingam SS, Carcereny E, Felip E, Han JY, Hida T, Hughes BGM, Kim SW, Nishio M, Seto T, Okamoto T, Zhang X, Martini JF, Wang E, De Beukelaer S, Bauer TM. Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial. JTO Clin Res Rep. 2024 May 16;5(7):100685. doi: 10.1016/j.jtocrr.2024.100685.
  49. Neal JW, Santoro A, Gonzalez-Cao M, Lim FL, Fang B, Gentzler RD, Goldschmidt J, Khrizman P, Proto C, Patel S, Puri S, Liu SV, Massarelli E, Williamson D, Schwickart M, Scheffold C, Andrianova S, Felip E. Cabozantinib Plus Atezolizumab or Cabozantinib Alone in Patients With Advanced NSCLC Previously Treated With an Immune Checkpoint Inhibitor: Results From the Phase 1b COSMIC-021 Study. JTO Clin Res Rep. 2024 Mar 20;5(10):100666. doi: 10.1016/j.jtocrr.2024.100666.
  50. Conde E, Hernandez S, Rodriguez Carrillo JL, Martinez R, Alonso M, Curto D, Jimenez B, Caminoa A, Benito A, Garrido P, Clave S, Arriola E, Esteban-Rodriguez I, De Castro J, Sansano I, Felip E, Rojo F, Dómine M, Abdulkader I, Garcia-Gonzalez J, Teixido C, Reguart N, Compañ D, Insa A, Mancheño N, Palanca S, Juan-Vidal O, Baixeras N, Nadal E, Cebollero M, Calles A, Martin P, Salas C, Provencio M, Aranda I, Massuti B, Lopez-Vilaro L, Majem M, Paz-Ares L, Lopez-Rios F. RET Fusion Testing in Patients With NSCLC: The RETING Study. JTO Clin Res Rep. 2024 Feb 20;5(4):100653. doi: 10.1016/j.jtocrr.2024.100653.
  51. Arriola E, de Castro J, García-Campelo R, Bernárdez B, Bernabé R, Bruna J, Dómine M, Isla D, Juan-Vidal Ó, López-Fernández T, Nadal E, Rodríguez-Abreu D, Vares M, Asensio Ú, García LF, Felip E. Expert Consensus on the Management of Adverse Events of Lorlatinib in the Treatment of ALK+ Advanced Non-small Cell Lung Cancer. Clin Drug Investig. 2024 Aug;44(8):553-576. doi: 10.1007/s40261-024-01379-7.
  52. Sebri V, Marzorati C, Dorangricchia P, Monzani D, Grasso R, Prelaj A, Provenzano L, Mazzeo L, Dumitrascu AD, Sonnek J, Szewczyk M, Watermann I, Trovò F, Dollis N, Sarris E, Garassino MC, Bestvina CM, Pedrocchi A, Ambrosini E, Kosta S, Felip E, Soleda M, Roca AA, Rodríguez-Morató J, Nuara A, Lourie Y, Fernandez-Pinto M, Aguaron A, Pravettoni G. The impact of decision tools during oncological consultation with lung cancer patients: A systematic review within the I3LUNG project. Cancer Med. 2024 May;13(9):e7159. doi: 10.1002/cam4.7159.
  53. Fernandez Montes A, Elez E, de la Haba-Rodriguez J, Paez D, Mendez-Vidal MJ, Felip E, Rodriguez-Lescure A. Medical oncology workload, workforce census, and needs in Spain: two nationwide studies by the Spanish Society of medical oncology. Clin Transl Oncol. 2024 Jan;26(1):98-108. doi: 10.1007/s12094-023-03225-2.
  54. Ospina AV, Bolufer Nadal S, Campo-Cañaveral de la Cruz JL, González Larriba JL, Macía Vidueira I, Massutí Sureda B, Nadal E, Trancho FH, Álvarez Kindelán A, Del Barco Morillo E, Bernabé Caro R, Bosch Barrera J, Calvo de Juan V, Casal Rubio J, de Castro J, Cilleruelo Ramos Á, Cobo Dols M, Dómine Gómez M, Figueroa Almánzar S, Garcia Campelo R, Insa Mollá A, Jarabo Sarceda JR, Jiménez Maestre U, López Castro R, Majem M, Martinez-Marti A, Martínez Téllez E, Sánchez Lorente D, Provencio M. Multidisciplinary approach for locally advanced non-small cell lung cancer (NSCLC): 2023 expert consensus of the Spanish Lung Cancer Group GECP. Clin Transl Oncol. 2024 Jul;26(7):1647-1663. doi: 10.1007/s12094-024-03382-y.
  55. Viñolas N, Mezquita L, Corral J, Cobo M, Gil-Moncayo F, Paz-Ares L, Remon J, Rodríguez M, Ruano-Raviña A, Conde E, Majem M, Garrido P, Felip E, Isla D, de Castro J. The role of sex and gender in the diagnosis and treatment of lung cancer: the 6th ICAPEM Annual Symposium. Clin Transl Oncol. 2024 Feb;26(2):352-362. doi: 10.1007/s12094-023-03262-x.
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Code Clinical trial title
BO29554 (BFAST) A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON−SMALL CELL LUNG CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (BFAST: BLOOD FIRST ASSAY SCREENING TRIAL).
MK-3475-587 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.
U31402-A-U102 A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF U3-1402 IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER.
TPX-0005-01(TRIDENT-1) 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).
1438-0001 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.
73841937NSC1001 An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer.
4020-01-001 (AMBER) 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).
CA209-8TT Pan Tumor Study for Long Term Follow-up of Cancer Survivors who have participated in Trials investigating Nivolumab.
GCT1042-01 A First-in-Human, Open-label, Dose-escalation Trial with Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects with Malignant Solid Tumors.
CJDQ443A12101 A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation.
BO42864 (AcceleRET) A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non- Small Cell Lung Cancer.
849-007-III (KRYSTAL-07) A Phase 3 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation.
D9570C00001 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 .
20160323 (AMG757) A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer.
ASTX029-01 A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors.
GCT1046-04 ‘A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor’
MK-1084-001 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.
BLU-945-1101 ‘A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer’
20190135 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
D7020C00001 (ARTEMIDE-01) 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.
NVL-520-01 (NUVALENT) A Phase 1/2 study of the highly selective ROS1 inhibitor NUV-520 in patients with advanced NSCLC and other solid tumors.
FS120-19101 A Phase 1/2 Open-Label Study to Evaluate the Safety and Antitumor  Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab in Subjects With Advanced Malignancies.
BAY 2927088 / 21607 First-in-human study of BAY2927088 in patients with advanced cancer harboring an EGFR and/or HER2 mutation.
NVL-655-01 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)
NVL-655-01-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)
AB-106-G208 (AnHearth) (TRUST-II) A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors.
B7461039 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
CMGY825A12101 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
DS1062-A-U304 (Tropion-LUNG08) 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)
MCLA-129-CL01 “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”
20200469 A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer
BNT116-01 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.
TIG-006 A Multicenter, Open-Label, Phase I/II Study of EOS884448 in combination with pembrolizumab or inupadenant in participants with advanced solid tumors.
D5087C00001 (SAFFRON) 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)
20210104 (FORTITUDE-301) “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)”
GALLANT-1 An open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension study to investigate the safety and efficacy of GB1211 (a galectin-3 inhibitor) in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC).
COMBI-TED 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)
CJDQ443B12201 (KontRASt-06) An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer with PD-L1 expression <1% or STK11 co-mutations.
61186372NSC2002 (PALOMA-2) 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)
B9991046 MASTER AVELUMAB MASTER PROTOCOL (B9991046): AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES,
IO102-IO103-022 (IOB-022) A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with Pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head and Neck (SCCHN), and Metastatic Urothelial Bladder Cancer (mUBC).
213824 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.
D533BC00001 (LATIFY) "A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY"
GS-US-626-6216 "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"
PLATFORMPANSC2001 (KALEIDOSCOPE) MASTER A Phase 1/2 Open-label Platform Study to Evaluate the Safety and Efficacy of Multiple Amivantamab-based Therapeutic Combinations in Participants with Advanced, Unresectable Lung Cancer (LC)
PLATFORMPANSC2001 SUBSTUDY 61186372PANSC2001 (METalmark) Estudio Fase I/II para establecer la seguridad y eficacia preliminar de la combinación de amivantamab y capmatinib para pacientes con NSCLC avanzado/metastásico con mutación MET exon14 skipping y amplificación de MET (METalmark)
1479-0001 Open label, Phase Ib dose expansion trial, of BI 1810631 as monotherapy in patients with advanced or metastatic NSCLC with HER2 mutations
BGBC016 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
BGB-900-102 Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors
D4191C00137 (ROSY-D) Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit from Continued Treatment
DZ2022E0005 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.
Nav-1003 "A Phase 1 Study of the SHP2 Inhibitor BBP-398 in combination with the KRASG12C Inhibitor Sotorasib in Patients with Advanced Solid Tumors and a KRAS-G12C Mutation"
A2A-005 (ITeos_A2A-005_NSCLC) A2A-005 A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy.
M21-404 A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors
BO44178 A PHASE II, RANDOMIZED, MULTICENTER, DOUBLEBLIND, CONTROLLED STUDY OF RO7247669 PLUS PLATINUM-BASED CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC NON−SMALL-CELL LUNG CANCER
FURMO-004 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
DS1062-A-U303 (TROPION-LUNG07) 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)
BGB-LC-201 A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
D9350C00001 (EGRET) 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
GFH925X0201 A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
CA115-001 Phase 1b/2 Study of BMS-986442 in Combination with Nivolumab or Nivolumab and Chemotherapies in Participants with Advanced Solid Tumors and Non-small Cell Lung Cancer
MS100070_0176 “An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies”
BO44426 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
20210004 (DELLPHI-304) "A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects with Relapsed Small Cell Lung Cancer After Platinum-based First Line Chemotherapy”
MK-2870-004 “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”
PYX-201-101 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
61186372NSC2005 (SKIPPirr) Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated with Amivantamab, an EGFR-MET bispecific antibody, Among Post-osimertinib Treated EGFRm NSCLC;  SKIPPirr, a Phase 2 Study
86974680NSC1001 “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.”
AK112-301 (HARMONI) A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed EGFR-TKI Treatment
CLN-081-001 “A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received PlatinumBased Systemic Chemotherapy”
BP44382 (Tridenis) 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
FURMO-002 A Phase 1b dose escalation and dose expansion study evaluating the safety, pharmacokinetics and antitumor activity of Furmonertinib in patients with advanced or metastatic solid tumors
CA127-1030 (TRIDENT-3) 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
SR7075-ONC-2009 Phase I/II dose expansion study for an EGFRxCD28 costimulatory bispecific antibody in combination with cemiplimab in patients with advanced solid tumors
61186372NSC2007 (COCOON) 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
SMT112-3003 (HARMONI-3) 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
MK-2870-007 "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%"
MS201924_0022 An Open-label, Multicenter, Controlled Phase 1b/2a to evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR Inhibitor M1774 in combination with Cemiplimab in Participants with Non-squamous Non-small Cell Lung Cancer that have progressed on prior anti- PD-(L)1 and Platinum-based Therapies
20190341 (CodeBreaK 202) “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)”
ROMast-001 “A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)”
87704916LUC1001 A Phase 1 Study of Intratumoral Delivery of JNJ 87704916 in Combination with Systemic Immunotherapies in Patients with Non-Small Cell Lung Cancers
J3M-MC-JZQB (SUNRAY-01) 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
STX-721-101 First-In-Human Study of STX-721 In Participants With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
1479-0008 (Beamion LUNG-2) 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
SGNB6A-002 "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"
MK-1084-004 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%.
PLATFORMPANSC2001 SUBSTUDY 61186372PANSC2002 (POLYDAMAS) Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer (PolyDamas)
XmAb717-06 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
BO45217 (Krascendo 1) 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+.
21948 “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”
20220127 "A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors Conditions"
SGNDV-005 A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2.
MK-3475A-F84 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%”
BAY 2862789/22231 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
SPLFIO-174 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
F60087CI101 "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)"
NIS102748 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)

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, Francisco Grau, 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 particular focus on cell signaling, cancer stem cells, and immuno-oncology (IO), we develop and lead proof-of-concept clinical trials with targeted therapies. These include first-in-human studies of targeted therapies, rational combinations of targeted therapies, biomarker-driven trials, 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 match molecular biology and optimal tumor models 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 promising novel anticancer therapies. In close collaboration with VHIO’s Cancer Genomics Group directed by Ana Vivancos, we also work on different projects exploring novel biomarkers for immuno-oncology (IO) for patient selection and enrolment in our phase I clinical trials.

VHIO is a founding member of both the WIN - Worldwide Innovative Networking in personalized cancer medicine and the Cancer Core Europe (CCE) consortia. 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. Supported by CCE and co-funded by pharmaceutical companies, this innovative academic study integrates flexible molecular prescreening with the development of new diagnostic tests based on circulating tumor DNA (ctDNA) or gene expression (Nanostring). 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 collaborated 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 of paramount importance throughout. This project concluded in 2024.

In collaboration with VHIO’s UITM – CaixaResearch, our teams continue to establish VHIO as a leading reference in cancer drug discovery and development. In 2024, 624 patients were enrolled in our portfolio of 266 phase I and Basket studies with active recruitment at some time in the year. Supported by VHIO’s CaixaResearch Advanced Oncology Research Program, 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 this 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 2024 the trial received regulatory approval in Spain and Denmark and conditional approval in the Netherlands. 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.

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 throughout 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 AKT1, EGFR, IDH1, ALK, ROS1, BRAF, NRAS, KRAS, FGFR1 and 2, MET, HER2, HER3, RET, ATM, BRCA, amplifications in HER2, AKT 1, 2, and 3, FGFR1, MET, NOTCH1-4, and rearrangements of NTRK1-3, ROS1, ALK, BRAF, RSPO2/3, RET, NRG and FGFR1-3.
  • 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 disease.
  • Within the scope of our CAIMI program and the AstraZeneca Partner 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.
  • In collaboration with Alena Gros’ Tumor Immunology and 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 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 Award.
  • 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
  • Build and strengthen our capacities to develop radioligand therapies.
  • Garralda E, Beaulieu ME, Moreno V, Casacuberta-Serra S, Martínez-Martín S, Foradada L, Alonso G, Massó-Vallés D, López-Estévez S, Jauset T, Corral de la Fuente E, Doger B, Hernández T, Perez-Lopez R, Arqués O, Castillo Cano V, Morales J, Whitfield JR, Niewel M, Soucek L, Calvo E. MYC targeting by OMO-103 in solid tumors: a phase 1 trial. Nat Med. 2024 Mar;30(3):762-771.
  • Desai J, Alonso G, Kim SH, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller WH Jr, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim TW, Moreno V, Ou SI, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel MR, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL; GO42144 Investigator and Study Group; Han SW. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):271-278.
  • Carmona J, Chavarria E, Donoghue K, von Gertten C, Oberrauch P, Pailler E, Scoazec G, Weijer R, Balmaña J, Brana I, Brunelli C, Delaloge S, Deloger M, Delpy P, Ernberg I, Fitzgerald RC, Garralda E, Lablans M, Lëhtio J, Lopez C, Fernández M, Miceli R, Nuciforo P, Perez-Lopez R, Provenzano E, Schmidt MK, Serrano C, Steeghs N, Tamborero D, Wirta V, Baird RD, Barker K, Barlesi F, Baumann M, Bergh J, de Braud F, Fizazi K, Fröhling S, Piris-Giménez A, Seamon K, Van der Heijden MS, Zwart W, Tabernero J. Cancer Core Europe: Leveraging Institutional Synergies to Advance Oncology Research and Care Globally. Cancer Discov. 2024 Jul 1;14(7):1147-1153.
  • Westphalen CB, Martins-Branco D, Beal JR, Cardone C, Coleman N, Schram AM, Halabi S, Michiels S, Yap C, André F, Bibeau F, Curigliano G, Garralda E, Kummar S, Kurzrock R, Limaye S, Loges S, Marabelle A, Marchió C, Mateo J, Rodon J, Spanic T, Pentheroudakis G, Subbiah V. The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development. Ann Oncol. 2024 Nov;35(11):936-953.
  1. Garralda E, Beaulieu ME, Moreno V, Casacuberta-Serra S, Martínez-Martín S, Foradada L, Alonso G, Massó-Vallés D, López-Estévez S, Jauset T, Corral de la Fuente E, Doger B, Hernández T, Perez-Lopez R, Arqués O, Castillo Cano V, Morales J, Whitfield JR, Niewel M, Soucek L, Calvo E. MYC targeting by OMO-103 in solid tumors: a phase 1 trial. Nat Med. 2024 Mar;30(3):762-771. doi: 10.1038/s41591-024-02805-1.
  2. Desai J, Alonso G, Kim SH, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller WH Jr, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim TW, Moreno V, Ou SI, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel MR, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL; GO42144 Investigator and Study Group; Han SW. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):271-278. doi: 10.1038/s41591-023-02696-8.
  3. Westphalen CB, Martins-Branco D, Beal JR, Cardone C, Coleman N, Schram AM, Halabi S, Michiels S, Yap C, André F, Bibeau F, Curigliano G, Garralda E, Kummar S, Kurzrock R, Limaye S, Loges S, Marabelle A, Marchió C, Mateo J, Rodon J, Spanic T, Pentheroudakis G, Subbiah V. The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development. Ann Oncol. 2024 Nov;35(11):936-953. doi: 10.1016/j.annonc.2024.07.730.
  4. Melero I, de Miguel Luken M, de Velasco G, Garralda E, Martín-Liberal J, Joerger M, Alonso G, Goebeler ME, Schuler M, König D, Dummer R, Reig M, Rodriguez Ruiz ME, Calvo E, Esteban-Villarrubia J, Oberoi A, Sabat P, Soto-Castillo JJ, Koster KL, Saavedra O, Sayehli C, Gromke T, Läubli H, Ramelyte E, Fortuny M, Landa-Magdalena A, Moreno I, Torres-Jiménez J, Hernando-Calvo A, Hess D, Racca F, Richly H, Schmitt AM, Eggenschwiler C, Sanduzzi-Zamparelli M, Vilalta-Lacarra A, Trojan J, Koch C, Galle PR, Foerster F, Trajanoski Z, Hackl H, Gogolla F, Koll FJ, Wild P, Chun FKH, Reis H, Lloyd P, Machacek M, Gajewski TF, Fridman WH, Eggermont AMM, Bargou R, Schöniger S, Rüschoff J, Tereshchenko A, Zink C, da Silva A, Lichtenegger FS, Akdemir J, Rüdiger M, L'Huillier P, Dutta A, Haake M, Auckenthaler A, Gjorgjioska A, Rössler B, Hermann F, Liebig M, Reichhardt D, Schuberth-Wagner C, Wischhusen J, Fettes P, Auer M, Klar K, Leo E. Neutralizing GDF-15 can overcome anti-PD-1 and anti-PD-L1 resistance in solid tumours. Nature. 2025 Jan;637(8048):1218-1227. doi: 10.1038/s41586-024-08305-z. Epub 2024 Dec 11.
  5. Carmona J, Chavarria E, Donoghue K, von Gertten C, Oberrauch P, Pailler E, Scoazec G, Weijer R, Balmaña J, Brana I, Brunelli C, Delaloge S, Deloger M, Delpy P, Ernberg I, Fitzgerald RC, Garralda E, Lablans M, Lëhtio J, Lopez C, Fernández M, Miceli R, Nuciforo P, Perez-Lopez R, Provenzano E, Schmidt MK, Serrano C, Steeghs N, Tamborero D, Wirta V, Baird RD, Barker K, Barlesi F, Baumann M, Bergh J, de Braud F, Fizazi K, Fröhling S, Piris-Giménez A, Seamon K, Van der Heijden MS, Zwart W, Tabernero J. Cancer Core Europe: Leveraging Institutional Synergies to Advance Oncology Research and Care Globally. Cancer Discov. 2024 Jul 1;14(7):1147-1153. doi: 10.1158/2159-8290.CD-24-0377.
  6. Román Alonso M, Grinyó-Escuer A, Duro-Sánchez S, Rius-Ruiz I, Bort-Brusca M, Escorihuela M, Maqueda-Marcos S, Pérez-Ramos S, Gago J, Nogales V, Espinosa-Bravo M, Peg V, Escrivá-de-Romaní S, Foradada L, Soucek L, Braña I, Galvao V, Martín-Lluesma S, Moessner E, Klein C, Garralda E, Saura C, Arribas J. Generation of chimeric antigen receptor T cells targeting p95HER2 in solid tumors. Nat Commun. 2024 Nov 18;15(1):9589. doi: 10.1038/s41467-024-53265-7.
  7. Herrera M, Pretelli G, Desai J, Garralda E, Siu LL, Steiner TM, Au L. Bispecific antibodies: advancing precision oncology. Trends Cancer. 2024 Oct;10(10):893-919. doi: 10.1016/j.trecan.2024.07.002.
  8. Mirallas O, Martin-Cullell B, Navarro V, Vega KS, Recuero-Borau J, Gómez-Puerto D, López-Valbuena D, Salva de Torres C, Andurell L, Pedrola A, Berché R, Palmas F, Ucha JM, Villacampa G, Rezqallah A, Sanz-Beltran J, Bach R, Bueno S, Viaplana C, Molina G, Hernando-Calvo A, Aguilar-Company J, Roca M, Muñoz-Couselo E, Martínez-Martí A, Alonso A, Eremiev S, Macarulla T, Oaknin A, Saura C, Élez E, Felip E, Peñuelas Á, Burgos R, Pardo PG, Garralda E, Tabernero J, Serradell S, Servitja S, Paez D, Dienstmann R, Carles J. Development of a prognostic model to predict 90-day mortality in hospitalised cancer patients (PROMISE tool): a prospective observational study. Lancet Reg Health Eur. 2024 Oct 9;46:101063. doi: 10.1016/j.lanepe.2024.101063.
  9. Grivas P, Garralda E, Meric-Bernstam F, Mellinghoff IK, Goyal L, Harding JJ, Dees EC, Bahleda R, Azad NS, Karippot A, Kurzrock R, Tabernero J, Kononen J, Ng MCH, Mehta R, Uboha NV, Bigot F, Boni V, Bowyer SE, Breder V, Cervantes A, Chan N, Cleary JM, Dhawan M, Eefsen RL, Ewing J, Graham DM, Guren TK, Won Kim J, Koynov K, Oh DY, Redman R, Yen CJ, Spetzler D, Roubaudi-Fraschini MC, Nicolas-Metral V, Ait-Sarkouh R, Zanna C, Ennaji A, Pokorska-Bocci A, Flaherty KT. Evaluating Debio 1347 in Patients with FGFR Fusion-Positive Advanced Solid Tumors from the FUZE Multicenter, Open-Label, Phase II Basket Trial. Clin Cancer Res. 2024 Oct 15;30(20):4572-4583. doi: 10.1158/1078-0432.CCR-24-0012.
  10. Forster M, Brana I, Pousa AL, Doger B, Roxburgh P, Bajaj P, Peguero J, Krebs M, Carcereny E, Patel G, Mueller C, Brignone C, Triebel F. Eftilagimod Alpha (Soluble LAG3 Protein) Combined with Pembrolizumab as Second-Line Therapy for Patients with Metastatic Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2024 Sep 3;30(17):3726-3734. doi: 10.1158/1078-0432.CCR-24-0473.
  11. Wyatt AW, Litiere S, Bidard FC, Cabel L, Dyrskjøt L, Karlovich CA, Pantel K, Petrie J, Philip R, Andrews HS, Vellanki PJ, Tolmeijer SH, Villalobos Alberu X, Alfano C, Bogaerts J, Calvo E, Chen AP, Toledo RA, de Vries EGE, Seymour L, Laurie SA, Garralda E; RECIST ctDNA workshop group. Plasma ctDNA as a Treatment Response Biomarker in Metastatic Cancers: Evaluation by the RECIST Working Group. Clin Cancer Res. 2024 Nov 15;30(22):5034-5041. doi: 10.1158/1078-0432.CCR-24-1883.
  12. Jiménez-Labaig P, Rullan A, Braña I, Hernando-Calvo A, Moreno V, Doger B, Bitar G, Ap Dafydd D, Melcher A, Harrington KJ. Intratumoral therapies in head and neck squamous cell carcinoma: A systematic review and future perspectives. Cancer Treat Rev. 2024 Jun;127:102746. doi: 10.1016/j.ctrv.2024.102746.
  13. Jiménez-Labaig P, Rullan A, Hernando-Calvo A, Llop S, Bhide S, O'Leary B, Braña I, Harrington KJ. A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies. Cancer Treat Rev. 2024 Jul;128:102772. doi: 10.1016/j.ctrv.2024.102772.
  14. Hernando-Calvo A, Rossi A, Vieito M, Voest E, Garralda E. Agnostic drug development revisited. Cancer Treat Rev. 2024 Jul;128:102747. doi: 10.1016/j.ctrv.2024.102747.
  15. Martín-Cullell B, Virgili AC, Riera P, Fumagalli C, Mirallas O, Pelegrín FJ, Sánchez-Cabús S, Molina V, Szafranska J, Páez D. Histopathological, Clinical, And Molecular (HICAM) score for patients with colorectal liver metastases. Br J Surg. 2024 Mar 2;111(3):znae016. doi: 10.1093/bjs/znae016.
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  17. Prior O, Macarro C, Navarro V, Monreal C, Ligero M, Garcia-Ruiz A, Serna G, Simonetti S, Braña I, Vieito M, Escobar M, Capdevila J, Byrne AT, Dienstmann R, Toledo R, Nuciforo P, Garralda E, Grussu F, Bernatowicz K, Perez-Lopez R. Identification of Precise 3D CT Radiomics for Habitat Computation by Machine Learning in Cancer. Radiol Artif Intell. 2024 Mar;6(2):e230118. doi: 10.1148/ryai.230118. Erratum in: Radiol Artif Intell. 2024 May;6(3):e249001. doi: 10.1148/ryai.249001.
  18. Methodology for the Development of Innovative Cancer Therapies Taskforce. Electronic address: lseymour@ctg.queensu.ca. Testing new anticancer drugs before curative locoregional therapies: MDICT 2024 recommendations. ESMO Open. 2024 Aug;9(8):103649. doi: 10.1016/j.esmoop.2024.103649.
  19. Lakhani N, Cosman R, Banerji U, Rasco D, Tomaszewska-Kiecana M, Garralda E, Kornacki D, Li J, Tian C, Bourayou N, Powderly J. A first-in-human phase I study of the PD-1 inhibitor, retifanlimab (INCMGA00012), in patients with advanced solid tumors (POD1UM-101). ESMO Open. 2024 Apr;9(4):102254. doi: 10.1016/j.esmoop.2024.102254.
  20. Curigliano G, Jimenez MM, Shimizu T, Keam B, Meric-Bernstam F, Rutten A, Glaspy J, Schuler PJ, Parikh NS, Ising M, Hassounah N, Wu J, Leyk M, Chen X, Burks H, Chaudhury A, Otero J, Cabanas EG. A phase I trial of LHC165 single agent and in combination with spartalizumab in patients with advanced solid malignancies. ESMO Open. 2024 Aug;9(8):103643. doi: 10.1016/j.esmoop.2024.103643.
  21. Ligero M, Gielen B, Navarro V, Cresta Morgado P, Prior O, Dienstmann R, Nuciforo P, Trebeschi S, Beets-Tan R, Sala E, Garralda E, Perez-Lopez R. A whirl of radiomics-based biomarkers in cancer immunotherapy, why is large scale validation still lacking? NPJ Precis Oncol. 2024 Feb 21;8(1):42. doi: 10.1038/s41698-024-00534-9.
  22. Lin CC, Garralda E, Schöffski P, Hong DS, Siu LL, Martin M, Maur M, Hui R, Soo RA, Chiu J, Zhang T, Ma B, Kyi C, Tan DS, Cassier PA, Sarantopoulos J, Weickhardt A, Carvajal RD, Spratlin J, Esaki T, Rolland F, Akerley W, Deschler-Baier B, Rispoli L, Samant TS, Chowdhury NR, Gusenleitner D, Kwak EL, Askoxylakis V, De Braud F. A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies. Oncoimmunology. 2023 Dec 20;13(1):2290787. doi: 10.1080/2162402X.2023.2290787. eCollection 2024.
  23. Subbiah V, Hu MI, Mansfield AS, Taylor MH, Schuler M, Zhu VW, Hadoux J, Curigliano G, Wirth L, Gainor JF, Alonso G, Adkins D, Godbert Y, Ahn MJ, Cassier PA, Cho BC, Lin CC, Zalutskaya A, Barata T, Trask P, Scalori A, Bordogna W, Heinzmann S, Brose MS. Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study. Thyroid. 2024 Jan;34(1):26-40. doi: 10.1089/thy.2023.0363. Erratum in: Thyroid. 2024 Apr 16. doi: 10.1089/thy.2023.0363.correx.
  24. Nakajima EC, Simpson A, Bogaerts J, de Vries EGE, Do R, Garalda E, Goldmacher G, Kinahan PE, Lambin P, LeStage B, Li Q, Lin F, Litière S, Perez-Lopez R, Petrick N, Schwartz L, Seymour L, Shankar L, Laurie SA. Tumor Size Is Not Everything: Advancing Radiomics as a Precision Medicine Biomarker in Oncology Drug Development and Clinical Care. A Report of a Multidisciplinary Workshop Coordinated by the RECIST Working Group. JCO Precis Oncol. 2024 Apr;8:e2300687. doi: 10.1200/PO.23.00687. Erratum in: JCO Precis Oncol. 2024 Jun;8:e2400309. doi: 10.1200/PO.24.00309.
  25. Hernando-Calvo A, Yang SYC, Vila-Casadesús M, Han M, Liu ZA, Berman AHK, Spreafico A, Razak AA, Lheureux S, Hansen AR, Lo Giacco D, Abbas-Aghababazadeh F, Matito J, Haibe-Kains B, Pugh TJ, Bratman SV, Aleshin A, Berche R, Saavedra O, Garralda E, Elston S, Siu LL, Ohashi PS, Vivancos A, Bedard PL. Combined Transcriptome and Circulating Tumor DNA Longitudinal Biomarker Analysis Associates With Clinical Outcomes in Advanced Solid Tumors Treated With Pembrolizumab. JCO Precis Oncol. 2024 Aug;8:e2400100. doi: 10.1200/PO.24.00100.
  26. Garralda E, Schram AM, Bedard PL, Schwartz GK, Yuen E, McNeely SC, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. Oncologist. 2024 Jan 5;29(1):e131-e140. doi: 10.1093/oncolo/oyad215.
  27. Geva R, Vieito M, Ramon J, Perets R, Pedregal M, Corral E, Doger B, Calvo E, Bardina J, Garralda E, Brown RJ, Greger JG, Wu S, Steinbach D, Yao TS, Cao Y, Lauring J, Chaudhary R, Patel J, Patel B, Moreno V. Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors. Cancer Immunol Immunother. 2024 Aug 6;73(10):205. doi: 10.1007/s00262-024-03790-7.
  28. Carreras MJ, Renedo-Miró B, Valdivia C, Tomás-Guillén E, Farriols A, Mañós L, Vidal J, Alcalde M, De la Paz I, Jiménez-Lozano I, Palacio-Lacambra ME, Sabaté N, Felip E, Garralda E, Garau M, Gorgas MQ, Monterde J, Tabernero J. Drug Cost Avoidance Resulting from Participation in Clinical Trials: A 10-Year Retrospective Analysis of Cancer Patients with Solid Tumors. Cancers (Basel). 2024 Apr 17;16(8):1529. doi: 10.3390/cancers16081529.
  29. Jimenez-Labaig P, Aymerich C, Braña I, Rullan A, Cacicedo J, González-Torres MÁ, Harrington KJ, Catalan A. A comprehensive examination of mental health in patients with head and neck cancer: systematic review and meta-analysis. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae031. doi: 10.1093/jncics/pkae031.
  30. Leary A, Estévez-García P, Sabatier R, Ray-Coquard I, Romeo M, Barretina-Ginesta P, Gil-Martin M, Garralda E, Bosch-Barrera J, Morán T, Martin-Martorell P, Nadal E, Gascón P, Rodon J, Lizcano JM, Muñoz-Guardiola P, Fierro-Durán G, Pedrós-Gámez O, Pérez-Montoyo H, Yeste-Velasco M, Cortal M, Pérez-Campos A, Alfon J, Domenech C, Pérez-Fidalgo A, Oaknin A. ENDOLUNG trial. A phase 1/2 study of the Akt/mTOR inhibitor and autophagy inducer Ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with advanced/recurrent endometrial cancer. BMC Cancer. 2024 Jul 22;24(1):876. doi: 10.1186/s12885-024-12501-5. Erratum in: BMC Cancer. 2024 Jul 29;24(1):911. doi: 10.1186/s12885-024-12700-0.
  31. Cho BC, Braña I, Cirauqui B, Aksoy S, Couture F, Hong RL, Miller WH Jr, Chaves-Conde M, Teixeira M, Leopold L, Munteanu M, Ge JY, Swaby RF, Hughes BGM. Pembrolizumab plus epacadostat in patients with recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE-669/ECHO-304): a phase 3, randomized, open-label study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1254. doi: 10.1186/s12885-023-11316-0.
  32. Hernando-Calvo A, Han M, Ayodele O, Wang BX, Bruce JP, Abbas-Aghababazadeh F, Vila-Casadesús M, Sanz-Garcia E, Yang SYC, Berman HK, Vivancos A, Lam B, Lungu I, Salawu A, Stayner LA, Haibe-Kains B, Bedard PL, Avery L, Razak ARA, Pugh TJ, Spreafico A, Siu LL, Hansen AR. A Phase II, Open-Label, Randomized Trial of Durvalumab With Olaparib or Cediranib in Patients With Mismatch Repair-Proficient Colorectal or Pancreatic Cancer. Clin Colorectal Cancer. 2024 Sep;23(3):272-284.e9. doi: 10.1016/j.clcc.2024.05.002. Epub 2024 May 15.
  33. Baranda JC, Robbrecht D, Sullivan R, Doger B, Santoro A, Barve M, Grob JJ, Bechter O, Vieito M, de Miguel MJ, Schadendorf D, Johnson M, Pouzin C, Cantalloube C, Wang R, Lee J, Chen X, Demers B, Amrate A, Abbadessa G, Hodi FS. Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of SAR439459, a TGFβ inhibitor, as monotherapy and in combination with cemiplimab in patients with advanced solid tumors: Findings from a phase 1/1b study. Clin Transl Sci. 2024 Jun;17(6):e13854. doi: 10.1111/cts.13854.
  34. Robbrecht D, Grob JJ, Bechter O, Simonelli M, Doger B, Borbath I, Butler MO, Cheng T, Romano PM, Pons-Tostivint E, Di Nicola M, Curigliano G, Ryu MH, Rodriguez-Vida A, Schadendorf D, Garralda E, Abbadessa G, Demers B, Amrate A, Wang H, Lee JS, Pomponio R, Wang R. Biomarker and pharmacodynamic activity of the transforming growth factor-beta (TGFβ) inhibitor SAR439459 as monotherapy and in combination with cemiplimab in a phase I clinical study in patients with advanced solid tumors. Clin Transl Sci. 2024 Feb;17(2):e13736. doi: 10.1111/cts.13736.
  35. Griesinger F, Curigliano G, Subbiah V, Baik CS, Tan DS, Lee DH, Misch D, Garralda E, Kim DW, van der Wekken AJ, Gainor JF, Paz-Ares L, Liu SV, Kalemkerian GP, Bowles DW, Mansfield AS, Lin JJ, Smoljanovic V, Rahman A, Zalutskaya A, Louie-Gao M, Boral AL, Mazières J. Pralsetinib in patients with RET fusion-positive non-small-cell lung cancer: A plain language summary of the ARROW study. Future Oncol. 2024 Feb;20(6):297-306. doi: 10.2217/fon-2023-0155.
  36. Martin-Liberal J, Garralda E, García-Donas J, Soto-Castillo JJ, Mussetti A, Codony C, Martin-Lluesma S, Muñoz S, Galvao V, Lostes J, Rotxes M, Prat-Vidal C, Palomero J, Muñoz A, Moreno R, García Del Muro X, Sureda A, Alemany R, Gros A, Piulats JM. Clinical protocol phase II study of tumor infiltrating lymphocytes in advanced tumors with alterations in the SWI/SNF complex: the TILTS study. Future Oncol. 2024;20(32):2437-2445. doi: 10.1080/14796694.2024.2385287.
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For a listing of early phase clinical trials in oncology please see the corresponding table under ‘Transversal Clinical Trials Services and Units’ (select from the submenu above).

Group Leader Ana Oaknin Clinical Investigators and Medical Oncologists Lorena Fariñas, Carmen García Durán, David Garcia-Illescas, Roberta Mazzeo

Research Groups

Gynecological Malignancies Group

Summary

Our clinical research focuses on gynecological malignancies and the development of novel therapies against these tumor types. We are also members of some of the most relevant societies and groups in gynecological oncology. Our Group Leader Ana Oaknin is the Spanish representative and Chair of the Gynecologic Cancer InterGroup’s (GCIG) Cervix Cancer Committee, and co-chaired the 1st GCIG Cervical Cancer Consensus Conference - Clinical Research (CCCC-CR) in 2024. She is also the Spanish clinical lead of the Gynecologic Oncology Group (GOG). Our group also belongs to the European Network of Gynecological Oncology Trial groups (ENGOT).

Advancing the treatment of gynecological malignancies, we have contributed to the development of a number of therapies that are now the current standard of care for different malignancies. As an example, at the 2023 European Society for Medical Oncology (ESMO) Virtual Plenary, Ana Oaknin reported the results from BEATcc (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), a randomised phase III trial of first-line atezolizumab combined with a platinum doublet and bevacizumab for metastatic cervical cancer (Oaknin A et al. Ann Oncol. 2023), demonstrating improved progression-free and overall survival for women with advanced cervical cancer. The findings were published in The Lancet (Oaknin A et al. Lancet. 2024) and support the adoption of this regimen as a new first-line therapy option for these patients.

We also lead and participate in several important clinical trials that have generated new and compelling data to expand therapeutic strategies against metastatic cervical cancer, mainly focused on new immunotherapy agents and rationale-based combinations.

Ana Oaknin currently serves as a Faculty Coordinator of the European Society for Medical Oncology’s (ESMO) Annual Congress Gynecological Tumors Track (2025-2026), Subject Editor, Gynecological Malignancies, for ESMO's Guidelines Committee (2021-2024), and is also a Member of the European Society of Gynaecological Oncology’s (ESGO) Training and Education Committee (2024-2026). In 2024, Ana was awarded Highly Cited Researcher designation (Clarivate) under the category of clinical medicine, and conferred International Membership of the Society of Gynecological Oncology (SGO).

  • 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 immunotherapeutics 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:

  • We led the phase 3 BEATcc (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030) study demonstrating that the addition of atezolizumab to a standard bevacizumab-plus-platinum regimen for patients with metastatic, persistent, or recurrent cervical cancer significantly improves survival outcomes and may be considered a new first-line treatment option.
  • Ana Oaknin is the Principal Investigator of the phase 2 ATOMICC clinical trial to test anti-PD-1 dostarlimab as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemoradiation.
  • Ana Oaknin was distinguished with the PharmaMar Foundation Argonauta Lifetime Achievement Award in Clinical Research for her efforts to transform the treatment of gynecological neoplasms and her pioneering work in the development of personalized therapies and immunological treatments that have improved the survival outcomes of patients globally.
  • Develop and advance novel immunotherapeutics for the treatment of endometrial cancer and cervical cancer.
  • Apply cellular therapy to metastatic cervical cancer through the adoptive cell transfer 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.
  • 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. Efficacy of Trastuzumab Deruxtecan in HER2-Expressing Solid Tumors by Enrollment HER2 IHC Status: Post Hoc Analysis of DESTINY-PanTumor02. Adv Ther. 2024 Nov;41(11):4125-4139.
  • Hasegawa K, Takahashi S, Ushijima K, Okadome M, Yonemori K, Yokota H, Vergote I, Monk BJ, Tewari KS, Fujiwara K, Li J, Jamil S, Paccaly A, Takehara K, Usami T, Aoki Y, Suzuki N, Kobayashi Y, Yoshida Y, Watari H, Seebach F, Lowy I, Mathias M, Fury MG, Oaknin A. Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer. Cancer Med. 2024 Sep;13(18):e70236.
  • Oaknin A, Moore K, Meyer T, López-Picazo González J, Devriese LA, Amin A, Lao CD, Boni V, Sharfman WH, Park JC, Tahara M, Topalian SL, Magallanes M, Molina Alavez A, Khan TA, Copigneaux C, Lee M, Garnett-Benson C, Wang X, Naumann RW. Nivolumab with or without ipilimumab in patients with recurrent or metastatic cervical cancer (CheckMate 358): a phase 1-2, open-label, multicohort trial. Lancet Oncol. 2024 May;25(5):588-602.
  • Oaknin A, Gladieff L, Martínez-García J, Villacampa G, Takekuma M, De Giorgi U, Lindemann K, Woelber L, Colombo N, Duska L, Leary A, Godoy-Ortiz A, Nishio S, Angelergues A, Rubio MJ, Fariñas-Madrid L, Yamaguchi S, Lorusso D, Ray-Coquard I, Manso L, Joly F, Alarcón J, Follana P, Romero I, Lebreton C, Pérez-Fidalgo JA, Yunokawa M, Dahlstrand H, D'Hondt V, Randall LM; ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030 Investigators. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024 Jan 6;403(10421):31-43.
  • Ana Oaknin was awarded Highly Cited Researcher designation (Clarivate) under the category of clinical medicine.
  • Ana Oaknin was conferred International Membership of the Society of Gynecological Oncology (SGO).
  • Ana Oaknin was distinguished with the PharmaMar Foundation Argonauta Lifetime Achievement Award in Clinical Research for her efforts to transform the treatment of gynecological neoplasms and her pioneering work in the development of personalized therapies and immunological treatments that have improved the survival outcomes of patients globally.
  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: Multisponsor.
    Project title: Phase I-II Study to Assess the Safety, Tolerability and Efficacy of Lurbinectedin and Dostarlimab in Advanced/Recurrent Endometrial Cancer Patients with Disease Progression after Prior Therapy with Platinum-based Chemotherapy.
    Duration: 21/08/2022 – 31/12/2025
    PI: Ana Oaknin
  4. 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
  5. 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 
  6. 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. Quesada S, Penault-Llorca F, Matias-Guiu X, Banerjee S, Barberis M, Coleman RL, Colombo N, DeFazio A, McNeish IA, Nogueira-Rodrigues A, Oaknin A, Pignata S, Pujade-Lauraine É, Rouleau É, Ryška A, Van Der Merwe N, Van Gorp T, Vergote I, Weichert W, Wu X, Ray-Coquard I, Pujol P; expert consensus group. Homologous recombination deficiency in ovarian cancer: Global expert consensus on testing and a comparison of companion diagnostics. Eur J Cancer. 2025 Jan 17;215:115169. doi: 10.1016/j.ejca.2024.115169. Epub 2024 Dec 9.
  2. Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquín A, Gálvez-Montosa F, Mathews CA, Konecny GE, Ray-Coquard I, Oaknin A, Rubio Pérez MJ, Bonaventura A, Diver EJ, Ayuk SM, Wang Y, Corr BR, Salutari V. The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-330. doi: 10.1016/j.annonc.2024.11.011. Epub 2024 Nov 29.
  3. Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquín A, Gálvez-Montosa F, Mathews CA, Konecny GE, Ray-Coquard I, Oaknin A, Rubio Pérez MJ, Bonaventura A, Diver EJ, Ayuk SM, Wang Y, Corr BR, Salutari V. The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-330. doi: 10.1016/j.annonc.2024.11.011. Epub 2024 Nov 29.
  4. Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquín A, Gálvez-Montosa F, Mathews CA, Konecny GE, Ray-Coquard I, Oaknin A, Rubio Pérez MJ, Bonaventura A, Diver EJ, Ayuk SM, Wang Y, Corr BR, Salutari V. The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-330. doi: 10.1016/j.annonc.2024.11.011. Epub 2024 Nov 29.
  5. Mirallas O, Martin-Cullell B, Navarro V, Vega KS, Recuero-Borau J, Gómez-Puerto D, López-Valbuena D, Salva de Torres C, Andurell L, Pedrola A, Berché R, Palmas F, Ucha JM, Villacampa G, Rezqallah A, Sanz-Beltran J, Bach R, Bueno S, Viaplana C, Molina G, Hernando-Calvo A, Aguilar-Company J, Roca M, Muñoz-Couselo E, Martínez-Martí A, Alonso A, Eremiev S, Macarulla T, Oaknin A, Saura C, Élez E, Felip E, Peñuelas Á, Burgos R, Pardo PG, Garralda E, Tabernero J, Serradell S, Servitja S, Paez D, Dienstmann R, Carles J. Development of a prognostic model to predict 90-day mortality in hospitalised cancer patients (PROMISE tool): a prospective observational study. Lancet Reg Health Eur. 2024 Oct 9;46:101063. doi: 10.1016/j.lanepe.2024.101063.
  6. Kuchimanchi M, Jørgensen TL, Hanze E, André T, Jain A, Berton D, Alskär O, Zub O, Oaknin A, Shahin MS, Koliadi A, Pothuri B, Krivak T, Pishchyk M, Segev Y, Backes FJ, Gennigens C, Bouberhan S, Zajic S, Melhem M, Buscema J. Population pharmacokinetics and exposure-response relationships of dostarlimab in primary advanced or recurrent endometrial cancer in part 1 of RUBY. Br J Clin Pharmacol. 2025 Mar;91(3):841-855. doi: 10.1111/bcp.16325. Epub 2024 Nov 8.
  7. Moore KN, Lorusso D, Oaknin A, Oza A, Colombo N, Van Gorp T, O'Malley DM, Banerjee S, Murphy CG, Harter P, Konecny GE, Pautier P, Method M, Wang Y, Coleman RL, Birrer M, Matulonis UA. Safety and tolerability of mirvetuximab soravtansine monotherapy for folate receptor alpha-expressing recurrent ovarian cancer: An integrated safety summary. Gynecol Oncol. 2024 Dec;191:249-258. doi: 10.1016/j.ygyno.2024.10.013.
  8. Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, Lugowska I, Moiseyenko V, Gumus M, Arslan C, Lindsay CR, Deva S, Taus Á, Oaknin A, Rottey S, Cicin I, Goksu SS, Smolin A, Roselló-Keränen S, Habigt C, Marbach D, Boetsch C, Dejardin D, Sleiman N, Evers S, Richard M, Ardeshir C, Charo J, Kraxner A, Teichgräber V, Keshelava N, Dziadziuszko R. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. EBioMedicine. 2024 Nov;109:105374. doi: 10.1016/j.ebiom.2024.105374.
  9. Hasegawa K, Takahashi S, Ushijima K, Okadome M, Yonemori K, Yokota H, Vergote I, Monk BJ, Tewari KS, Fujiwara K, Li J, Jamil S, Paccaly A, Takehara K, Usami T, Aoki Y, Suzuki N, Kobayashi Y, Yoshida Y, Watari H, Seebach F, Lowy I, Mathias M, Fury MG, Oaknin A. Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer. Cancer Med. 2024 Sep;13(18):e70236. doi: 10.1002/cam4.70236.
  10. Denschlag D, Heitz F, Pfisterer J, Tutschkow D, Reuss A, Meier W, Harter P, Wimberger P, Mirza MR, Ray-Coquard I, Scambia G, Kim JW, Colombo N, Oaknin A, Sehouli J, Lindemann K, Lebreton C, Eichbaum M, Spiegelberg S, Woopen H, du Bois A. Impact of metformin, statins, and beta blockers on survival in patients with primary ovarian cancer: combined analysis of four prospective trials of AGO-OVAR and ENGOT/GCIG collaborators. Int J Gynecol Cancer. 2024 Dec 2;34(12):1914-1923. doi: 10.1136/ijgc-2024-005663.
  11. González-Martín A, Rubio MJ, Heitz F, Depont Christensen R, Colombo N, Van Gorp T, Romeo M, Ray-Coquard I, Gaba L, Leary A, De Sande LM, Lebreton C, Redondo A, Fabbro M, Barretina Ginesta MP, Follana P, Pérez-Fidalgo JA, Rodrigues M, Santaballa A, Sabatier R, Bermejo-Pérez MJ, Lotz JP, Pardo B, Marquina G, Sánchez-Lorenzo L, Quindós M, Estévez-García P, Guerra Alía E, Manso L, Casado V, Kommoss S, Tognon G, Henry S, Bruchim I, Oaknin A, Selle F. Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial. J Clin Oncol. 2024 Dec 20;42(36):4294-4304. doi: 10.1200/JCO.24.00668.
  12. Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Cvek J, Randall L, Pereira de Santana Gomes AJ, Contreras Mejía F, Helpman L, Akıllı H, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Colombo N, Chang CL, Bednarikova M, Zhu H, Oaknin A, Christiaens M, Petru E, Usami T, Liu P, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Oct 5;404(10460):1321-1332. doi: 10.1016/S0140-6736(24)01808-7. Epub 2024 Sep 14. Erratum in: Lancet. 2024 Nov 2;404(10464):1730. doi: 10.1016/S0140-6736(24)02371-7.
  13. 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. Efficacy of Trastuzumab Deruxtecan in HER2-Expressing Solid Tumors by Enrollment HER2 IHC Status: Post Hoc Analysis of DESTINY-PanTumor02. Adv Ther. 2024 Nov;41(11):4125-4139. doi: 10.1007/s12325-024-02975-x.
  14. Bonfill-Teixidor E, Neva-Alejo A, Arias A, Cuartas I, Iurlaro R, Planas-Rigol E, Solé L, Pecharromán I, Cabrera S, García Á, Garcia-Illescas D, Espinosa L, Gil-Moreno A, Oaknin A, Seoane J. Cervical Cancer Evades the Host Immune System through the Inhibition of Type I Interferon and CXCL9 by LIF. Clin Cancer Res. 2024 Oct 1;30(19):4505-4516. doi: 10.1158/1078-0432.CCR-24-0385.
  15. Leary A, Estévez-García P, Sabatier R, Ray-Coquard I, Romeo M, Barretina-Ginesta P, Gil-Martin M, Garralda E, Bosch-Barrera J, Morán T, Martin-Martorell P, Nadal E, Gascón P, Rodon J, Lizcano JM, Muñoz-Guardiola P, Fierro-Durán G, Pedrós-Gámez O, Pérez-Montoyo H, Yeste-Velasco M, Cortal M, Pérez-Campos A, Alfon J, Domenech C, Pérez-Fidalgo A, Oaknin A. Correction: ENDOLUNG trial. A phase 1/2 study of the Akt/mTOR inhibitor and autophagy inducer Ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with advanced/recurrent endometrial cancer : Alexandra Leary. BMC Cancer. 2024 Jul 29;24(1):911. doi: 10.1186/s12885-024-12700-0. Erratum for: BMC Cancer. 2024 Jul 22;24(1):876. doi: 10.1186/s12885-024-12501-5.
  16. Birrer M, Li G, Yunokawa M, Lee JY, Kim BG, Oppermann CP, Zhou Q, Nishio S, Okamoto A, Wu X, Mileshkin L, Oaknin A, Ray-Coquard I, Hasegawa K, Jehl G, Vugmeyster Y, Zhang S, Bajars M, Yonemori K. Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1204-1211. doi: 10.1001/jamaoncol.2024.2145.
  17. Olawaiye AB, Kim JW, Bagameri A, Bishop E, Chudecka-Głaz A, Devaux A, Gladieff L, Gordinier ME, Korach J, McCollum ME, Mileshkin L, Monk BJ, Nicum S, Nogueira-Rodrigues A, Oaknin A, O'Malley DM, Orlando M, Dreiling L, Tudor IC, Lorusso D. Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer. J Gynecol Oncol. 2024 Jul;35(4):e111. doi: 10.3802/jgo.2024.35.e111.
  18. Kristeleit R, Leary A, Oaknin A, Redondo A, George A, Chui S, Seiller A, Liste-Hermoso M, Willis J, Shemesh CS, Xiao J, Lin KK, Molinero L, Guan Y, Ray-Coquard I, Mileshkin L. PARP inhibition with rucaparib alone followed by combination with atezolizumab: Phase Ib COUPLET clinical study in advanced gynaecological and triple-negative breast cancers. Br J Cancer. 2024 Sep;131(5):820-831. doi: 10.1038/s41416-024-02776-7.
  19. Vergote I, González-Martín A, Fujiwara K, Kalbacher E, Bagaméri A, Ghamande S, Lee JY, Banerjee S, Maluf FC, Lorusso D, Yonemori K, Van Nieuwenhuysen E, Manso L, Woelber L, Westermann A, Covens A, Hasegawa K, Kim BG, Raimondo M, Bjurberg M, Cruz FM, Angelergues A, Cibula D, Barraclough L, Oaknin A, Gennigens C, Nicacio L, Teng MSL, Whalley E, Soumaoro I, Slomovitz BM; innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024 Jul 4;391(1):44-55. doi: 10.1056/NEJMoa2313811.
  20. Grau Bejar JF, Yaniz Galende E, Zeng Q, Genestie C, Rouleau E, de Bruyn M, Klein C, Le Formal A, Edmond E, Moreau M, Plat A, Gouy S, Maulard A, Pautier P, Michels J, Oaknin A, Colomba-Blameble E, Leary A. Immune predictors of response to immune checkpoint inhibitors in mismatch repair-deficient endometrial cancer. J Immunother Cancer. 2024 Jul 1;12(7):e009143. doi: 10.1136/jitc-2024-009143.
  21. Coleman RL, Lorusso D, Oaknin A, Cecere SC, Denys H, Colombo N, van Gorp T, Konner JA, Romeo Marin M, Harter P, Murphy C, Wang Y, Esteves B, Method M, Matulonis U. Mirvetuximab soravtansine in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer: final overall survival and post hoc sequence of therapy subgroup results from the SORAYA trial. Int J Gynecol Cancer. 2024 Aug 5;34(8):1119-1125. doi: 10.1136/ijgc-2024-005401.
  22. Valabrega G, Pothuri B, Oaknin A, Graybill WS, Sánchez AB, McCormick C, Baurain JF, Tinker AV, Denys H, O'Cearbhaill RE, Hietanen S, Moore RG, Knudsen AØ, de La Motte Rouge T, Heitz F, Levy T, York W, Gupta D, Monk BJ, González-Martín A. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 Aug;187:128-138. doi: 10.1016/j.ygyno.2024.03.009.
  23. Oaknin A, Moore K, Meyer T, López-Picazo González J, Devriese LA, Amin A, Lao CD, Boni V, Sharfman WH, Park JC, Tahara M, Topalian SL, Magallanes M, Molina Alavez A, Khan TA, Copigneaux C, Lee M, Garnett-Benson C, Wang X, Naumann RW. Nivolumab with or without ipilimumab in patients with recurrent or metastatic cervical cancer (CheckMate 358): a phase 1-2, open-label, multicohort trial. Lancet Oncol. 2024 May;25(5):588-602. doi: 10.1016/S1470-2045(24)00088-3.
  24. Grau-Bejar JF, Farinas-Madrid L, García-Duran C, García-Illescas D, Mazzeo R, Oaknin A. Immunotherapy in the treatment of advanced or recurrent endometrial cancer. Clin Adv Hematol Oncol. 2024 Apr;22(3):129-139.
  25. Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Sukhin V, Cloven N, Pereira de Santana Gomes AJ, Contreras Mejía F, Reiss A, Ayhan A, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Lazzari R, Chang CL, Lampé R, Zhu H, Oaknin A, Christiaens M, Polterauer S, Usami T, Li K, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9.
  26. Bartoletti M, Montico M, Lorusso D, Mazzeo R, Oaknin A, Musacchio L, Scambia G, Puglisi F, Pignata S. Incorporation of anti-PD1 or anti PD-L1 agents to platinum-based chemotherapy for the primary treatment of advanced or recurrent endometrial cancer. A meta-analysis. Cancer Treat Rev. 2024 Apr;125:102701. doi: 10.1016/j.ctrv.2024.102701.
  27. Ledermann JA, Matias-Guiu X, Amant F, Concin N, Davidson B, Fotopoulou C, González-Martin A, Gourley C, Leary A, Lorusso D, Banerjee S, Chiva L, Cibula D, Colombo N, Croce S, Eriksson AG, Falandry C, Fischerova D, Harter P, Joly F, Lazaro C, Lok C, Mahner S, Marmé F, Marth C, McCluggage WG, McNeish IA, Morice P, Nicum S, Oaknin A, Pérez-Fidalgo JA, Pignata S, Ramirez PT, Ray-Coquard I, Romero I, Scambia G, Sehouli J, Shapira-Frommer R, Sundar S, Tan DSP, Taskiran C, van Driel WJ, Vergote I, Planchamp F, Sessa C, Fagotti A. ESGO-ESMO-ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease. Ann Oncol. 2024 Mar;35(3):248-266. doi: 10.1016/j.annonc.2023.11.015.
  28. Mutch D, Voulgari A, Chen XM, Bradley WH, Oaknin A, Perez Fidalgo JA, Montosa FG, Herraez AC, Holloway RW, Powell MA, Nowicka M, Schaefer G, Merchant M, Yan Y. Primary results and characterization of patients with exceptional outcomes in a phase 1b study combining PARP and MEK inhibition, with or without anti-PD-L1, for BRCA wild-type, platinum-sensitive, recurrent ovarian cancer. Cancer. 2024 Jun 1;130(11):1940-1951. doi: 10.1002/cncr.35222.
  29. Friedman CF, D'Souza A, Bello Roufai D, Tinker AV, de Miguel M, Gambardella V, Goldman J, Loi S, Melisko ME, Oaknin A, Spanggaard I, Shapiro GI, ElNaggar AC, Panni S, Ravichandran V, Frazier AL, DiPrimeo D, Eli LD, Solit DB. Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the phase 2 SUMMIT basket trial. Gynecol Oncol. 2024 Feb;181:162-169. doi: 10.1016/j.ygyno.2023.12.004.
  30. García-Illescas D, Mazzeo R, García-Durán C, Oaknin A. The evolving landscape of antibody-drug conjugates in ovarian cancer: new drugs for a new era. Curr Opin Obstet Gynecol. 2024 Apr 1;36(2):104-111. doi: 10.1097/GCO.0000000000000934.
  31. Oaknin A, Ghamande SA, Kasamatsu Y, Gil-Martin M, Grau-Bejar JF, Garcia-Duran C, Sato M, Siddiqui A, Chaudhary SP, Vugmeyster Y, Hasegawa K. Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer. Clin Cancer Res. 2024 Mar 1;30(5):975-983. doi: 10.1158/1078-0432.CCR-23-1829.
  32. Bogani G, Coleman RL, Vergote I, van Gorp T, Ray-Coquard I, Oaknin A, Matulonis U, O'Malley D, Raspagliesi F, Scambia G, Monk BJ. Mirvetuximab soravtansine-gynx: first antibody/antigen-drug conjugate (ADC) in advanced or recurrent ovarian cancer. Int J Gynecol Cancer. 2024 Apr 1;34(4):469-477. doi: 10.1136/ijgc-2023-004924.
  33. Oaknin A, Gladieff L, Martínez-García J, Villacampa G, Takekuma M, De Giorgi U, Lindemann K, Woelber L, Colombo N, Duska L, Leary A, Godoy-Ortiz A, Nishio S, Angelergues A, Rubio MJ, Fariñas-Madrid L, Yamaguchi S, Lorusso D, Ray-Coquard I, Manso L, Joly F, Alarcón J, Follana P, Romero I, Lebreton C, Pérez-Fidalgo JA, Yunokawa M, Dahlstrand H, D'Hondt V, Randall LM; ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030 Investigators. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024 Jan 6;403(10421):31-43. doi: 10.1016/S0140-6736(23)02405-4.
  34. Meric-Bernstam F, Makker V, Oaknin A, Oh DY, Banerjee S, González-Martín A, Jung KH, Ługowska I, Manso L, Manzano A, Melichar B, Siena S, Stroyakovskiy D, Fielding A, Ma Y, Puvvada S, Shire N, Lee JY. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2024 Jan 1;42(1):47-58. doi: 10.1200/JCO.23.02005.

Group Leader Cristina Saura Medical Oncologists Miriam Arumi, Judith Balmaña, Meritxell Bellet, Maria Borrell, Mara Cruellas, Santiago Escrivá, Nàdia Gómez, Patricia Gómez, Esaú Monescillo, Mafalda Oliveira, Carolina Ortiz, Isabel Pimentel, Alejandra Rezqallah, Angélica Rodriguez, Lucia Sanz, Esther Zamora Clinical Nurses Ana Baizán, Verónica Rodriguez, Anna Suñol Visiting Scientists Vittoria Barberi, Mariangela Gaudio, Marta Perachino

Research Groups

Breast Cancer Group

Summary

Under the leadership of Cristina Saura, VHIO’s Breast Cancer Group specializes in clinical and translational research focused on new drug development.

Beyond maintaining high patient recruitment rates in our clinical trials, our leading role in several clinical trials enables us to leverage translational data to guide and accelerate drug development. Key areas of focus include:

  • HER2-positive disease: We actively participate in major trials evaluating novel therapies and combinations, including trastuzumab, deruxtecan, tucatinib, emerging ADCs, and TKIs. Our commitment extends to cell therapy research. Advances in systemic treatments are significantly improving cure rates and overall survival in both metastatic and early-stage disease.
  • Luminal disease: Collaborating with VHIO's Experimental Therapeutics and Cancer Cell Cycle Groups led by Violeta Serra and Marcos Malumbres, we investigate resistance mechanisms and strategies to resensitize tumors to therapy using PI3K, AKT, and CDK4/6 inhibitors, novel SERDs, and PARP inhibitors. A new wave of PI3K inhibitors is offering promising options for patients with PI3K-mutant tumors, and we are proud to remain at the forefront of clinical research and offer our patients the option to participate in the most promising trials. Additionally, we are launching projects using spatial transcriptomics and prospectively collecting blood samples to detect minimal residual disease after surgery, aiming to refine adjuvant treatment strategies.
  • Triple-negative disease: Alongside clinical trials exploring immunotherapy combinations and ADCs, our integrative multi-omics platform is identifying predictive biomarkers of response to chemotherapy and ICIs in early TNBC, with over 70 patients enrolled and initial results expected in 2025. We are also collaborating with VHIO’s Tumor Immunology and Immunotherapy Group on personalized T-cell therapies.
  • Circulating tumor DNA (ctDNA): In partnership with VHIO's Cancer Genomics Group, we lead multiple projects to advance ctDNA detection in early disease, including unexplored samples like breast milk. Securing funding to expand our studies in breast milk as a source of biomarkers remains a priority, and we are working to integrate DNA methylation analysis for improving early 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.
  • To continue to significantly contribute to drug approval of new compounds in the breast cancer field.
  • Further advance precision medicine through our expertise in the field and VHIO’s Molecular Prescreening Program  to optimize potential treatment benefits in specific populations of breast cancer patients.
  • Identify promising and challenging new indications of ctDNA in breast cancer for early diagnosis in blood or in new biologic samples including breast milk as a potential source for early breast cancer diagnosis associated with pregnancy.
  • Study the influence of host and breast microbiome in response to systemic therapy; with particular emphasis on immune checkpoint inhibitors and other treatments that modulate the immune system.
  • Integrate real-world data, artificial intelligence and machine learning in the diagnostic and therapeutic algorithms of breast cancer management.
  • Establish and develop a program of personalized T-cell therapy in breast cancer.
  • Consolidate research projects to strengthen and contribute to breast cancer survivors’ return to normal life.
  • Consolidate an oncogeriatric project for the aging population to advance research and innovation for the optimal treatment of these patients.
  • Jhaveri KL, Neven P, Casalnuovo ML, Kim SB, Tokunaga E, Aftimos P, Saura C, O'Shaughnessy J, Harbeck N, Carey LA, Curigliano G, Llombart-Cussac A, Lim E, García Tinoco ML, Sohn J, Mattar A, Zhang Q, Huang CS, Hung CC, Martinez Rodriguez JL, Ruíz Borrego M, Nakamura R, Pradhan KR, Cramer von Laue C, Barrett E, Cao S, Wang XA, Smyth LM, Bidard FC; EMBER-3 Study Group. Imlunestrant with or without Abemaciclib in Advanced Breast Cancer. N Engl J Med. 2024 Dec 11. doi: 10.1056/NEJMoa2410858.
  • Oliveira M, Pominchuk D, Nowecki Z, Hamilton E, Kulyaba Y, Andabekov T, Hotko Y, Melkadze T, Nemsadze G, Neven P, Vladimirov V, Zamagni C, Denys H, Forget F, Horvath Z, Nesterova A, Ajimi M, Kirova B, Klinowska T, Lindemann JPO, Lissa D, Mathewson A, Morrow CJ, Traugottova Z, van Zyl R, Arkania E. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol. 2024 Nov;25(11):1424-1439.
  • Turner N, Saura C, Aftimos P, van den Tweel E, Oesterholt M, Koper N, Colleoni M, Kaczmarek E, Punie K, Song X, Armstrong A, Bianchi G, Stradella A, Ladoire S, Lim JSJ, Quenel-Tueux N, Tan TJ, Escrivá-de-Romaní S, O'Shaughnessy J; TULIP Trial Investigators. Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP). J Clin Oncol. 2024 Oct 23:JCO2400529. doi: 10.1200/JCO.24.00529.
  • Oliveira M, Rugo HS, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Toi M, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Nowecki Z, Park YH, Sohn JH, Tokunaga E, Yousef S, Zhukova L, Fulford M, Andrews H, Wadsworth I, D'Cruz C, Turner NC; CAPItello-291 study group. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2024 Sep;25(9):1231-1244.

Competitive funding:

  1. Title: ctDNA in breast milk for early detection of pregnancy associated breast cancer
    Funding: Instituto de Salud Carlos III (ISCIII).
    Title: ctDNA in breast milk for early detection of pregnancy associated breast cancer-
    Funding: Intensificación FIS – Instituto de Salud Carlos III (ISCIII).
  2. Title: ctDNA in breast milk for early detection of pregnancy associated breast cancer Funding: Ayudas PFIS for a PhD Student – Instituto de Salud Carlos III (ISCIII).
  3. Title: Detección del ctADN de la leche materna y análisis del metiloma para el diagnóstico precoz del cáncer de mama asociado al embarazo en poblaciones de alto riesgo: Meth-MMATERNA.
    Funding: Instituto de Salud Carlos III (ISCIII)
  4. Title: Plataforma integrativa multiómica para la identificación de biomarcadores predictivos de respuesta a quimioterapia e inmunoterapia en cáncer de mama triple negativo temprano (PORTRAIT-TNBC).
    Funding: Instituto de Salud Carlos III (ISCIII).
  5. Title: Caracterización multiómica del cáncer de mama en mujeres jóvenes: impacto de la lactancia y el embarazo en su mal pronóstico.
    Funding: Instituto de Salud Carlos III (ISCIII).
  6. Title: Clonal hematopoiesis of indeterminate potential in cancer patients: impact on immune dysfunction, tratment response and therapy related malignancies.
    Funding: Instituto de Salud Carlos III (ISCIII).
  7. Title: LABEL: Redefining prognosis in Early Lobular Breast Cancer (ILC): Validation of a novel Ki67 threshold as a prognostic factor and correlation of this new cut-off with intrinsic subtypes (PAM72) and Endopredict/EPclin.
    Funding: Sociedad Española de Oncología Médica (SEOM).
  8. Title: Terapia celular adoptiva mediante transferencia de linfocitos CD3+/PD1+ infiltrantes de tumor en pacientes con cáncer de mama avanzado.
    Funding: Asociación Española Contra el Cáncer (AECC).
  9. Title: MMATERNA: maternal breast milk ctDNA detection for early diagnosis of pregnancy associated breast cancer.
    Funding: CaixaImpulse.
  10. Title: Clinical outcomes of CDK4/6 inhibitor + endocrine therapy as first line treatment in patients with metastatic breast cancer and carriers of a germline or a somatic pathogenic variant in an HRR-related gene.
    Funding: Premio M. Chiara Giorgetti-Asociación Cáncer de Mama Metastático.
  11. Title: Predictive spatial transcriptomics to identify minimal residual disease in ER+ HER2- breast cancer.
    Funding: Premio M. Chiara Giorgetti- Asociación Cáncer de Mama Metastático.
  12. Title: ADVANTAGE: To define best management in ER+HER2neg patients with oligometastatic disease (OM) in first line treatment for ABC with CDK4/6 inhibitors; comparison of PFS for those OM patients achieving or not NED status (by means of local ablative techniques).
    Funding: Metapremio M. Chiara Giorgetti- Asociación Cáncer de Mama Metastático.
  13. Title: OPTimizing adjuvant prescription of PEMbrolizumab in patients with early-stage triple-negative breast cancer achieving pathologic complete response after standard neoadjuvant chemotherapy and pembrolizumab.
    Funding: IGR – CRIS Contra el Cáncer.
  14. Title: ETNA: adjuvant single agent immunotherapy in Early Triple Negative BreAst cancer with high stromal tumor-infiltrating lymphocytes (TILs) score.
    Funding: IGR- CRIS Contra el Cáncer.
  15. Title: PRECAM: predictores de cardiotoxicidad en cáncer de mama HER2-postivo precoz.
    Funding: Marató de TV3.
    Title: SPECTA: screening cancer patients for efficient clinical trial access.
    Funding: EORTC 1553.
  16. Title: Metastatic Cells Alter Systemic Fatty Acid Metabolism to Weaken Anti-Tumor Immunity.
    Funding: TRIP CLINICS.
  17. Title: Surveillance in Early Triple Negative breAst cancer with high stromal tumor-infiltrating lymphocytes (TILs) score (ETNA-cohort2).
    Funding: Fundación CRIS.
  18. Title: Utilidad del ctDNA para la detección precoz de recidica en cáncer de mama RH+/HER2- mediante el seguimiento de mutaciones presentes en el tumor primario o mutaciones emergentes de ESR1.
    Funding: Fundación FERO.

Non-competitive funding:

  1. Title: ADVANTAGE: To define best management in ER+HER2neg patients with oligometastatic disease (OM) in first line treatment for ABC with CDK4/6 inhibitors ; comparison of PFS for those OM patients achieving or not NED status (by means of local ablative techniques).
    Funding: El Paseico de la Mama.
  2. Title: Clinical outcomes of CDK4/6 inhibitor + endocrine therapy as first line treatment in patients with metastatic breast cancer and carriers of a germline or a somatic pathogenic variant in an HRR-related gene.
    Funding: El Paseico de la Mama.
  3. Title: Resonancia nuclear magnètica para mejorar el estiadaje de cáncer de mama en mujeres embarazadas.
    Funding: El Paseico de la Mama.
  4. Title: TOTEM: Development of LCMSM for accurate measurement of estradiol in premnenopasual patients receving LHRH agonistis and aromatase inhibitors or tamoxifen.
    Funding: El Paseico de la Mama.
  5. Title: Understanding CDK4/6i and SERD resistance in metastatic ER+ breast cancer using patient samples and PDXs.
    Funding: Astra Zeneca (AZ).
  6. Title: EUtilidad del ctDNA para la detección precoz de recidiva en cáncer de mama RH+/HER2- mediante el seguimiento de mutaciones presentes en el tumor primario o mutaciones emergentes de ESR1.
  7. Title: Exploiting post-transcriptional regulation to uncover novel vulnerabilities of metastatic cells.
  8. Title: Understanding CDK4/6i and SERD resistance in metastatic ER+ breast cancer using patient samples and PDXs.
  9. Title: Estudio de biomarcadores circulantes en sangre en pacientes con cáncer de mama.
  10. Title: Modulation of androgen receptor signalling as a therapeutic strategy for oestrogen receptor-positive metastatic breast cancer.
  11. Title: Patient stratification based on DNA repair functionality for cancer precision medicine.
  12. Title: Developing integrated clinical, in vivo and ex vivo platforms to understand platinum response and resistance in breast cancer.
  13. Title: Nuevos factores predictivos de respuesta a terapias dirigidas y factores pronóstico en cáncer de mama con mutaciones hereditarias en BRCA1 y BRCA: capacidad de reparación del daño en el ADN y perfil inmunológico tumoral.
  14. Title: HELIX: Retrospective and prospective study of  variables predicting liver toxicity of CDK4/6  including serial fibroscans  and basal lab immune parameters together with liver biopsy if ≥G3 develops to gain insight regarding mechanisms driving to liver toxicity.
  15. Title: Impacto y valor pronóstico de vesículas extracelulares tumorales provenientes de células madre cancerígenas en tumores de mama triple negativo-DipEV.
  16. Title: INveStigation of PIK3CA mutaTIONs in healthy breast tissue (Inspektion).
  17. Title: Análisis observacional del tratamiento con Palbociclib (FIBHCSC).
  1. Jhaveri KL, Neven P, Casalnuovo ML, Kim SB, Tokunaga E, Aftimos P, Saura C, O'Shaughnessy J, Harbeck N, Carey LA, Curigliano G, Llombart-Cussac A, Lim E, García Tinoco ML, Sohn J, Mattar A, Zhang Q, Huang CS, Hung CC, Martinez Rodriguez JL, Ruíz Borrego M, Nakamura R, Pradhan KR, Cramer von Laue C, Barrett E, Cao S, Wang XA, Smyth LM, Bidard FC; EMBER-3 Study Group. Imlunestrant with or without Abemaciclib in Advanced Breast Cancer. N Engl J Med. 2024 Dec 11. doi: 10.1056/NEJMoa2410858. Epub ahead of print. PMID: 39660834.
  2. Oliveira M, Pominchuk D, Nowecki Z, Hamilton E, Kulyaba Y, Andabekov T, Hotko Y, Melkadze T, Nemsadze G, Neven P, Vladimirov V, Zamagni C, Denys H, Forget F, Horvath Z, Nesterova A, Ajimi M, Kirova B, Klinowska T, Lindemann JPO, Lissa D, Mathewson A, Morrow CJ, Traugottova Z, van Zyl R, Arkania E. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol. 2024 Nov;25(11):1424-1439. doi: 10.1016/S1470-2045(24)00387-5. PMID: 39481395.
  3. Turner N, Saura C, Aftimos P, van den Tweel E, Oesterholt M, Koper N, Colleoni M, Kaczmarek E, Punie K, Song X, Armstrong A, Bianchi G, Stradella A, Ladoire S, Lim JSJ, Quenel-Tueux N, Tan TJ, Escrivá-de-Romaní S, O'Shaughnessy J; TULIP Trial Investigators. Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP). J Clin Oncol. 2024 Oct 23:JCO2400529. doi: 10.1200/JCO.24.00529. Epub ahead of print. PMID: 39442070.
  4. Dent RA, Kim SB, Oliveira M, Barrios C, O'Shaughnessy J, Isakoff SJ, Saji S, Freitas-Junior R, Philco M, Bondarenko I, Lian Q, Bradley D, Hinton H, Wongchenko MJ, Reilly SJ, Turner N. Ipatasertib plus Paclitaxel for Patients with PIK3CA/AKT1/PTEN-Altered Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer in the IPATunity130 Phase III Trial. Clin Cancer Res. 2024 Oct 1;30(19):4329-4338. doi: 10.1158/1078-0432.CCR-24-0465. PMID: 39058425; PMCID: PMC11443247.
  5. O'Regan RM, Zhang Y, Fleming GF, Francis PA, Kammler R, Viale G, Dell'Orto P, Lang I, Bellet M, Bonnefoi HR, Tondini C, Villa F, Bernardo A, Ciruelos EM, Neven P, Karlsson P, Müller B, Jochum W, Zaman K, Martino S, Geyer CE Jr, Jerzak KJ, Davidson NE, Coleman RE, Ingle JN, van Mackelenbergh MT, Loi S, Colleoni M, Schnabel CA, Treuner K, Regan MM. Breast Cancer Index in Premenopausal Women With Early-Stage Hormone Receptor-Positive Breast Cancer. JAMA Oncol. 2024 Oct 1;10(10):1379-1389. doi: 10.1001/jamaoncol.2024.3044. PMID: 39145953; PMCID: PMC11327904.
  6. Villacampa G, Navarro V, Matikas A, Ribeiro JM, Schettini F, Tolosa P, Martínez-Sáez O, Sánchez-Bayona R, Ferrero-Cafiero JM, Salvador F, Papakonstantinou A, Prat A, Oliveira M, Pascual T. Neoadjuvant Immune Checkpoint Inhibitors Plus Chemotherapy in Early Breast Cancer: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Oct 1;10(10):1331-1341. doi: 10.1001/jamaoncol.2024.3456. PMID: 39207778.
  7. Oliveira M, Rugo HS, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Toi M, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Nowecki Z, Park YH, Sohn JH, Tokunaga E, Yousef S, Zhukova L, Fulford M, Andrews H, Wadsworth I, D'Cruz C, Turner NC; CAPItello-291 study group. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2024 Sep;25(9):1231-1244. doi: 10.1016/S1470-2045(24)00373-5. PMID: 39214106.
  8. Jhaveri KL, Accordino MK, Bedard PL, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop IE, Oliveira M, Schmid P, Saura C, Turner NC, Varga A, Cheeti S, Hilz S, Hutchinson KE, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman JL, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer. J Clin Oncol. 2024 Nov 20;42(33):3947-3956. doi: 10.1200/JCO.24.00110. Epub 2024 Sep 5. PMID: 39236276; PMCID: PMC11575912.
  9. Walbaum B, García-Fructuoso I, Martínez-Sáez O, Schettini F, Sánchez C, Acevedo F, Chic N, Muñoz-Carrillo J, Adamo B, Muñoz M, Partridge AH, Bellet M, Brasó-Maristany F, Prat A, Vidal M. Hormone receptor-positive early breast cancer in young women: A comprehensive review. Cancer Treat Rev. 2024 Sep;129:102804. doi: 10.1016/j.ctrv.2024.102804. Epub 2024 Jul 14. PMID: 39084152.
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  23. Alés-Martínez JE, Balmaña J, Sánchez-Rovira P, Salvador Bofill FJ, García Sáenz JÁ, Pimentel I, Morales S, Fernández-Abad M, Lahuerta Martínez A, Ferrer N, Zamora P, Bermejo B, Díaz-Redondo T, López-Ceballos MH, Galán M, Pérez-Escuredo J, Calabuig L, Sampayo M, Pérez-Garcia JM, Cortés J, Llombart-Cussac A. Olaparib plus trastuzumab in HER2-positive advanced breast cancer patients with germline BRCA1/2 mutations: The OPHELIA phase 2 study. Breast. 2024 Oct;77:103780. doi: 10.1016/j.breast.2024.103780. Epub 2024 Aug 2. PMID: 39116683; PMCID: PMC11362778.
  24. Yaringaño J, Roca-Herrera M, Eremiev S, Mascaró-Baselga P, Benito P, Núñez F, Benavente S, Pimentel I. Sacituzumab govitecan response in extensive leptomeningeal carcinomatosis from triple-negative breast cancer: a case report. Front Oncol. 2024 Aug 12;14:1378248. doi: 10.3389/fonc.2024.1378248. PMID: 39188688; PMCID: PMC11345153.
  25. Pérez-García JM, Cortés J, Ruiz-Borrego M, Colleoni M, Stradella A, Bermejo B, Dalenc F, Escrivá-de-Romaní S, Calvo Martínez L, Ribelles N, Marmé F, Cortés A, Albacar C, Gebhart G, Prat A, Kerrou K, Schmid P, Braga S, Di Cosimo S, Gion M, Antonarelli G, Popa C, Szostak E, Alcalá-López D, Gener P, Rodríguez-Morató J, Mina L, Sampayo-Cordero M, Llombart-Cussac A; PHERGain Trial Investigators. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial. Lancet. 2024 Apr 27;403(10437):1649-1659. doi: 10.1016/S0140-6736(24)00054-0. Epub 2024 Apr 3.PMID: 38582092.
  26. Harbeck N, Ciruelos E, Jerusalem G, Müller V, Niikura N, Viale G, Bartsch R, Kurzeder C, Higgins MJ, Connolly RM, Baron-Hay S, Gión M, Guarneri V, Bianchini G, Wildiers H, Escrivá-de-Romaní S, Prahladan M, Bridge H, Kuptsova-Clarkson N, Scotto N, Verma S, Lin NU; DESTINY-Breast12 study group. Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: a phase 3b/4 trial. Nat Med. 2024 Dec;30(12):3717-3727. doi: 10.1038/s41591-024-03261-7. Epub 2024 Sep 13. Erratum in: Nat Med. 2024 Dec;30(12):3780. doi: 10.1038/s41591-024-03349-0. PMID: 39271844; PMCID: PMC11645283.
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  • PATRICIA: Ensayo clínico fase II de la combinación de palbociclib y trastuzumab con o sin letrozol en pacientes postmenopáusicas con cáncer de mama localmente avanzado o metastásico HER2-positivo previamente tratado.
  • A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GDC-0077 AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT SOLID TUMORS AND IN COMBINATION WITH ENDOCRINE AND TARGETED THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT HORMONE-RECEPTOR POSITIVE BREAST CANCER.
  • 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).
  • AN OBSERVATIONAL, RETROSPECTIVE STUDY ON THE PROGRESS OF BREAST CANCER CASES IN MALES AND THE ASSESSMENT OF RELAPSE RISK THROUGH GENE SEQUENCING.
  • A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast CancerA Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast Cancer.
  • Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination with Pembrolizumab for First-Line Treatment of Patients with Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer.
  • A Phase 2 Study of ZEN003694 in Combination with Talazoparib in Patients with Triple-Negative Breast Cancer.
  • HER2-PREDICT: TRANSLATIONAL STUDY OF TUMOR SAMPLES FROM DS8201-A-U301 AND DS8201-A-U302 TRIALS.
  • A phase Ib study of Ipatasertib, an AKT inhibitor, in combination with Pertuzumab plus Trastuzumab in patients with PI3KCA-mutant, HER2-positive locally advanced or metastatic breast cancer (IPATHER).
  • 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.
  • A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Abemaciclib to Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer.
  • A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-0077 PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN PATIENTS WITH PIK3CA-MUTANT, HORMONE RECEPTORPOSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER.
  • A PHASE Ia/b, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF BTRC4017A ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT AND IN COMBINATION WITH TRASTUZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HER2-EXPRESSING CANCERS.
  • A Randomized, multicenter, double-lbind, placebo -controlled  phase 3 study of nivolumab VS placebo in combination with neoadjuvant chemotherapy and adjuvant endocrine Therapy in the treatment of high-risk, stage II-III estrogen receptro-positive (ER+), human epidermal growth factor receptro 2- negative (HER2-) breast cancer.
  • 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.
  • STUDY TO EVALUATE THE EFFECT OF METFORMIN IN THE PREVENTION OF HYPERGLYCEMIA IN HR[+]/HER2[-] PIK3CA-MUTATED ADVANCED BREAST CANCER PATIENTS TREATED WITH ALPELISIB PLUS ENDOCRINE THERAPY. THE METALLICA STUDY.
  • A PHASE III RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER.
  • DOLAF- An international multicenter phase II trial of Durvalumab (MEDI4736) plus OLAparib plus Fulvestrant in metastatic or locally advanced ER-positive, HER2-negative breast cancer patients selected using criteria that predict sensitivity to olaparib.
  • A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING  PREOPERATIVE THERAPY.
  • 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.
  • A Randomised, Multicentre, Double-Blind, Phase 3 Study of AZD9833 (An Oral SERD) plus Palbociclib plus Anastrozole Placebo versus Anastrozole plus Palbociclib plus AZD9833 Placebo for the Treatment of Patients with Estrogen Receptor-ositive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.
  • A Phase II with 2 parallel cohorts clinical trial targeting estrogen receptor negative or PAM50 non-luminal disease with Atezolizumab in combination with Trastuzumab and Vinorelbine in HER2-positive advanced/metastatic breast cancer – ATREZZO Study.
  • A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING EFFICACY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY.
  • A Phase 3, double-blind, randomized study to assess the efficacy and safety of switching to AZD9833 (an oral SERD) + CDK4/6 inhibitors (palbociclib or abemaciclib) vs continuing aromatase inhibitor + CDK4/6 inhibitors in patients with acquired ESR1 mutation without radiological progression during 1L treatment with AI + CDK4/6i for HR+/HER2- mBC-ctDNA guided early switch study.
  • Chemotherapy-Free pCR-Guided Strategy with subcutaneous trastuzumab-pertuzumab and T-DM1 in HER2-positive early breast cancer (PHERGAIN-2).
  • Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09).
  • A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer.
  • An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2 Positive Breast Cancer (DESTINY- Breast12).
  • Estudio de fase 3, aleatorizado, abierto, en el que se compara LY3484356 con la hormonoterapia de preferencia del investigador en pacientes con cáncer de mama localmente avanzado o metastásico, con expresión de receptores estrogénicos y sin sobreexpresión del receptor HER2, que anteriormente han recibido hormonoterapia.
  • Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS).
  • Predicting olaparib sensitivity in metastatic HER2-negative breast cancer with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutation or RAD51-negative test: RADIOLA TRIAL.
  • A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer.
  • A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GDC‑9545 COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE  ONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR−POSITIVE, HER2‑NEGATIVE EARLY BREAST CANCER.
  • Estudio Fase 3 Abierto de Neoadyuvancia con Trastuzumab Deruxtecan (T-DXd) en monoterapia o T-DXd seguido de THP comparado con ddAC-THP en pacientes con cáncer de mama en estadio temprano HER2-positivo de alto riesgo (DESTINY-Breast 11).
  • 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.
  • Phase 3 Open Label Randomized Study of Dato-DXd Versus TPC in Metastatic Triple Negative Breast Cancer for Patients Who are Not a Candidate for Immunotherapy (TROPION-Breast02).
  • Phase 3 Open Label Randomized Study of Dato-DXd Versus TPC in Metastatic Triple Negative Breast Cancer for Patients Who are Not a Candidate for Immunotherapy (TROPION-Breast02).
  • Evaluating outcomes in patients with locally advanced or metastatic breast cancer participating in abemaciclib Patient Support Program in Spain.
  • Treatment of advanced or metastatic triple-negative breast cancer with adoptive therapy of PD1+ tumor-infiltrating lymphocytes (TILS001 trial).
  • Phase II, Multi-Centre, Open-Label, Global Study to Assess the Efficacy and Safety of Neoadjuvant Therapy with Olaparib Monotherapy And Olaparib Plus Durvalumab Combination Therapy in Patients with Triple Negative Breast Cancer and Germline BRCA Mutations (OlympiaN).
  • Study to evaluate the extend overall survival (OS) from Parsifal Trial: efficacy and safety of Palbociclib in combination with Fulvestrant or Letrozole in patients with Her2 negative, ER+, Metastatic Breast Cancer (Parsifal-Long).
  • A phase 2 trial of neoadjuVAnt muLti-agENt chemotherapy or patritumab deruxtecan (U3-1402; HER3-DXd) with or without endocrINE therapy for high-risk/HER2- breast cancer.
  • A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.
  • A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab for metastatic HER2+ breast cancer.
  • A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1.
  • Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan with or without Durvalumab Versus Investigator’s Choice of Therapy in Patients with Stage I-III Triple Negative Breast Cancer who have Residual Invasive Disease in Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03).
  • EUROPA T-DXd: EXPERIENCIA EN EL MUNDO REAL EUROPEO DE PACIENTES CON CÁNCER DE MAMA POSITIVO PARA HER2 AVANZADO/METASTÁSICO PREVIAMENTE TRATADO QUE ACCEDEN A TRASTUZUMAB DERUXTECÁN A TRAVÉS DE UN PROGRAMA DE ACCESO INDIVIDUAL.
  • 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.
  • Un ensayo de fase 3 aleatorizado, doble ciego, controlado con placebo en sujetos con carcinoma de mama metastásico HER2/ neu negativo HR positivo y HR negativo que compara la dosis biologiocal óptima de efti en combinación con paclitaxel semanal vs. paclitaxel + placebo.
  • 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.
  • A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS  FULVESTRANT VERSUS ALPELISIB PLUS  FULVESTRANT IN PATIENTS WITH HORMONE  RECEPTOR-POSITIVE, HER2-NEGATIVE, PIK3CA MUTATED, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO PROGRESSED DURING OR AFTER CDK4/6 INHIBITOR AND ENDOCRINE COMBINATION THERAPY.
  • PHASE II STUDY FOR PIK3CA/PTEN-ALTERED ADVANCED METAPLASTIC BREAST CANCER TREATED WITH MEN1611 MONOTHERAPY OR IN COMBINATION WITH ERIBULIN.
  • A multi-center, multi-country prospective observational study of patients initiating T-DXd in the first or second treatment line for HER2+ unresectable and/or metastatic breast cancer.
  • AN OPEN-LABEL INTERVENTIONAL, MULTICENTER, RANDOMIZED,  PHASE 2 STUDY OF FULVESTRANT WITH OR WITHOUT SAMURACICLIB IN  PARTICIPANTS WITH METASTATIC OR LOCALLY ADVANCED HORMONE RECEPTOR POSITIVE AND HUMAN EPIDERMAL GROWTH FACTOR  RECEPTOR 2-NEGATIVE BREAST CANCER.
  • A Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable,  Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy.

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

Research Groups

Melanoma and Other Cutaneous Tumors Group

Summary

VHIO’s Melanoma and Other Cutaneous Tumors Research Group mainly focuses on clinical research, with particular emphasis on novel targeted therapies and mechanisms of resistance to immunotherapy. We also focus on translational research in cutaneous, mucosal, acral and uveal melanoma, among other skin cancers including squamous and basocellular skin tumors. We also lead and develop clinical trials in early and late-stage cutaneous tumors. Over the last few years we have established our Unit as a reference in combating these diseases, with one of the largest therapeutic arsenals against skin cancers.

Our consolidated research team incorporates clinical investigators, dermatologists, other medical specialists, and cancer researchers. We adopt a purely multidisciplinary and translational research model which enables us to lead one of the largest melanoma networks in Spain and indeed Europe.

We continue to make significant progress by (co) leading and participating in multiple phase I, II and III clinical studies in melanoma and other skin cancers to evaluate novel therapies in the metastatic, neoadjuvant and adjuvant settings. We also actively participate in different preclinical and clinical projects, with particular emphasis on overcoming resistance to standard targeted therapies and immunotherapies.

In collaboration with other medical departments, including internal medicine, cardiology, neurology, nephrology, hepatology, and endocrinology, we have consolidated a working group on immunotherapy toxicity at the Vall d’Hebron University Hospital (Vall d’Hebron Barcelona Hospital Campus). We aim to identify and manage immunotherapy-related toxicities earlier and pursue research into the mechanisms underlying immune-related adverse events.

  • Maintain our Cutaneous Tumor Unit as a reference for melanoma and other skin tumors through a consolidated referral network and continue to (co) lead and participate in large-scale clinical trials from the very beginning, including trial design, planning and implementation.
  • Improve treatment outcomes in cutaneous or ocular melanoma, and advance insights into the development and progression of these diseases.
  • Deliver early clinical drug development and the identification of biomarkers of tumor progression and validation of novel therapeutic targets in melanoma and other cutaneous tumors.
  • Expand our collaboration with VHIO researchers to achieve a deeper understanding of tumor immunology and the biology of skin tumors.
  • Elucidate the molecular mechanisms that drive the development and progression of other cutaneous tumors, particularly squamous and basal cell skin cancer.
  • Discover effective molecular targets for metabolic therapies to broaden the therapeutic arsenal against skin tumors.
  • We continue to lead one of the largest melanoma research networks in Spain and Europe. Our Unit is also one of the most active groups in metastatic and adjuvant clinical studies in melanoma and other cutaneous tumors. Each clinical trial is closely linked to translational research projects led by VHIO investigators, bridging the gap between research and clinical application.
  • We have further strengthened our collaboration with VHIO investigators and other researchers who are studying skin tumors to better understand tumor immunology in melanoma, identify biomarkers of disease progression, and validate new therapeutic targets in melanoma and other skin cancers.
  • We are also expanding our database lock to collect and store samples for future national and international partnerships and projects.
  • To maintain the quality of care and clinical research at the Cutaneous Tumors Unit as a center of excellence at the Spanish and European level.
  • Strengthen leadership in skin tumors through collaborations and new projects.
  • Define the members and the role of each member of the Skin Tumor Unit in the Oncology Department.
  • Continue to contribute to the training of other healthcare professionals in the field of cutaneous tumors and the management of immune-mediated toxicity, as well as advance the management of skin tumors and immune-mediated toxicity.
  • Optimize the recruitment of patients with skin tumors in different phase I/II/III/IV clinical trials.
  • Promote and expand translational research, especially in the field of immunotherapy and targeted therapies, in collaboration with VHIO investigators and other national and international partnerships.
  • Consolidate a biorepository (Seroteca) for future national collaborations, ensuring sustainable access to biological samples.
  • Spreafico A, Couselo EM, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane IM, Sanmamed MF, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umaña P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack RF, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Front Oncol. 2024 Mar 21;14:1346502.
  • McGrail K, González-Sánchez E, Granado-Martínez P, Orsenigo R, Ding Y, Ferrer B, Hernández-Losa J, Ortega I, Martín-Caballero J, Muñoz-Couselo E, García-Patos V, Recio JA. Loss of Lkb1 cooperates with BrafV600E and ultraviolet radiation, increasing melanoma multiplicity and neural-like dedifferentiation. Mol Oncol. 2024. doi: 10.1002/1878-0261.13715.
  • Gogas H, Ravimohan S, Datta A, Chhibber A, Couselo EM, Diab A, Pereira C, Quéreux G, Sandhu S, Curti B, Khushalani NI, Taylor MH, Daniels GA, Spreafico A, Meniawy T, Van Den Eertwegh AJM, Sun Y, Arriaga Y, Zhou M, Long GV, Lebbé C. Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab. NPJ Precis Oncol. 2024 Jul 19;8(1):150.
  • Usset J, Rosendahl Huber A, Andrianova MA, Batlle E, Carles J, Cuppen E, Elez E, Felip E, Gómez-Rey M, Lo Giacco D, Martinez-Jimenez F, Muñoz-Couselo E, Siu LL, Tabernero J, Vivancos A, Muiños F, Gonzalez-Perez A, Lopez-Bigas N. Five latent factors underlie response to immunotherapy. Nat Genet. 2024 Oct;56(10):2112-2120.
  • Eva Muñoz was awarded a SEOM BMS Grant for Translational Research in Immuno-Oncology for a project entitled: Biopsia liquida ultrasensible como biomarcador de enfermedad mínima residual y riesgo de recurrencia en pacientes con melanoma operables.

Competitive funding:

  1. Grantor: ROCHE FARMA S.A.
    Project title: Observational cross-sectional study evaluating the sociodemographic and clinical characteristics of patients with metastatic melanoma BRAF V600 mutation that shows response (CR/PR) after being treated for at least one year with Cobimetinib + Vemurafenib based on routine clinical
    Duration: 28/04/2017 – 31/12/2025
    PI: Eva Muñoz
  2. Grantor: Merck, Sharp & Dohme de España. S.A.
    Project title: Apoyo a la financiación de los gastos relacionados con proyectos de investigación dentro del área de melanoma y tumores cutáneos
    Duration: 21/11/2019 – 31/12/2025
    PI: Eva Muñoz
  3. Grantor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION (BMSIC)
    Project title: Phase II study to compare the effect of early detection of asymptomatic brain mets vs standard follow-up on OS and symptomatic Br Mets free survival (SBMFS) in patients with previously untreated, unresectable or metastatic melanoma
    Duration: 10/12/2019 – 31/12/2025
    PI: Eva Muñoz
  1. Cañueto J, Muñoz-Couselo E, Cardona-Machado C, Becerril-Andrés S, Martín-Vallejo J, Serra-Guillén C, Soria A, Serrano-Domingo JJ, Ortiz-Velez C, Lostes J, García-Castaño A, Puig S, Fernández de Misa R, Medina J, Aguado C, Ayala de Miguel P, Navarro-Navarro I, Masferrer E, Delgado M, Bellido-Hernández L, Sanmartin O. Efficacy and safety of cemiplimab in the treatment of advanced cutaneous squamous cell carcinoma: A multicentre real-world retrospective study from Spain and systematic review of the published data. J Eur Acad Dermatol Venereol. 2024 Aug;38(8):e666-e670. doi: 10.1111/jdv.19821.
  2. Clavero-Rovira L, Gómez-Tomás Á, Bassas-Freixas P, Bodet D, Ferrer B, Hernández-Losa J, Muñoz-Couselo E, Pérez-Benavente A, García-Patos V, Ferrándiz-Pulido C. Mucosal Melanoma Clinical Management and Prognostic Implications: A Retrospective Cohort Study. Cancers (Basel). 2024 Jan 3;16(1):227. doi: 10.3390/cancers16010227.
  3. Mandalà M, Lorigan P, Sergi MC, Benannoune N, Serra P, Vitale MG, Giannarelli D, Arance AM, Couselo EM, Neyns B, Tucci M, Guida M, Spagnolo F, Rossi E, Occelli M, Queirolo P, Quaglino P, Depenni R, Merelli B, Placzke J, Di Giacomo AM, Del Vecchio M, Indini A, da Silva IP, Menzies AM, Long GV, Robert C, Rutkowski P, Ascierto PA. Combined immunotherapy in melanoma patients with brain metastases: A multicenter international study. Eur J Cancer. 2024 Mar;199:113542. doi: 10.1016/j.ejca.2024.113542.
  4. Riveiro-Barciela M, Barreira-Díaz A, Salcedo MT, Callejo-Pérez A, Muñoz-Couselo E, Iranzo P, Ortiz-Velez C, Cedrés S, Díaz-Mejía N, Ruiz-Cobo JC, Morales R, Aguilar-Company J, Zamora E, Oliveira M, Sanz-Martínez MT, Viladomiu L, Martínez-Gallo M, Felip E, Buti M. An algorithm based on immunotherapy discontinuation and liver biopsy spares corticosteroids in two thirds of cases of severe checkpoint inhibitor-induced liver injury. Aliment Pharmacol Ther. 2024 Apr;59(7):865-876. doi: 10.1111/apt.17898.
  5. Spreafico A, Couselo EM, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane IM, Sanmamed MF, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umaña P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack RF, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Front Oncol. 2024 Mar 21;14:1346502. doi: 10.3389/fonc.2024.1346502.
  6. Remon J, Auclin E, Zubiri L, Schneider S, Rodriguez-Abreu D, Minatta N, Gautschi O, Aboubakar F, Muñoz-Couselo E, Pierret T, Rothschild SI, Cortiula F, Reynolds KL, Thibault C, Gavralidis A, Blais N, Barlesi F, Planchard D, Besse BMD. Immune checkpoint blockers in solid organ transplant recipients and cancer: the INNOVATED cohort. ESMO Open. 2024 May;9(5):103004. doi: 10.1016/j.esmoop.2024.103004.
  7. Márquez-Rodas I, Muñoz Couselo E, Rodríguez Moreno JF, Arance Fernández AM, Berciano Guerrero MÁ, Campos Balea B, de la Cruz Merino L, Espinosa Arranz E, García Castaño A, Berrocal Jaime A. SEOM-GEM clinical guidelines for cutaneous melanoma (2023). Clin Transl Oncol. 2024 Nov;26(11):2841-2855. doi: 10.1007/s12094-024-03497-2.
  8. McGrail K, González-Sánchez E, Granado-Martínez P, Orsenigo R, Ding Y, Ferrer B, Hernández-Losa J, Ortega I, Martín-Caballero J, Muñoz-Couselo E, García-Patos V, Recio JA. Loss of Lkb1 cooperates with BrafV600E and ultraviolet radiation, increasing melanoma multiplicity and neural-like dedifferentiation. Mol Oncol. 2025 Feb;19(2):329-343. doi: 10.1002/1878-0261.13715.
  9. Gonzalez-Cao M, Puertolas T, Manzano JL, Maldonado C, Yelamos O, Berciano-Guerrero MÁ, Cerezuela P, Martin-Liberal J, Muñoz-Couselo E, Espinosa E, Drozdowskyj A, Berrocal A, Soria A, Marquez-Rodas I, Martin-Algarra S, Quindos M, Puig S; Spanish Melanoma Group (GEM). Access to melanoma drugs in Spain: a cross-sectional survey. Clin Transl Oncol. 2024 Oct;26(10):2572-2583. doi: 10.1007/s12094-024-03501-9.
  10. Gogas H, Ravimohan S, Datta A, Chhibber A, Couselo EM, Diab A, Pereira C, Quéreux G, Sandhu S, Curti B, Khushalani NI, Taylor MH, Daniels GA, Spreafico A, Meniawy T, Van Den Eertwegh AJM, Sun Y, Arriaga Y, Zhou M, Long GV, Lebbé C. Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab. NPJ Precis Oncol. 2024 Jul 19;8(1):150. doi: 10.1038/s41698-024-00641-7.
  11. Hughes BGM, Guminski A, Bowyer S, Migden MR, Schmults CD, Khushalani NI, Chang ALS, Grob JJ, Lewis KD, Ansstas G, Day F, Ladwa R, Stein BN, Muñoz Couselo E, Meier F, Hauschild A, Schadendorf D, Basset-Seguin N, Modi B, Dalac-Rat S, Dunn LA, Flatz L, Mortier L, Guégan S, Heinzerling LM, Mehnert JM, Trabelsi S, Soria-Rivas A, Stratigos AJ, Ulrich C, Wong DJ, Beylot-Barry M, Bossi P, Bugés Sánchez C, Chandra S, Robert C, Russell JS, Silk AW, Booth J, Yoo SY, Seebach F, Lowy I, Fury MG, Rischin D. A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6. J Am Acad Dermatol. 2025 Jan;92(1):68-77. doi: 10.1016/j.jaad.2024.06.108. Epub 2024 Sep 7.
  12. Usset J, Rosendahl Huber A, Andrianova MA, Batlle E, Carles J, Cuppen E, Elez E, Felip E, Gómez-Rey M, Lo Giacco D, Martinez-Jimenez F, Muñoz-Couselo E, Siu LL, Tabernero J, Vivancos A, Muiños F, Gonzalez-Perez A, Lopez-Bigas N. Five latent factors underlie response to immunotherapy. Nat Genet. 2024 Oct;56(10):2112-2120. doi: 10.1038/s41588-024-01899-0.
  13. Cohen G, Rapoport B, Chan SW, Ruff P, Arance A, Mujika Eizmendi K, Houghton B, Brown MP, Zielinski RM, Muñoz Couselo E, Lyle M, Anderson JR, Jain L, de Alwis D, Lala M, Akala O, Chartash E, Jacobs C. Pembrolizumab 400 mg every 6 weeks as first-line therapy for advanced melanoma (KEYNOTE-555): Results from cohort B of an open-label, phase 1 study. PLoS One. 2024 Nov 12;19(11):e0309778. doi: 10.1371/journal.pone.0309778.
  14. Amaral T, Ottaviano M, Arance A, Blank C, Chiarion-Sileni V, Donia M, Dummer R, Garbe C, Gershenwald JE, Gogas H, Guckenberger M, Haanen J, Hamid O, Hauschild A, Höller C, Lebbé C, Lee RJ, Long GV, Lorigan P, Muñoz Couselo E, Nathan P, Robert C, Romano E, Schadendorf D, Sondak V, Suijkerbuijk KPM, van Akkooi ACJ, Michielin O, Ascierto PA; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Cutaneous melanoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025 Jan;36(1):10-30. doi: 10.1016/j.annonc.2024.11.006. Epub 2024 Nov 14.
  15. Dummer R, Sandhu S, Miller WH, Butler MO, Taylor MH, Heinzerling L, Blank CU, Munoz-Couselo E, Burris HA, 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 BRAF V600-Mutant Metastatic Melanoma. Clin Cancer Res. 2025 Mar 19. doi: 10.1158/1078-0432.CCR-24-0254. Epub ahead of print.
  • Principle investigator: Phase 3 Randomized, Double-blind Study of Encorafenib and Binimetinib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants with BRAF V600E/K Mutation-Positive Metastatic OR unresectable locally advanced Melanoma.
  • Principle investigator: Phase IB open-label, phase i study of neo-ptc-01 in patients with advanced or metastatic melanoma, NTC-001.
  • Principle investigator: 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.
  • Principle investigator: Phase 3, 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. Study Number: Study PH-L19IL2TNF-01/1.
  • Principle investigator: Phase 3 CA224-127- A Phase 3, Open-label, Randomized, Non-Inferiority Trial for Subcutaneous Formulation of Nivolumab + Relatlimab Fixed-Dose Combination versus Intravenous Administration of Nivolumab + Relatlimab Fixed-Dose Combination in Adult Participants with Previously Untreated Metastatic or Unresectable Melanoma.
  • Investigadora principal del estadio fase III, aleatorizado, doble ciego, comparativo con placebo y con tratamiento activo de V940 (ARNm-4157) adyuvante más pembrolizumab frente a un placebo adyuvante más pembrolizumab en participantes con melanoma en estadio II-IV de alto riesgo.
  • Principle investigator: Phase 3 A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting.
  • Principle investigator: Phase 1/2 open-label, multicenter 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.
  • Principle investigator: Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared with OPDIVO® (Nivolumab) in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma
  • Principle investigator: Phase 2 Study Evaluating INCB099280 in Participants with Advanced Squamous Cell Carcinoma.
  • Principle investigator: 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).
  • Principle investigator: Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma. Protocol Number: IOV-MEL-301.
  • Principle investigator: Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC).
  • Principle investigator: 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 (PRISM-MEL-301).

Group Leader Francesc Bosch Translational Research Coordinator Marta Crespo Clinical Research Coordinator Pau Abrisqueta Hematologists/Lead Investigators Pere Barba, David Beneitez, Andrés Jerez, David Valcárcel Postdoctoral Scientists Pamela Acha, Cristina Hernández, Iñaki Salvador PhD Students Maite Ergüin, Patricia Fernández, Sofía Mallorquí, Daniel Medina, Carlota Pagès, Claudia Pellín Technicians Marina Corominas, Ana María Garrido Statistician Víctor Navarro Hematologists/Lab Specialists Olga Benitez, Adoración Blanco, Cecilia Carpio, Maria Laura Fox, Laura Gallur, Sara Garrido, Mercedes Gironella, Gloria Hidalgo, Marta Hidalgo, Gloria Iacoboni, Félix López, Ana Marín, Lucía Martín, Maria Martinez, Julia Montoro, Mayda Navarrete, Pável Oliveira, Margarita Ortega, Guillem Orti, Ana Ortuño, Carles Palacio, Ana Pérez, Elisa Roldán, Olga Salamero, Silvia Saumell, Ángel Serna

Research Groups

Experimental Hematology Group

Summary

VHIO’s Experimental Hematology Group conducts preclinical, translational and clinical research on hematological neoplasms of both lymphoid and myeloid origin. Our research team comprises hematologists and cancer biologists who work closely together to design and lead our research lines.

We aim to address unmet clinical needs identified by hematologists. To translate our research results into clinical benefits for patients, we conduct preclinical studies, develop early phase clinical trials, and define novel biomarkers to improve diagnosis, prognosis and treatment outcomes.

We seek to provide new therapeutic options for our patients by deciphering the mechanisms implicated in the pathogenesis and progression of hematological malignancies. Our investigators conduct preclinical studies to assess novel therapeutic strategies for patients. We identify new biomarkers in hematology to improve diagnosis and prognosis, and develop rationale-based therapies.

Our Hematology Clinical Trials Unit is currently conducting more than 132 clinical studies with active recruitment, including a total of 50 phase I and basket trials, and first-in-human studies evaluating targeted therapies, both in lymphoid and myeloid malignancies. In 2024, 147 patients were included in our studies, with 36 patients enrolled in phase I and basket trials.

Figure: Influence of TP53 gene mutations and their allelic status in myelodysplastic syndromes with isolated 5q deletion, Júlia Montoro et al, Blood, 2024.
  • 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.
  • Decipher the mechanisms involved in the pathogenesis and progression of hematological neoplasms.
  • Preclinically assess new treatment modalities in experimental models that mimic the tumor microenvironment using primary cells, transgenic mouse models, patient-derived xenograft (PDX) models and 3D ex-vivo cultures.
  • Identify new biomarkers for a more rationale-based, personalized treatment of patients.
  • Gain a deeper understanding of the crosstalk mechanisms between tumor cells and the microenvironment that guide the development of personalized, more efficient immunotherapies.
  • 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 launched a nationwide biomarker study and a patient registry for people diagnosed with chronic lymphocytic leukemia (CLL).
  • We have led several projects in the study of clinical-biological biomarkers to assess the efficacy and safety of CAR-T cells.
  • We have assessed novel genetic prognostic markers for patients with myelodysplastic syndromes (MDS).
  • 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 immune dynamics in the efficacy of immunotherapy for the treatment of lymphoid malignancies.
  • Advance our nation-wide study for biomarkers and a registry of patients diagnosed with CLL.
  • Montoro MJ, Palomo L, Haferlach C, Acha P, Chan O, Navarro V, Kubota Y, Schulz FI, Meggendorfer M, Briski R, Al Ali N, Xicoy B, López-Cadenas F, Bosch F, González T, Eder LN, Jerez A, Wang YH, Campagna A, Santini V, Bernal Del Castillo T, Such E, Tien HF, Diaz Varela N, Platzbecker U, Haase D, Díez-Campelo M, Della Porta M, Garcia-Manero G, Wiseman DH, Germing U, Maciejewski JP, Komrokji RS, Sole F, Haferlach T, Valcárcel D. Influence of TP53 gene mutations and their allelic status in myelodysplastic syndromes with isolated 5q deletion. Blood. 2024 Oct 17;144(16):1722-1731.
  • Iacoboni G, Navarro V, Martín-López AÁ, Rejeski K, Kwon M, Jalowiec KA, Amat P, Reguera-Ortega JL, Gallur L, Blumenberg V, Gutiérrez-Herrero S, Roddie C, Benzaquén A, Delgado-Serrano J, Sánchez-Salinas MA, Bailén R, Carpio C, López-Corral L, Hernani R, Bastos M, O'Reilly M, Martín-Martín L, Subklewe M, Barba P. Recent Bendamustine Treatment Before Apheresis Has a Negative Impact on Outcomes in Patients With Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy. J Clin Oncol. 2024 Jan 10;42(2):205-217.
  • Salamero O, Molero A, Pérez-Simón JA, Arnan M, Coll R, Garcia-Avila S, Acuña-Cruz E, Cano I, Somervaille TCP, Gutierrez S, Arévalo MI, Xaus J, Buesa C, Limón A, Faller DV, Bosch F, Montesinos P. Iadademstat in combination with azacitidine in patients with newly diagnosed acute myeloid leukaemia (ALICE): an open-label, phase 2a dose-finding study. Lancet Haematol. 2024 Jul;11(7):e487-e498.
  • Abrisqueta P, González-Barca E, Panizo C, Pérez JMA, Miall F, Bastos-Oreiro M, Triguero A, Banerjee L, McMillan A, Seymour E, Hirata J, de Guzman J, Sharma S, Jin HY, Musick L, Diefenbach C. Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study. Lancet Haematol. 2024 Feb;11(2):e136-e146.
  1. Platzbecker U, Santini V, Fenaux P, Sekeres MA, Savona MR, Madanat YF, Díez-Campelo M, Valcárcel D, Illmer T, Jonášová A, Bělohlávková P, Sherman LJ, Berry T, Dougherty S, Shah S, Xia Q, Sun L, Wan Y, Huang F, Ikin A, Navada S, Feller F, Komrokji RS, Zeidan AM. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jan 20;403(10423):249-260. doi: 10.1016/S0140-6736(23)01724-5. Epub 2023 Dec 1. Erratum in: Lancet. 2024 Jan 20;403(10423):248. doi: 10.1016/S0140-6736(24)00057-6.
  2. Roddie C, Sandhu KS, Tholouli E, Logan AC, Shaughnessy P, Barba P, Ghobadi A, Guerreiro M, Yallop D, Abedi M, Pantin JM, Yared JA, Beitinjaneh AM, Chaganti S, Hodby K, Menne T, Arellano ML, Malladi R, Shah BD, Mountjoy L, O'Dwyer KM, Peggs KS, Lao-Sirieix P, Zhang Y, Brugger W, Braendle E, Pule M, Bishop MR, DeAngelo DJ, Park JH, Jabbour E. Obecabtagene Autoleucel in Adults with B-Cell Acute Lymphoblastic Leukemia. N Engl J Med. 2024 Dec 12;391(23):2219-2230. doi: 10.1056/NEJMoa2406526. E
  3. Cwynarski K, Iacoboni G, Tholouli E, Menne T, Irvine DA, Balasubramaniam N, Wood L, Shang J, Xue E, Zhang Y, Basilico S, Neves M, Raymond M, Scott I, El-Kholy M, Jha R, Dainton-Smith H, Hussain R, Day W, Ferrari M, Thomas S, Lilova K, Brugger W, Marafioti T, Lao-Sirieix P, Maciocia P, Pule M. TRBC1-CAR T cell therapy in peripheral T cell lymphoma: a phase 1/2 trial. Nat Med. 2025 Jan;31(1):137-143. doi: 10.1038/s41591-024-03326-7. Epub 2024 Nov 11.
  4. Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, Cheah CY, Ma CY, Huang H, Kwan A, Wei MC, Yin S, Bartlett NL. Durable Responses With Mosunetuzumab in Relapsed/Refractory Indolent and Aggressive B-Cell Non-Hodgkin Lymphomas: Extended Follow-Up of a Phase I/II Study. J Clin Oncol. 2024 Jul 1;42(19):2250-2256. doi: 10.1200/JCO.23.02329.
  5. Iacoboni G, Navarro V, Martín-López AÁ, Rejeski K, Kwon M, Jalowiec KA, Amat P, Reguera-Ortega JL, Gallur L, Blumenberg V, Gutiérrez-Herrero S, Roddie C, Benzaquén A, Delgado-Serrano J, Sánchez-Salinas MA, Bailén R, Carpio C, López-Corral L, Hernani R, Bastos M, O'Reilly M, Martín-Martín L, Subklewe M, Barba P. Recent Bendamustine Treatment Before Apheresis Has a Negative Impact on Outcomes in Patients With Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy. J Clin Oncol. 2024 Jan 10;42(2):205-217. doi: 10.1200/JCO.23.01097.
  6. Iacoboni G, Navarro V, Sesques P, Rejeski K, Bastos-Oreiro M, Serpenti F, Martin Lopez AA, Iraola-Truchuelo J, Delgado J, Perez A, Guerreiro M, Caballero AC, Martinez-Cibrian N, Luzardo Henriquez H, Sanchez Pina JM, Sancho JM, Ghesquieres H, Mussetti A, Lopez Corral L, Hernani R, Reguera JL, Sureda A, Bosch F, Martin Garcia-Sancho A, Kwon M, Subklewe M, Kuhnl A, Bachy E, Barba P, Villacampa G, Abrisqueta P. Development and validation of the post-CAR prognostic index for large B-cell lymphoma patients after CAR-T progression in third or later line treatment. J Hematol Oncol. 2024 Oct 29;17(1):102. doi: 10.1186/s13045-024-01608-8.
  7. Sesques P, Kirkwood AA, Kwon M, Rejeski K, Jain MD, Di Blasi R, Brisou G, Gros FX, le Bras F, Bories P, Choquet S, Rubio MT, Iacoboni G, O'Reilly M, Casasnovas RO, Bay JO, Mohty M, Joris M, Abraham J, Castilla Llorente C, Loschi M, Carras S, Chauchet A, La Rochelle LD, Hermine O, Guidez S, Cony-Makhoul P, Fogarty P, Le Gouill S, Morschhauser F, Gastinne T, Cartron G, Subklewe M, Locke FL, Sanderson R, Barba P, Houot R, Bachy E. Novel prognostic scoring systems for severe CRS and ICANS after anti-CD19 CAR T cells in large B-cell lymphoma. J Hematol Oncol. 2024 Aug 6;17(1):61. doi: 10.1186/s13045-024-01579-w.
  8. Montoro MJ, Palomo L, Haferlach C, Acha P, Chan O, Navarro V, Kubota Y, Schulz FI, Meggendorfer M, Briski R, Al Ali N, Xicoy B, López-Cadenas F, Bosch F, González T, Eder LN, Jerez A, Wang YH, Campagna A, Santini V, Bernal Del Castillo T, Such E, Tien HF, Diaz Varela N, Platzbecker U, Haase D, Díez-Campelo M, Della Porta M, Garcia-Manero G, Wiseman DH, Germing U, Maciejewski JP, Komrokji RS, Sole F, Haferlach T, Valcárcel D. Influence of TP53 gene mutations and their allelic status in myelodysplastic syndromes with isolated 5q deletion. Blood. 2024 Oct 17;144(16):1722-1731. doi: 10.1182/blood.2024023840.
  9. Malinverni C, Bernardelli A, Glimelius I, Mirandola M, Smedby KE, Tisi MC, Giné E, Albertsson-Lindblad A, Marin-Niebla A, Di Rocco A, Moita F, Sciarra R, Bašić-Kinda S, Hess G, Ohler A, Eskelund CW, Re A, Ferrarini I, Kolstad A, Räty R, Quaglia FM, Eyre TA, Scapinello G, Stefani PM, Morello L, Nassi L, Hohaus S, Ragaini S, Zilioli VR, Bruna R, Cocito F, Arcari A, Jerkeman M, Visco C. Outcomes of younger patients with mantle cell lymphoma experiencing late relapse (>24 months): the LATE-POD study. Blood. 2024 Aug 29;144(9):1001-1009. doi: 10.1182/blood.2023023525.
  10. Malinverni C, Bernardelli A, Glimelius I, Mirandola M, Smedby KE, Tisi MC, Giné E, Albertsson-Lindblad A, Marin-Niebla A, Di Rocco A, Moita F, Sciarra R, Bašić-Kinda S, Hess G, Ohler A, Eskelund CW, Re A, Ferrarini I, Kolstad A, Räty R, Quaglia FM, Eyre TA, Scapinello G, Stefani PM, Morello L, Nassi L, Hohaus S, Ragaini S, Zilioli VR, Bruna R, Cocito F, Arcari A, Jerkeman M, Visco C. Outcomes of younger patients with mantle cell lymphoma experiencing late relapse (>24 months): the LATE-POD study. Blood. 2024 Aug 29;144(9):1001-1009. doi: 10.1182/blood.2023023525.
  11. Crochet G, Iacoboni G, Couturier A, Bachy E, Iraola-Truchuelo J, Gastinne T, Cartron G, Fradon T, Lesne B, Kwon M, Gounot R, Martínez-Cibrian N, Castilla-Llorente C, Abrisqueta P, Guerreiro M, Sarkozy C, Aspa-Cilleruelo JM, Camus V, Guidez S, Chauchet A, Deconinck E, Bouabdallah K, Bosch F, Barba P, Morschhauser F, Houot R. Efficacy of CAR T-cell therapy is not impaired by previous bispecific antibody treatment in large B-cell lymphoma. Blood. 2024 Jul 18;144(3):334-338. doi: 10.1182/blood.2024024526.
  12. Mingot-Castellano ME, García-Candel F, Martínez-Nieto J, García-Arroba J, de la Rubia-Comos J, Gómez-Seguí I, Paciello-Coronel ML, Valcárcel-Ferreiras D, Jiménez M, Cid J, Lozano M, García-Gala JM, Angós-Vazquez S, Vara-Pampliega M, Guerra-Domínguez L, Ávila-Idrobo LF, Oliva-Hernandez A, Zalba-Marcos S, Tallón-Ruiz I, Ortega-Sánchez S, Goterris-Viciedo R, Moreno-Jiménez G, Domínguez-Acosta L, Araiz-Ramírez M, Hernández-Mateos L, Flores-Ballesteros E, Del Río-Garma J, Pascual-Izquierdo C. ADAMTS13 recovery in acute thrombotic thrombocytopenic purpura after caplacizumab therapy. Blood. 2024 May 2;143(18):1807-1815. doi: 10.1182/blood.2023022725.
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  75. Mingot-Castellano ME, Reguera-Ortega JL, Zafra Torres D, Hernani R, Lopez-Godino O, Guerreiro M, Herrero B, López-Corral L, Luna A, Gonzalez-Pinedo L, Chinea-Rodriguez A, Africa-Martín A, Bailen R, Martinez-Cibrian N, Balsalobre P, Filaferro S, Alonso-Saladrigues A, Barba P, Perez-Martinez A, Calbacho M, Perez-Simón JA, Sánchez-Pina JM, On Behalf Of The Spanish Group Of Hematopoietic Transplant And Cell Therapy Geth-Tc. Use of Eltrombopag to Improve Thrombocytopenia and Tranfusion Requirement in Anti-CD19 CAR-T Cell-Treated Patients. J Clin Med. 2024 Aug 28;13(17):5117. doi: 10.3390/jcm13175117.
  76. Bardón-Cancho EJ, Marco-Sánchez JM, Benéitez-Pastor D, Payán-Pernía S, Llobet AR, Berrueco R, García-Morin M, Beléndez C, Senent L, Acosta MJO, Pleguezuelos IP, Velasco P, Collado A, Moreno-Carbonell M, Argilés B, de Soto IP, Del Mar Bermúdez M, Salido Fiérrez EJ, Blanco-Álvarez A, Navarro PG, Cela E. Spanish registry of hemoglobinopathies and rare anemias (REHem-AR): demographics, complications, and management of patients with β-thalassemia. Ann Hematol. 2024 May;103(5):1525-1539. doi: 10.1007/s00277-024-05694-z. Epub 2024 Mar 23. Erratum in: Ann Hematol. 2024 Aug;103(8):3283-3284. doi: 10.1007/s00277-024-05838-1.
  77. Abrisqueta P. New Insights into First-Line Therapy in Diffuse Large B-Cell Lymphoma: Are We Improving Outcomes? J Clin Med. 2024 Mar 27;13(7):1929. doi: 10.3390/jcm13071929.
  78. Sobas M, Knopinska-Posluszny W, Piątkowska-Jakubas B, García-Álvarez F, Díez MEA, Caballero M, Martínez-Cuadrón D, Aguiar E, González-Campos J, Garrido A, Algarra L, Salamero O, de la Serna J, Sayas MJ, Perez-Encinas MM, Vives S, Vidriales B, Labrador J, Prado AI, Celebrin L, Mayer J, Brioso J, de Laiglesia A, Bergua JM, Amigo ML, Rodriguez-Medina C, Polo M, Pluta A, Cichocka E, Skarupski M, Sanz MA, Wierzbowska A, Montesinos P. Incidence, risk factors, and outcomes of second neoplasms in patients with acute promyelocytic leukemia: the PETHEMA-PALG experience. Ann Hematol. 2024 Feb;103(2):451-461. doi: 10.1007/s00277-023-05582-y.
  79. Bermejo-Peláez D, Rueda Charro S, García Roa M, Trelles-Martínez R, Bobes-Fernández A, Hidalgo Soto M, García-Vicente R, Morales ML, Rodríguez-García A, Ortiz-Ruiz A, Blanco Sánchez A, Mousa Urbina A, Álamo E, Lin L, Dacal E, Cuadrado D, Postigo M, Vladimirov A, Garcia-Villena J, Santos A, Ledesma-Carbayo MJ, Ayala R, Martínez-López J, Linares M, Luengo-Oroz M. Digital Microscopy Augmented by Artificial Intelligence to Interpret Bone Marrow Samples for Hematological Diseases. Microsc Microanal. 2024 Mar 7;30(1):151-159. doi: 10.1093/micmic/ozad143.
  80. Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007.
  81. Ghione P, Palomba ML, Ray MD, Limbrick-Oldfield EH, Owen J, Kanters S, Bobillo S, Ribiero MT, Jacobson CA, Neelapu SS, Ghesquieres H, Nahas M, Beygi S, Patel AR, Gribben JG. A Comparison of 3-Year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) With SCHOLAR-5 in Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 May;24(5):e191-e195.e6. doi: 10.1016/j.clml.2024.01.011.
  82. Meireles AM, Iacoboni G, Moço LM, Ramos I, Brás G, Azevedo J, Rodrigues Â, Moreira C, Mariz M. Hemophagocytic lymphohistiocytosis in a patient with Epstein-Barr virus-positive diffuse large B-cell lymphoma treated with chimeric antigen receptor T-cell therapy. Immunotherapy. 2024;16(18-19):1105-1111. doi: 10.1080/1750743X.2024.2409622.
  83. Harrison CN, Mesa R, Talpaz M, Gupta V, Gerds AT, Perkins A, Goh YT, Fox ML, McLornan D, Palmer J, Foltz L, Vannucchi A, Koschmieder S, Passamonti F, Lee SE, Ellis C, Strouse B, Gonzalez Carreras FJ, Oh ST. Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib. Clin Lymphoma Myeloma Leuk. 2025 Mar;25(3):199-211. doi: 10.1016/j.clml.2024.10.001.
  84. Muñoz NG, Ortega S, Solanich X, Cid J, Díaz M, Moreno AB, Ancochea Á, Santos M, Hernández I, Sanchez JM, Luaña A, García J, Escoda L, Medina L, Ferrer GJ, López J, Céspedes R, Díaz JA, Pons V, Valcárcel D, Grifols JR. Diagnosis and clinical management of thrombotic thrombocytopenic purpura (TTP): a consensus statement from the TTP Catalan group. Blood Transfus. 2024 Mar;22(2):176-184. doi: 10.2450/BloodTransfus.522.
  85. Pernas B, Iacoboni G, Los-Arcos I, Carpio C, Márquez-Algaba E, Sanchez-Salinas MA, Albasanz A, Esperalba J, Viñado B, Camps IR, Barba P. Patients with aggressive B-cell lymphoma receiving CAR T-cell therapy have a low rate of severe infections despite lack of universal antibacterial and antifungal prophylaxis. Eur J Haematol. 2024 Aug;113(2):227-234. doi: 10.1111/ejh.14207.
  86. Cordoba R, Sánchez-García J, Domingo-Domenech E, López Jiménez J, Martínez Pozo A, Carpio C, Bendaña Á, González AJ, González de Villambrosia S, Gómez Codina J, Navarro B, Rodríguez G, Naves A, Baeza L, Martín García-Sancho A. 18F-FDG-PET/CT response after first-line treatment as a prognostic factor for survival in peripheral T-cell lymphoma: a Spanish retrospective study. Expert Rev Hematol. 2024 Jan-Mar;17(1-3):95-100. doi: 10.1080/17474086.2024.2313457.
  87. Pardos-Gea J, Benítez O. Retroperitoneal and lower extremities muscle bleeding in acquired haemophilia A (AHA): Risk factors and implications in disability and survival. Eur J Haematol. 2024 Nov;113(5):685-692. doi: 10.1111/ejh.14279.
  88. Sekeres MA, Santini V, Díez-Campelo M, Komrokji RS, Fenaux P, Savona MR, Madanat YF, Valcárcel-Ferreiras D, Oliva EN, Regnault A, Creel K, Sengupta N, Dougherty S, Shah S, Sun L, Wan Y, Navada S, Zeidan AM, Platzbecker U. Sustained benefits of imetelstat on patient-reported fatigue in patients with lower-risk myelodysplastic syndromes ineligible for, or relapsed/refractory to, erythropoiesis-stimulating agents and high transfusion burden in the phase 3 IMerge study. Leuk Lymphoma. 2025 Mar;66(3):529-534. doi: 10.1080/10428194.2024.2426057.
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For a full listing of clinical trials in hematology please see the corresponding table under ‘Transversal Clinical Trials Services and Units’ (select from the submenu above).

Group Leaders Joaquin Mateo, Joan Carles Senior Researcher Irene Casanova Staff Researcher Gisela Mir Medical Oncologists Nely Diaz, Macarena González, David Marmolejo, Rafael Morales, Cristina Suárez Postdoctoral Fellows Nicolas Anselmino, Richard Norris Clinical Research Fellow Pablo Cresta 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, Gemma Pruna Research Nurse Ana Maria Castañeira 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 with molecular correlative studies, following a bench-to-bedside-and-back research approach. Investigator-initiated clinical trials play a key role in our strategy, serving as a platform for correlative studies that help optimize the drug development pathway for prostate cancer patients.

We integrate expertise from clinical research, molecular biology, genomics, transcriptomics, computational sciences, and clinical data to advance precision medicine for prostate cancer patients. Our team includes medical oncologists, biomedical scientists specializing in cancer biology, genomics, and transcriptomics, as well as experts in bioinformatics, liquid biopsy, and clinical data.

To support this effort, we have established a platform for collecting longitudinal biospecimens from patients with advanced prostate cancer, including both tumor tissue and liquid biopsies. 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 options. 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.

We have also launched HOPE-Prostate, a collaborative project with the SOLTI Group and Spanish prostate cancer medical societies. This initiative empowers metastatic prostate cancer patients to undergo molecular testing. To facilitate this, we developed an interactive platform integrating next-generation sequencing (NGS) of tumor samples and liquid biopsy data with patient self-reported clinical data. As part of our initiative, we study patient perspectives on the value of NGS analysis, gaining insights into their perception of treatment recommendations made by a panel of specialists. In the first year of the project, we recruited over 100 patients.

Our research is generously funded by grants 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, and ”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.

In summary, our research integrates different modalities of clinical and translational research aiming to improve the outcomes for patients with prostate cancer.

  • To test and develop new therapeutic strategies for prostate cancer in clinical trials.
  • Investigate correlations between molecular profiles and clinical outcome data that can guide more precise prostate cancer treatment strategies.
  • 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.
  • Apply computational pipelines toward investigating genomic signatures in prostate cancer.
  • Development of academic clinical trials to validate our laboratory results in the clinic and leveraging patient biopsies for correlative studies.
  • Integration of clinical and laboratory research to facilitate the translation of research findings into advances in patient care.
  • Publication in Cancer Cell of our study on the characterization of extracellular vesicles (EVs) from patients' plasma samples.
  • Results from different clinical trials in which our group has actively participated have been published in the Journal of Clinical Oncology and Nature Medicine.
  • Completion of patient recruitment for the IRONMAN registry in Spain, with 511 patients.
  • 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.
  • Casanova-Salas I, Aguilar D, Cordoba-Terreros S, Agundez L, Brandariz J, Herranz N, Mas A, Gonzalez M, Morales-Barrera R, Sierra A, Soriano-Navarro M, Cresta P, Mir G, Simonetti S, Rodrigues G, Arce-Gallego S, Delgado-Serrano L, Agustí I, Castellano-Sanz E, Mast R, de Albert M, Celma A, Santamaria A, Gonzalez L, Castro N, Suanes MDM, Hernández-Losa J, Nonell L, Peinado H, Carles J, Mateo J. Circulating tumor extracellular vesicles to monitor metastatic prostate cancer genomics and transcriptomic evolution. Cancer Cell. 2024 Jul 8;42(7):1301-1312.e7.
  • Garcia-Ruiz A, Macarro C, Zacchi F, Morales-Barrera R, Grussu F, Casanova-Salas I, Sanguedolce F, Gonzalez M, Cresta-Morgado P, de Albert M, Garcia-Bennett J, Marmolejo D, Planas J, Roche S, Mast R, Zatse C, Piulats JM, Herrera-Imbroda B, Regis L, Agundez L, Olmos D, Calvo N, Escobar M, Carles J, Mateo J, Perez-Lopez R. Whole-body Magnetic Resonance Imaging as a Treatment Response Biomarker in Castration-resistant Prostate Cancer with Bone Metastases: The iPROMET Clinical Trial. Eur Urol. 2024 Sep;86(3):272-274.
  • Mateo J, de Bono JS, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Agarwal N, Olmos D, Thiery-Vuillemin A, Özgüroğlu M, Mehra N, Matsubara N, Young Joung J, Padua C, Korbenfeld E, Kang J, Marshall H, Lai Z, Barnicle A, Poehlein C, Lukashchuk N, Hussain M. Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial. J Clin Oncol. 2024 Feb 10;42(5):571-583.
  • Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschäbitz S, Oldenburg J, Ye D, Lin X, Healy CG, Di Santo N, Laird AD, Zohren F, Agarwal N. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med. 2024 Jan;30(1):257-264.
  • Irene Casanova-Salas received the Prostate Cancer Foundation Young Investigator Award.
  • Nicolas Anselmino received an AECC Talent Award.

New in 2024:

  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: 2024-2026.
    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.

Ongoing projects in 2024:


  1. 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.
  2. 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.
  3. 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.
  4. 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
  5. Project title: Prostate Cancer Genomic Evolution and Signatures of DNA Damage Repair Deficiencies.
    Grantor: CRIS Cancer Foundation.
    Duration: 2021-2025.
    PI: Joaquin Mateo.
  1. Fracassi G, Lorenzin F, Orlando F, Gioia U, D'Amato G, Casaramona AS, Cantore T, Prandi D, Santer FR, Klocker H, d'Adda di Fagagna F, Mateo J, Demichelis F. CRISPR/Cas9 screens identify LIG1 as a sensitizer of PARP inhibitors in castration-resistant prostate cancer. J Clin Invest. 2024 Dec 24;135(4):e179393. doi: 10.1172/JCI179393.
  2. 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. 2024 Dec 4:S2588-9311(24)00273-6. doi: 10.1016/j.euo.2024.11.011. Epub ahead of print.
  3. Seed G, Beije N, Yuan W, Bertan C, Goodall J, Lundberg A, Tyler M, Figueiredo I, Pereira R, Baker C, Bogdan D, Gallagher L, Cieslik JP, Greening S, Lambros M, Neves R, Magraner-Pardo L, Fowler G, Ebbs B, Miranda S, Flohr P, Bianchini D, Rescigno P, Porta N, Hall E, Gurel B, Tunariu N, Sharp A, Pettit S, Stoecklein NH, Sandhu S, Quigley D, Lord CJ, Mateo J, Carreira S, de Bono J. Elucidating acquired PARP inhibitor resistance in advanced prostate cancer. Cancer Cell. 2024 Dec 9;42(12):2113-2123.e4. doi: 10.1016/j.ccell.2024.10.015.
  4. Seed G, Beije N, Yuan W, Bertan C, Goodall J, Lundberg A, Tyler M, Figueiredo I, Pereira R, Baker C, Bogdan D, Gallagher L, Cieslik JP, Greening S, Lambros M, Neves R, Magraner-Pardo L, Fowler G, Ebbs B, Miranda S, Flohr P, Bianchini D, Rescigno P, Porta N, Hall E, Gurel B, Tunariu N, Sharp A, Pettit S, Stoecklein NH, Sandhu S, Quigley D, Lord CJ, Mateo J, Carreira S, de Bono J. Elucidating acquired PARP inhibitor resistance in advanced prostate cancer. Cancer Cell. 2024 Dec 9;42(12):2113-2123.e4. doi: 10.1016/j.ccell.2024.10.015.
  5. Protasoni M, López-Polo V, Stephan-Otto Attolini C, Brandariz J, Herranz N, Mateo J, Ruiz S, Fernandez-Capetillo O, Kovatcheva M, Serrano M. Cyclophilin D plays a critical role in the survival of senescent cells. EMBO J. 2024 Dec;43(23):5972-6000. doi: 10.1038/s44318-024-00259-2.
  6. 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.
  7. 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.
  8. Mateo J, Zurita AJ. 177Lu-PSMA-617 for metastatic prostate cancer: aiming for the right spot. Lancet. 2024 Sep 28;404(10459):1174-1176. doi: 10.1016/S0140-6736(24)01919-6.
  9. Corres-Mendizabal J, Zacchi F, Martín-Martín N, Mateo J, Carracedo A. Metastatic hormone-naïve prostate cancer: a distinct biological entity. Trends Cancer. 2024 Sep;10(9):825-841. doi: 10.1016/j.trecan.2024.06.005.
  10. Casanova-Salas I, Aguilar D, Cordoba-Terreros S, Agundez L, Brandariz J, Herranz N, Mas A, Gonzalez M, Morales-Barrera R, Sierra A, Soriano-Navarro M, Cresta P, Mir G, Simonetti S, Rodrigues G, Arce-Gallego S, Delgado-Serrano L, Agustí I, Castellano-Sanz E, Mast R, de Albert M, Celma A, Santamaria A, Gonzalez L, Castro N, Suanes MDM, Hernández-Losa J, Nonell L, Peinado H, Carles J, Mateo J. Circulating tumor extracellular vesicles to monitor metastatic prostate cancer genomics and transcriptomic evolution. Cancer Cell. 2024 Jul 8;42(7):1301-1312.e7. doi: 10.1016/j.ccell.2024.06.003.
  11. Carmichael J, Figueiredo I, Gurel B, Beije N, Yuan W, Rekowski J, Seed G, Carreira S, Bertan C, Fenor de La Maza MLD, Chandran K, Neeb A, Welti J, Gallagher L, Bogdan D, Crespo M, Riisnaes R, Ferreira A, Miranda S, Lu J, Shen MM, Hall E, Porta N, Westaby D, Guo C, Grochot R, Lord CJ, Mateo J, Sharp A, de Bono J. RNASEH2B loss and PARP inhibition in advanced prostate cancer. J Clin Invest. 2024 Jun 4;134(21):e178278. doi: 10.1172/JCI178278.
  12. Zacchi F, Carles J, Gonzalez M, Maldonado X, Perez-Lopez R, Semidey ME, Mateo J. Case report: Exceptional and durable response to Radium-223 and suspension of androgen deprivation therapy in a metastatic castration-resistant prostate cancer patient. Front Oncol. 2024 Mar 8;14:1331643. doi: 10.3389/fonc.2024.1331643.
  13. Garcia-Ruiz A, Macarro C, Zacchi F, Morales-Barrera R, Grussu F, Casanova-Salas I, Sanguedolce F, Gonzalez M, Cresta-Morgado P, de Albert M, Garcia-Bennett J, Marmolejo D, Planas J, Roche S, Mast R, Zatse C, Piulats JM, Herrera-Imbroda B, Regis L, Agundez L, Olmos D, Calvo N, Escobar M, Carles J, Mateo J, Perez-Lopez R. Whole-body Magnetic Resonance Imaging as a Treatment Response Biomarker in Castration-resistant Prostate Cancer with Bone Metastases: The iPROMET Clinical Trial. Eur Urol. 2024 Sep;86(3):272-274. doi: 10.1016/j.eururo.2024.02.016.
  14. Chen N, McGrath CB, Ericsson CI, Vaselkiv JB, Rencsok EM, Stopsack KH, Guard HE, Autio KA, Rathkopf DE, Enting D, Bitting RL, Mateo J, Githiaka CW, Chi KN, Cheng HH, Davis ID, Anderson SG, Badal SAM, Bjartell A, Russnes KM, Heath EI, Pomerantz MM, Henegan JC, Hyslop T, Esteban E, Omlin A, McDermott R, Fay AP, Popoola AA, Ragin C, Nowak J, Gerke T, Kantoff PW, George DJ, Penney KL, Mucci LA; IRONMAN Registry. Marital Status, Living Arrangement, and Survival among Individuals with Advanced Prostate Cancer in the International Registry for Men with Advanced Prostate Cancer. Cancer Epidemiol Biomarkers Prev. 2024 Mar 1;33(3):419-425. doi: 10.1158/1055-9965.EPI-23-1207.
  15. Mateo J, de Bono JS, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Agarwal N, Olmos D, Thiery-Vuillemin A, Özgüroğlu M, Mehra N, Matsubara N, Young Joung J, Padua C, Korbenfeld E, Kang J, Marshall H, Lai Z, Barnicle A, Poehlein C, Lukashchuk N, Hussain M. Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial. J Clin Oncol. 2024 Feb 10;42(5):571-583. doi: 10.1200/JCO.23.00339.
  16. Shore N, Carles J, McDermott R, Agarwal N, Tombal B. Treatment intensification with radium-223 plus enzalutamide in patients with metastatic castration-resistant prostate cancer. Front Med (Lausanne). 2024 Oct 24;11:1460212. doi: 10.3389/fmed.2024.1460212.
  17. Azad AA, Fizazi K, Matsubara N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschäbitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Lin X, DeAnnuntis L, Di Santo N, Zielinski MA, Agarwal N. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: Safety analyses from the randomized, placebo-controlled, phase III TALAPRO-2 study. Eur J Cancer. 2024 Dec;213:115078. doi: 10.1016/j.ejca.2024.115078.
  18. Jiménez N, Garcia de Herreros M, Reig Ò, Marín-Aguilera M, Aversa C, Ferrer-Mileo L, García-Esteve S, Rodríguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MÁ, Cros S, Chirivella I, Domènech M, Figols M, Carles J, Suárez C, Herrero Rivera D, González-Billalabeitia E, Cívico C, Sala-González N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Prognostic Gene Expression Signature Based on RB1, PTEN, and TP53 in Metastatic Hormone-sensitive Prostate Cancer Patients. Eur Urol Oncol. 2024 Aug;7(4):954-964. doi: 10.1016/j.euo.2023.12.012.
  19. Shore ND, Gratzke C, Feyerabend S, Werbrouck P, Carles J, Vjaters E, Tammela TLJ, Morris D, Aragon-Ching JB, Concepcion RS, Emmenegger U, Fleshner N, Grabbert M, Lietuvietis V, Mahammedi H, Cruz FM, Paula A, Pieczonka C, Rannikko A, Richardet M, Silveira G, Kuss I, Le Berre MA, Verholen F, Sarapohja T, Smith MR, Fizazi K. Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS. Oncologist. 2024 Jul 5;29(7):581-588. doi: 10.1093/oncolo/oyae019.
  20. Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschäbitz S, Oldenburg J, Ye D, Lin X, Healy CG, Di Santo N, Laird AD, Zohren F, Agarwal N. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med. 2024 Jan;30(1):257-264. doi: 10.1038/s41591-023-02704-x. Epub 2023 Dec 4. Erratum in: Nat Med. 2024 May;30(5):1505. doi: 10.1038/s41591-024-02835-9.
  • Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First) (ZZ-First). NCT04332744.
  • A phase II, open-label, biomarker-guided study of Carboplatin efficacy in pretreated metastatic castration-resistant Prostate Cancer (mCRPC)-BioChiP. Recruitment completed. EudraCT: 2019-002104-40.
  • A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (ASCERTAIN). NCT05938270.
  • SOLTI-2102-HOPE-PROSTATE: Real world clinical practice study to assess the feasibility and impact of liquid biopsy based genomic profiling on treatment decision making for patients with metastatic prostate cancer. (2023-Ongoing).
  • IRONMAN-ES: Estudio prospectivo observacional de parámetros clinicos y biomarcadores en cáncer de próstata avanzado en hospitales de España.

Group Leader Judith Balmaña Laboratory Head Sara Gutiérrez-Enríquez Medical Oncologists Mara Cruellas, Alejandra Rezqallah Genetic Counselors Estela Carrasco, Adrià López-Fernández Associate investigators Berta Campos, Alejandro Moles-Fernández Predoctoral Students Ester Aguado-Flor, Joanna Domènech-Vivó, Setareh Kompanian Lab Manager Joanna Domènech-Vivó Graduate Students Carmen Moreno, Laia Peralba-Parada Clinical Nurse Specialist Eduard Pérez Ballestero Project Manager Laura Duran Data Curators Anna Moreno, 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. Additionally, a longitudinal national-based registry of mutation carriers is collecting prospective data to assess health outcomes.

We are also involved in the clinical development of PARP inhibitors (PARPi) in early gBRCA1/2 breast cancer, and novel combinations in advanced disease. We have consolidated our collaboration with VHIO’s Experimental Therapeutics Group led by Violeta Serra. This has resulted in a large collection of BRCA1/2-associated patient-derived xenografts (PDX) that we are leveraging to identify mechanisms of resistance to targeted therapies, discover novel biomarkers, and assess new combinatorial treatments at disease progression. 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 and in standard clinical practice.

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 yielded key insights on the characterization of new pathogenic variants in HBOC genes and 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 Jordi Giralt of VHIO’s Radiation Oncology Group, led by Xavier Maldonado, Sara Gutiérrez-Enríquez is independently leading research on predictive genetic and cellular markers of susceptibility to radiotherapy-induced clinical toxicity.

Figure I: Changes in breast cancer risk distribution of women with family history after incorporating breast density and polygenic risk score in risk estimation.
Figure II: Percentage of BRCA1, BRCA2 and PALB2 variants reported in the ClinVar database (https://www.ncbi.nlm.nih.gov/clinvar/, accessed July-September 2024) according to their clinical significance.
  • 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 late toxicity after radiotherapy.
  • We have continued to expand our longitudinal registry focused on individuals with inherited cancer predisposition. We are investigating clinical outcomes of breast cancer patients harboring pathogenic variants in HBOC genes (RAD51C/D, ATM).
  • 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 are clinically validating the RAD51predict assay as a functional biomarker of homologous recombination repair deficiency and a predictor of PARPi resistance.
  • 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.
  • In collaboration with Violeta Serra, Head of VHIO’s Experimental Therapeutics Group and members of the ENIGMA consortium, we have shown that RAD51 foci can serve as reliable tumour-derived evidence for classifying BRCA1/2 or PALB2 germline variants.
  • Through the RADprecise project, we have discovered a microRNA profile in whole blood samples that could potentially serve as a biomarker for predicting radiation-induced late toxicity in breast cancer patients prior to radiotherapy. Funded by ERAPerMed, this project aims to personalize radiotherapy by incorporating cellular response to irradiation in treatment planning to minimize radiation toxicity.
  • 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 validation and implementation of RAD51 assay as a biomarker for PARPi therapy and HRR-D beyond BRCA1/2 deficiency.
  • Clinical development of novel PARPi as monotherapy or in combination.
  • 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 (HRD) in variant classification.
  • Decipher the genetic susceptibility underlying the radiotherapy-induced tissue toxicity and the radiotherapy efficacy for tumor control.
  • Torres-Esquius S, Llop-Guevara A, Gutiérrez-Enríquez S, Romey M, Teulé À, Llort G, Herrero A, Sánchez-Henarejos P, Vallmajó A, González-Santiago S, Chirivella I, Cano JM, Graña B, Simonetti S, Díaz de Corcuera I, Ramon Y Cajal T, Sanz J, Serrano S, Otero A, Churruca C, Sánchez-Heras AB, Servitja S, Guillén-Ponce C, Brunet J, Denkert C, Serra V, Balmaña J. Prevalence of Homologous Recombination Deficiency Among Patients With Germline RAD51C/D Breast or Ovarian Cancer. JAMA Netw Open. 2024 Apr 1;7(4):e247811.
  • Porras LM, Padilla N, Moles-Fernández A, Feliubadaló L, Santamariña-Pena M, Sánchez AT, López-Novo A, Blanco A, de la Hoya M, Molina IJ, Osorio A, Pineda M, Rueda D, Ruiz-Ponte C, Vega A, Lázaro C, Díez O, Gutiérrez-Enríquez S, de la Cruz X. A New Set of in Silico Tools to Support the Interpretation of ATM Missense Variants Using Graphical Analysis. J Mol Diagn. 2024 Jan;26(1):17-28.
  • Casartelli C, Tommasi C, Lazzarin A, Corianò M, Tornali C, Serra O, Campanini N, Gutiérrez-Enríquez S, Sikokis A, Zanoni D, Minari R, Bortesi B, Michiara M, Boggiani D, Uliana V, Llop-Guevara A, Serra V, Musolino A, Pellegrino B. Functional HRD by RAD51 identifies BRCA1 VUS associated with loss of gene function and response to DNA-damaging agents. ESMO Open. 2024 Jul;9(7):103629.

Judith Balmaña:

  • Chair of HBOC Thematic Group ERN-GENTURIS.
EBCC (European Breast Cancer Conference):
  • Member of the Scientific Committee for the 2024 meeting.
  • Invited talk for the Debate on: Every woman deserves to know her own genetic risk to get breast cancer.
  • Invited as Chair of a Multidisciplinary Case Discussion on the clinical management of hereditary breast cancer.
ESMO BREAST conference:
  • Member of the Scientific Committee for the 2024 meeting.
  • Invited talk on: Systemic therapy horizons for hereditary breast cancer beyond BRCA.
European Society of Human Genetics (ESHG) Annual Meeting: Invited talk on Delivering Targeted Therapy for Hereditary Cancers. ESMO Congress 2024:
  • Member of the Scientific Committee.

Sara Gutiérrez-Enríquez: 

  • Invited speaker on the Advances in HBOC Genetic Diagnosis and in Radiogenomics. Sociedad de Lucha contra el Cáncer, Ecuador.
  • Scientific Organizing Committee, Variant Effect Prediction Training Course, Human Genome Organisation, HUGO.
  • Expert Panel Membership, ENIGMA BRCA1 and BRCA2 Variant Curation Expert

New in 2024:

  1. Project title: Comprehensive RNA expression and DNA repair functional analysis of clinically actionable hereditary breast/ovarian cancer genes in patients with uninformative multi-gene panel result. PI19/01303.
    PI: Sara Gutiérrez-Enríquez.
    Funding agency: Instituto de Salud Carlos III (ISCIII).
    Duration: 2020-2024.
  2. 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.
  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: Grup de Recerca en Càncer Hereditari – SGR 01112. Collaborators: Judith Balmaña and Sara Gutiérrez-Enríquez.
    Funding agency: Departament de recerca i universitats de la Generalitat de Catalunya.
    Duration: 2022-2024.
  6. 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 2023-2025.
  7. Project title: Feasibility analysis of implementing whole-genome sequencing for breast cancer genetic diagnosis and risk stratification. Funding agency: BCRF.
    Duration: 2023, 2024
  8. 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.
    Duration: 2024-2026.
Judith Balmaña:
  1. Villacampa G, Llop-Guevara A, Filmann N, Herencia A, Fasching PA, Karn T, Marmé F, Klare P, Müller V, Stefek A, Schem C, Uleer C, Fehm T, Doering G, Stickeler E, van Mackelenbergh M, Felder B, Nekljudova V, Balmaña J, Denkert C, Loibl S, Serra V. RAD51 testing in patients with early HER2-negative breast cancer and homologous recombination deficiency: post-hoc analysis of the GeparOla trial. Clin Cancer Res. 2024 Dec 30. doi: 10.1158/1078-0432.CCR-24-3148.
  2. Pal T, Schon KR, Astiazaran-Symonds E, Balmaña J, Foulkes WD, James P, Klugman S, Livinski AA, Mak JS, Ngeow J, Voian N, Wick MJ, Hanson H, Stewart DR, Tischkowitz M; ACMG Professional Practice and Guidelines Committee. Electronic address: documents@acmg.net. Management of individuals with heterozygous germline pathogenic variants in ATM: A clinical practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2025 Jan;27(1):101243. doi: 10.1016/j.gim.2024.101243. Epub 2024 Dec 5.
  3. Herencia-Ropero A, Llop-Guevara A, Staniszewska AD, Domènech-Vivó J, García- Galea E, Moles-Fernández A, Pedretti F, Domènech H, Rodríguez O, Guzmán M, Arenas EJ, Verdaguer H, Calero-Nieto FJ, Talbot S, Tobalina L, Leo E, Lau A, Nuciforo P, Dienstmann R, Macarulla T, Arribas J, Díez O, Gutiérrez-Enríquez S, Forment JV, O'Connor MJ, Albertella M, Balmaña J, Serra V. The PARP1 selective inhibitor saruparib (AZD5305) elicits potent and durable antitumor activity in patient-derived BRCA1/2-associated cancer models. Genome Med. 2024 Aug 26;16(1):107. doi: 10.1186/s13073-024-01370-z.
  4.  Alés-Martínez JE, Balmaña J, Sánchez-Rovira P, Salvador Bofill FJ, García Sáenz JÁ, Pimentel I, Morales S, Fernández-Abad M, Lahuerta Martínez A, Ferrer N, Zamora P, Bermejo B, Díaz-Redondo T, López-Ceballos MH, Galán M, Pérez- Escuredo J, Calabuig L, Sampayo M, Pérez-Garcia JM, Cortés J, Llombart-Cussac A. Olaparib plus trastuzumab in HER2-positive advanced breast cancer patients with germline BRCA1/2 mutations: The OPHELIA phase 2 study. Breast. 2024 Oct;77:103780. doi: 10.1016/j.breast.2024.103780.
  5.  van de Haar J, Roepman P, Andre F, Balmaña J, Castro E, Chakravarty D, Curigliano G, Czarnecka AM, Dienstmann R, Horak P, Italiano A, Marchiò C, Monkhorst K, Pritchard CC, Reardon B, Russnes HEG, Sirohi B, Sosinsky A, Spanic T, Turnbull C, Van Allen E, Westphalen CB, Tamborero D, Mateo J. ESMO Recommendations on clinical reporting of genomic test results for solid cancers. Ann Oncol. 2024 Nov;35(11):954-967. doi: 10.1016/j.annonc.2024.06.018.
  6.  Rowlands CF, Allen S, Balmaña J, Domchek SM, Evans DG, Hanson H, Hoogerbrugge N, James PA, Nathanson KL, Robson M, Tischkowitz M, Foulkes WD, Turnbull C. Population-based germline breast cancer gene association studies and meta- analysis to inform wider mainstream testing. Ann Oncol. 2024 Oct;35(10):892-901. doi: 10.1016/j.annonc.2024.07.244.
  7.  Carmona J, Chavarria E, Donoghue K, von Gertten C, Oberrauch P, Pailler E, Scoazec G, Weijer R, Balmaña J, Brana I, Brunelli C, Delaloge S, Deloger M, Delpy P, Ernberg I, Fitzgerald RC, Garralda E, Lablans M, Lëhtio J, Lopez C, Fernández M, Miceli R, Nuciforo P, Perez-Lopez R, Provenzano E, Schmidt MK, Serrano C, Steeghs N, Tamborero D, Wirta V, Baird RD, Barker K, Barlesi F, Baumann M, Bergh J, de Braud F, Fizazi K, Fröhling S, Piris-Giménez A, Seamon K, Van der Heijden MS, Zwart W, Tabernero J. Cancer Core Europe: Leveraging Institutional Synergies to Advance Oncology Research and Care Globally. Cancer Discov. 2024 Jul 1;14(7):1147-1153. doi: 10.1158/2159-8290.CD-24-0377.
  8.  Munté E, Feliubadaló L, Del Valle J, González S, Ramos-Muntada M, Balmaña J, Ramon Y Cajal T, Tuset N, Llort G, Cadiñanos J, Brunet J, Capellá G, Lázaro C, Pineda M. Open-Source Bioinformatic Pipeline to Improve PMS2 Genetic Testing Using Short-Read NGS Data. J Mol Diagn. 2024 Aug;26(8):727-738. doi: 10.1016/j.jmoldx.2024.05.005.
  9.  Bancroft EK, Page EC, Brook MN, Pope J, Thomas S, Myhill K, Helfand BT, Talaty P, Ong KR, Douglas E, Cook J, Rosario DJ, Salinas M, Buys SS, Anson J, Davidson R, Longmuir M, Side L, Eccles DM, Tischkowitz M, Taylor A, Cruellas M, Ballestero EP, Cleaver R, Varughese M, Barwell J, LeButt M, Greenhalgh L, Hart R, Azzabi A, Jobson I, Cogley L, Evans DG, Rothwell J, Taylor N, Hogben M, Saya S; IMPACT Study Steering Committee; IMPACT Collaborators; Eeles RA, Aaronson NK. The psychosocial impact of prostate cancer screening for BRCA1 and BRCA2 carriers. BJU Int. 2024 Sep;134(3):484-500. doi: 10.1111/bju.16432.
  10.  Tung N, Ricker C, Messersmith H, Balmaña J, Domchek S, Stoffel EM, Almhanna K, Arun B, Chavarri-Guerra Y, Cohen SA, Cragun D, Crew KD, Hall MJ, Idos G, Lopez G, Pal T, Pirzadeh-Miller S, Pritchard C, Rana HQ, Swami U, Vidal GA. Selection of Germline Genetic Testing Panels in Patients With Cancer: ASCO Guideline. J Clin Oncol. 2024 Jul 20;42(21):2599-2615. doi: 10.1200/JCO.24.00662.
  11.  Torres-Esquius S, Llop-Guevara A, Gutiérrez-Enríquez S, Romey M, Teulé À, Llort G, Herrero A, Sánchez-Henarejos P, Vallmajó A, González-Santiago S, Chirivella I, Cano JM, Graña B, Simonetti S, Díaz de Corcuera I, Ramon Y Cajal T, Sanz J, Serrano S, Otero A, Churruca C, Sánchez-Heras AB, Servitja S, Guillén-Ponce C, Brunet J, Denkert C, Serra V, Balmaña J. Prevalence of Homologous Recombination Deficiency Among Patients With Germline RAD51C/D Breast or Ovarian Cancer. JAMA Netw Open. 2024 Apr 1;7(4):e247811. doi: 10.1001/jamanetworkopen.2024.7811.
  12.  Rofes P, Dueñas N, Del Valle J, Navarro M, Balmaña J, Ramón Y Cajal T, Tuset N, Castillo C, González S, Brunet J, Capellá G, Lázaro C, Pineda M. Tumor analysis of MMR genes in Lynch-like syndrome: Challenges associated with results interpretation. Cancer Med. 2024 Apr;13(7):e7041. doi: 10.1002/cam4.7041.
  13.  Rezqallah A, Torres-Esquius S, Llop-Guevara A, Cruellas M, Martinez MT, Romey M, Denkert C, Serra V, Chirivella I, Balmaña J. Two Germline Pathogenic Variants in Cancer Susceptibility Genes and Their Null Implication in Breast Cancer Pathogenesis: The Importance of Tumoral Homologous Recombination Deficiency Testing. JCO Precis Oncol. 2024 Mar;8:e2300446. doi: 10.1200/PO.23.00446.
  14.  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, de Gonzalez AB, 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; GEMO Study Collaborators; EMBRACE Collaborators; Colonna SV, Cook LS, Daly MB, Dansonka- Mieszkowska A, de la Hoya M, deFazio A, DePersia A, Ding YC, 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; kConFab Investigators; 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, 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. Large-scale genome-wide association study of 398,238 women unveils seven novel loci associated with high-grade serous epithelial ovarian cancer risk. medRxiv [Preprint]. 2024 Mar 4:2024.02.29.24303243. doi: 10.1101/2024.02.29.24303243.
  15.  Sánchez-Heras AB, Dámaso E, Castillejo A, Robledo M, Teulé A, Lázaro C, Sánchez-Martínez R, Zúñiga Á, López-Fernández A, Balmaña J, Robles L, Ramon Y Cajal T, Castillejo MI, Ibañez RP, Sevila CM, Sánchez-Mira A, Escandell I, Gómez L, Berbel P, Soto JL. Genetic and clinical characterization of a novel FH founder mutation in families with hereditary leiomyomatosis and renal cell cancer syndrome. Orphanet J Rare Dis. 2024 Jan 26;19(1):26. doi: 10.1186/s13023-024-03017-z.
  16.  Harvey-Jones E, Raghunandan M, Robbez-Masson L, Magraner-Pardo L, Alaguthurai T, Yablonovitch A, Yen J, Xiao H, Brough R, Frankum J, Song F, Yeung J, Savy T, Gulati A, Alexander J, Kemp H, Starling C, Konde A, Marlow R, Cheang M, Proszek P, Hubank M, Cai M, Trendell J, Lu R, Liccardo R, Ravindran N, Llop- Guevara A, Rodriguez O, Balmana J, Lukashchuk N, Dorschner M, Drusbosky L, Roxanis I, Serra V, Haider S, Pettitt SJ, Lord CJ, Tutt ANJ. Longitudinal profiling identifies co-occurring BRCA1/2 reversions, TP53BP1, RIF1 and PAXIP1 mutations in PARP inhibitor-resistant advanced breast cancer. Ann Oncol. 2024 Apr;35(4):364-380. doi: 10.1016/j.annonc.2024.01.003.
  17.  Lambertini M, Blondeaux E, Agostinetto E, Hamy AS, Kim HJ, Di Meglio A, Bernstein Molho R, Hilbers F, Pogoda K, Carrasco E, Punie K, Bajpai J, Ignatiadis M, Moore HCF, Phillips KA, Toss A, Rousset-Jablonski C, Peccatori FA, 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, Del Mastro L, Puglisi F, Del Pilar Estevez-Diz M, Rodriguez-Wallberg KA, Mrinakova B, Meister S, Livraghi L, Clatot F, Yerushalmi R, De Angelis C, Sánchez-Bayona R, Meattini I, Cichowska-Cwalinska N, Berlière M, Salama M, De Giorgi U, Sonnenblick A, Chiodi C, Lee YJ, Maria C, Azim HA Jr, Boni L, Partridge AH; BRCA BCY Collaboration. Pregnancy After Breast Cancer in Young BRCA Carriers: An International Hospital-Based Cohort Study. JAMA. 2024 Jan 2;331(1):49-59. doi: 10.1001/jama.2023.25463.
  Sara Gutiérrez-Enríquez:
  1. 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. 2024 Dec 27;199:108072. doi: 10.1016/j.lungcan.2024.108072.
  2. Jaikuna T, Wilson F, 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, Paul Symonds R, Talbot CJ, Rancati T, Rattay T, Reyes V, Rosenstein BS, de Ruysscher D, Vega A, Veldeman L, Webb A, West CM, Aznar MC, Vasquez Osorio E. Optimising inter-patient image registration for image-based data mining in breast radiotherapy. Phys Imaging Radiat Oncol. 2024 Sep 7;32:100635. doi: 10.1016/j.phro.2024.100635.
  3. Herencia-Ropero A, Llop-Guevara A, Staniszewska AD, Domènech-Vivó J, García-Galea E, Moles-Fernández A, Pedretti F, Domènech H, Rodríguez O, Guzmán M, Arenas EJ, Verdaguer H, Calero-Nieto FJ, Talbot S, Tobalina L, Leo E, Lau A, Nuciforo P, Dienstmann R, Macarulla T, Arribas J, Díez O, Gutiérrez-Enríquez S, Forment JV, O'Connor MJ, Albertella M, Balmaña J, Serra V. The PARP1 selective inhibitor saruparib (AZD5305) elicits potent and durable antitumor activity in patient-derived BRCA1/2-associated cancer models. Genome Med. 2024 Aug 26;16(1):107. doi: 10.1186/s13073-024-01370-z.
  4. Casartelli C, Tommasi C, Lazzarin A, Corianò M, Tornali C, Serra O, Campanini N, Gutiérrez-Enríquez S, Sikokis A, Zanoni D, Minari R, Bortesi B, Michiara M, Boggiani D, Uliana V, Llop-Guevara A, Serra V, Musolino A, Pellegrino B. Functional HRD by RAD51 identifies BRCA1 VUS associated with loss of gene function and response to DNA-damaging agents. ESMO Open. 2024 Jul;9(7):103629. doi: 10.1016/j.esmoop.2024.103629.
  5. Torres-Esquius S, Llop-Guevara A, Gutiérrez-Enríquez S, Romey M, Teulé À, Llort G, Herrero A, Sánchez-Henarejos P, Vallmajó A, González-Santiago S, Chirivella I, Cano JM, Graña B, Simonetti S, Díaz de Corcuera I, Ramon Y Cajal T, Sanz J, Serrano S, Otero A, Churruca C, Sánchez-Heras AB, Servitja S, Guillén-Ponce C, Brunet J, Denkert C, Serra V, Balmaña J. Prevalence of Homologous Recombination Deficiency Among Patients With Germline RAD51C/D Breast or Ovarian Cancer. JAMA Netw Open. 2024 Apr 1;7(4):e247811. doi: 10.1001/jamanetworkopen.2024.7811.
  6. Critical Assessment of Genome Interpretation Consortium. CAGI, the Critical Assessment of Genome Interpretation, establishes progress and prospects for computational genetic variant interpretation methods. Genome Biol. 2024 Feb 22;25(1):53. doi: 10.1186/s13059-023-03113-6.
  7. Rosas JC, Aguado-Barrera ME, Azria D, Briers E, Elliott R, Farcy-Jacquet MP, Giraldo A, Gutiérrez-Enríquez S, Rancati T, Rattay T, Reyes V, Rosenstei"n B, De Ruysscher D, Sperk E, Stobart H, Talbot C, Vega A, Taboada-Valladares B, Veldeman L, Ward T, Webb A, West C, Chang-Claude J, Seibold P; REQUITE Consortium. Reply to: Comments on "(Pre)treatment risk factors for late fatigue and fatigue trajectories following radiotherapy for breast cancer". Int J Cancer. 2024 Feb 15;154(4):759-761. doi: 10.1002/ijc.34772.
  8. Porras LM, Padilla N, Moles-Fernández A, Feliubadaló L, Santamariña-Pena M, Sánchez AT, López-Novo A, Blanco A, de la Hoya M, Molina IJ, Osorio A, Pineda M, Rueda D, Ruiz-Ponte C, Vega A, Lázaro C, Díez O, Gutiérrez-Enríquez S, de la Cruz X. A New Set of in Silico Tools to Support the Interpretation of ATM Missense Variants Using Graphical Analysis. J Mol Diagn. 2024 Jan;26(1):17-28. doi: 10.1016/j.jmoldx.2023.09.009.

Group Leader Irene Braña Medical Oncologists and Clinical Investigators Juan David Assaf, 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 cancer, nasopharyngeal, sinonasal, and NUT carcinoma.

We have collaborated in the early clinical drug development of anti-PD1 therapies for patients with head and neck squamous cell carcinoma. Our involvement in these clinical studies has enabled us to provide selected patients with access to novel therapies prior to the evaluation by the Spanish regulatory authority and healthcare reimbursement system. As an example, we participated in the phase III KEYNOTE-048 study which led to the subsequent approval of anti-PD1 immunotherapy pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and the publication of results using different PD-L1 cut-offs (Burtness et al. 2022).

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.

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 to develop window-of-opportunity, neoadjuvant, and adjuvant studies for head and neck cancer patients.
  • 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 predicitive biomarkers of response in patients (supported by funding received from 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
  • Start a new research line on cancer prevention and create an education program for the community to promote healthy life-style and decrease risk factors associated with head and neck cancers.
  • Forster M, Brana I, Pousa AL, Doger B, Roxburgh P, Bajaj P, Peguero J, Krebs M, Carcereny E, Patel G, Mueller C, Brignone C, Triebel F. Eftilagimod Alpha (Soluble LAG3 Protein) Combined with Pembrolizumab as Second-Line Therapy for Patients with Metastatic Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2024 Sep 3;30(17):3726-3734.
  • 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.
  1. Identification of Precise 3D CT Radiomics for Habitat Computation by Machine Learning in Cancer. Prior O, Macarro C, Navarro V, Monreal C, Ligero M, Garcia-Ruiz A, Serna G, Simonetti S, Braña I, Vieito M, Escobar M, Capdevila J, Byrne AT, Dienstmann R, Toledo R, Nuciforo P, Garralda E, Grussu F, Bernatowicz K, Perez-Lopez R. Radiol Artif Intell. 2024 Mar;6(2):e230118. doi: 10.1148/ryai.230118.
  2. Intratumoral therapies in head and neck squamous cell carcinoma: A systematic review and future perspectives. Jiménez-Labaig P, Rullan A, Braña I, Hernando-Calvo A, Moreno V, Doger B, Bitar G, Ap Dafydd D, Melcher A, Harrington KJ. Cancer Treat Rev. 2024 Jun;127:102746. doi: 10.1016/j.ctrv.2024.102746.
  3. A comprehensive examination of mental health in patients with head and neck cancer: systematic review and meta-analysis. Jimenez-Labaig P, Aymerich C, Braña I, Rullan A, Cacicedo J, González-Torres MÁ, Harrington KJ, Catalan A. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae031. doi: 10.1093/jncics/pkae031.
  4. A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies. Jiménez-Labaig P, Rullan A, Hernando-Calvo A, Llop S, Bhide S, O'Leary B, Braña I, Harrington KJ. Cancer Treat Rev. 2024 Jul;128:102772. doi: 10.1016/j.ctrv.2024.102772.
  5. Eftilagimod Alpha (Soluble LAG3 Protein) Combined with Pembrolizumab as Second-Line Therapy for Patients with Metastatic Head and Neck Squamous Cell Carcinoma. Forster M, Brana I, Pousa AL, Doger B, Roxburgh P, Bajaj P, Peguero J, Krebs M, Carcereny E, Patel G, Mueller C, Brignone C, Triebel F. Clin Cancer Res. 2024 Sep 3;30(17):3726-3734. doi: 10.1158/1078-0432.CCR-24-0473.
  6. Pembrolizumab plus epacadostat in patients with recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE-669/ECHO-304): a phase 3, randomized, open-label study. Cho BC, Braña I, Cirauqui B, Aksoy S, Couture F, Hong RL, Miller WH Jr, Chaves-Conde M, Teixeira M, Leopold L, Munteanu M, Ge JY, Swaby RF, Hughes BGM. BMC Cancer. 2024 Jul 25;23(Suppl 1):1254. doi: 10.1186/s12885-023-11316-0.

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 Groups

Radiation Oncology Group

Summary

At the Vall d’Hebron University Hospital’s Department of Radiation Oncology and VHIO, our clinicians and researchers are committed to enhancing multidisciplinary patient care through research.

HUVH-VHIO Radiation Oncology is a high-tech department with 16 physicians, 40 radiotherapists, and 3 dedicated nurses. We develop cutting-edge technologies and techniques, as well as renew quality (ISO 9001:2015 accreditation) and safety (UNE 17009 certification) certifications.

Our department is equipped with 4 accelerators and 1 dual energy computed tomography (CT) scanner. The implementation of these complex platforms requires additional expertise provided by our department, in addition to specialized training for indications, operating procedures, quality control, and the incorporation of novel tools and approaches for data analysis.

We treat more than 80% pediatric patients in Catalonia requiring radiotherapy. We also manage complex cases from other autonomous regions in Spain that do not have the necessary technology in-house. We also offer treatment to patients from overseas.

We are active members of several research organizations and consortia, such as the European Organisation for Research and Treatment of Cancer (EORTC), Urogenital Tumor Study Group (GETUG), International Society of Paediatric Oncology (SIOP), Eurocare, Radiogenomics consortium. We also serve on the Instituto de Investigación en Oncología Radioterápica’s (IRAD) Board of Directors. Moreover, our group has established synergies to further strengthen research both nationally (Institute of Materials Science of Barcelona - ICMAB-CSIC, Universitat Autònoma de Barcelona – UAB) and internationally at the Karolinska Proton Center in Sweden.

Our group is related to the Vall d’Hebron Research Institute (VHIR) and VHIO through collaborative research agreements in clinical trials. 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 co-directed by Joaquin Mateo and Joan Carles, 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.

Although our main focus is on clinical research, we also support translational research projects led by various VHIO groups. In 2024, we (co) authored 24 articles, and have collaborated in more than 40 clinical trials.

Our innovation achievements in radiotherapy focus on precision and personalization to enhance treatment effectiveness while minimizing side effects. We employ respiratory control for tumors in moving organs like the lungs and liver, synchronizing treatment with breathing rhythms, and deep inspiration breath hold (DIBH) techniques to reduce heart exposure in left breast cancer. Tracking technology in prostate cancer treatments ensures accurate radiation delivery using implanted markers. We apply adaptive radiotherapy to gynecological, bladder, head and neck tumors, allowing real-time adjustments based on anatomical changes. We also contribute to a European clinical trial exploring adaptive radiation therapy with increased doses in combination with chemotherapy.

In functional radiosurgery, interdisciplinary synergies enable the treatment of advanced movement disorders. Additionally, we use stereotactic radiotherapy (SRT) for refractory arrhythmias, integrating Electroanatomic Mapping (EAM) and radiotherapy planning for personalized treatment. Holocranial irradiation with hippocampal protection minimizes long-term toxicity, while SBRT dose distribution offers a definitive treatment option for selected breast cancer patients without surgery.

Figure: Stereoatactic body radiation therapy (SBRT) dose distribution in the definitive treatment of selected breast cancer patients without planned surgical intervention. Radiation is highly focused IGRT 4D guided in five fractions on the gross tumor volume (GTV) and clinical target volume (CTV), drastically minimizing the dose in critical organs as lung, heart, coronary arteries, healthy mammary gland and costal wall.
  • 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 in projects supported through competitive grants.
  • Advance clinical research in radiogenomics, nanoparticles, polymorphisms and radioimmunotherapy (RIT), and expand our research in collaboration with VHIO's Radiomics Group, led by Raquel Perez-Lopez.
  • 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), and image-guided radiotherapy (IGRT).
  • Renew the 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.
  • We have strengthened synergies with European partners, including Instituto de investigación en Oncología Radioterápica (IRAD), Institute of Materials Science of Barcelona - ICMAB-CSIC (Universitat Autònoma de Barcelona – UAB), VHIO's Hereditary Cancer Genetics, Prostate Cancer, and Radiomics Groups, as well as international institutions such as the Karolinska Proton Center (Stockholm, Sweden),and the MD Anderson Cancer Center (Houston, Texas, US).
  • We have increased the number of funded projects supported by the European Commission (CAT_Clin_ART from the EU4H_2023), Fondo de Investigaciones Sanitarias (FIS PI24/00527), ICMAB-CSIC, and IRAD (Exosomes project).
  • We launched the SBRT program for primary kidney cancer.
  • Consolidation of the VMAT technique to total body irradiation (TBI) in adults and children, as a national reference.
  • We have increased our participation in international clinical trials, including studies spearheaded by the International Society of Paediatric Oncology (SIOP) for the treatment of patients with medulloblastoma (SIOP PNET5), ependymoma (SIOP EPII), and Wilms tumors (umbrella study).
  • We continue to serve as national representatives of radiation oncology at the International Society of Paediatric Oncology (SIOP).
  • We are also active members of the SIOP Europe (European Society for Paediatric Oncology) and European Organisation for Research and Treatment of Cancer (EORTC) QUARTET project that supports the delivery of high-quality radiotherapy for children and adolescents with cancer across Europe in clinical trials.
  • The continued development and advancement of stereotactic radiotherapy for the treatment of patients with refractory ventricular arrhythmias.
  • We have obtained ISO 9001/2015 quality management as well as UNE 179003:2013 safety certification in radiation oncology.
  • Two Units of proton therapy are being installed in Barcelona in 2026. 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.
  • Bossi A, Foulon S, Maldonado X, Sargos P, MacDermott R, Kelly P, Fléchon A, Tombal B, Supiot S, Berthold D, Ronchin P, Kacso G, Salem N, Calabro F, Berdah JF, Hasbini A, Silva M, Boustani J, Ribault H, Fizazi K; PEACE-1 investigators. Efficacy and safety of prostate radiotherapy in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet. 2024 Nov 23;404(10467):2065-2076.
  • Ong WL, Romero T, Roy S, Nikitas J, Joseph D, Zapatero A, Malone S, Morgan SC, Steinberg ML, Valle LF, Zaorsky NG, Martin Ma T, Rettig MB, Nickols N, Jiang T, Reiter RE, Eleswarapu SV, Maldonado X, Sun Y, Nguyen PL, Millar JL, Martin JM, Spratt DE, Kishan AU; MARCAP Consortium Investigators. Testosterone Recovery Following Androgen Suppression and Prostate Radiotherapy (TRANSPORT): A Pooled Analysis of Five Randomized Trials from the Meta-Analysis of Randomized Trials in Cancer of the Prostate (MARCAP) Consortium. Eur Urol. 2024. doi: 10.1016/j.eururo.2024.09.009.
  • de Leeuw ALMP, Giralt J, Tao Y, Benavente S, France Nguyen TV, Hoebers FJP, Hoeben A, Terhaard CHJ, Wai Lee L, Friesland S, Steenbakkers RJHM, Tans L, Heukelom J, Kayembe MT, van Kranen SR, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O. A multicentric randomized controlled phase III trial of adaptive and 18F-FDG-PET-guided dose-redistribution in locally advanced head and neck squamous cell carcinoma (ARTFORCE). Radiother Oncol. 2024 Jul;196:110281.
  • Timmermann B, Alapetite C, Dieckmann K, Kortmann RD, Lassen-Ramshad Y, Maduro JH, Ramos Albiac M, Ricardi U, Weber DC. ESTRO-SIOPE guideline: Clinical management of radiotherapy in atypical teratoid/rhabdoid tumors (AT/RTs). Radiother Oncol. 2024 Jul;196:110227.
  • To reach excellence, technological sophistication and complexity are necessary as well as quality and safety. The HUVH-VHIO Radiation Oncology Department achieved both ISO 9001:2015 quality and UNE 17009 safety certifications, as the first hospital to do so in Spain.  ·       According to the 2023 Merco Healthcare Reputation Monitor ranking (Corporate Reputation Business Monitor), the HUVH-VHIO Radiation Oncology Department is the best Radiotherapy Oncology Service in Spain (2023).
  • We are involved in the HUVH-VHIO Oncohematology Coordination led by VHIO’s Director Josep Tabernero. We collaborated to achieve the OECI standard for Comprehensive Cancer Centers.
Funded Projects:
  1. 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.
  2. 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.
  3. 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.
  4. EPA (AG) 07/2019 JAN-CPR-2018-01 /212082PCR 4053 Observational study to retrospectively describe the evolution of patients with prostate cancer throughout the disease through the reuse of electronic health records with artificial intelligence (SI: X. Maldonado).
  5. PA(AG)04/2018(5428) Study of genomic, transcriptomic and molecular profiles of advanced prostate cancer (PI:  J. Mateo).
  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).
  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: Altabas).
  8. FIS PI20/556 research project. New therapeutic approaches in head and neck cancer. University Hospital Research Institute Foundation. Vall d’Hebron (PI: S. Benavente). 2020-2024.
  9. 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 treatment. The main aim will be normal tissue toxicity data from patients and electronic data capture. A unique element of this project is the centralized storage of radiotherapy treatment plans (PI:  S. Gutiérrez, SI:  V.Reyes).
  10. 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: Reyes). 2024-2027.
  11. 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.
  12. 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.
  13. PR/AG 191/2019. Identification of novel prognostic biomarkers in high-risk cutaneous squamous cell carcinoma patients by NGS strategy (Co-PI: R. Granado).
  14. UMBRELLA SIOP-RTSG 2016 protocol. Registry of the treatment of all pediatric kidney tumors.
  15. 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.
  16. European medical application and Radiation protection Concept: strategic research agenda and roadmap interlinking to health and digitisation aspects - EURAMED rocc-n-roll (PI: J. Giralt). EU Horizon 2020 research and innovation programme. Grant agreement no: 899995
  17. PIANOFORTE-EMPATHY proton project on assessing dose distribution in adaptive proton therapy (Co-PI   Maldonado).
  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-I: X. Maldonado.
  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.
  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.
  4. QUARTE; 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.
  5. COGNITO: Evaluation of long-term cognitive effects in childhood cancer survivors. Reference: PR(AMI)389/2017. EU project 899995 – EURAMED. PI: M.Ramos.
  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.
  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.
  8. EORTC Research Project 2011. E2RADIatE – ReCare. A prospective observational cohort on high-dose re-irradiation. ReCare Consortiu Team member: S. Benavente.
  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.
  10. Development in PROMs as a clinical and research tool in gynaecological patients treated with radiotherapy. E. Recalde.
  1. Bossi A, Foulon S, Maldonado X, Sargos P, MacDermott R, Kelly P, Fléchon A, Tombal B, Supiot S, Berthold D, Ronchin P, Kacso G, Salem N, Calabro F, Berdah JF, Hasbini A, Silva M, Boustani J, Ribault H, Fizazi K; PEACE-1 investigators. Efficacy and safety of prostate radiotherapy in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet. 2024 Nov 23;404(10467):2065-2076. doi: 10.1016/S0140-6736(24)01865-8. Erratum in: Lancet. 2025 May 10;405(10490):1665. doi: 10.1016/S0140-6736(25)00903-1.
  2. Ong WL, Romero T, Roy S, Nikitas J, Joseph D, Zapatero A, Malone S, Morgan SC, Steinberg ML, Valle LF, Zaorsky NG, Martin Ma T, Rettig MB, Nickols N, Jiang T, Reiter RE, Eleswarapu SV, Maldonado X, Sun Y, Nguyen PL, Millar JL, Martin JM, Spratt DE, Kishan AU; MARCAP Consortium Investigators. Testosterone Recovery Following Androgen Suppression and Prostate Radiotherapy (TRANSPORT): A Pooled Analysis of Five Randomized Trials from the Meta-Analysis of Randomized Trials in Cancer of the Prostate (MARCAP) Consortium. Eur Urol. 2025 Jan;87(1):49-57. doi: 10.1016/j.eururo.2024.09.009. Epub 2024 Sep 20.
  3. Zacchi F, Carles J, Gonzalez M, Maldonado X, Perez-Lopez R, Semidey ME, Mateo J. Case report: Exceptional and durable response to Radium-223 and suspension of androgen deprivation therapy in a metastatic castration-resistant prostate cancer patient. Front Oncol. 2024 Mar 8;14:1331643. doi: 10.3389/fonc.2024.1331643.
  4. Gomez-Iturriaga A, Büchser D, Lopez-Campos F, Maldonado X. Enhancing Androgen Deprivation Therapy (ADT) integration in prostate cancer: Insights for Stereotactic Body Radiotherapy (SBRT) and brachytherapy modalities. Clin Transl Radiat Oncol. 2024 Jan 28;45:100733. doi: 10.1016/j.ctro.2024.100733.
  5. González-San Segundo C, López Campos F, Gómez Iturriaga A, Rodríguez A, Olivera J, Duque-Santana V, Sancho G, Henríquez I, Conde AJ, Valero J, Maldonado X, Glaria L, Caballero B, Sanmamed N, Mases J, Boladeras-Inglada AM, Montijano M, Santos M, Álvarez A, Martínez JI, Couñago F. A randomised trial of short- vs long-term androgen deprivation with salvage radiotherapy for biochemical failure following radical prostatectomy: URONCOR 06-24. BJU Int. 2024 Oct;134(4):568-577. doi: 10.1111/bju.16484. Geng-Cahuayme AAA, Peregrín-Pastor B, Ramos-Albiac M, Recalde-Vizcay E, Parada-Zuluaga JS, Giralt-López de Sagredo J, Maldonado-Pijoan X, Giraldo-Marín A. Stereotactic ablative radiotherapy (SABR) for patients with lung tumor and severe pulmonary function impairment. Clin Transl Oncol. 2024 Dec;26(12):3246-3251. doi: 10.1007/s12094-024-03557-7.
  6. de Leeuw ALMP, Giralt J, Tao Y, Benavente S, France Nguyen TV, Hoebers FJP, Hoeben A, Terhaard CHJ, Wai Lee L, Friesland S, Steenbakkers RJHM, Tans L, Heukelom J, Kayembe MT, van Kranen SR, Bartelink H, Rasch CRN, Sonke JJ, Hamming-Vrieze O. A multicentric randomized controlled phase III trial of adaptive and 18F-FDG-PET-guided dose-redistribution in locally advanced head and neck squamous cell carcinoma (ARTFORCE). Radiother Oncol. 2024 Jul;196:110281. doi: 10.1016/j.radonc.2024.110281.
  7. Timmermann B, Alapetite C, Dieckmann K, Kortmann RD, Lassen-Ramshad Y, Maduro JH, Ramos Albiac M, Ricardi U, Weber DC. ESTRO-SIOPE guideline: Clinical management of radiotherapy in atypical teratoid/rhabdoid tumors (AT/RTs). Radiother Oncol. 2024 Jul;196:110227. doi: 10.1016/j.radonc.2024.110227.
  8. Li JS, Blanchard P, Wong CHL, Ahn YC, Bonomo P, Bresson D, Caudell J, Chen MY, Chow VLY, Chua MLK, Corry J, Dupin C, Giralt J, Hu CS, Kwong DLW, Le QT, Lee AWM, Lee NY, Li YZ, Lim CM, Lin JC, Mendenhall WM, Moya-Plana A, O'Sullivan B, Ozyar E, Pan JJ, Qiu QH, Sher DJ, Snyderman CH, Tao YG, Tsang RK, Wang XS, Wu PA, Yom SS, Ng WT. International Recommendations on Postoperative Management for Potentially Resectable Locally Recurrent Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1294-1306. doi: 10.1016/j.ijrobp.2024.07.2143.
  9. 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. Epub 2024 Nov 9.
  10. Benavente S, Giraldo A, Seoane A, Ramos M, Vergés R. Clinical effects of re-evaluating a lung SBRT failure mode and effects analysis in a radiotherapy department. Clin Transl Oncol. 2024 Dec;26(12):3142-3149. doi: 10.1007/s12094-024-03539-9.
  11. Yaringaño J, Roca-Herrera M, Eremiev S, Mascaró-Baselga P, Benito P, Núñez F, Benavente S, Pimentel I. Sacituzumab govitecan response in extensive leptomeningeal carcinomatosis from triple-negative breast cancer: a case report. Front Oncol. 2024 Aug 12;14:1378248. doi: 10.3389/fonc.2024.1378248.
  12. Corral J, Algara M, Muñoz-Montplet C, Eraso A, Giralt J, Defourny N, Lievens Y, Borras JM. Challenges in assessing national radiotherapy costs: application of the ESTRO-HERO model in Spain. Front Public Health. 2024 Dec 19;12:1474376. doi: 10.3389/fpubh.2024.1474376.
  13. Larrosa C, Mico S, Ramos M, Perez-Jaume S, Sánchez M, Castañeda A, Garraus M, Mora J. Radiation recall reaction induced by gemcitabine/docetaxel in children: A retrospective study on risk factors and outcomes. Pediatr Blood Cancer. 2024 Oct;71(10):e31221. doi: 10.1002/pbc.31221.
  14. Najjari-Jamal D, Rovirosa A, Gimeno-Morales M, Majercakova K, Sánchez M, Garcia S, Guevara D, Muñoz T, De la Fuente C, Micó S, Stefanovic M, Matute R, Córdoba S. Reirradiation Practice in Gynecological Cancer: Insights from a National Survey in Spain. Clin Transl Oncol. 2025 Jun;27(6):2494-2501. doi: 10.1007/s12094-024-03804-x. Epub 2024 Dec 5.
  15. Leong T, Smithers BM, Michael M, Haustermans K, Wong R, Gebski V, O'Connell RL, Zalcberg J, Boussioutas A, Findlay M, Willis D, Moore A, Murray WK, Lordick F, O'Callaghan C, Swallow C, Darling G, Miller D, Strickland A, Liberman M, Mineur L, Simes J; Australasian Gastro-Intestinal Trials Group, National Health and Medical Research Council Clinical Trials Centre, Trans-Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer, and Canadian Cancer Trials Group. Preoperative Chemoradiotherapy for Resectable Gastric Cancer. N Engl J Med. 2024 Nov 14;391(19):1810-1821. doi: 10.1056/NEJMoa2405195.
  16. Navalpotro B. ICO-ICS PRAXIS para el tratamiento médico y con irradiación del adenocarcinoma de páncreas. ISBN: 978-84-128170-1-0.
  17. García-Álvarez A, Geng-Cahuayme AAA. Manual CTO de Medicina y Cirugía - Oncología. 14th edition. Madrid: CTO Editorial SL; 2024.
  18. Jaikuna T, Wilson F, 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, Paul Symonds R, Talbot CJ, Rancati T, Rattay T, Reyes V, Rosenstein BS, de Ruysscher D, Vega A, Veldeman L, Webb A, West CM, Aznar MC, Vasquez Osorio E. Optimising inter-patient image registration for image-based data mining in breast radiotherapy. Phys Imaging Radiat Oncol. 2024 Sep 7;32:100635. doi: 10.1016/j.phro.2024.100635.
  19. Rosas JC, Aguado-Barrera ME, Azria D, Briers E, Elliott R, Farcy-Jacquet MP, Giraldo A, Gutiérrez-Enríquez S, Rancati T, Rattay T, Reyes V, Rosenstein B, De Ruysscher D, Sperk E, Stobart H, Talbot C, Vega A, Taboada-Valladares B, Veldeman L, Ward T, Webb A, West C, Chang-Claude J, Seibold P; REQUITE Consortium. Reply to: Comments on "(Pre)treatment risk factors for late fatigue and fatigue trajectories following radiotherapy for breast cancer". Int J Cancer. 2024 Feb 15;154(4):759-761. doi: 10.1002/ijc.34772.
  20. Granado R, Benavente S. Tumores de las glándulas salivares. En: F. Calvo, J. Giralt, C. Ferrer, V. Morillo, M. Rubio, M. Santos, editores. Oncología Radioterápica: fundamentos, resultados, gestión y práctica clínica. Aran ediciones S.L., 2024.
  • 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.IP 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.

Group Leader Teresa Macarulla Senior Clinical Investigator and Medical Oncologist Jaume Capdevila Medical Oncologists and Clinical Fellows Daniel Alejandro Acosta, Florian Castet, Alejandro Garcia, Jorge Hernando, Eduardo Terán, Sharela Vega Visiting Clinical Fellows Qianyun Hao (Peking University), Anthony Turpin (ESMO Fellow), Xuesong Zhao (Pekin University) Clinical Research Oncology Nurses Helena Palma, Alexandre Sierra Data Curator Gloria Castillo

Preclinical and Translational Team Leader Tian Tian Lab Manager Jessica Querol Postdoctoral Fellows Sefora Conti, José María Herranz PhD Candidates Francheska Cadacio, Joel Castro, Sofía Llorente, Mariana Yáñez Medical Oncologist-PhD Candidate Natalia Tissera Master’s Students Hidde Cammenga (Medical Student, Utrecht University), Ariadna Cerdà Research Assistants Carlos Ros, Daniel Sin, Junxiao Wang

Research Groups

Upper Gastrointestinal and Endocrine Tumors Group

Summary

Led by Teresa Macarulla, our Gastrointestinal and Endocrine Tumors Group develops molecular therapies against gastrointestinal (GI) malignancies. We drive pioneering research and lead early phase clinical trials to identify novel biomarkers and targets that accelerate the delivery of precision oncology for patients with biliary tract, pancreatic, gastric, and neuroendocrine cancers, among others.

Our multidisciplinary team integrates medical oncologists, preclinical and translational researchers, dedicated research nurses overseeing patients in research programs, laboratory technicians experts in molecular biology and animal models, and data curators. Our team collaborates with VHIO researchers, surgeons, pathologists, radiologists, gastroenterologists, and clinical biologists through our highly interactive and multidisciplinary Task Forces.

In 2024, we played a central role in several clinical trials evaluating immunotherapy and targeted agents for upper GI and endocrine tumors. Notably, we contributed to the OPTIMIZE-1 trial that supports the clinical benefit of CD40 agonist mitazalimab with mFOLFIRINOX in pancreatic cancer patients, and led the clinical evaluation of [177Lu]Lu-DOTA-TATE plus long-acting octreotide in gastroenteropancreatic neuroendocrine tumors. Importantly, we opened multiple clinical studies across different phases assessing the safety, efficacy and survival benefit of novel therapies in patients with upper GI and endocrine tumors.

Our translational investigators have advanced the development and validation of liquid biopsy technologies and biomarkers to enable a more precise monitoring of cancer patients. Moreover, our comprehensive collection of patient-derived models and preclinical resources has facilitated numerous studies uncovering novel actionable biology in GI cancers. This, in turn, establishes a compelling rationale for the clinical evaluation of new therapies.

Through cutting-edge research, our multidisciplinary group has become a reference in GI and endocrine malignancies, reflected in invited talks at international conferences and several opinion articles and editorials published in top biomedical journals.

  • Molecular characterization and biomarker discovery in upper gastrointestinal (GI) and endocrine malignancies, particularly in gastric, pancreatic, biliary tract and endocrine cancers.
  • Implementation of liquid biopsy approaches for real-time monitoring of disease evolution in patients undergoing treatment.
  • Development of preclinical models (organoids, PDXs, and transgenic models) to investigate mechanisms of primary and secondary resistance to therapy.
  • Design of early clinical studies and investigator-initiated trials (IIT) to accelerate the development of innovative anti-tumor agents.
  • Participation and coordination of late-stage clinical research studies to assess the clinical impact of new therapeutic strategies and identify novel prognostic and predictive biomarkers.
  • Expansion of research lines in upper GI and endocrine cancers, including the study of microbiota, cancer immunology, and the tumor microenvironment (TME).
  • Our research portfolio encompasses over 20 translational projects focused on upper GI and endocrine malignancies, supported by national and international collaborations. Key research activities include investigating treatment resistance in BRCA-mutated pancreatic cancer, advancing analytical approaches for liquid biopsy, developing novel cell-based therapies for pancreaticobiliary cancers, and evaluating cutting-edge therapies.
  • We coordinate a work package of the IMMUNE4ALL national consortium that seeks to enhance the efficacy of immunotherapies in GI malignancies, including cholangiocarcinoma and gastroenteropancreatic neuroendocrine neoplasms. This project is supported by the Instituto de Salud Carlos III (ISCIII).
  • We coordinate the EU-funded TRANSCAN-3 project SIMMBAP to understand the systemic immunological determinants of tumor evolution and therapy response in BRCA-mutated pancreatic cancer.
  • We have also consolidated an academic-pharma partnership with AstraZeneca through the Partner of Choice program, which supports our efforts to identify predictive biomarkers in pancreatic ductal adenocarcinoma (PDAC).
  • Expand our involvement in clinical trials to improve patient outcomes.
  • Accelerate translational research to identify new biomarkers and therapeutic strategies.
  • Develop innovative therapeutic approaches, including immunotherapies and cell-based treatments, to provide the best possible care to patients.
  • Van Laethem JL, Borbath I, Prenen H, Geboes KP, Lambert A, Mitry E, Cassier PA, Blanc JF, Pilla L, Batlle JF, Garrote MR, Pazo-Cid RA, Gallego I, Smith KE, Ellmark P, Pico de Coaña Y, Ambarkhane SV, Macarulla T. Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study. Lancet Oncol. 2024 Jul;25(7):853-864.
  • González-Medina A, Vila-Casadesús M, Gomez-Rey M, Fabregat-Franco C, Sierra A, Tian TV, Castet F, Castillo G, Matito J, Martinez P, Miquel JM, Nuciforo P, Pérez-López R, Macarulla T, Vivancos A. Clinical Value of Liquid Biopsy in Patients with FGFR2 Fusion-Positive Cholangiocarcinoma During Targeted Therapy. Clin Cancer Res. 2024 Oct 1;30(19):4491-4504.
  • Yáñez-Bartolomé M, Serra-Camprubí Q, Arenas EJ, Escorihuela M, Castet F, Fabregat-Franco C, Querol J, Arribas J, Peiró S, Macarulla T, Tian TV. Generation of Metastatic Cholangiocarcinoma Patient-Derived Xenograft Models. Methods Mol Biol. 2024;2806:139-151.
  • Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz PL, Chasen B, Tafuto S, Lastoria S, Capdevila J, García-Burillo A, Oh DY, Yoo C, Halfdanarson TR, Falk S, Folitar I, Zhang Y, Aimone P, de Herder WW, Ferone D; all the NETTER-2 Trial Investigators. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024 Jun 29;403(10446):2807-2817.
  • Teresa Macarulla: ESMO Gastrointestinal Cancers Congress Chair.
  • Tian Tian: VIII Young Investigator Award of the AstraZeneca Foundation.
  • Sefora Conti: Juan de la Cierva Postdoctoral Fellowship (Spanish Ministry of Science and Innovation).
  • Natalia Tissera: La Pedrera MD/PhD Fellowship (La Pedrera Foundation).
  • Sofía Llorente: Joan Oró Predoctoral Fellowship (Generalitat de Catalunya).
  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: Systemic immunological determinants of tumor evolution and therapy response in BRCA-mutated pancreatic cancer.
    Coordinator: Teresa Macarulla. Sub-aim PI: Tian Tian.
    Funding entity: AECC- JTC TRANSCAN.
    Duration: 01/12/2023-30/11/2026.
  6. 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.
  7. 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.
  8. Project title: Pancreatic cancer and alterations in DNA damage response genes: analysis of predictive biomarkers and mechanisms of resistance to platinum-based chemotherapy and PARP inhibitors.
    Principal investigator: Teresa Macarulla.
    Funding entity: ISCIII.
    Duration: 01/01/2020-30/06/2024
  9. Project title: Nanomedicine upscaling for early clinical phase of multimosal cancer therapy.
    Principal investigator: Teresa Macarulla.
    Funding entity: NOCANTHER European Commission.
    Duration: 01/04/2016-31/12/2024.
  10. Project title: AstraZeneca translational project.
    Principal investigator: Teresa Macarulla.
    Funding entity: AstraZeneca.
    Duration: 21/03/2018-31/12/2024.
  11. Project title: AstraZeneca translational.
    Principal investigator: Teresa Macarulla.
    Funding entity: AstraZeneca.
    Duration: 30/07/2020-31/12/2025.
  12. Project title: AstraZeneca translational biomarker discovery.
    Principal investigator: Teresa Macarulla.
    Funding entity: AstraZeneca.
    Duration: 09/09/2021-31/12/2025.
  13. Project title: Ajuts de Suport a la Recerca.
    Principal investigator: Teresa Macarulla.
    Funding entity: AGAUR.
    Duration: 01/01/2022-30/06/2025.
  14. 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.
  15. Project title: Aztrazeneca translational project.
    Principal investigators: Teresa Macarulla, Tian Tian.
    Funding entity: AstraZeneca.
    Duration: 09/06/2024-31/12/2027.
  16. 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.
  17. Project title: Biomarker Phase II Study of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer.
    Principal investigator: Jaume Capdevila, Translational investigator: Tian Tian.
    Funding entity: GETNE.
    Duration: 11/05/2023-10/05/2024.
  18. Project title: Alentis translational research grant.
    Principal investigators: Tian Tian and Teresa Macarulla.
    Funding entity: ALENTIS Therapeutics AG.
    Duration: 01/08/2023-31/07/2025.
  19. Project title: Incyte translational research grant.
    Principal investigators: Teresa Macarulla and Tian Tian.
    Funding entity: Incyte.
    Duration: 01/01/2023-31/12/2024.
  20. Project title: LOXO oncology translational research grant.
    Principal investigators: Tian Tian and Teresa Macarulla.
    Funding entity: LOXO Oncology, Lilly.
    Duration: 01/01/2022-30/06/2024.
  21. Project title: Proteínas de fusión BRD-NUT en el carcinoma de línea media NUT: del diagnóstico al tratamiento.
    Principal investigator: Tian Tian.
    Funding entity: Plan Estatal de I+D+i Orientada a los Retos de la Sociedad, Ministerio de Ciencia e Innovación.
    Duration: 01/10/2020-29/02/2024.
  22. Project title: Programa Talents 2024-2025.
    Principal investigator: Tian Tian.
    Funding entity: Pedrera.
    Duration: 21/03/2024-20/03/2025.
  23. Project title: Servier translational project.
    Principal investigator: Tian Tian.
    Funding entity: Servier.
    Duration: 18/07/2024-31/12/2025.
  24. Project title: VIII EDICIÓN PREMIOS JOVENES INVESTIGADORES – Hacia una terapia de receptores de antígenos quiméricos de próxima generación para el colangiocarcinoma (TARQ-CCA).
    Principal investigator: Tian Tian.
    Funding entity: Astrazeneca.
    Duration: 29/11/2024-28/11/2026.
  25. Project title: Toward Novel Strategies to Enhance Targeted Therapy for Cholangiocarcinoma – ENHANCE-CCA.
    Principal investigator: Tian Tian.
    Funding entity: Ministerio de Ciencia e Innovación (Generación de Conocimiento). Duration: 01/09/2024-31/08/2027.
  26. Project title: Validación de la firma de expresión génica VIGex como biomarcador predictivo de inhibidores de puntos de control inmunitarios en pacientes con adenocarcinoma gastroesofágico.
    Principal investigator: Daniel Acosta.
    Funding entity: SEOM.
    Duration: 01/10/2024-30/09/2026.
  27. 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.
  28. 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.
  29. Project title: Estudio de la expresión de antígenos como posibles dianas de conjugados anticuerpo-fármaco en tumores neuroendocrinos.
    Principal investigator: Jaume Capdevila.
    Funding entity: GETNE.
    Duration: 05/11/2021-30/11/2024.
  30. 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.
  31. 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.
  32. 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.
  33. Project title: Wearables en pacientes con tumores neuroendocrinos gastroenteropancreaticos.
    Principal investigator: Jaume Capdevila.
    Funding entity: Netfit.
    Duration: 12/02/2021-31/12/2025.
  34. Project title: DLL3 DETERMINATION IN NEUROENDOCRINE NEOPLASMS.
    Principal investigator: Jaume Capdevila.
    Funding entity: Amgen.
    Duration: 29/04/2021-31/12/2025.
  1. Sánchez Becerra MV, Escudero Iriarte C, Travert C, Tian TV, Besse B. Promising response to lurbinectedin in NUT carcinoma: a case report and review of emerging therapeutic strategies. Ann Oncol. 2025 Feb;36(2):225-227. doi: 10.1016/j.annonc.2024.10.008. Epub 2024 Oct 11.
  2. Van Laethem JL, Borbath I, Prenen H, Geboes KP, Lambert A, Mitry E, Cassier PA, Blanc JF, Pilla L, Batlle JF, Garrote MR, Pazo-Cid RA, Gallego I, Smith KE, Ellmark P, Pico de Coaña Y, Ambarkhane SV, Macarulla T. Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study. Lancet Oncol. 2024 Jul;25(7):853-864. doi: 10.1016/S1470-2045(24)00263-8.
  3. Luk IS, Bridgwater CM, Yu A, Boila LD, Yáñez-Bartolomé M, Lampano AE, Hulahan TS, Boukhali M, Kathiresan M, Macarulla T, Kenerson HL, Yamamoto N, Sokolov D, Engstrom IA, Sullivan LB, Lampe PD, Cooper JA, Yeung RS, Tian TV, Haas W, Saha SK, Kugel S. SRC inhibition enables formation of a growth suppressive MAGI1-PP2A complex in isocitrate dehydrogenase-mutant cholangiocarcinoma. Sci Transl Med. 2024 May 15;16(747):eadj7685. doi: 10.1126/scitranslmed.adj7685.
  4. Riesco-Martinez MC, Capdevila J, Alonso V, Jimenez-Fonseca P, Teule A, Grande E, Sevilla I, Benavent M, Alonso-Gordoa T, Custodio A, Anton-Pascual B, Hernando J, Polo E, Castillo-Trujillo OA, Lamas-Paz A, Teijo A, Rodriguez-Gil Y, Soldevilla B, Garcia-Carbonero R. Nivolumab plus platinum-doublet chemotherapy in treatment-naive patients with advanced grade 3 Neuroendocrine Neoplasms of gastroenteropancreatic or unknown origin: The multicenter phase 2 NICE-NEC trial (GETNE-T1913). Nat Commun. 2024 Aug 8;15(1):6753. doi: 10.1038/s41467-024-50969-8.
  5. Mirallas O, Martin-Cullell B, Navarro V, Vega KS, Recuero-Borau J, Gómez-Puerto D, López-Valbuena D, Salva de Torres C, Andurell L, Pedrola A, Berché R, Palmas F, Ucha JM, Villacampa G, Rezqallah A, Sanz-Beltran J, Bach R, Bueno S, Viaplana C, Molina G, Hernando-Calvo A, Aguilar-Company J, Roca M, Muñoz-Couselo E, Martínez-Martí A, Alonso A, Eremiev S, Macarulla T, Oaknin A, Saura C, Élez E, Felip E, Peñuelas Á, Burgos R, Pardo PG, Garralda E, Tabernero J, Serradell S, Servitja S, Paez D, Dienstmann R, Carles J. Development of a prognostic model to predict 90-day mortality in hospitalised cancer patients (PROMISE tool): a prospective observational study. Lancet Reg Health Eur. 2024 Oct 9;46:101063. doi: 10.1016/j.lanepe.2024.101063.
  6. Herencia-Ropero A, Llop-Guevara A, Staniszewska AD, Domènech-Vivó J, García-Galea E, Moles-Fernández A, Pedretti F, Domènech H, Rodríguez O, Guzmán M, Arenas EJ, Verdaguer H, Calero-Nieto FJ, Talbot S, Tobalina L, Leo E, Lau A, Nuciforo P, Dienstmann R, Macarulla T, Arribas J, Díez O, Gutiérrez-Enríquez S, Forment JV, O'Connor MJ, Albertella M, Balmaña J, Serra V. The PARP1 selective inhibitor saruparib (AZD5305) elicits potent and durable antitumor activity in patient-derived BRCA1/2-associated cancer models. Genome Med. 2024 Aug 26;16(1):107. doi: 10.1186/s13073-024-01370-z.
  7. Romesser PB, Capdevila J, Garcia-Carbonero R, Philip T, Fernandez Martos C, Tuli R, Rodriguez-Gutierrez A, Kuipers M, Becker A, Coenen-Stass A, Sarholz B, You X, Miller ED. A Phase Ib Study of the DNA-PK Inhibitor Peposertib Combined with Neoadjuvant Chemoradiation in Patients with Locally Advanced Rectal Cancer. Clin Cancer Res. 2024 Feb 16;30(4):695-702. doi: 10.1158/1078-0432.CCR-23-1129.
  8. Coveler AL, Reilley MJ, Zalupski M, Macarulla T, Fountzilas C, Ponz-Sarvisé M, Nagrial A, Uboha NV, Frentzas S, Overman M, Noonan A, Messersmith WA, Pavlakis N, Mettu NB, Bisha I, Wang Y, Smith P, Murtomaki E, Bielska AA, Bragulat V, Cooper ZA, Kumar R, Spigel DR. A Phase Ib/II Randomized Clinical Trial of Oleclumab with or without Durvalumab plus Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2024 Oct 15;30(20):4609-4617. doi: 10.1158/1078-0432.CCR-24-0499.
  9. González-Medina A, Vila-Casadesús M, Gomez-Rey M, Fabregat-Franco C, Sierra A, Tian TV, Castet F, Castillo G, Matito J, Martinez P, Miquel JM, Nuciforo P, Pérez-López R, Macarulla T, Vivancos A. Clinical Value of Liquid Biopsy in Patients with FGFR2 Fusion-Positive Cholangiocarcinoma During Targeted Therapy. Clin Cancer Res. 2024 Oct 1;30(19):4491-4504. doi: 10.1158/1078-0432.CCR-23-3780.
  10. Lamarca A, Macarulla T. Facts and Hopes in the Systemic Therapy of Biliary Tract Carcinomas. Clin Cancer Res. 2024 Sep 3;30(17):3688-3696. doi: 10.1158/1078-0432.CCR-22-2438.
  11. Mortier L, Villabona L, Lawrence B, Arance A, Butler MO, Beylot-Barry M, Saiag P, Samimi M, Ascierto PA, Spada F, De Pontville M, Maio M, Berrocal A, Espinosa E, Capdevila J, Levin M, Das D, Krepler C, Grebennik D, Chiarion-Sileni V. Pembrolizumab for the First-Line Treatment of Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma: Results from the Single-Arm, Open-Label, Phase III KEYNOTE-913 Study. Am J Clin Dermatol. 2024 Nov;25(6):987-996. doi: 10.1007/s40257-024-00885-w.
  12. Prior O, Macarro C, Navarro V, Monreal C, Ligero M, Garcia-Ruiz A, Serna G, Simonetti S, Braña I, Vieito M, Escobar M, Capdevila J, Byrne AT, Dienstmann R, Toledo R, Nuciforo P, Garralda E, Grussu F, Bernatowicz K, Perez-Lopez R. Identification of Precise 3D CT Radiomics for Habitat Computation by Machine Learning in Cancer. Radiol Artif Intell. 2024 Mar;6(2):e230118. doi: 10.1148/ryai.230118. Erratum in: Radiol Artif Intell. 2024 May;6(3):e249001. doi: 10.1148/ryai.249001.
  13. Rimini M, Fornaro L, Rizzato MD, Antonuzzo L, Rossari F, Satake T, Vandeputte H, Vivaldi C, Pressiani T, Lucchetti J, Kim JW, Abidoye O, Rapposelli IG, Tamberi S, Finkelmeier F, Giordano G, Nichetti F, Chon HJ, Braconi C, Pirrone C, Castet F, Tamburini E, Yoo C, Parisi A, Diana A, Scartozzi M, Prager GW, Avallone A, Schirripa M, Kim IH, Perkhofer L, Oneda E, Verrico M, Adeva J, Chan SL, Spinelli GP, Personeni N, Garajova I, Rodriquenz MG, Leo S, Salani F, De Rosa A, Lavacchi D, Foti S, Ikeda M, Dekervel J, Niger M, Balsano R, Tonini G, Kang M, Bekaii-Saab T, Esposito L, Boccaccino A, Himmelsbach V, Landriscina M, Djaballah SA, Zanuso V, Masi G, Lonardi S, Rimassa L, Casadei-Gardini A. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: A large real-life worldwide population. Eur J Cancer. 2024 Sep;208:114199. doi: 10.1016/j.ejca.2024.114199.
  14. Sedlack AJH, Varghese DG, Naimian A, Yazdian Anari P, Bodei L, Hallet J, Riechelmann RP, Halfdanarson T, Capdevilla J, Del Rivero J. Update in the management of gastroenteropancreatic neuroendocrine tumors. Cancer. 2024 Sep 15;130(18):3090-3105. doi: 10.1002/cncr.35463.
  15. Lebeaud A, Antoun L, Paccard JR, Edeline J, Bourien H, Fares N, Tournigand C, Lecomte T, Tougeron D, Hautefeuille V, Viénot A, Henriques J, Williet N, Bachet JB, Smolenschi C, Hollebecque A, Macarulla T, Castet F, Malka D, Neuzillet C, Vernerey D, Boilève A, Turpin A. Management of biliary tract cancers in early-onset patients: A nested multicenter retrospective study of the ACABI GERCOR PRONOBIL cohort. Liver Int. 2024 Aug;44(8):1886-1899. doi: 10.1111/liv.15922.
  16. Pérez-Wert P, Custodio A, Jimenez-Fonseca P, Carmona-Bayonas A, Lecumberri A, Cacho Lavin D, Losantos García I, Fernández Montes A, Cano JM, Limón ML, Hernández San Gil R, Diez M, Vidal Tocino R, Macías Declara I, Visa L, Pimentel Cáceres P, Gil Raga M, Martínez Moreno E, Sauri T, Martín Richard M, Granja M, Cerdà P, Gómez González L, Mérida-García A, Ruiz Martín M, Gallego J; AGAMENON-SEOM study group. Efficacy and safety of chemotherapy in young patients with advanced gastroesophageal adenocarcinoma: data from the Spanish AGAMENON-SEOM registry. Gastric Cancer. 2024 Jan;27(1):131-145. doi: 10.1007/s10120-023-01443-9.
  17. Medel-Jara P, Reyes Placencia D, Fuentes-López E, Corsi O, Latorre G, Antón R, Jiménez E, Miralles-Marco A, Caballero C, Boggino H, Cantero D, Barros R, Santos-Antunes J, Díez M, Quiñones LA, Riquelme E, Rollán A, Cerpa LC, Valdés I, Nyssen OP, Moreira L, Gisbert JP, Camargo MC, Ortiz-Olvera N, Leon-Takahashi AM, Ruiz-Garcia E, Fernández-Figueroa EA, Garrido M, Owen GI, Cervantes A, Fleitas T, Riquelme A. Quadruple therapies show a higher eradication rate compared to standard triple therapy for Helicobacter pylori infection within the LEGACy consortium. A multicenter observational study in European and Latin American countries. United European Gastroenterol J. 2024 Nov;12(9):1190-1199. doi: 10.1002/ueg2.12605.
  18. Capdevila J, Krajewska J, Hernando J, Robinson B, Sherman SI, Jarzab B, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Williamson D, Levytskyy R, Oliver J, Keam B, Brose MS. Increased Progression-Free Survival with Cabozantinib Versus Placebo in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Irrespective of Prior Vascular Endothelial Growth Factor Receptor-Targeted Therapy and Tumor Histology: A Subgroup Analysis of the COSMIC-311 Study. Thyroid. 2024 Mar;34(3):347-359. doi: 10.1089/thy.2023.0463.
  19. Veas Rodríguez J, Prieto A, Vilaprinyo E, Bonet M, Diez M, Salud A, Montal R. Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2024 Sep;201:104416. doi: 10.1016/j.critrevonc.2024.104416.
  20. Serra-Bardenys G, Blanco E, Escudero-Iriarte C, Serra-Camprubí Q, Querol J, Pascual-Reguant L, Morancho B, Escorihuela M, Tissera NS, Sabé A, Martín L, Segura-Bayona S, Verde G, Aiese Cigliano R, Millanes-Romero A, Jerónimo C, Cebrià-Costa JP, Nuciforo P, Simonetti S, Viaplana C, Dienstmann R, Oliveira M, Peg V, Stracker TH, Arribas J, Canals F, Villanueva J, Di Croce L, García de Herreros A, Tian TV, Peiró S. LOXL2-mediated chromatin compaction is required to maintain the oncogenic properties of triple-negative breast cancer cells. FEBS J. 2024 Jun;291(11):2423-2448. doi: 10.1111/febs.17112.
  21. Lahmer T, Salmanton-García J, Marchesi F, El-Ashwah S, Nucci M, Besson C, Itri F, Jaksic O, Čolović N, Weinbergerová B, Seval GC, Adžić-Vukičević T, Szotkowski T, Sili U, Dargenio M, van Praet J, van Doesum J, Schönlein M, Ráčil Z, Žák P, Poulsen CB, Magliano G, Jiménez M, Bonuomo V, Piukovics K, Dragonetti G, Demirkan F, Blennow O, Valković T, Gomes Da Silva M, Maertens J, Glenthøj A, Fernández N, Bergantim R, Verga L, Petzer V, Omrani AS, Méndez GA, Machado M, Ledoux MP, Bailén R, Duarte RF, Del Principe MI, Farina F, Martín-Pérez S, Dávila-Valls J, Marchetti M, Bilgin YM, Fracchiolla NS, Cattaneo C, Espigado I, Cordoba R, Collins GP, Labrador J, Falces-Romero I, Prezioso L, Meers S, Passamonti F, Buquicchio C, López-García A, Kulasekararaj A, Ormazabal-Vélez I, Cuccaro A, Garcia-Vidal C, Busca A, Navrátil M, de Jonge N, Biernat MM, Guidetti A, Abu-Zeinah G, Samarkos M, Anastasopoulou A, de Ramón C, González-López TJ, Hoenigl M, Finizio O, Pinczés LI, Ali N, Vena A, Tascini C, Stojanoski Z, Merelli M, Emarah Z, Kohn M, Barać A, Mladenović M, Mišković B, Ilhan O, Çolak GM, Čerňan M, Gräfe SK, Ammatuna E, Hanakova M, Víšek B, Cabirta A, Nordlander A, Nunes Rodrigues R, Hersby DS, Zambrotta GPM, Wolf D, Núñez-Martín-Buitrago L, Arellano E, Aiello TF, García-Sanz R, Prattes J, Egger M, Limongelli A, Bavastro M, Cvetanoski M, Dibos M, Rasch S, Rahimli L, Cornely OA, Pagano L; EPICOVIDEHA registry. Need for ICU and outcome of critically ill patients with COVID-19 and haematological malignancies: results from the EPICOVIDEHA survey. Infection. 2024 Jun;52(3):1125-1141. doi: 10.1007/s15010-023-02169-7. Epub 2024 Feb 22. Erratum in: Infection. 2024 Jun;52(3):1191-1194. doi: 10.1007/s15010-024-02240-x.
  22. La Salvia A, Lens-Pardo A, López-López A, Carretero-Puche C, Capdevila J, Benavent M, Jiménez-Fonseca P, Castellano D, Alonso T, Teule A, Custodio A, Tafuto S, La Casta A, Spada F, Lopez-Gonzalvez A, Gil-Calderon B, Espinosa-Olarte P, Barbas C, Garcia-Carbonero R, Soldevilla B. Metabolomic profile of neuroendocrine tumors identifies methionine, porphyrin, and tryptophan metabolisms as key dysregulated pathways associated with patient survival. Eur J Endocrinol. 2024 Jan 3;190(1):62-74. doi: 10.1093/ejendo/lvad160.
  23. Lo Prinzi F, Salani F, Rimini M, Rizzato MD, Antonuzzo L, Camera S, Satake T, Vandeputte H, Vivaldi C, Pressiani T, Lucchetti J, Kim JW, Abidoye O, Rapposelli IG, Tamberi S, Finkelmeier F, Giordano G, Pircher C, Chon HJ, Braconi C, Pastorino A, Castet F, Tamburini E, Yoo C, Parisi A, Diana A, Scartozzi M, Prager GW, Avallone A, Schirripa M, Kim IH, Perkhofer L, Oneda E, Verrico M, Adeva J, Chan SL, Spinelli GP, Personeni N, Garajova I, Rodriquenz MG, Leo S, Melo Alvim C, Roque R, Fornaro L, De Rosa A, Lavacchi D, Rossari F, Ikeda M, Dekervel J, Niger M, Balsano R, Tonini G, Kang M, Bekaii-Saab T, Viola MG, Silvestro L, Esposito L, Boccaccino A, Himmelsbach V, Landriscina M, Ahcene Djaballah S, Zanuso V, Masi G, Lonardi S, Rimassa L, Casadei-Gardini A. Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population. Oncologist. 2025 Mar 10;30(3):oyae256. doi: 10.1093/oncolo/oyae256.
  24. Gardner FP, Wainberg ZA, Fountzilas C, Bahary N, Womack MS, Macarulla T, Garrido-Laguna I, Peterson PM, Borazanci E, Johnson M, Ceccarelli M, Pelzer U. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 1b/2 Trial of Nabpaclitaxel + Gemcitabine ± Olaratumab in Treatment-Naïve Participants with Metastatic Pancreatic Cancer. Cancers (Basel). 2024 Mar 28;16(7):1323. doi: 10.3390/cancers16071323.
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Code Clinical trial title
3082-CL-0101 A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation
20230223 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
CL1-95029-002 "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"
1479-0012 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)
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
JZP598-302 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)
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
D7025C00001 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)
TT420C2308 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).
TAS-120-206 A Phase 2 Study of Futibatinib in Combination with PD-1 Antibody-based Standard of Care Therapy in Patients with Solid Tumors
INTEGRATE IIb “A Randomised Phase III Open Label Study of regorafenib + nivolumab vs standard chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)”
2023-12144 Estudio observacional, internacional, retrospectivo de revisión de historias clínicas, para describir las características, patrones de tratamiento y resultados clínicos en los pacientes tratados con selpercatinib dentro de un Programa de Acceso Temprano en España y Portugal
TAS-120-205 Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
1438-0007 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)
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.
GETNE-T2217 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
DIM-95031-002 An open-label early access phase 3b study of Ivosidenib in patients with a pretreated locally advanced or metastatic cholangiocarcinoma
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.
Actuate 1801/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.
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)
EF-39 "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) "
GETNE-T2216 Biomarker Phase II Study Of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer
2021-10496 "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"
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
219369 PH2 Open label study evaluating Dostarlimab in the Neoadjuvant Treatment of locally advanced (la) dMMR/MSI-H rectal cancer (RC)
2020-9610 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
P-VCNA-003 A phase IIb, open-label, randomized study of Gemcitabine and NabPaclitaxel plus/VCN-01 in Patients with Metastatic Pancreas Cancer
ONCO01P04 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
GEMCAD 2103 "Estudio de fase II de atezolizumab más tiragolumab en combinación con quimio-radioterapia en carcinoma de células escamosas localizado del canal anal."
D7986C00001 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
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
D-FR-60010-015 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.
20210098 “Estudio de fase 1b/3 de bemarituzumab más quimioterapia y nivolumab frente a solo quimioterapia y nivolumab en sujetos con cáncer gástrico y de la unión gastroesofágica avanzado no tratado previamente con sobreexpresión de GFR2b FORTITUDE-102)”
A-20-1013-C-03 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.
E7386-G000-201 An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors
SN201 A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma
FW-2020-1 A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in combination with nivolumab in adults with advanced solid tumors
CNIS793B12301 A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)
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.
ACT16902 A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with advanced and metastatic gastrointestinal cancer).
DP-1111-02CT 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
HS-19-657 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.
MK-6482-016 An Open-label, Multicenter, Phase 2 Study of Pembrolizumab Plus Lenvatinib in Combination With MK-6482 in Multiple Solid Tumors.
M20-732 A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma.
DS8201-A-U306 A Phase 3, multicenter, 2-arm randomized, open-label study of trastuzumab deruxtecan in subjects with HER2-positive metastatic and/or unresectable gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen
D910GC00001 A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC) (MATTERHORN).
MK-7902-014 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.
2020-012-00EU1 An Open-Label Phase 2 Study of Surufatinib in Patients with Neuroendocrine Tumours in Europe.
NLM-2020-01 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.
D910SC00001 A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma.
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).
ABT-C11-2020 A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer.
LOXO-IDH-20002 A Phase 1 Study of LY3410738 Administered to Patients with Advanced Solid Tumors with IDH1 R132 Mutations.
CNIS793B12201 A phase II, open label, randomized, parallel arm study of NIS793 (with and without spartalizumab) in combination with SOC chemotherapy gemcitabine/nab-paclitaxel, and gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
Nocanther A feasibility clinical investigation of intratumoral injection of magnetic nanoparticles associated to hyperthermia treatment in locally advanced pancreatic cancer.
MK-7902-015 A Phase 3, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Pembrolizumab + Lenvatinib + Chemotherapy Induction Therapy Followed by Pembrolizumab + Lenvatinib Compared with Chemotherapy in Participants with Previously Untreated Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma.
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 Systemic Chemotherapy (POD1UM-303/InterAACT 2).
ZWI-ZW25-203 A Phase 2b, open-label, single-arm study of ZW25 monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers.
D967LC00001 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).
D967LC00001 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).
AMCMEDONC17-010 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.
EOADR1-19 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.
D-US-60010-001 An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas.
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).
CAAA601A22301 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.
GEMCAD 1703 Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial).
VHIO19001 Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with respectable Gastric cancer (GC) or Gastroesophageal Junction cancer (GEJC) – MONEO Study.
ITM-LET-01 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).
INCB 54828-302 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).
8951-CL-0301 A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of IMAB362 Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.
MK-3475-811 Ensayo de fase III, aleatorizado y doble ciego para comparar trastuzumab más quimioterapia y pembrolizumab con trastuzumab más quimioterapia y placebo como tratamiento de primera línea en participantes con adenocarcinoma gástrico o de la unión gastroesofágica avanzado con HER2 positivo (KEYNOTE 811).
EF-27 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.
WO39608 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).
CA209-577 A Randomized, Multicenter, Double Blind, Phase III Study of Nivolumab or Placebo in Subjects with Resected Lower Esophageal, or Gastroesophageal Junction Cancer.
1203-GITCG INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL.
MCLA-128-CL01 A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors
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.

Group Leader Elena Élez Colon Cancer Team: Medical Oncologists and Clinical Investigators Iosune Baraibar, Marta Rodríguez, Francisco Javier Ros, Francesc Salvà, Nadia Saoudí Research Oncology Nurse Ariadna García Research Coordinator Sebastián Guzmán Colon Task Force Manager Mireia Sanchis Nutritionist Adriana Alcaraz Rectal Cancer Team: Medical Oncologist and Senior Consultant Jaume Capdevila Medical Oncologists Alejandro García, Jorge Hernando Research Oncology Nurse Ana Vazquez Sample Manager Ines Suárez

Research Groups

Colorectal Cancer Group

Summary

VHIO’s Colorectal Cancer Group, led by Elena Élez, has extensive experience in managing this disease. We (co) lead several clinical and translational research projects aimed at identifying novel prognostic and predictive biomarkers to help guide treatment decision making and expose mechanisms of drug resistance in colorectal cancer (CRC).

Our group is recognized as a reference in BRAF-mutated CRC research. This mutation is associated with aggressive clinicopathological and molecular features, including mucinous differentiation and microsatellite instability. Illustrating our efforts in this area, our investigators participated in the BEACON phase III landmark study that led to the approval of the BRAF inhibitor encorafenib in combination with cetuximab for the treatment of patients with BRAFV600E-mutated CRC. Furthermore, we have expanded our patient cohort of BRAF-mutated CRC through an investigator-initiated trial evaluating the efficacy of a novel drug combination —encorafenib, cetuximab and bevacizumab—in this setting.

We actively lead and participate in other important clinical studies aimed at expanding effective therapeutic strategies against metastatic CRC, including immune-based therapeutic combinations. Our drug development efforts have contributed to the approval of several targeted treatments, including trifluridine-tipiracil plus bevacizumab in refractory mCRC, pembrolizumab in MSI-H advanced CRC, and fruquintinib in refractory mCRC.

A key line of research that we intend to consolidate in the coming years is centered on early-onset CRC (EO-CRC). The rising global incidence in younger people (< 50 years old) remains an urgent concern. While the reasons for this alarming trend are not entirely clear, it is likely that there is an association with the environmental exposures that an individual experiences throughout their life (exposome), leading to genetic and epigenetic alterations in colorectal epithelial cells, the gut microbiota and host immunity. We aim to uncover mechanisms involved in the pathogenesis of CRC in younger patients and investigate the interplay of diverse driving factors.

The microbiome has been shown to play a key role in drug metabolism, efficacy, and toxicity, as well as cancer development. Our studies in this field leverage multidisciplinary collaborations and new approaches to integrate analysis of diverse biological samples (feces and saliva) and sophisticated experimental systems to probe their functionality.

Considering the mounting evidence demonstrating the importance of nutrition-microbiome interactions in cancer, we have designed a food frequency questionnaire (FFQ) to study the dietary patterns of the Spanish population and its impact on the intestinal microbiota. The questionnaire’s validity will be assessed by comparing the food and nutrient intake reported by patients with three-day food records in healthy individuals. Additionally, the reproducibility of the FFQ will be tested in patients diagnosed with colon cancer at the Vall d’Hebron University Hospital.

We are also developing specific projects in rectal cancer. Focused mainly on localized stages, these efforts aim to optimize perioperative treatment and surgery. Led by Jaume Capdevila, clinical trials have been developed for this patient population, including the DUREC study which has been designed to assess the addition of immunotherapy (durvalumab) to standard of care chemotherapy and radiotherapy to increase the probability of cure.

Translational efforts in rectal cancer also include microbiota analysis and its impact on rectal cancer treatment efficacy. Among other studies underway, we focus on studying the microbiota and its association with rectal cancer development and treatment response, and are leading the TAU-TEM study investigating early-stage disease, promoting collaboration with other disciplines including surgery and radiotherapy.

  • Contribute to drug development in colorectal cancer (CRC) through our participation in optimally designed international and innovative clinical trials.
  • Study the mechanisms of cancer drug resistance in BRAF-mutated CRC.
  • Identify novel predictive biomarkers of treatment response.
  • Investigate early-onset CRC. Identify and understand the mechanisms involved, with particular emphasis on the impact of the microbiome.
  • Develop and implement new diagnostic approaches and tumor-on-a-chip models to study the CRC tumor microenvironment.
  • Characterize the potential of the gut microbiome as a determinant of treatment response or resistance and evaluate its therapeutic actionability in CRC.
  • Validate and assess the reproducibility of the food frequency questionnaire to study the dietary patterns of the Spanish population and its impact on the intestinal microbiota.
  • Study colorectal cancer liver metastases from different perspectives to deepen insights into their growth pattern and role as a prognostic factor.
  • We have initiated the BRAVE trial: Bevacizumab plus encoRAfenib-cetuximab in BRAFV600E-mutated metastatic colorectal cancer (mCRC), a phase II study with a safety lead-in cohort. This study represents unparalleled opportunity to advance insights into BRAFV600E mCRC, with the groundbreaking objective of preventing acute signalling rewiring and tumor tissue remodelling that confer resistance to targeted agents. The project introduces two disruptive concepts to the clinic: first, the integration of an antiangiogenic agent into the backbone of targeted combination therapy as a strategy to delay treatment resistance by preventing vascular remodeling; and second, the potential utility of BRAFV600E mutant allele frequency (MAF) in circulating tumor DNA (ctDNA) as a predictive biomarker of response to therapy , linking liquid biopsy biomarkers to vasculature, necropsy, and other histopathological features of tumors.
  • Funded by the Instituto de Salud Carlos III (ISCIII) and European Union, BeLIVER is a project focused on comprehensively investigating the functional role of the tumor microenvironment (TME) in the immune evasion of liver metastasis and functionally study liver metastasis heterogeneity by identifying predictive biomarkers of response to immunotherapies; proposing combinatorial treatments to improve immunotherapy responses; and discovering novel immunotherapeutic targets.
  • Co-authored by Elena Élez, first results of the Checkmate 8HW phase III trial were presented at the 2024 ASCO Gastrointestinal Cancers Symposium. This study is assessing first-line nivolumab plus ipilimumab in patients with unresectable microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) mCRC. Data show that this immunotherapy combination decreased the risk of health-related quality of life (HRQoL ) deterioration and reduced symptoms compared with standard chemotherapy.
  • Announced by the European Medicines Agency (EMA) in June 2024, the highly selective and potent VEGFR inhibitor fruquintinib was approved as the first novel targeted therapy in the EU for mCRC, irrespective of biomarker status, in over a decade. Based on the results from the phase III multicenter and international FRESCO-2 trial co-directed by VHIO’s Director Josep Tabernero and Elena Élez as co-author, fruquintinib is indicated for the treatment of adult patients with refractory mCRC who have progressed on all available standard therapies or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
  • Aimed at strengthening and expanding our research lines and activities, in 2024 we set up Working Groups (WGs). Considering the number of associated research projects currently underway, the first area of focus is research into liver metastases, These WGs, which we hope to consolidate in 2025, promote collaboration and synergies between the different translational groups, oncologists, radiologists, and other relevant stakeholders, and will provide detailed analysess of progress and report on the outcomes of related projects.
  • Recent research suggests a potential association between emotional stress and response to immunotherapy in patients with melanoma. The gut-brain axis is well-known, however, the connection between cancer and depression remains an underexplored area of study. In this context, a collaboration between the Vall d’Hebron University Hospital’s Oncology and Mental Health Departments has been established during 2024. The main objective is to design a project in 2025 that integrates a joint approach to investigate the relationship between cancer, depression, and their interaction with the microbiome.
  • A  major challenge in 2024 has been the consolidation of circuits and initiatives to facilitate the collection of faecal samples from our patients to use in microbiome studies. We plan to continue this work in the upcoming year, expanding our analyses to cohorts of patients selected on the basis of the molecular features of their tumors.
  • In the same context, we will continue to validate and assess the reproducibility of a food frequency questionnaire (FFQ) designed to study the dietary patterns of the Spanish population and their impact on the intestinal microbiota.
  • Several patients and healthy volunteers are already taking part in this survey, and we hope to expand these cohorts in the coming year. Focused on disease prevention, we are also studying the dietary patterns of our patients hand in hand with our nutritionist.
  • Using multiple omics techniques, one focus area in 2025 will be to generate sufficient data to study the mechanisms involved in the increasing incidence rates of colorectal cancer in younger people (< 50 years old) in Spain. under the age of 50 in Spain.
  • We will also continue to advocate for precision medicine using liquid biopsy in patients with localized disease through Master Observational Trials.
  • We will also increase our BRAF-mutated CRC cohort of patients thanks to the investigator-initiated BRAVE trial, funded by the Instituto de Salud Carlos III (ISCIII) (ICI21/00097). This study has been designed to evaluate the efficacy a novel combination of drugs —encorafenib, cetuximab and bevacizumab-bvzr—in patients with BRAFV600E-mutated CRC.
  • Andre T, Elez E, Van Cutsem E, Jensen LH, Bennouna J, Mendez G, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Lenz HJ, Manzano Mozo JL, Tortora G, Garcia-Carbonero R, Dahan L, Chalabi M, Joshi R, Goekkurt E, Braghiroli MI, Cil T, Cela E, Chen T, Lei M, Dixon M, Abdullaev S, Lonardi S; CheckMate 8HW Investigators. Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. N Engl J Med. 2024 Nov 28;391(21):2014-2026.
  • Ambrosini M, Rousseau B, Manca P, Artz O, Marabelle A, André T, Maddalena G, Mazzoli G, Intini R, Cohen R, Cercek A, Segal NH, Saltz L, Varghese AM, Yaeger R, Nusrat M, Goldberg Z, Ku GY, El Dika I, Margalit O, Grinshpun A, Murtaza Kasi P, Schilsky R, Lutfi A, Shacham-Shmueli E, Khan Afghan M, Weiss L, Westphalen CB, Conca V, Decker B, Randon G, Elez E, Fakih M, Schrock AB, Cremolini C, Jayachandran P, Overman MJ, Lonardi S, Pietrantonio F. Immune checkpoint inhibitors for POLE or POLD1 proofreading-deficient metastatic colorectal cancer. Ann Oncol. 2024 Jul;35(7):643-655.
  • Kawazoe A, Xu RH, García-Alfonso P, Passhak M, Teng HW, Shergill A, Gumus M, Qvortrup C, Stintzing S, Towns K, Kim TW, Shiu KK, Cundom J, Ananda S, Lebedinets A, Fu R, Jain R, Adelberg D, Heinemann V, Yoshino T, Elez E; LEAP-017 Investigators. Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study. J Clin Oncol. 2024 Aug 20;42(24):2918-2927.
  • Siena S, Raghav K, Masuishi T, Yamaguchi K, Nishina T, Elez E, Rodriguez J, Chau I, Di Bartolomeo M, Kawakami H, Suto F, Koga M, Inaki K, Kuwahara Y, Takehara I, Barrios D, Kobayashi K, Grothey A, Yoshino T. HER2-related biomarkers predict clinical outcomes with trastuzumab deruxtecan treatment in patients with HER2-expressing metastatic colorectal cancer: biomarker analyses of DESTINY-CRC01. Nat Commun. 2024 Nov 25;15(1):10213.
  • Francesc Salvà was awarded with the Best Applied Postgraduate Project, Visión estratégica, habilidades y valores para el liderazgo by the Instituto de Formación Médica y Liderazgo (IFMiL) for his project entitled: Implementació del procés de cáncer colorrectal a l’Hospital Vall d’Hebrón (2023-2024).
  • Elena Élez was awarded with an Investigadors Emergents Grant Dionís Torres Segura Grant for her project entitled: Evaluation of tertiary lymphoid structures (TLS) as biomarker in metastatic colorectal cancer treated with immune-checkpoint combinations.
  • Elena Élez recieved a Programa CRIS de Talento Médico Investigador Grant for the project CRIS de biomarcadores de cáncer de colon.
    • 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.
    • 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.
    • 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.
    • Implementation of minimally invasive methods for the dynamic evaluation of primary and acquired mechanisms of resistance and response to targeted therapies in BRAFV600E mutated colorectal cancer. PI: Elena Élez. Grantor: Digestive Tumour Treatment Group (TTD). Duration: 03/01/2022 – 02/28/2024.
    • 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.
    • 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.
    • BioPrinted hydROgel MicrofluIdicS to mimic patient-specific tumour mEtastatic (PROMISE). Grantor: "La Caixa" Foundation. Duration: 01/12/2020 – 30/05/2025.
    • Moving liquid biopsy beyond current applications: a prospective study of prognostic and predictive values of circulating tumour DNA in metastatic colorectal cancer. PI: Elena Élez. Grantor: MaratóTV3. Duration: 01/06/2020 – 31/01/2024.
    • 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.
    • Implementación de métodos mínimamente invasivos para la evaluación dinámica de mecanismos de resistencia primaria y adquirida a terapias dirigidas en cáncer colorrectal BRAF V600E mutado. PI: Elena Élez. Grantor: Mutual Medica. Duration: 2022 – 2024.
    • 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.
    • 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.
    • Isolation and Identification of circulating extracellular vesicles-associated biomarkers from patients with colorectal cancer & Preliminary studies on the mechanism of action of CRC-exosomes and IVIG on CRC tumor cells. PI: Josep Villanueva; Héctor Pálmer; Elena Élez; Ana Vivancos. Grantor: Grifols, S.A. Duration: 2021 – 2024.
    • 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.
    • 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.
    • 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.
    • MicroOrganoSphere™ (MOS) Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC). PI: Elena Élez Grantor: Xilis, Inc. Duration: 2023 - 2024.
    • 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.
    • 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.
  1. Andre T, Elez E, Van Cutsem E, Jensen LH, Bennouna J, Mendez G, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Lenz HJ, Manzano Mozo JL, Tortora G, Garcia-Carbonero R, Dahan L, Chalabi M, Joshi R, Goekkurt E, Braghiroli MI, Cil T, Cela E, Chen T, Lei M, Dixon M, Abdullaev S, Lonardi S; CheckMate 8HW Investigators. Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. N Engl J Med. 2024 Nov 28;391(21):2014-2026. doi: 10.1056/NEJMoa2402141.
  2. Ambrosini M, Rousseau B, Manca P, Artz O, Marabelle A, André T, Maddalena G, Mazzoli G, Intini R, Cohen R, Cercek A, Segal NH, Saltz L, Varghese AM, Yaeger R, Nusrat M, Goldberg Z, Ku GY, El Dika I, Margalit O, Grinshpun A, Murtaza Kasi P, Schilsky R, Lutfi A, Shacham-Shmueli E, Khan Afghan M, Weiss L, Westphalen CB, Conca V, Decker B, Randon G, Elez E, Fakih M, Schrock AB, Cremolini C, Jayachandran P, Overman MJ, Lonardi S, Pietrantonio F. Immune checkpoint inhibitors for POLE or POLD1 proofreading-deficient metastatic colorectal cancer. Ann Oncol. 2024 Jul;35(7):643-655. doi: 10.1016/j.annonc.2024.03.009.
  3. Kawazoe A, Xu RH, García-Alfonso P, Passhak M, Teng HW, Shergill A, Gumus M, Qvortrup C, Stintzing S, Towns K, Kim TW, Shiu KK, Cundom J, Ananda S, Lebedinets A, Fu R, Jain R, Adelberg D, Heinemann V, Yoshino T, Elez E; LEAP-017 Investigators. Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study. J Clin Oncol. 2024 Aug 20;42(24):2918-2927. doi: 10.1200/JCO.23.02736.
  4. Siena S, Raghav K, Masuishi T, Yamaguchi K, Nishina T, Elez E, Rodriguez J, Chau I, Di Bartolomeo M, Kawakami H, Suto F, Koga M, Inaki K, Kuwahara Y, Takehara I, Barrios D, Kobayashi K, Grothey A, Yoshino T. HER2-related biomarkers predict clinical outcomes with trastuzumab deruxtecan treatment in patients with HER2-expressing metastatic colorectal cancer: biomarker analyses of DESTINY-CRC01. Nat Commun. 2024 Nov 25;15(1):10213. doi: 10.1038/s41467-024-53223-3. Erratum in: Nat Commun. 2025 Jan 15;16(1):704. doi: 10.1038/s41467-025-56170-9.
  5. Lenz HJ, Parikh A, Spigel DR, Cohn AL, Yoshino T, Kochenderfer M, Elez E, Shao SH, Deming D, Holdridge R, Larson T, Chen E, Mahipal A, Ucar A, Cullen D, Baskin-Bey E, Kang T, Hammell AB, Yao J, Tabernero J. Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial. J Immunother Cancer. 2024 Mar 13;12(3):e008409. doi: 10.1136/jitc-2023-008409.
  6. Randon G, Nakamura Y, Yaeger R, Lonardi S, Cremolini C, Elez E, Nichetti F, Ghelardi F, Nasca V, Bergamo F, Conca V, Ros J, Bando H, Maddalena G, Oldani S, Prisciandaro M, Raimondi A, Schrock AB, Agnelli L, Walch H, Yoshino T, Pietrantonio F. Negative Hyperselection of Patients with HER2+ and RAS Wild-Type Metastatic Colorectal Cancer Receiving Dual HER2 Blockade: the PRESSING-HER2 Study. Clin Cancer Res. 2024 Jan 17;30(2):436-443. doi: 10.1158/1078-0432.CCR-23-1379.
  7. Martínez-Quintanilla J, Cabot D, Sabia D, Arqués O; PMPnet Group; Vergés J, Chicote I, Bijelic L; PMPnet Group; Cabellos L, Alcántara AM, Ramos I, Barrios P, Crusellas O, Palacio LM; PMPnet Group; Cámara JA, Barriuso J; PMPnet Group; Jiménez JJ, Muñoz-Torres P, Nonell L, Flores R, Médico E, Guaglio M; PMPnet Group; Ros J, Élez E, Tabernero J, Aziz O, Deraco M, Palmer HG; PMPnet Group; PMPnet Group. Precision Oncology and Systemic Targeted Therapy in Pseudomyxoma Peritonei. Clin Cancer Res. 2024 Sep 13;30(18):4082-4099. doi: 10.1158/1078-0432.CCR-23-4072.
  8. Mirandola A, Kudriavtsev A, Cofre Muñoz CI, Navarro RC, Macagno M, Daoud S, Sanchez C, Pastor B, Pisareva E, Marin MS, Ruiz JG, Piris A, Rodriguez AG, Gonzalez NS, Vivancos A, Quarà V, Mellano A, Borghi F, Corti G, Marchiò C, Sapino A, Bartolini A, Crisafulli G, Bardelli A, Di Maio M, Lossaint G, Frayssinoux F, Crapez E, Ychou M, Soler RS, Fenocchio E, Fernandez Calotti PX, Mazard T, Vivas CS, Elez E, Di Nicolantonio F, Thierry AR. Post-surgery sequelae unrelated to disease progression and chemotherapy revealed in follow-up of patients with stage III colon cancer. EBioMedicine. 2024 Oct;108:105352. doi: 10.1016/j.ebiom.2024.105352.
  9. Ambrosini M, Tougeron D, Modest D, Guimbaud R, Kopetz S, Decraecker M, Kim S, Coutzac C, Perkins G, Alouani E, Marmorino F, Pernot S, Sinicrope FA, Elez E, Parent P, Cremolini C, Pietrantonio F, Lonardi S, Gallois C, Taieb J. BRAF + EGFR +/- MEK inhibitors after immune checkpoint inhibitors in BRAF V600E mutated and deficient mismatch repair or microsatellite instability high metastatic colorectal cancer. Eur J Cancer. 2024 Oct;210:114290. doi: 10.1016/j.ejca.2024.114290.
  10. Janku F, Kim TM, Iyer G, Spreafico A, Elez E, de Jonge M, Yamamoto N, van der Wekken AJ, Ascierto PA, Maur M, Marmé F, Kiladjian JJ, Basu S, Baffert F, Buigues A, Chen C, Cooke V, Giorgetti E, Kim J, McCarthy F, Moschetta M, Dummer R. First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations. Eur J Cancer. 2024 Jan;196:113458. doi: 10.1016/j.ejca.2023.113458.
  11. García-Alfonso P, Elez E, Soto-Alsar J, Páez D, Fernández-Montes A, Graña B, Salud A, Yubero A, Gómez-España MA, Macías I, Quintero G, López-López C, Fernández-Rodríguez T, Grávalos C, González-Flores E, Guix M, García Paredes B, Reina JJ, Rodríguez Mowbray JR, Sastre J, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Maintenance with 5-FU/LV-aflibercept after induction with FOLFIRI-aflibercept versus FOLFIRI-aflibercept until progression as second-line treatment in older adults with metastatic colorectal cancer: the AFEMA phase II randomized trial. ESMO Open. 2024 Dec;9(12):103986. doi: 10.1016/j.esmoop.2024.103986.
  12. Segal NH, Tie J, Kopetz S, Ducreux M, Chen E, Dienstmann R, Hollebecque A, Reilley MJ, Elez E, Cosaert J, Cain J, Soo-Hoo Y, Hewson N, Cooper ZA, Kumar R, Tabernero J. COLUMBIA-1: a randomised study of durvalumab plus oleclumab in combination with chemotherapy and bevacizumab in metastatic microsatellite-stable colorectal cancer. Br J Cancer. 2024 Oct;131(6):1005-1013. doi: 10.1038/s41416-024-02796-3.
  13. Elez E, Cubillo A, Alfonso PG, Middleton MR, Chau I, Alkuzweny B, Alcasid A, Zhang X, Van Cutsem E. Binimetinib in combination with nivolumab or nivolumab and ipilimumab in patients with previously treated microsatellite-stable metastatic colorectal cancer with RAS mutations in an open-label phase 1b/2 study. BMC Cancer. 2024 Apr 11;24(1):446. doi: 10.1186/s12885-024-12153-5.
  14. Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Élez E, Wyrwicz L, Stroyakovskiy D, Liposits G, Bondarenko I, Modest DP, Amellal N, Tabernero J; SUNLIGHT Investigators. Plain language summary of SUNLIGHT: trifluridine/tipiracil and bevacizumab for refractory metastatic colorectal cancer. Future Oncol. 2024;20(36):2823-2832. doi: 10.1080/14796694.2024.2366100.
  15. Elez E, Kopetz S, Tabernero J, Bekaii-Saab T, Taieb J, Yoshino T, Manji G, Fernandez K, Abbattista A, Zhang X, Morris VK. SEAMARK: phase II study of first-line encorafenib and cetuximab plus pembrolizumab for MSI-H/dMMR BRAFV600E-mutant mCRC. Future Oncol. 2024 Apr;20(11):653-663. doi: 10.2217/fon-2022-1249.
  16. García-Alfonso P, Vera R, Aranda E, Élez E, Rivera F. Delphi consensus for the third-line treatment of metastatic colorectal cancer. Clin Transl Oncol. 2024 Jun;26(6):1429-1437. doi: 10.1007/s12094-023-03369-1.
  17. Salvà F, Saoudi N, Rodríguez M, Baraibar I, Ros J, García A, Tabernero J, Elez E. Determinants of Metastatic Colorectal Cancer With Permanent Liver- Limited Disease. Clin Colorectal Cancer. 2024 Sep;23(3):207-214. doi: 10.1016/j.clcc.2024.05.010.
  18. Ros J, Vaghi C, Baraibar I, Saoudi González N, Rodríguez-Castells M, García A, Alcaraz A, Salva F, Tabernero J, Elez E. Targeting KRASG12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver. Int J Mol Sci. 2024 Mar 14;25(6):3304. doi: 10.3390/ijms25063304.
  19. Salva de Torres C, Baraibar I, Saoudi González N, Ros J, Salva F, Rodríguez-Castells M, Alcaraz A, García A, Tabernero J, Élez E. Current and Emerging Treatment Paradigms in Colorectal Cancer: Integrating Hallmarks of Cancer. Int J Mol Sci. 2024 Jun 26;25(13):6967. doi: 10.3390/ijms25136967.
  20. Saoudi González N, Ros J, Baraibar I, Salvà F, Rodríguez-Castells M, Alcaraz A, García A, Tabernero J, Élez E. Cetuximab as a Key Partner in Personalized Targeted Therapy for Metastatic Colorectal Cancer. Cancers (Basel). 2024 Jan 18;16(2):412. doi: 10.3390/cancers16020412.
  21. González NS, Marchese PV, Baraibar I, Ros J, Salvà F, Rodríguez M, Salvà C, Vaghi C, Alcaraz A, García A, Tabernero J, Élez E. Epidermal growth factor receptor antagonists in colorectal cancer: emerging strategies for precision therapy. Expert Opin Investig Drugs. 2024 Jun;33(6):613-625. doi: 10.1080/13543784.2024.2349287.
  22. Contreras-Toledo D, Jiménez-Fonseca P, López CL, Montes AF, López Muñoz AM, Vázquez Rivera F, Alonso V, Alcaide J, Salvà F, Covela Rúa M, Guillot M, Martín Carnicero A, Jimeno Mate R, Cameselle García S, Asensio Martínez E, González Astorga B, Fernandez-Diaz AB, González Villaroel P, Virgili Manrique AC, Melián Sosa M, Alonso B, Cousillas Castiñeiras A, Castañón López C, Aparicio J, Carmona-Bayonas A. Dynamic nature of BRAF or KRAS p.G12C mutations in second-line therapy for advanced colorectal cancer patients: do early and late effects exist? Br J Cancer. 2024 Mar;130(5):777-787. doi: 10.1038/s41416-023-02563-w.
  23. Genova C, Marconi S, Chiorino G, Guana F, Ostano P, Santamaria S, Rossi G, Vanni I, Longo L, Tagliamento M, Zullo L, Dal Bello MG, Dellepiane C, Alama A, Rijavec E, Ludovini V, Barletta G, Passiglia F, Metro G, Baglivo S, Chiari R, Rivoltini L, Biello F, Baraibar I, Gil-Bazo I, Novello S, Grossi F, Coco S. Extracellular vesicles miR-574-5p and miR-181a-5p as prognostic markers in NSCLC patients treated with nivolumab. Clin Exp Med. 2024 Aug 6;24(1):182. doi: 10.1007/s10238-024-01427-8.
  24. Cabrero-de Las Heras S, Hernández-Yagüe X, González A, Losa F, Soler G, Bugés C, Baraibar I, Esteve A, Pardo-Cea MÁ, Ree AH, Martínez-Bosch N, Nieva M, Musulén E, Meltzer S, Lobato T, Vendrell-Ayats C, Queralt C, Navarro P, Montagut C, Grau-Leal F, Camacho D, Legido R, Mulet-Margalef N, Martínez-Balibrea E. Changes In Serum CXCL13 Levels Are Associated With Outcomes of Colorectal Cancer Patients Undergoing First-Line Oxaliplatin-Based Treatment. Biomed Pharmacother. 2024 Jul;176:116857. doi: 10.1016/j.biopha.2024.116857.
  25. Ros J, Matito J, Villacampa G, Comas R, Garcia A, Martini G, Baraibar I, Saoudi N, Salvà F, Martin Á, Antista M, Toledo R, Martinelli E, Pietrantonio F, Boccaccino A, Cremolini C, Dienstmann R, Tabernero J, Vivancos A, Elez E. Corrigendum to "Plasmatic BRAF-V600E allele fraction as a prognostic factor in metastatic colorectal cancer treated with BRAF combinatorial treatments": [Annals of Oncology 34 (2023) 543-552]. Ann Oncol. 2024 Oct;35(10):922. doi: 10.1016/j.annonc.2023.07.010. Epub 2024 Aug 12. Erratum for: Ann Oncol. 2023 Jun;34(6):543-552.
  26. García-Alfonso P, Jimenez-Fonseca P, Soto-Alsar J, Baraibar I, Santos C, La Casta A, Ghanem I, Pulido Cortijo G, Mariño Méndez A, Pazo-Cid R, Vera R, Melián M, Alcaide J, Graña B, Páez D, Gallego I, Lobo M, Borregón M, Fernández Montes A, Martínez de Castro E, Carmona-Bayonas A, Aranda E. Three-year survival follow-up of patients with gastrointestinal cancer treated during the COVID-19 pandemic in Spain: data from the PANDORA-TTD20 study. Oncologist. 2024 Nov 16:oyae300. doi: 10.1093/oncolo/oyae300.
  27. Ros J, Ucha JM, Garcia-Galea E, Gomez P, Martini G, Balconi F, Comas R, Alonso V, Rodriguez M, Baraibar I, Salva F, Saoudi N, Alcaraz A, Garcia A, Tabernero J, Elez E. Real-World Data of Patients with BRAFV600E-Mutated Metastatic Colorectal Cancer Treated with Trifluridine/Tipiracil. Cancers (Basel). 2024 Dec 12;16(24):4140. doi: 10.3390/cancers16244140.
  • MK-3475-158. Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158). ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 1412-0001. A first-in-human phase Ia/b, open label, multicentre, dose escalation study of BI 905711 in patients with advanced gastrointestinal cancers. ELENA ÉLEZ FERNÁNDEZ.
  • 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.    ELENA ÉLEZ FERNÁNDEZ.
  • IFOM-CPT005/2019/PO004. POST-SURGICAL LIQUID BIOPSY - GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS.       ELENA ÉLEZ FERNÁNDEZ
  • STEMNESS-CRC A Phase III, Randomized, Clinical Study of Napabucasin in Combination with FOLFIRI and Best Supportive Care (BSC). ELENA ÉLEZ FERNÁNDEZ.
  • CL3-95005-007. An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. ELENA ÉLEZ FERNÁNDEZ.
  • 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 BRAF V600E-MUTANT COLORECTAL CANCER (BREAKWATER). ELENA ÉLEZ FERNÁNDEZ.
  • 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). ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • MK-7902-017. Randomized Study of Lenvatinib in Combination with Pembrolizumab Versus Standard of Care in Participants with Metastatic Colorectal Cancer Who Have Received and Progressed Through or Became Intolerant to Prior Treatment. ELENA ÉLEZ FERNÁNDEZ.
  • 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). ELENA ÉLEZ FERNÁNDEZ.
  • 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).   ELENA ÉLEZ FERNÁNDEZ
  • CA209-9N9. A study of Nivolumab in combination with Trametinib with or without Ipilimumab in participants with previously treated metastatic colorectal cancers. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • CIRCULATE-SPAIN-01. Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA. ELENA ÉLEZ FERNÁNDEZ.
  • 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.         ELENA ÉLEZ FERNÁNDEZ.
  • GS-US-587-6156 (ELEVATE). Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (CRC). ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • GEMCAD 2102. Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC) - PEMBROLA.            ELENA ÉLEZ FERNÁNDEZ.
  • 61186372GIC2002. A Phase 1b/2, open-label, study of amivantamab monotherapy and in combination with chemotherapy in patients with advance metastatic colorectal cancer.         ELENA ÉLEZ FERNÁNDEZ.
  • 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). ELENA ÉLEZ FERNÁNDEZ.
  • 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). ELENA ÉLEZ FERNÁNDEZ.
  • NOUS-209-01. Multicentre, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumours. ELENA ÉLEZ FERNÁNDEZ.
  • 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.        ELENA ÉLEZ FERNÁNDEZ.
  • XL092-303. A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • 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). ELENA ÉLEZ FERNÁNDEZ.
  • 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. ELENA ÉLEZ FERNÁNDEZ.
  • CL3-95005-007. An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. ELENA ÉLEZ FERNÁNDEZ.
  • IGM-8444-001. AN OPEN-LABEL, MULTICENTER, PHASE 1a/1b STUDY OF IGM-8444 AS A SINGLE AGENT AND IN COMBINATION IN SUBJECTS WITH RELAPSED, REFRACTORY, OR NEWLY DIAGNOSED CANCERS. ELENA ÉLEZ FERNÁNDEZ.
  • Nutide-323. A randomised, open-label, Phase II, dose/schedule optimisation study of NUC 3373/leucovorin/irinotecan plus bevacizumab (NUFIRI-bev) versus 5 FU/leucovorin/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with previously treated unresectable metastatic colorectal cancer. ELENA ÉLEZ FERNÁNDEZ.
  • 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.  JAUME CAPDEVILA CASTILLON
  • GEMCAD 1703. Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial). 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. JAUME CAPDEVILA CASTILLON.
  • E7386-G000-201. An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors. JAUME CAPDEVILA CASTILLO.
  • GEMCAD 2103. Estudio de fase II de atezolizumab más tiragolumab en combinación con quimio-radioterapia en carcinoma de células escamosas localizado del canal anal. JAUME CAPDEVILA CASTILLON.
  • 219369 PH2. Open label study evaluating Dostarlimab in the Neoadjuvant Treatment of locally advanced (la) dMMR/MSI-H rectal cancer (RC). JAUME CAPDEVILA CASTILLON.

Group Leader Joan Carles Medical Oncologists and Clinical Fellows Carlo Cicala, Nely Diaz, Diego Gómez, Macarena González, David Marmolejo, Rafael Morales, César Serrano, Cristina Suárez, 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, several advances have led to the more effective treatment of non-prostate genitourinary (GU) malignancies. Immunotherapy (IO) is proving to be increasingly important for the treatment of both bladder and kidney cancer. In bladder cancer, combining antibody drug conjugates (ADCs) and IO has changed the first-line treatment landscape of patients with metastatic disease. IO has become a standard treatment for high risk bladder cancer patients in the adjuvant setting, with two IO treatments demonstrating improved progression-free survival (PFS).

In kidney cancer, immune-based combination therapy, or IO plus antiangiogenics, are now considered as standard first-line treatment. Also, HIF2α inhibitors have demonstrated their role in second line metastatic disease. We are now studying novel combinations including HIF2α inhibitors and other immunomodulators to improve OS. We are moving these drugs to the adjuvant setting to demonstrate that they are more active when used earlier in the disease evolution. In collaboration with Danna-Farber Cancer Institute we are exploring possible predictive biomarkers of response to HIF2α inhibitors.

In close collaboration with the Urology Department at the Vall d’Hebron University Hospital (HUVH), we are participating in phase I clinical studies with drugs targeting FGFR and Nectin 4. We are also evaluating ADCs with new intravesical drug delivery devices that provide local and sustained release in patients with non-muscle invasive bladder cancer who experience relapse or progress despite adequate intravesical Bacillus Calmette-Guerin (BCG) therapy, for whom early radical cystectomy is recommended. These new treatments and devices are intended to preserve the bladder.

Theragnosis represents an innovative treatment approach in prostate cancer based on administering radio-ligands using beta and alpha emitters. This therapy is now moving to other GU malignancies like kidney cancer.

We also work together with other renowned research centers including the Cleveland Clinic (Ohio, USA), University of California, San Francisco (California, USA), Fred Hutchinson Cancer Center (Seatle, USA), The Netherlands Cancer Institute (Amsterdam, The Netherlands), and participate in studies carried out in partnership with the Gustave Roussy Institute (Paris, France), Barts Health NHS Trust – Hospital (London, UK), and Kantonsspital St. Gallen (Switzerland).

Initiated in May last year, CARE1 is a European project coordinated by Gustave Roussy. Focused on pragmatic clinical trials, and leveraging a unique academic European network, CARE 1 aims to improve the first-line treatment of patients with metastatic kidney cancer by implementing a routine biomarker. Our participation in this project is supported by the CRIS Cancer Foundation and the EU Horizon Europe research and innovation programme.

Supported by funding received from the Spanish Society of Medical Oncology (SEOM), we are coordinating a national study to identify predictive biomarkers of response to first-line therapy in renal cell carcinoma (RCC). Througn a Spanish Genitourinary Oncology Group (SOGUG) grant, we also participate in a project devoted to paired tumor biopsy analysis.

In 2023, we launched the CHECKYMID trial to prospectively investigate the role and safety of IO in the treatment of patients with cancer (RCC, bladder, lung, or melanoma) and affected by immune-mediated inflammatory diseases (IMIDs). We coordinate this study in collaboration with the rheumatology, digestive and dermatology teams at HUVH. In this first year of the project, we have enrolled 6 patients.

We have consolidated our center as a reference for clinical and translational research into primary brain tumors, leading to first author oral presentations in clinical studies for tovorafenib, a drug that has received approval by the FDA for pediatric low-grade glioma (ESMO Congress 2024); and ataxia telangiectasia and Rad3-related protein (ATR) inhibitor tuvusertib with activity in isocitrate dehydrogenase (IDH) mutant gliomas (EANO 2024). Tuvusertib will be further evaluated in an investigator-initiated trial (IIT) that will be co-led by VHIO.

We continue to lead the Adolescent Working Group of the GEINO Spanish cooperative group for research in neuro-oncology and have participated in the updating of the clinical guidelines for low-grade glioma, that were the first national guidelines to incorporate the results of the INDIGO trial. We have partnered with cure51, and other oncology centers of excellence, in a pioneering public-private collaboration to leverage a cohort of patients with long-term survival, after a diagnosis of glioblastoma, to discover new therapies for this and other hard-to-treat tumors. Aimed at truly understanding the impact of the disease on patients and their families, we are developing an electronic tool to empower patients with gliomas to self-report their quality of life.

In the sarcoma field, we have continued our collaboration with the Spanish Sarcoma Group (GEIS) and EURACAN (European Reference Network (ERN) for rare tumors).

Together with GEIS, we have been able to perform several phase I academic trials including GEIS 52/69- IMMUNOSARC, a study exploring the combination of nivolumab and sunitinib as well as vivolumab, with tailored chemotherapy in the first-line treatment of specific sarcoma subtypes with good results, that have allowed the transition to and completion of the phase II study in 2024.

In collaboration with Laura Soucek’s lab and Peptomyc (a spin-off from VHIO and ICREA), the Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center and Oregon Health and Science University, and thanks to the support of the Osteosarcoma Institute, Curing Kid’s Cancer Foundation, The Morgan Adams Foundation and the Kirsten Ann Carr Fund, the sarcoma team has launched OSTEOMYC. OSTEOMYC is an academic phase II pilot study testing the activity of OMO-103, currently the only MYC inhibitor available, in patients with advanced/metastatic osteosarcoma from 12 years old. The planned correlative studies, including the exploration of a predictive signature developed during the phase I trial, will help us to understand the role of the drug in this population and open the field to future development. In addition, this will be our first VHIO promoted trial to opt for the FAIR for AYA Stamp recognition by ACCELERATE, a platform aimed at accelerating the process of evaluating innovative therapies and introducing them in standard cancer care in children and adolescents.

Another of our highlighted interests is the use of liquid biopsy in sarcoma. The INSIGHT trial is a phase 3, randomized, open-label study designed to evaluate the efficacy of ripretinib vs. sunitinib in patients with advanced GIST previously treated with imatinib and who harbor KIT exon 11 + 17 and/or 18 secondary mutations, detected by ctDNA. This study has the potential of defining the implementation of liquid biopsy in GIST treatment. The basis for this trial comes from recent seminal works in which we have been actively involved or taken a leadership role (Serrano et al, Ann Oncol 2023; Heinrich et al, Nat Med 2024). In the same vein, our group has been actively involved in the clinical development of vimseltinib, a novel CSFR1 inhibitor, which will be the first therapy approved for tenosynovial giant cell tumor (TGCT) (Gelderblom et al, Lancet 2024).

Our Serum Bank now includes most of the tumor types that we study (CNS tumors, GIST; renal cell carcinoma and bone sarcoma), and we will continue to collect samples from our patients.

We have consolidated our Unit for Adolescent and Younger Adults (AYAs) for patients aged between 16 and 25 years old. This program collects data for the development of new treatments for tumors that occur during adulthood but are predominantly seen in pediatric populations, and vice versa. Led by both adult and pediatric oncologists, this Unit is initially treating patients with CNS tumors, sarcoma, and testicular tumors, but also aims to include other tumor types and advance insights into late cancer therapy toxicity. Since we created the AYAs Unit more than 80 patients have been treated and evaluated.

Regarding tumors of unknown primary (CUP), we are collaborating with investigators at the Josep Carreras Leukaemia Research Institute led by Manel Esteller. By employing multi-omics (genomics, transcriptomics and epigenomics) to characterize the molecular features of 500 CUP cancer cases, we aim to deepen our understanding of the molecular mechanisms governing the development of these tumors. Supported by the Carlos III Health Institute (ISCIII), we lead and coordinate the IMPaCT-GENóMICA precision medicine program to advance the diagnosis of CUP tumors. We are also collaborating with VHIO’s Computational Immunogenomics Group led by Francisco Martínez Jiménez, to understand the genomic basis of tumorigenesis and its interplay with the immune system.

In germ cell tumors, we are leading a late relapse project in Spain (RELAGERM). This project is part of an international initiative led by the Instituto Oncologico della Svizzera Italiana. Additionally, we are leading a national study evaluating the efficacy and safety of cisplatin-based chemotherapy in patients over 40 years of age diagnosed with metastatic germ cell tumors.

Dedicated to promoting education and exchange, in 2024 we welcomed seven fellows from Spain and abroad for 3-month short stays.

  • Design and develop clinical trials covering all malignancies studied by our group. We seek to provide our patients with the most novel and optimal treatments including immune-based therapeutics, targeted therapies, and new therapeutic modalities, including minimally invasive treatments.
  • Conduct clinical trials at different stages of disease with emphasis on a histology-tailored design and multidisciplinary approaches to optimize outcomes.
  • Continue to expand our kidney cancer Task Force at VHIO in collaboration with researchers at the Vall d'Hebron Research Institute (VHIR) and Bellvitge Biomedical Research Institute (IDIBELL).
  • Expand biobanks and data repositories to support precision oncology in genitourinary (GU) cancers.
  • Explore the clinical utility of liquid biopsy in renal cancer, using prospective and retrospective analysis of samples from patients with metastatic renal cancer.
  • Develop our translational platform for gastrointestinal stromal tumor (GIST) and expand research in collaboration with the Spanish Sarcoma Group (GEIS), and other European referral centers. We are also an active member of the European References Network (ERN) for rare tumors (EURACAN).
  • Continue to strengthen our network as a CSUR for other regions in Spain (currently especially tight with Lleida in Catalonia, Baleares, Galicia and Basque country). We are proud to give advice and collaborate with physicians on how to treat sarcoma patients.
  • Expand our translational research platform for glioblastoma in collaboration with VHIO's Gene Expression and Cancer Group led by Joan Seoane, and set up our central nervous system tumors (CNS) Task Force at VHIO.
  • Increase our collaboration with ACCELERATE, a platform aimed at accelerating the process of evaluating innovative therapies and introduce them in standard cancer care in children and adolescents.
  • We have initiated several quality-of-life and patient perspective academic studies. We also collaborate with patient advocacy groups to put patient perspectives at the heart of cancer care as well as our research into sarcoma.
  • Provide comprehensive support services, including counselling, rehabilitation, and survivorship programs, to address the physical, emotional, and social needs of GU cancer patients.
  • Continue to foster collaboration between academic institutions, industry and patient advocacy groups to increase patient participation in clinical trials.
  • Develop educational resources to empower patients and their families to make informed decisions about their care.
  • In 2024, we have consolidated our Serum Bank, to include different tumor types such as: 587 kidney cancer blood samples from 44 patients and 81 sarcoma and GIST tumor blood samples from 7 patients.
  • Continued integration of multidisciplinary care teams, including surgeons, oncologists, radiologists, pathologists, and support care specialists, to enhance personalized treatment strategies for GU 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.
  • We continue to foster and develop new collaborations with different VHIO groups and external partners.
  • Funding has been approved for the Tuvastat clinical study. Co-led by VHIO, this investigator-initiated trial (IIT) has been designed to evaluate ataxia telangiectasia and Rad3-related protein (ATR) inhibition in patients with I isocitrate dehydrogenase (IDH)-mutant grade 3 gliomas.
  • 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 and cancers of unknown primary origin.
  • 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.
  • We aim to further incorporate patient perspectives in regular practice and research.
  • Increase and establish new collaborations with other VHIO research groups.
  • Heinrich MC, Jones RL, George S, Gelderblom H, Schöffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Siontis BL, Goldstein D, Boye K, Sanchez C, Steeghs N, Rutkowski P, Druta M, Serrano C, Somaiah N, Chi P, Reichmann W, Sprott K, Achour H, Sherman ML, Ruiz-Soto R, Blay JY, Bauer S. Ripretinib versus sunitinib in gastrointestinal stromal tumor: ctDNA biomarker analysis of the phase 3 INTRIGUE trial. Nat Med. 2024 Feb;30(2):498-506.
  • Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, Vu TQ, Antonuzzo L, Wiechno P, Atduev V, Kann AG, Kim TH, Suárez C, Chang CH, Roghmann F, Özgüroğlu M, Eigl BJ, Oliveira N, Buchler T, Gadot M, Zakharia Y, Armstrong J, Gupta A, Hois S, van der Heijden MS; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024;391:1773-1786.
  • Choueiri TK, Powles T, Peltola K, de Velasco G, Burotto M, Suarez C, Ghatalia P, Iacovelli R, Lam ET, Verzoni E, Gümüş M, Stadler WM, Kollmannsberger C, Melichar B, Venugopal B, Gross-Goupil M, Poprach A, De Santis M, Schutz FA, Park SH, Nosov DA, Porta C, Lee JL, Garcia-Del-Muro X, Biscaldi E, Manneh Kopp R, Oya M, He L, Wang A, Perini RF, Vickery D, Albiges L, Rini B; LITESPARK-005 Investigators. Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma. N Engl J Med. 2024 Aug 22;391(8):710-721.
  • Sweis RF, Gajate P, Morales-Barrera R, Lee JL, Necchi A, de Braud F, Penel N, Grünwald V, Maruzzo M, Meran J, Ishida TC, Bao W, Zhou Y, Ellinghaus P, Rosenberg JE. Rogaratinib Plus Atezolizumab in Cisplatin-Ineligible Patients With FGFR RNA-Overexpressing Urothelial Cancer: The FORT-2 Phase 1b Nonrandomized Clinical Trial. JAMA Oncol. 2024 Nov;10(11):1565-1570.
  1. Ensayo clinico Fase I-II, abierto, prospectivo y muticéntrico, que explora la combinación de Trabectedina y Radioterapia en pacientes con Sarcoma de tejidos Blandos. TRASTS (GEIS 37)-II. PI: Claudia Valverde.
  2. An international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma. RG-13-277. IP: Claudia Valverde
  3. 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). WO39613. PI: Rafael Morales.
  4. Multicenter, open-label Phase I study evaluating the safety and tolerability of HMPL-306 in subjects with locally advanced or metastatic solid tumors. with IDH mutations. 2020-306-GLOB2. PI: Maria Vieito.
  5. Phase II multicohort trial of trabectedin and low-dose radiation therapy in advanced/metastatic sarcomas (SYNERGIAS). GEIS-75. PI: Claudia Valverde.
  6. 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). CAAA603A12101 (NEORAY). PI: María Vieito.
  7. A Phase 1b, open-label study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI5752 in combination with axitinib in subjects with advanced renal cell carcinoma. D7980C00003. PI: Cristina Suárez.
  8. 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). D910PC00001 (VOLGA). PI: Rafael Morales.
  9. Phase I/II, multicenter, open-label, clinical and pharmacokinetic study of PM14 in combination with irinotecan in pretreated patients with selected advanced solid tumors. PM14-A-002-20. PI: María Vieito.
  10. 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. GEIS-83 (PRIME). PI: Claudia Valverde.
  11. Estudio observacional multicéntrico de pacientes que reciben tratamiento sistémico para sarcoma sinovial avanzado y mixoide/ liposacroma de células redondas. 212342. PI: Claudia Valverde.
  12. 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. PH-L19TNFDOX2-03/16 (FIBROSARC). PI: Claudia Valverde.
  13. A randomized, blinded, placebo-controlled, Phase 2 Study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma. INBRX-109 SA CS (CHONDRAGON). PI: Claudia Valverde.
  14. 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. CAAA601A52101. PI: María Vieito An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma. FaR-RMS. PI: Claudia Valverde.
  15. 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. WP43295. PI: Maria Vieito.
  16. 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. ADCT-601-102. PI: Claudia Valverde.
  17. 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. XL092-002. PI: Cristina Suárez.
  18. 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. RC48-G001. PI: Rafael Morales
  19. A Phase 3 study for the treatment of newly diagnosed H3 K27M-mutant diffuse glioma. ONC-201-108. PI: Maria Vieito.
  20. A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors. XB002-101 (JEWEL-101). PI: Maria Vieito.
  21. First-in-human (FIH) study of IDRX-42 in participants with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). IDRX-42-001. PI: César Serrano.
  22. A multicenter, open-label phase 1/2 study of TYRA-300 in advanced urothelial carcinoma and other solid tumors with activating FGFR3 gene alterations. TYR300-101 (SURF-301). PI: Rafael Morales.
  23. 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). BLU-285-1406 GIST. PI: César Serrano.
  24. A randomised phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cáncer. DISCUS-14. PI: Rafael Morales.
  25. 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). IT-03 (INVINCIBLE-3). PI: Claudia Valverde.
  26. 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. Debio0123-GBM-105. PI: María Vieito.
  27. 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. CFT1946-1101. PI: Maria Vieito.
  28. 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.
Transversal Clinical Trials Services and Units

Clinical Trials at a Glance

Annual Distribution of Oncology Clinical Trials with Active Patient Recruitment
2 Multiphase clinical trials with active recruitment in phase I and phase II Basket in 2024.
3 Multiphase clinical trials with active recruitment in phase I and phase II STT in 2024.
7 Master phase I trial sub-studies with active recruitment in 2024.
5 Master phase II Basket trial sub-studies with active recruitment in 2024.
3 Master phase II STT trial sub-studies with active recruitment in 2024.
In 2024, our Clinical Trials Office also managed 5 phase III trials in radiotherapy. With active recruitment at some point in 2024, these studies included at total of 14 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 Ana Matres Coordinator, Start-Up Unit Nuria Farràs Head, Data Entries Ignacio Carcela Head, Hematology Laura Segura Lead Study Coordinators Eulalia Aliende, Aitana Almodóvar, Eva Banús, Laia Catalan, 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, Laura Blanco, Taiana Cristina Burgin, Cristina Calderón, Júlia Caparrós, Gregorio Casas, Paula Chiquillo, Gemma Comas, Paula Cruz, Natalia Écija, Carlos Fernandez, Alba Galiana, Alexia Garcia, Beatriz García, Isaac Gimenez, Sara Herbera, Montserrat Hernández, Silvia Hurtado, Bàrbara Juanmiquel, Esther Llaudet Planas, Nura Lutfi, Marc Majo, Sonia Martinez, Mireia Mira, Antonio Molina, Daniel Muñoz, Gemma Mur, Alicia Nogueroles, Inés Ortuño, Anna Peñalver, Jordi Perera, Gemma Pujadas, Marta Quintero, Maria Rion, Maria Teresa Romero, Marta Rotxés, Alvaro Rueda, Laura Sancho, Júlia Sedó, Júlia Sellés Altés, Samira Serhir, Anna Serradell, Pol Sisó, Alex Subias, Albert Texidor, Júlia Toledo, Alejandro Torres Data Entries Judit Abós, Annalisa Aiti, Laura Arias, María Artero, Nestor Babon, Helena Carbonero, Anna Casas, Marta Chavero, Ana Cos, David Díaz, Marta Díaz, Ruben Díaz, Sandra Diez, Carlos Domínguez, Dídac Fernández, Marta García, Ada González, Silvia Gracia, Andrea Illescas, Neus Iserte, Sandra Justicia, Eva Marín, Sílvia Marín, Sara Martínez, Sonia Martínez, Olga Masip, Mireia Masot, Maria Mateu, Carina Monclús, Andrea Monzo, Cristina Navarro, Marco Neves, Ana Nicolas, Paula Núnez, Maria Ortega, Raquel Ortiz, Mònica Pascual, Sergio Perez, Laura Pol, Irene Quevedo, Maria Rebollo, Anna Ricart, Laura Roa, Angel Romano, Rosa Romero, Luciana Ruiz, Hugo Somoza, Marta Urdi, Laia Vila, Núria Vilaplana, Anna Viñals, Elena Vizcaino, Irati Wyatt Clinical Trials Assistants Laura Cruz, Núria Lafuente, Sara Vázquez

Transversal Clinical Trials Services and Units

Clinical Trials Office

Summary

Founded in 1997, the Clinical Trials Office is established by experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, led by VHIO’s Director Josep Tabernero.

Our team, managed by the Clinical Trials Office Director, Cristina Pérez, comprises study coordinators, data managers and research support staff who coordinate phase I-IV clinical trials covering all tumour types and also participate in several translational research projects conducted at VHIO.

In oncology, hematology and radiotherapy, in 2024 we managed 290 phase I trials, 27 basket trials, 162 phase II trials, 183 phase III clinical trials, and 3 medical device trials and 70 post-authorization and rollover studies, with active recruitment at some time in the year. Patient enrolment in our oncology, hematology and radiotherapy clinical trials totaled at 1,309.

244 new trials were initiated in 2024, including 14 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2024 and are still enrolled and receiving study treatment (1,029 patients in total, and 2,091 in follow-up) in Phase 0, I, II, III and medical device trials.

Clinical Trials in Oncology

In 2024 we managed 242 phase I, 24 basket, 137 phase II, and 121 phase III clinical trials, and 3 medical device trials with active recruitment at some time in the year (Figure I), with patient enrolment totalling at 1,148 (Figure II), and 40 post-authorization and rollover studies with active recruitment at some time in the year.

196 new trials were initiated, including 11 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2024 and are still enrolled and receiving study treatment (872 patients in total, and 1,818 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).

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

In 2024 we managed 48 phase I, 3 basket, 25 phase II and 57 phase III clinical studies with active recruitment at some time in the year (Figure III), with patient enrolment totalling at 147 (Figure IV), and 28 post-authorization and rollover studies with active recruitment at some time in the year.

45 new trials were initiated, including 2 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2024 and are still enrolled and receiving study treatment (156 patients in total, and 224 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 2024, 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, Francisco Grau, 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 Ana Matres Coordinator, Start-Up Unit Nuria Farràs Head, Data Entries Ignacio Carcela Head, Hematology Laura Segura Lead Study Coordinators Eulalia Aliende, Aitana Almodóvar, Eva Banús, Laia Catalan, 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, Laura Blanco, Taiana Cristina Burgin, Cristina Calderón, Júlia Caparrós, Gregorio Casas, Paula Chiquillo, Gemma Comas, Paula Cruz, Natalia Écija, Carlos Fernandez, Alba Galiana, Alexia Garcia, Beatriz García, Isaac Gimenez, Sara Herbera, Montserrat Hernández, Silvia Hurtado, Bàrbara Juanmiquel, Esther Llaudet Planas, Nura Lutfi, Marc Majo, Sonia Martinez, Mireia Mira, Antonio Molina, Daniel Muñoz, Gemma Mur, Alicia Nogueroles, Inés Ortuño, Anna Peñalver, Jordi Perera, Gemma Pujadas, Marta Quintero, Maria Rion, Maria Teresa Romero, Marta Rotxés, Alvaro Rueda, Laura Sancho, Júlia Sedó, Júlia Sellés Altés, Samira Serhir, Anna Serradell, Pol Sisó, Alex Subias, Albert Texidor, Júlia Toledo, Alejandro Torres Data Entries Judit Abós, Annalisa Aiti, Laura Arias, María Artero, Nestor Babon, Helena Carbonero, Anna Casas, Marta Chavero, Ana Cos, David Díaz, Marta Díaz, Ruben Díaz, Sandra Diez, Carlos Domínguez, Dídac Fernández, Marta García, Ada González, Silvia Gracia, Andrea Illescas, Neus Iserte, Sandra Justicia, Eva Marín, Sílvia Marín, Sara Martínez, Sonia Martínez, Olga Masip, Mireia Masot, Maria Mateu, Carina Monclús, Andrea Monzo, Cristina Navarro, Marco Neves, Ana Nicolas, Paula Núnez, Maria Ortega, Raquel Ortiz, Mònica Pascual, Sergio Perez, Laura Pol, Irene Quevedo, Maria Rebollo, Anna Ricart, Laura Roa, Angel Romano, Rosa Romero, Luciana Ruiz, Hugo Somoza, Marta Urdi, Laia Vila, Núria Vilaplana, Anna Viñals, Elena Vizcaino, Irati Wyatt Clinical Trials Assistants Laura Cruz, Núria Lafuente, 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 Carla Barjola, Andrea Caballero, Anguiela Cachique, Carles Caro, Sara Claveria, Mª Elena de Cabo, Elvira Domingo, Mª Luisa Fargas, Eva Gomez, Julia Gónzalez, Carla Gotor, Margarida Marcos, Marta Mate, Carmen Moína, Mireia Moral, Isabel Muñoz, Teresa Navarro, Carla Sanchez, Tania Sanchez, Carla Solana, Julia Soto, Adriana Terres, Judit Torres, Lydia Velez Operational Research Nurses Anna Maria Carro, Inés Depares, Andrea Martinez, Alba Silverio, Rubén X. Torres Nursing Assistants Xenia Ángeles, Katherine Espinoza, Susana Flores, Melania Fornies, Mireia Hernández, Mª Ascension Martin, Marta Marzo, Laura Maza, Lucia Melero, Ana Belen Ortiz, Alba Pardes Head of the Clinical Research Onco-Hematology Pharmacy Unit Anna Farriols Head of the Pharmacy Service Maria Queralt Gorgas Pharmacists Montserrat Carreres, Matilde Casañ, Carla Esteban, Celia Fernández, Lorena García, Patricia García, Pablo González, Ariadna Gracia, Rocío Paucar, Pilar Rovira, Eugenia Serramontmany, Manuel Serrano, Lucia Sopena, Carlota Varon Technicians Montserrat Aguilar, Romina Bellini, Esther Carabantes, Bryan Cárdenas, Angélica Cely, Elisabeth Gabilan, Cristina Gullón, Ariadna Javalera, Jennifer Jimenez, Roser Klimt, 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 Secretary Isabel Mª Alerany Administrator 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. Occupying a total surface area of 1000 m2, our Unit is located within the general area of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus.

This privileged environment with direct access to patients, coupled with VHIO’s translational approach to research and superb scientific framework, has enabled our unit to establish itself as one of the few comprehensive facilities in Europe to rapidly transform the latest discoveries into actionable insights to benefit patients. The UITM – CaixaResearch incorporates a multidisciplinary team comprised 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.

In 2024, our unit participated in 266 phase I clinical trials, 24 of which are Basket trials. Thanks to our multidisciplinary team we have continued to expand our portfolio of phase I and Basket trials, with 624 patients enrolled. This year, we opened 90 new studies, treated over 1,314 patients throughout the year and performed over 740 first visits.

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 several research lines led by other VHIO groups, thus connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists collaborate in our trials to facilitate biomarker development, achieve a deep understanding of the mechanism of action of anticancer agents, and increase our understanding on the mechanisms of cancer drug resistance.

In collaboration with several other VHIO groups, we co-lead our CaixaResearch Advanced Oncology Research Program (2020-2025), also supported by the ”la Caixa” Foundation.

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 the array of technologies available for high-throughput molecular analysis of patient samples.

In addition to our clinical trials in oncology, in 2024 our Unit also participated in 48 phase I, 3 basket, and 25 phase II clinical trials in hematology, with 76 patients enrolled.

Optimal patient treatment and care and pioneering research at UITM-CaixaResearch would not be possible without the essential collaboration of many other teams of oncology professionals. They 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 a new class of drugs.

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 (Basket/Octopus trials), and immuno-oncology.
  • We have expanded our portfolio of drugs targeting developmental pathways, cell signaling mediators (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 GlaxoSmithKline OCTC, Roche ImCORE, and the Astra Zeneca Partner of Choice Network Abbvie, Amgen, and Janssen. New alliances have been built with Daiichi Sankyo.
  • 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 circulating tumor DNA (ctDNA) or gene expression analyses (Nanostring). 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, supported by the Cancer Core Europe (CCE) consortium, is co-funded by pharmaceutical companies and has an adaptive design to expand the number of study modules.
  • We have introduced Molecular Tumor Board meetings to discuss the most relevant genomic features of complicated cases and evaluate possible treatment options.
  • 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 several 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 Carla Barjola, Andrea Caballero, Anguiela Cachique, Carles Caro, Sara Claveria, Mª Elena de Cabo, Elvira Domingo, Mª Luisa Fargas, Eva Gomez, Julia Gónzalez, Carla Gotor, Margarida Marcos, Marta Mate, Carmen Moína, Mireia Moral, Isabel Muñoz, Teresa Navarro, Carla Sanchez, Tania Sanchez, Carla Solana, Julia Soto, Adriana Terres, Judit Torres, Lydia Velez Operational Research Nurses Anna Maria Carro, Inés Depares, Andrea Martinez, Alba Silverio, Rubén X. Torres Nursing Assistants Xenia Ángeles, Katherine Espinoza, Susana Flores, Melania Fornies, Mireia Hernández, Mª Ascension Martin, Marta Marzo, Laura Maza, Lucia Melero, Ana Belen Ortiz, Alba Pardes

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, side effect profiles and the quality of life of our patients. Advances in oncology care and the delivery of more powerful anti-cancer medicines are driven by optimal processes in clinical trials.

Our expert clinical research oncology nurses assume a central role in clinical studies and work closely with multidisciplinary teams to develop and evaluate patient treatment with quality of care. They also contribute to clinical trials by identifying patterns in side effects of 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.

Our team is directed 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 comprised 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.

We also provide patients and their families with the information and professional guidance required to make fully informed decisions concerning their treatment options. Our clinical teams also continue to follow up patients that were recruited prior to 2024 who are still enrolled and 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 Onco-Hematology Pharmacy Unit Anna Farriols Head of the Pharmacy Service Maria Queralt Gorgas Pharmacists Montserrat Carreres, Matilde Casañ, Carla Esteban, Celia Fernández, Lorena García, Patricia García, Pablo González, Ariadna Gracia, Rocío Paucar, Pilar Rovira, Eugenia Serramontmany, Manuel Serrano, Lucia Sopena, Carlota Varon Technicians Montserrat Aguilar, Romina Bellini, Esther Carabantes, Bryan Cárdenas, Angélica Cely, Elisabeth Gabilan, Cristina Gullón, Ariadna Javalera, Jennifer Jimenez, Roser Klimt, 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 Secretary Isabel Mª Alerany Administrator Nida Mehmood

Transversal Clinical Trials Services and Units

Clinical Research Oncology Pharmacy Unit

Summary

Our Unit is ISO 9001:2015 certified and is part of the Medical Oncology Department of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus. It is thanks to the funding received from the ”la Caixa” Foundation that our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch Clinical Research Onco-Hematology Unit opened in 2020. Equipped with all the very latest technologies, this facility further enables us to provide optimal quality in pharmaceutical care and continue to respond to all regulatory requirements.

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

Oncology Pharmaceutical Care Program

Our team of expert pharmacists are specialized in hospital pharmacy, oncology and hematology. The unit’s laboratory technicians prepare cytostatics and other parenteral therapies used in clinical trials, as well as closely monitor and follow-up our patients.

Pharmacological Research in Oncology Support Program

This program is directed by our team of pharmacists and laboratory technicians specialized in clinical trials. They are responsible for the management of study supplies including storage, dispensation, and traceability control.

In 2024 they managed drugs used in 915 open clinical trials in oncology and hematology, and 13,359 resupply deliveries/clinical trial supply deliveries. Our cutting-edge system for controlling storage temperature—performing electronic temperature recordings every 5 minutes daily—displays readings on computers equipped with audiovisual alarms as well as an around-the-clock SMS alert system for monitoring and reporting temperature deviations.

Regarding the design and validation of our unit’s drug preparation process traceability system, we ensure qualitative and quantitative quality control of our computerized system.

In 2024 our dispensing staff actively participated in 279 pre-study visits, 231 initial visits, 2,476 monitoring visits, 219 close-out visits and successfully passed 19 audits, 1 ISO inspections, and 2 FDA inspections.

Additionally, 51,997 clinical trial drugs have been dispensed and validated by our pharmacists, including 16,739 for oral administration, 3,201 for IM/ subcutaneous administration, and 32,169 for IV administration. Of these 19,158 were cytostatic drug preparations for infusion. A total of 231 Standardized Dispensing Procedures for clinical trials have been drawn up and we have performed 990 updates of these procedures due to subsequent amendments to protocols or pharmacy manuals. 103 storage temperature data reports have also been prepared by our dispensing team.

We also included 371 antineoplastic therapeutic schedules in our prescription software.

Our Pharmaceutical Care Program for patients enrolled in phase I clinical trials: we performed 1,643 C1D1 visits, 728 screenings, as well as compiled patient diaries and/or instructions for patients (in the absence of documentation provided by the respective sponsor). We have seen a total of 3,134 patients in pharmaceutical care consultations. During these consultations, the pharmacist reviews concomitant medications to detect prohibited drugs or relevant interactions, potentially preventing screening failures and enhancing the efficacy and safety of treatments.

  • Excellence in the services that we provide to clinical oncology research programs through optimal efficacy, efficiency and safety.
  • Management, dispensing, preparation and administration of clinical study drugs according to protocol specifications. Ensure traceability of the entire circuit with the development and implementation of new software.
  • Maximized control of storage temperature of samples and preparations.
  • Optimal use of a computerized program, IPharma-FUNDANET®, for the management of clinical trial supplies.
  • Provision of a pharmaceutical care program for patients in phase I, II and III studies treated with orally administered medicines to improve safety, compliance and the efficacy of these therapies.
  • Successful sponsor audits as well as inspections carried out by regulatory authorities.
  • Replacing paper medical orders, we have implemented electronic prescription ordering for intravenous (IV) administration medication in our site prescription software.
  • We have developed new traceability software that includes global pharmacotherapeutic processes; the prescription, validation, dispensing, preparation and administration of drugs in the oncology and hematology clinical trial settings.
  • Qualitative and quantitative quality control of all parenteral anticancer preparations, including automated visual control using a camera and automated gravimetric control with connected scales, to guarantee patient safety and protocol compliance.
  • Qualitative control using barcodes or other systems to verify all medication dispensed to patients for cancer therapies.
  • Our Unit provides clinical and technical support for the prescription, preparation, and administration of cytostatics in clinical trials, as well as e-records of usage and timings.
  • ISO9001:2015 certification renewed. Successful sponsor audits, regulatory inspections, and participation in the renewal of VHIO’s Phase I Unit reaccreditation.

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

Transversal Clinical Trials Services and Units

Academic Contract Research Organization (VHIO-aCRO)

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 12 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 2024, we continued working with the new Clinical Trials Information System (CTIS) under the clinical trials regulation (EU 536/2014), in effect since January 2022. We have successfully transitioned all our clinical trials to CTIS.

  • 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 2024, 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, three clinical trials in cell therapy with tumor-infiltrating lymphocytes (TILs) are currently logistically managed by our team: NEXTGEN-TIL-ACT, TILTS-001, and PragmaTIL. Sponsored by VHIO and funded by the European Union, PragmaTIL is received regulatory approval in 2024 and will be initiated across three EU sites: VHIO, Herlev Hospital in Denmark, and the Netherlands Cancer Institute (NKI).
    We are also managing a clinical trial with natural killer cells (NKs) that has opened for recruitment in two Spanish clinical sites, as well as a multicenter French-sponsored study for patients with peripheral T-cell lymphoma (PTCL) in Spain.
  • During 2024, we successfully met the regulatory requirements for all of our trials (first submissions and amendments).
  • This year we transitioned all our active clinical trials from the previous Spanish Agency of Medicines and Medical Devices (AEMPS) platform to CTIS.
  • Our clinical research associates monitored more than 160 patients across different hospitals in Spain.
  • We managed clinical trial drug requirements in more than 35 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.
  • Manage more haemato-oncology clinical trials.
  • Continue working in cell therapy clinical trials.
  • Gain experience managing clinical trials under the new IVDR (In Vitro Diagnostic Medical Devices Regulation).
  • 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

Director Gemma Sala Quality Team: Quality Managers Javier Fonts, Alba Martinez, Melisa Belén Oliva Quality Technicians Miriam Artigas, Vanessa Soriano Head of the 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

Headed 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 organizational structure includes two main areas: Clinical Trials Quality and General & Laboratory Quality, each with clearly defined objectives and responsibilities. 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.
  • 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 2024, we have collaborated in more than 900 active clinical trials in oncology and haematology, and have successfully passed 21 external audits, 6 internal audits, and 2 U.S. Food and Drug Administration (FDA) inspections.
  • 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.
  • VHIO's Moodle learning platform for internal trainings and the SOPs Reading Log.
  • 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.

Hematology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2024

Code Clinical Trial Title Phase
LOXO-ENC-23001 A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants with Recurrent, Advanced or Metastatic Solid Tumors. I
D926UC00001/Prostata 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
C2321001 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
MK-5684-U01 / MK-5684-01A 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
GO44537 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
AMX-500-001 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
CBT307-1 A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients with PSMA+ Advanced and/or Metastatic Solid Tumours. I
20180146 A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer. I
EPI-7386-CS-010 A Phase 1/2 Study of EPI-7386 in Combination with Enzalutamide Compared with Enzalutamide Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer. I
D9721C00002 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
D7980C00003 A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination with Axitinib in Subjects with Advanced Renal Cell Carcinoma. I
D926UC00001/Bufeta 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
WO39613 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
MK-3475-U04/MK-3475-04C 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
MK-3475-U04/MK-3475-04B Phase 1/2 Umbrella Study of Pembrolizumab in Combination with Investigational Agents as First-Line Treatment in Locally Advanced or Metastatic Urothelial Cancer. I
GO39374 A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GDC-0077 AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT SOLID TUMORS AND IN COMBINATION WITH ENDOCRINE AND TARGETED THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT HORMONE-RECEPTOR POSITIVE BREAST CANCER. I
CO40115 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
D8530C00001 A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast CancerA Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast Cancer. I
GO40311 A PHASE Ia/b, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF BTRC4017A ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT AND IN COMBINATION WITH TRASTUZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HER2-EXPRESSING CANCERS. I
CO42867 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
C4891026 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. I
TACTIVE-U/C-C4891024 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
CT7001_003 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
TACTIVE-U / B-C4891023 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
VHIO20002 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
CAAA603A12101 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
BP42573 AN OPEN-LABEL, MULTICENTER, PHASE I STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7428731 IN PARTICIPANTS WITH GLIOBLASTOMA EXPRESSING MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR VARIANT III. I
CAAA601A52101 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
EDO-S101-1006 A PHASE 1 STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF TINOSTAMUSTINE, A NOVEL ALKALATING AND DEACETYLASE INHIBITING MOLECULE, AS ADJUVANT TREATMENT IN PATIENTS WITH NEWLY DIAGNOSED UNMETHYLATED MGMT-PROMOTER GLIOBLASTOMA. I
Debio0123-GBM-105 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
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. I
GO41751 A PHASE I, OPEN-LABEL, DOSE-ESCALATION PHARMACOKINETICS OF BLYG8824A ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC COLORECTAL CANCER. I
IGM-8444-001 AN OPEN-LABEL, MULTICENTER, PHASE 1a/1b STUDY OF IGM-8444 AS A SINGLE AGENT AND IN COMBINATION IN SUBJECTS WITH RELAPSED, REFRACTORY, OR NEWLY DIAGNOSED CANCERS. I
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). I
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. I
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). I
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. I
61186372GIC2002 A Phase 1b/2, open-label, study of amivantamab monotherapy and in combination with chemotherapy in patients with advance metastatic colorectal cancer. I
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). I
MK1022-011 A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers. I
RLY-4008-101 A First-in-human Study of Highly Selective FGFR2 inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and other Advanced Solid Tumors. I
D926UC00001/Gastric 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
20230223 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
D967LC00001 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
CL1-95029-002 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
1479-0012 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
SN201 A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma. I
NLM-2020-01 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. I
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). I
D-FR-60010-015 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. I
D926UC00001/Endometri 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
STRO-002-GM1 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 Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers. I
D926UC00001/Ovari 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
REGN4018-ONC-1721 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
SL03-OHD-105 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
STRO-002-GM2 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
ALE.C04-001 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
1443-0002 Ensayo abierto de BI 765063 en combinación con BI 754091 (ezabenlimab) solo o con BI 836880, quimioterapia o cetuximab, en pacientes con carcinoma epidermoide de cabeza y cuello (CCECC) o carcinoma hepatocelular (CHC)  recurrente/metastásico. I
TTCC-2022-01 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
TNG462-C101 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
IDRX-42-001 FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST). I
DCC-2618-01-010 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
GEIS-83 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
ADCT-601-102 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
TRASTS Ensayo clinico Fase I-II, abierto, prospectivo y muticéntrico, que explora la combinación de Trabectedina y Radioterapia en pacientes con Sarcoma de tejidos Blandos. I
BO43328 A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TREATMENT COMBINATIONS IN PATIENTS WITH MELANOMA (MORPHEUS-MELANOMA). I
CGME751A12101 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
NTC-001 AN OPEN-LABEL, PHASE 1 STUDY OF NEO-PTC-01 IN PATIENTS WITH ADVANCED OR METASTATIC MELANOMA. I
CA115-001 Phase 1b/2 Study of BMS-986442 in Combination with Nivolumab or Nivolumab and Chemotherapies in Participants with Advanced Solid Tumors and Non-small Cell Lung Cancer. I
Debio 0123-SCLC-104 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
BO39610 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 NON-SMALL CELL LUNG CANCER (MORPHEUS-LUNG). I
U31402-A-U102 A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF U3-1402 IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER. I
73841937NSC1001 An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer. I
F60087CI101 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
22231 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
SPLFIO-174 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
21948 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
D9570C00001 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
XmAb717-06 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
BLU-945-1101 A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer. I
D7020C00001 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
STX-721-101 First-In-Human Study of STX-721 In Participants With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations. I
NVL-520-01 A Phase 1/2 study of the highly selective ROS1 inhibitor NUV-520 in patients with advanced NSCLC and other solid tumors. I
MS201924_0022 An Open-label, Multicenter, Controlled Phase 1b/2a to evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR Inhibitor M1774 in combination with Cemiplimab in Participants with Non-squamous Non-small Cell Lung Cancer that have progressed on prior anti- PD-(L)1 and Platinum-based Therapies. I
86974680NSC1001 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
BO44426 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
GALLANT-1 GLE003 An open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension study to investigate the safety and efficacy of GB1211 (a galectin-3 inhibitor) in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC). I
PLATFORMPANSC2001/61186372PANSC2001 Estudio Fase I/II para establecer la seguridad y eficacia preliminar de la combinación de amivantamab y capmatinib para pacientes con NSCLC avanzado/metastásico con mutación MET exon14 skipping y amplificación de MET (METalmark). I
1479-0001 Open label, Phase Ib dose expansion trial, of BI 1810631 as monotherapy in patients with advanced or metastatic NSCLC with HER2 mutations. I
GFH925X0201 A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation. I
ZL-1310-001 An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer. I
20230298 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
20160323 A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer. I
CAAA601A42101 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
BP44382 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
CMGY825A12101 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
20200469 A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer. I
MCLA-128-CL01 A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors. I
MK-3475-158 Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158) I
VHIO17002 Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours. I
MK-7339-002 A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer. I
BO41932 TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL. I
D9720C00001 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
SOLTI-1904 EfficACy of Spartalizumab acROss multiPle cancer-types in patients with PD1-high mRNA expressing tumOrs defined by a singLe and pre-specIfied cutoff (ACROPOLI trial). I
SGNDV-005 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
MK-6482-016 An Open-label, Multicenter, Phase 2 Study of Pembrolizumab Plus Lenvatinib in Combination With MK-6482 in Multiple Solid Tumors. I
AFM24-102 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
F8394-201 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
MEDOPP575 PatriTUmab-DeruXtEcan (HER3-DXd) in active brain metastases from HER3-expressing advanced breast and nOn–small cell lung cancers, and leptomeningeal carcinomatosis from HER3-expressing advanced solid tumors. I
E7386-G000-201 An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors. I
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. I
ML43332 A PHASE II, OPEN LABEL, RANDOMIZED, NONCOMPARATIVE COHORTS STUDY OF ADJUVANT ATEZOLIZUMAB OR ATEZOLIZUMAB PLUS TIRAGOLUMAB IN SOLID TUMORS WITH RESECTABLE DISEASE WITH INTERMEDIATE-HIGH RISK OF RECURRENCE AND HIGH TUMOR MUTATIONAL BURDEN (TMB-H) OR MICROSATELLITE INSTABILITY (MSI-H). I
NVL-655-01 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
GO44096 A PHASE II, STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS OF THE INTRAVENOUS FIXED-DOSE COMBINATION (IV FDC) OF TIRAGOLUMAB AND ATEZOLIZUMAB IN PARTICIPANTS WITH LOCALLY ADVANCED, RECURRENT OR METASTATIC SOLID TUMORS. I
CTNO155X2101 An open-label, multi-center, phase I, dose finding study of oral TNO155 in adult patients with advanced solid tumors. I
4010-01-001 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
PM14-A-001-17 Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors. I
LOXO-RET-17001 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
MCLA-158-CL01 Phase 1 dose escalation and cohort expansion study evaluating single-agent MCLA-158 in metastatic colorectal cancer and other advanced solid tumors. I
GCT1046-01 First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors. I
NP41300 AN OPEN LABEL, MULTICENTER, DOSE ESCALATION, PHASE 1 STUDY TO EVALUATE SAFETY/TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PRELIMINARY ANTI TUMOR ACTIVITY OF RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS. I
BP41628 AN OPEN LABEL, MULTICENTER, RANDOMIZED DOSEESCALATION AND EXTENSION, PHASE IA/IB STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF RO7284755, A PD-1 TARGETED IL-2 VARIANT (IL-2V) IMMUNOCYTOKINE, ALONE OR IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS. I
1438-0001 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
Debio 0123-101 A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors. I
ICT01-101 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
4020-01-001 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
IMC-P115C-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
SGNB6A-001 A Phase 1 Study of SGN-B6A in Advanced Solid Tumors. I
FS222-19101 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
BP44956 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
3082-CL-0101 A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation. I
PRT3789-01 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
R6569-ONC-1933 A Phase 1 Study of REGN6569, an Anti-GITR mAb, with Cemiplimab in Patients with Advanced Solid Tumor Malignancies. I
GCT1042-01 A First-in-Human, Open-label, Dose-escalation Trial with Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects with Malignant Solid Tumors. I
DSB2455-001 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
CTL-002-001 A PHASE I, FIRST IN HUMAN, TWO PART, OPEN-LABEL CLINICAL TRIAL OF INTRAVENOUS ADMINISTRATION OF CTL-002 GIVEN AS MONOTHERAPY AND/OR IN COMBINATION WITH AN ANTI-PD-1 CHECKPOINT-INHIBITOR IN SUBJECTS WITH ADVANCED STAGE, RELAPSED/REFRACTORY SOLID TUMORS. I
GO42144 A PHASE I DOSE-ESCALATION AND DOSE-EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC 6036 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION. I
D9720C00001 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
BT8009-100 Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies. I
CP-START-001 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
MS202659_0001 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
LOXO-FRA-24001 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
21820 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
2020-306-GLOB2 MULTICENTER, OPEN-LABEL PHASE I STUDY EVALUATING THE SAFETY AND TOLERABILITY OF HMPL-306 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH IDH MUTATIONS. I
CJDQ443A12101 A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation. I
M19-345 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
INCB 106385-102 A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors. I
SGNDV-004 A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors. I
PM1183-A-017-20 An Open-Label, Multicenter, Pharmacokinetic Study of Lurbinectedin in Patients with Advanced Solid Tumors and Varying Degrees of Hepatic Impairment. I
BNT151-01 Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT151 as a monotherapy and in combination with other anti-cancer agents in patients with solid tumors. I
LCB-2401-001 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
CO42800 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
LB-208-001 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
ELVN-002-003 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
SGNSTNV-001 A Phase 1 Study of SGN-STNV in Advanced Solid Tumors. I
M20-732 A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma. I
ZN-A-1041-101 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
BT5528-100 Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression. I
ASTX029-01 A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors. I
1463-0001 Phase I dose-finding study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers. I
SC201 A multicenter, open-label, phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced/metastatic solid tumors I
1403-0001 A phase Ia/Ib, open labeA phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 in patients with advanced or metastatic solid tumorsl, multicenter, dose-escalation study. I
20220028 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
VHIO20001 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
CIAG933A12101 Estudio de fase I, multicéntrico y abierto de IAG933 oral en pacientes adultos con mesotelioma avanzado y otros tumores sólidos. I
D9970C00001 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
DF6002-001 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
TAK-280-1501 A Phase 1/2, Firstin-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer. I
PM14-A-002-20 Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM14 in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors. I
MK-9999-U02/MK9999-02A 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
GCT1047-01 First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors. I
GS-US-570-6015 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
CYC065-101 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
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. I
MK-1084-001 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
CL1-95012-001 Estudio de primera administración en humanos de fase I/II, abierto, multicéntrico, de escalada de dosis y expansión con PRS-344/S095012 en pacientes con tumores sólidos. I
TK-8001-01 A phase 1/2, first-in-Human, open-label, accelerated titration, two-part clinical trial of TK-8001 (TCR1367-transduced autologous CD8+ T cells) in subjects with HLA-A*02:01 genotype and advanced-stage, MAGE-A1+ solid tumors in non-curable state that have received a minimum of two lines of approved systemic therapy. I
20190135 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
D8990C00001 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
D8470C00001 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
D6900C00001 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
INCB99280-204 A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation. I
RVU120-SOL-021 An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients with Relapse / Refractory Metastatic or Advanced Solid Tumors. I
TOS-358-001 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
VB-N02 A PHASE 1B OPEN-LABEL DOSE ESCALATION TRIAL OF THE SAFETY OF, AND ANTIGENSPECIFIC IMMUNE RESPONSES ELICITED BY, VB10.NEO IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC TUMORS . I
87704916LUC1001 A Phase 1 Study of Intratumoral Delivery of JNJ 87704916 in Combination with Systemic Immunotherapies in Patients with Non-Small Cell Lung Cancers. I
FS120-19101 A Phase 1/2 Open-Label Study to Evaluate the Safety and Antitumor  Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab in Subjects With Advanced Malignancies. I
WP43295 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
Debio 0123-102 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
ELVN-002-001 A Phase 1a/1b Study of ELVN-002 for the Treatment of HER2 mutant or HER2 amplified solid tumors. I
M23-385 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
87890387STM1001 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
DS1103-074 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
STX-478-101 First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents inParticipants With Advanced Solid Tumor. I
SR7075-ONC-2009 Phase I/II dose expansion study for an EGFRxCD28 costimulatory bispecific antibody in combination with cemiplimab in patients with advanced solid tumors. I
TT-CSP-001 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
XB002-101 A DOSE-ESCALATION AND EXPANSION STUDY OF THE SAFETY AND PHARMACOKINETICS OF XB002 AS SINGLE-AGENT AND COMBINATION THERAPY IN SUBJECTS WITH INOPERABLE LOCALLY ADVANCED OR METASTATIC SOLID TUMORS. I
H-200-001 A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers. I
3134001 Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumors. I
T3P1001 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
FURMO-002 A Phase 1b dose escalation and dose expansion study evaluating the safety, pharmacokinetics and antitumor activity of Furmonertinib in patients with advanced or metastatic solid tumors. I
TED16925 A Phase 1 open-label, first-in-human, single agent, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR443216 in participants with relapsed/refractory HER2+ solid tumors. I
1438-0007 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
HFB-200301-01 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
79032421STM1001 A Phase I Study of JNJ-79032421, a T-cell Redirecting Agent Targeting Mesothelin for Advanced Stage Solid Tumors. I
GRWD5769-ST-01 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
CFT1946-1101 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
RP2-001-18 An Open-Label, Multicenter, Phase 1 Study of RP2 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors. I
HFB-301001-01 A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients with Advanced Solid Tumors. I
NB003-001 A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Malignancies. I
CA111-001 A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors. I
PYX-201-101 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
BNT116-01 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
CYC140-101 A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF CYC140, AN ORAL PLK1 INHIBITOR, IN SUBJECTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA. I
20220073 Primer estudio en humanos de fase 1 para evaluar la seguridad, tolerabilidad y farmacocinética de AMG 305 en sujetos con tumores sólidos avanzados. I
CT-OST-499-01 Phase I/Ib trial of OST-122 in cancer patients with advanced solid tumors. I
TCTLR-101 Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies. I
ZL-1218-001 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
TCD16843 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
IMC-F106C-101 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
AMX-818-001 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
MCLA-129-CL01 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
TCD17620 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
INCA33890-101 A Phase 1, Open-Label, Multicenter Study of INCA033890 as Monotherapy in Participants With advanced or metastatic Solid Tumors. I
ADP-0000-001 A Screening Protocol To Determine Tumor Antigen Expression and HLA Sub-Type For Eligibility Determination For Clinical Trials Evaluating The Safety and Efficacy of Autologous T Cells Ecpressing Enhanced TCRS in Subjects With Solid or Hematological Malignancies. I
BNT142-01 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
ADP-0055-001 A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors. I
CHRO761A12101 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
GS-US-616-6291 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
IDE397-001 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
BGB-30813-101 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
CKFA115A12101C 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
D9350C00001 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
1403-0004 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
1403-0002 Estudio fase Ia/Ib, abierto, de escalado de dosis de la combinación de BI 907828 con BI 754091 (ezabenlimab) y BI 754111 y la combinación de BI 907828 con BI 754091 (ezabenlimab) seguido de cohortes de expansión, en pacientes con tumores sólidos avanzados. I
INP12-01 A phase I trial evaluating the safety, tolerability and pharmacokinetic profile of INP12 in patients with advanced solid tumors. I
BAY 2927088 / 21607 First-in-human study of BAY2927088 in patients with advanced cancer harboring an EGFR and/or HER2 mutation. I
CA052-002 A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab in Participants with Advanced Solid Tumors. I
XL092-002 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
TYR300-101 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
RLY-2608-101 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
LOXO-PIK-21001 Phase 1 Study of LOXO-783 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with Advanced Breast Cancer and Other Solid Tumors with a PIK3CA H1047R Mutation. I
M21-404 A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors. I
217228 Phase 1 first time-in-human, open-label study of GSK4381562A administered as monothereapy and in combination with anticancer agents in participants with selected Advanced Solid tumors. I
D8410C00001 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
EP0031-101 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
Nav-1003 A Phase 1 Study of the SHP2 Inhibitor BBP-398 in combination with the KRASG12C Inhibitor Sotorasib in Patients with Advanced Solid Tumors and a KRAS-G12C Mutation. I
GCT1053-01 First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate the safety of GEN1053 as monotherapy and as combination therapy in subjects with malignant solid tumors. I
GO43860 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
RP3-301 An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination with PD-1 Blockade in Patients with Solid Tumors. I
DAY101-102a A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations. I
NVL-655-01 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
CQEQ278A12101 A phase I/Ib, open-label, multi-center, study of QEQ278 in patients with advanced solid tumors. I
SGNPDL1V-001 A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors I
TIG-006 A Multicenter, Open-Label, Phase I/II Study of EOS884448 in combination with pembrolizumab or inupadenant in participants with advanced solid tumors. I
JK08.1.01 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
PM1183-A-014-15 Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors. I
SGNB7H4V-001 A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors. I
MS202329_0001 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
1480-0001 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
GS-US-548-5918 A Phase 2, Multi-Arm Study of Magrolimab in Patients with Solid Tumors. I
BBI-20201001 Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors. I
ADCT-901-101 ADCT-901-101, A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients With Selected Advanced Solid Tumors. I
ITF/3756/01 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
GCT1055-01 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
CPI-0209-01 A Phase 1/2 Study of CPI-0209 Monotherapy and in Combination with Other Therapy in Patients with Advanced Tumors. I
BO44157 BO44157, ESTUDIO DE FASE II MULTICÉNTRICO, ALEATORIZADO, ABIERTO, CONTROLADO DE RO7247669 ADMINISTRADO SOLO O EN COMBINACIÓN CON TIRAGOLUMAB FRENTE A ATEZOLIZUMAB EN PACIENTES CON CARCINOMA UROTELIAL LOCALMENTE AVANZADO O METASTÁSICO, NO TRATADOS PREVIAMENTE, QUE NO SON APTOS PARA RECIBIR QUIMIOTERAPIA BASADA EN PLATINO. II
MK-3475-365 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
CNIO-CP-2019-01 A phase II, open-label, biomarker-guided study of carboplatin efficacy in pre-treated metastatic castration- resistant prostate cancer (CRPC). II
CP-MGD019-02 A Phase 2, Randomized, Open Label, Study of LORIGERLIMAB with Docetaxel alone in Participants with Metastatic-Castration-Resistant Prostate Cancer. II
DISCUS-14 A randomised phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cáncer. II
MK-3475-03A A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (U03): Substudy 03A. II
V940-004 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
BO43936 A RANDOMIZED OPEN LABEL PHASE II STUDY OF IMMUNE CHECKPOINT COMBINATIONS WITH AXITINIB PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA. II
EUOG-2016-003 Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”). II
ABACUS-2 Estudio de fase 2 de neoadyuvancia con inhibidores de puntos de control inmunitario en cáncer urotelial (ABACUS-2). II
RC48-G001 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
V940-005 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
IMMU-132-06 A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy. II
SOLTI-1804 HER2-PREDICT: TRANSLATIONAL STUDY OF TUMOR SAMPLES FROM DS8201-A-U301 AND DS8201-A-U302 TRIALS. II
MedOPP240 STUDY TO EVALUATE THE EFFECT OF METFORMIN IN THE PREVENTION OF HYPERGLYCEMIA IN HR[+]/HER2[-] PIK3CA-MUTATED ADVANCED BREAST CANCER PATIENTS TREATED WITH ALPELISIB PLUS ENDOCRINE THERAPY. THE METALLICA STUDY. II
C4391025 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
SOLTI-1907 A Phase II with 2 parallel cohorts clinical trial targeting estrogen receptor negative or PAM50 non-luminal disease with Atezolizumab in combination with Trastuzumab and Vinorelbine in HER2-positive advanced/metastatic breast cancer – ATREZZO Study. II
BB-1701-G000-205 An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an anti-human epidermal growth factor receptor 2 (anti-HER2) antibody-drug conjugate (ADC), in Previously Treated Subjects with HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer. II
MEDOPP596 Phase II Study of Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-Low Breast Cancer Presenting with Newly Diagnosed or Progressing Brain Metastases. II
MedOPP293 Chemotherapy-Free pCR-Guided Strategy with subcutaneous trastuzumab-pertuzumab and T-DM1 in HER2-positive early breast cancer (PHERGAIN-2). II
ELA-0121 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
C4891026 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
STML-ELA-0222 Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE). II
SOLTI-1911 / BIG-21-02 Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS). II
SOLTI-1910 Predicting olaparib sensitivity in metastatic HER2-negative breast cancer with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutation or RAD51-negative test: RADIOLA TRIAL. II
TACTIVE-U / A-C4891006 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). II
CT7001_002 AN OPEN-LABEL INTERVENTIONAL, MULTICENTER, RANDOMIZED, PHASE 2 STUDY OF FULVESTRANT WITH OR WITHOUT SAMURACICLIB IN PARTICIPANTS WITH METASTATIC OR LOCALLY ADVANCED HORMONE RECEPTOR POSITIVE AND HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE BREAST CANCER. II
C4391002 Phase 1B/2, Open Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PF-07220060 in Combination with PF-07104091 Plus Endocrine Therapy in participants with Advanced Solid Tumor. II
SOLTI-2201 Prospective biomarker analysis in HR+/HER2- advanced or metastatic breast cancer patients treated with sacituzumab govitecan. II
MedOpp437 PHASE II STUDY FOR PIK3CA/PTEN-ALTERED ADVANCED METAPLASTIC BREAST CANCER TREATED WITH MEN1611 MONOTHERAPY OR IN COMBINATION WITH ERIBULIN. II
SOLTI-2104 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
IMP321-P016 Un ensayo de fase 3 aleatorizado, doble ciego, controlado con placebo en sujetos con carcinoma de mama metastásico HER2/ neu negativo HR positivo y HR negativo que compara la dosis biologiocal óptima de efti en combinación con paclitaxel semanal vs. paclitaxel + placebo. II
TILS001 Treatment of advanced or metastatic triple-negative breast cancer with adoptive therapy of PD1+ tumor-infiltrating lymphocytes (TILS001 trial). II
D931CC00001 Phase II, Multi-Centre, Open-Label, Global Study to Assess the Efficacy and Safety of Neoadjuvant Therapy with Olaparib Monotherapy And Olaparib Plus Durvalumab Combination Therapy in Patients with Triple Negative Breast Cancer and Germline BRCA Mutations (OlympiaN). II
MIN-003-1806 A randomized, double-blind, placebo-controlled adjuvant trial in newly diagnosed primary glioblastoma subjects to assess the efficacy and safety of 2-hydroxyoleic acid (2-OHOA) in combination with radiotherapy and temozolomide standard of care treatment. II
SC9-GBM-03 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
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). II
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. II
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). II
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). II
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. II
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. II
CIRCULATE-SPAIN-01 Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA. II
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. II
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. II
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. II
Nutide-323 A randomised, open-label, Phase II, dose/schedule optimisation study of NUC 3373/leucovorin/irinotecan plus bevacizumab (NUFIRI-bev) versus 5 FU/leucovorin/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with previously treated unresectable metastatic colorectal cancer. II
GEMCAD 2102 Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC) - PEMBROLA. II
NOUS-209-01 Multicentre, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumours. II
GS-US-587-6156 (ELEVATE) Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (CRC). II
219369 PH2 Open label study evaluating Dostarlimab in the Neoadjuvant Treatment of locally advanced (la) dMMR/MSI-H rectal cancer (RC). II
GEMCAD 2103 Estudio de fase II de atezolizumab más tiragolumab en combinación con quimio-radioterapia en carcinoma de células escamosas localizado del canal anal. II
TAS-120-205 Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements. II
D967LC00001 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). II
TAS-120-206 A Phase 2 Study of Futibatinib in Combination with PD-1 Antibody-based Standard of Care Therapy in Patients with Solid Tumors. II
M24-052 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
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. II
D9800C00001 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
ABT-C11-2020 A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer. II
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. II
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. II
Actuate 1801/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. II
A-20-1013-C-03 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. II
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. II
P-VCNA-003 A phase IIb, open-label, randomized study of Gemcitabine and NabPaclitaxel plus/VCN-01 in Patients with Metastatic Pancreas Cancer. II
D7986C00001 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
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. II
TTD-20-04 Olaparib and durvalumab (MEDI4736) in patients with metastatic pancreatic cancer and DNA Damage Repair genes alterations. II
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. II
GCT1046-05 A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer. II
MORAb-202-G000-201 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
DS6000-109 A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancers. II
ESR-20-21103 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
MedOPP557 Phase II study to assess the efficacy of niraparib rechallenge treatment after surgery in ovarian cancer patients with oligometastatic progression. II
ADP-0055-003 ADP-A2M4CD8 in HLA-A2+ Subjects with MAGE-A4 Positive Ovarian Cancer (SURPASS-3). II
IMGN853-0420 Multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers following 1 prior line of platinum-based chemotherapy. II
SGNTV-001 Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors. II
MK-7902-009 A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009). II
ASND0038 Newly Diagnosed Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma. II
219885 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
GS-US-548-5916 A Phase 2 Study of Magrolimab Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma. II
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). II
GETNE-T2318 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
GETNE-T2216 Biomarker Phase II Study Of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer. II
RG-13-277 (rEECur) An international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma. II
TRASTS 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
GEIS-52 Phase I-II trial of sunitinib plus nivolumab after standard treatment in advanced soft tissue and bone sarcomas. II
ADP-0044-002 A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma. II
SELNET-7-1 Phase I/II randomized clinical trial of selinexor plus gemcitabine in selected advanced soft-tissue sarcomas. II
GEIS-75 Phase II multicohort trial of trabectedin and low-dose radiation therapy in advanced/metastatic sarcomas (SYNERGIAS). II
FaR-RMS An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma. II
INBRX109 A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma. II
AL-DES-01 A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors. II
PM1183-C-010-22 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
PH-L19TNFSARC-03/18 A randomized study to investigate the efficacy and safety of the tumor-targeting human antibody-cytokine fusion protein L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcoma. II
TILTS-001 A phase 2, Multicenter Study of TILs Treatment in Advanced Tumors with Alterations in the SWI/SNF Complex: the TILTS Study. II
IMCGP100-203 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
ALKS 4230-006 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
C4221023 A Phase 2, Randomized, Open-label Study of Encorafenib and Binimetinib plus Pembrolizumab Versus Nivolumab and Ipilimumab in Participants with BRAF V600E/K Mutation-Positive Melanoma Who Progressed During or After Prior Treatment with Anti−PD-1 Therapy. II
CA209-7J3 CA209-7J3 II
V940-007 A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC). II
INCB99280-212 A Phase 2, Open-Label, Randomized Study of INCB099280 (Oral PD-L1 Inhibitor) in Participants With Locally Advanced or Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma. II
TPX-0005-01 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
61186372NSC2005 Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated with Amivantamab, an EGFR-MET bispecific antibody, Among Post-osimertinib Treated EGFRm NSCLC;  SKIPPirr, a Phase 2 Study. II
COMBI-TED 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
BO29554 A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON−SMALL CELL LUNG CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (BFAST: BLOOD FIRST ASSAY SCREENING TRIAL). II
ETOP 14-18 CHESS 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
ETOP 21-21 A multicentre, randomised, phase II trial of brigatinib consolidation versus observation or duvalumab in patients with stage III NSCLC and ALK-rearrangement, after definitive chemo-radiotherapy. II
20220127 A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors Conditions. II
BO45217 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
849-021 A Randomized Study of Two Dosing Regimens of Adagrasib in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation II
GCT1046-04 A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor. II
PLATFORMPANSC2001/61186372PANSC2002 Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer (PolyDamas). II
MO43156 A PHASE II, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER WHO HAVE NOT PROGRESSED AFTER PLATINUM-BASED CONCURRENT CHEMORADIATION. II
61186372NSC2007 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
GECP 20/10 PHASE II CLINICAL TRIAL OF AMG510 (SOTORASIB) IN STAGE III UNRESECTABLE NSCLC KRAS p.G12C PATIENTS AND MEDICALLY INELIGIBLE FOR CONCURRENT CHEMO-RADIOTHERAPY. II
CLN-081-001 A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received PlatinumBased Systemic Chemotherapy. II
AB-106-G208 A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors. II
BGBC016 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
BGB-LC-201 A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer. II
20210104 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
BO44178 A PHASE II, RANDOMIZED, MULTICENTER, DOUBLEBLIND, CONTROLLED STUDY OF RO7247669 PLUS PLATINUM-BASED CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC NON−SMALL-CELL LUNG CANCER. II
D9077C00001 Phase 2 open-label trial of neoadjuvant and adjuvant treatment in Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer. II
A2A-005 A2A-005 A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy. II
GECP 22-/02 (CA209-1240) 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
ETOP 18-21 A multicentre single-arm phase II clinical trial of Amivantamab, lazertinib plus bevacizumab in patients with EGFR-mutant advanced non-small cell lung cancer with progression on previous third-generation EGFR-TKI. II
BGB-900-102 Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors. II
CJDQ443B12201 An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer with PD-L1 expression <1% or STK11 co-mutations. II
IO102-IO103-022 A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with Pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head and Neck (SCCHN), and Metastatic Urothelial Bladder Cancer (mUBC). II
61186372NSC2002 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
213824 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
2SMALL Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients with Advanced Small Cell Lung Cancer that Progressed Following Prior Therapy with Platinum-Based Chemotherapy. II
1438-0005 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
DS7300-127 A Phase 2, multicenter, randomized, open-label study of DS-7300a, a B7-H3 antibody-drug-conjugate (ADC) in subjects with pretreated extensive-stage small lung cancer (ES-SCLCL). II
GECP 20/06 A Phase II study of pembrolizumab, lenvatinib and chemotherapy combination in first line extensive-stage small cell lung cancer (ES-SCLC). II
U31402-277 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. II
PMV-586-101 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. II
BO42843 A PHASE III, DOUBLE-BLIND, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) VERSUS PLACEBO AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE BLADDER CANCER WHO ARE CTDNA-POSITIVE FOLLOWING CYSTECTOMY. III
SGNDV-001 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
1333-GUCG A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone. III
D9723C00001 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
c16-174 Phase III Trial of Docetaxel vs. Docetaxel and Radium‐223 for Metastatic Castration‐Resistant Prostate Cancer (mCRPC). III
UC-GTG-2006 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
D361EC00001 A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) - CAPitello. III
D5086C00001 A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study of Savolitinib plus Durvalumab versus Sunitinib in Participants with MET-Driven, Unresectable and Locally Advanced, or Metastatic Papillary Renal Cell Carcinoma (PRCC). III
MK-6482-022 Phase 3 study of belzutifan plus pembrolizumab as adjuvant treatment in RCC. III
XL092-304 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
D910PC00001 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
17000139BLC3001 Phase 3, Multi-center, Randomized Study Evaluating Efficacy of Gemcitabine Intravesical Delivery System in combination with Anti- PD-1 Antibody versus Concurrent Chemoradiotherapy in Patients with Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder who are not Receiving Radical Cystectomy. III
IBCSG 59-19 / BIG 18-02 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
ABCSG 50 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
WO42633 EA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING  PREOPERATIVE THERAPY. III
D8535C00001 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
DS8201-A-U305 A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY OF TRASTUZUMAB DERUXTECAN (T-DXd) VERSUS  TRASTUZUMAB EMTANSINE (T-DM1) IN SUBJECTS WITH HIGH-RISK HER2-POSITIVE PRIMARY BREAST CANCER WHO HAVE RESIDUAL INVASIVE DISEASE IN BREAST OR AXILLARY YMPH NODES FOLLOWING NEOADJUVANT THERAPY. III
MK-2870-010 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
MK-2870-012 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
D8534C00001 A Phase 3, double-blind, randomized study to assess the efficacy and safety of switching to AZD9833 (an oral SERD) + CDK4/6 inhibitors (palbociclib or abemaciclib) vs continuing aromatase inhibitor + CDK4/6 inhibitors in patients with acquired ESR1 mutation without radiological progression during 1L treatment with AI + CDK4/6i for HR+/HER2- mBC-ctDNA guided early switch study. III
C4891001 ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER study to demonstrate that ARV-471 is superior to fulvestrant in prolonging PFS by BICR assessment in participants with ER(+)/HER2(-) aBC (all participants and participants with ESR1 mutation-positive BC) who have received prior endocrine-based treatment for their advanced disease. III
D967RC00001 Estudio Fase 3 Abierto de Neoadyuvancia con Trastuzumab Deruxtecan (T-DXd) en monoterapia o T-DXd seguido de THP comparado con ddAC-THP en pacientes con cáncer de mama en estadio temprano HER2-positivo de alto riesgo (DESTINY-Breast 11). III
SOLTI-2101 A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer. III
GS-US-598-6168 A Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable,  Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy. III
D8531C00002 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
CO44657 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
WO43571 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
WO44263 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
WO43919 A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS FULVESTRANT VERSUS ALPELISIB PLUS FULVESTRANT IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE, PIK3CA MUTATED, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO PROGRESSED DURING OR AFTER CDK4/6 INHIBITOR AND ENDOCRINE COMBINATION THERAPY. III
J2J-MC-JZLH 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
D926PC00001 Phase 3 Open Label Randomized Study of Dato-DXd Versus TPC in Metastatic Triple Negative Breast Cancer for Patients Who are Not a Candidate for Immunotherapy (TROPION-Breast02). III
D926XC00001 Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan with or without Durvalumab Versus Investigator’s Choice of Therapy in Patients with Stage I-III Triple Negative Breast Cancer who have Residual Invasive Disease in Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03). III
SGNTUC-028 A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab for metastatic HER2+ breast cancer. III
GS-US-592-6173 A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1. III
GS-US-592-6238 A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1. III
D926QC00001 Phase 3, Open-Label, Randomized Study of Neoadjuvant Datopotamab Deruxtecan with Durvalumab +/- Chemotherapy followed by Adjuvant Durvalumab, Versus Neoadjuvant Pembrolizumab + Chemotherapy and Adjuvant Pembrolizumab, in Patients with Stage II-III Triple Negative Breast Cancer (TROPION-Breast04). III
ONC-201-108 A Phase 3 study for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma. III
STEMNESS-CRC 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
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 BRAF V600E-MUTANT COLORECTAL CANCER (BREAKWATER). III
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. III
XL092-303 A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer. III
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. III
INCB 54828-302 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). III
TT420C2308 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
MK-7902-015 A Phase 3, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Pembrolizumab + Lenvatinib + Chemotherapy Induction Therapy Followed by Pembrolizumab + Lenvatinib Compared with Chemotherapy in Participants with Previously Untreated Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma. III
MK-7902-014 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
DS8201-A-U306 A Phase 3, multicenter, 2-arm randomized, open-label study of trastuzumab deruxtecan in subjects with HER2-positive metastatic and/or unresectable gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen. III
D7025C00001 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
ZWI-ZW25-301 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
MK-2870-015 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
INTEGRATE IIb A Randomised Phase III Open Label Study of regorafenib + nivolumab vs standard chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC). III
ARC-22 A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously-Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma. III
20210098 Estudio de fase 1b/3 de bemarituzumab más quimioterapia y nivolumab frente a solo quimioterapia y nivolumab en sujetos con cáncer gástrico y de la unión gastroesofágica avanzado no tratado previamente con sobreexpresión de GFR2b FORTITUDE-102). III
JZP598-302 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
D4191C00140 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
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. III
DIM-95031-002 An open-label early access phase 3b study of Ivosidenib in patients with a pretreated locally advanced or metastatic cholangiocarcinoma. III
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. III
MK-2870-020 / ENGOT-CX20 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
MK-2870-005 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
XPORT-EC-042 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
CORT125134-556 A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA). III
VS-6766-301 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
IMGN853-0421 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
MK-3475-689 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). III
Gortec 2018-01 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
221530 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
DP-1111-02CT 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
GETNE-T2217 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
DCC-2618-03-003 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
CGT9486-21-301 A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor. III
IT-03 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
PH-L19TNFDOX2-03/16 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
ABSK021-301 A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor. III
MK-3475-630 A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma(LA cSCC) (KEYNOTE-630). III
R2810-ONC-1788 A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma. III
IMC-F106C-301 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
IOV-MEL-301 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
20210031 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
20220083 A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting. III
MKV940-001 Estudio de fase III, aleatorizado, doble ciego, comparativo con placebo y con tratamiento activo de V940 (ARNm-4157) adyuvante más pembrolizumab frente a un placebo adyuvante más pembrolizumab en participantes con melanoma en estadio II-IV de alto riesgo. III
CA224-127 A Phase 3, Open-label, Randomized, Non-Inferiority Trial for Subcutaneous Formulation of Nivolumab + Relatlimab Fixed-Dose Combination versus Intravenous Administration of Nivolumab + Relatlimab Fixed-Dose Combination in Adult Participants with Previously Untreated Metastatic or Unresectable Melanoma. III
R3767-ONC-2055 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
PH-L19IL2TNF-01 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
D7988C00001 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
MK-3475-867 A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Medically Inoperable Stages I or IIA Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867). III
BO42864 A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non- Small Cell Lung Cancer. III
MK-3475A-F84 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
22615 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
ETOP 19-21 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
CGME751A12301 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
J2G-MC-JZJX 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
MK-2870-023 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
MK-1084-004 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
SGNB6A-002 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
849-007 A Phase 3 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation. III
MK-2870-019 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
1479-0008 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
J3M-MC-JZQB 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
20190341 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
SMT112-3003 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
MK-2870-007 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
CA127-1030 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
V940-002 “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
D9078C00001 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
AK112-301 A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed EGFR-TKI Treatment. III
MK-7684A-006 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
DS1062-A-U304 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
MK-2870-004 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
DZ2022E0005 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
BO42777 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
FURMO-004 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
D5087C00001 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
DS1062-A-U303 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
D533BC00001 A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY. III
GS-US-626-6216 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
MK-7339-013 A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC). III
DS7300-188 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
HLX10-020-SCLC302 A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC). III
20210004 A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects with Relapsed Small Cell Lung Cancer After Platinum-based First Line Chemotherapy. III
PM1183-C-008-21 A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer (SCLC) Patients (LAGOON). III
BAY 88-8223 / 20510 A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH. IV
9785-CL-0123 A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study. IV
ART-CAB-2013-01 Efficacy of Cabazitaxel, Abiraterone and doceTaxel Sequence in men with metastatic castration-resistant prostate cancer: a European, retrospective, observational study (CATS). IV
IRONMAN-ES IRONMAN-ES: Estudio prospectivo observacional de parámetros clinicos y biomarcadores en cáncer de próstata avanzado en hospitales de España. IV
22331 Treatment patterns in prostate cancer patients who received darolutamide in ARAMIS trial with extended follow-up. IV
ABSIDE-S 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
GS-ES-569-6845 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
D9673R00025 A multi-center, multi-country prospective observational study of patients initiating T-DXd in the first or second treatment line for HER2+ unresectable and/or metastatic breast cancer. IV
I3Y-MC-B013 Evaluating outcomes in patients with locally advanced or metastatic breast cancer participating in abemaciclib Patient Support Program in Spain. IV
C4221026/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. IV
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. IV
GEMCAD 2201 Circulating tumor DNA as complementary tool to assess response to neoadjuvant therapy in locally advanced rectal cancer. GEMCAD-REVEAL STUDY. IV
CA209-1227 Caracterización de la expresión de PD-L1 en el adenocarcinoma esofagogástrico avanzado/metastásico en España (estudio CÁRPATOS). IV
PANT-SP-2023-01 Estudio de factores pronósticos y predictivos de respuesta a tratamiento quimioterápico en pacientes diagnosticados de cáncer de páncreas avanzado. IV
02-MX-003 Observation of Residual Cancer with Liquid biopsy Evaluation (ORACLE). IV
BAY-LAR-2022-01 ON-TRK: Estudio prOspectivo No intervencionista en pacientes con cáncer de fusión TRK localmente avanzado o metastásico tratados con larotrectinib. IV
CDRB436X2X02B 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
2023-12144 Estudio observacional, internacional, retrospectivo de revisión de historias clínicas, para describir las características, patrones de tratamiento y resultados clínicos en los pacientes tratados con selpercatinib dentro de un Programa de Acceso Temprano en España y Portugal. IV
2021-10496 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
2020-9610 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
BLU-285-1406 GIST 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
GEIS 66 Exploración de reordenamiento génico NTRK 1/2/3 en GIST y sarcoma de hueso. GIBOTREK. IV
212342 Estudio Observacional Multicéntrico de Pacientes que Reciben Tratamiento Sistémico para Sarcoma Sinovial Avanzado y Mixoide/ Liposacroma de Células Redondas. IV
GEM-1801 ESTUDIO OBSERVACIONAL DESCRIPTIVO SOBRE LAS CARACTERÍSTICAS DEL MELANOMA AVANZADO Y METASTÁSICO EN ESPAÑA. IV
ROMast-001 A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s). IV
GECP 23/01 Características de la Disfunción Sexual en los pacientes con Cáncer de Pulmón. IV
B7461039 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
MS100070_0176 An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies. IV
D4191C00137 Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit from Continued Treatment. IV
GECP 23/04 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
NIS102748 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
ETOP LUNGSCOPE ETOP LUNGSCOPE. IV
GECP 21/05 Study of ctDNA as prognostic factor on resectable stage IIIA NSCLC patients treated with neoadjuvant treatment in real world. IV
CPDR001X2X01B 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
TAS-120-404 An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study. IV
TK-SCR-01 Assessing Frequency of HLA-Genotypes and Tumor Antigen Expression in Subjects with Relapsed/Refractory, Advanced-Stage Solid Tumors that may Qualify for T Cell Receptor Based Therapies. IV
TTD-20-01 Estudio epidemiológico observacional multicéntrico descriptivo sobre tumores digestivos. IV
CHECKIMID ESTUDIO OBSERVACIONAL, MULTICÉNTRICO, RETROSPECTIVO Y PROSPECTIVO, PARA EVALUAR LA EFECTIVIDAD Y SEGURIDAD DE LA INMUNOTERAPIA EN PACIENTES CON CÁNCER Y ENFERMEDADES INFLAMATORIAS INMUNOMEDIADAS. IV
CA209-8TT Pan Tumor Study for Long Term Follow-up of Cancer Survivors who have participated in Trials investigating Nivolumab. IV
MK-3475-587 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
Nocanther A feasibility clinical investigation of intratumoral injection of magnetic nanoparticles associated to hyperthermia treatment in locally advanced pancreatic cancer. Medical device
EF-39 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). Medical device
ONCO01P04 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. Medical device

Oncology Clinical Trials (Phase I + Baskets, II-III-IV) with active recruitment at some time in the year 2024

Code Clinical Trial Title Phase
MK2140-006 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
NP39488 AN OPEN-LABEL, MULTI-CENTER, PHASE IB STUDY OF RO7082859 AND ATEZOLIZUMAB (PLUS A SINGLE PRE-TREATMENT DOSE OF OBINUTUZUMAB) IN ADULT PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA. I
BP41072 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
GCT3009-01 Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A Firstin-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts. I
GCT3013-01 A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma. I
CYTB323A12101 Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL. I
GCT3013-02 A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody® -CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma. I
BGB-11417-101 A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies. I
SGN35C-001 A phase 1, open-label study to evaluate SGN-35C in adults with advanced malignancies. I
M23-647 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
M23-324 A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies. I
CO43805 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
IDP-121 Phase 1/2 multicenter, open-label, dose-escalation study of IDP-121 in patients with relapsed/refractory hematologic malignancies. I
D9571C00001 A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma. I
R1979-ONC-1504 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
GO29781 An open-label, multicenter, phase I/Ib trial evaluating the safety and pharmacokinetics of escalating doses of BTCT4465A as a single agent and combined with atezolizumab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. I
80948543LYM1002 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
R5837-ONC-2019 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
EONHL1-20 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
EZH-302 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
BGB-16673-101 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
BYON4228.001 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
87801493LYM1001 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
BO43243 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
DR-01-ONC-001 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
D7405C00001 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
DSP-5336-101 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
CC-99282-NHL-001 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
17-BI-1206-02 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
M22-132 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
CPIT565A12101 A phase I, open-label, multi-center study of PIT565 in patients with relapsed and/or refractory B-cell malignancies. I
CA123-1000 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
90014496LYM1001 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
CC-93269-MM-001 A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF CC-93269, A BCMA X CD3 T CELL ENGAGING ANTIBODY, IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA. I
M22-947 Relapsed or Refractory Multiple Myeloma: Dose Escalation and Expansion of ABBV-383 in Combination with Anti-Cancer Regimens. I
GO42552 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
GO43073 A phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety and pharmacokinetics of Xmab24306 in combination with Daratumumab in patients with relapsed/refractory multiple myeloma. I
R5458-ONC-2012 PHASE 1B STUDY OF REGN5458 (ANTI-BCMA X ANTICD3 BISPECIFIC ANTIBODY) PLUS OTHER CANCER TREATMENTS FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA. I
D9470C00001 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
75276617ALE1001 A First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants with Acute Leukemia. I
KO-MEN-001 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
CC-91633-AML-001 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
75276617ALE1002 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
KO-MEN-008 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
HM-FLTI-101 A Phase ½ Open Label, Multicenter, Dose Escalation, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patient with Relapsed or Refractory Acute Myeloid Leukemia (AML). I
TERN701-1012 A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Patients with Chronic Myeloid Leukemia. I
H3B-8800-G000-101 An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Spicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia. I
MK-1026-003 A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies. I
ATA129-EBV-205 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
2020-306-GLOB1 A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations. I
CCS1477-02 An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy in patients with advanced haematological malignancies. I
AP-0102 (SERPRO STUDY) A global, open label, adaptive design pivotal study to investigate the benefit and safety of SerpinPC in severe hemophilia A or B subjects previously receiving factor concentrate prophylaxis. II
GC-LTFU-001 Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells. II
54767414AMY2009 A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis. II
BGB-11417-201 A SingleArm, OpenLabel, Multicenter Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Bcl2 Inhibitor BGB11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma. II
D822GC00001 A Multicentre, Phase II, Randomised, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination with Venetoclax and Rituximab in Participants with Treatment Naïve Mantle Cell Lymphoma (TrAVeRse). II
R1979-ONC-1625 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
XPORT-DLBCL-030 A PHASE 2/3, MULTICENTER RANDOMIZED STUDY OF RITUXIMAB-GEMCITABINEDEXAMETHASONE- PLATINUM (R-GDP) WITH OR WITHOUT SELINEXOR IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (RR DLBCL). II
M-2020-371 A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma(R-R DLBCL),who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. II
ALLO-501A-201 A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy in Subjects with Relapsed/Refractory Large B-Cell Lymphoma (LBCL). II
GELLC-10-ZANUBIO 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
54179060CLL2032 (TAILOR) Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia. II
GELLC-9-Richter (MO43880) A Phase 1b study of JNJ-75348780 in Combination with other Anticancer Therapy in Participants with NHL and CLL. II
BGB-11417-203 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
KILT A randomized non comparative Phase II study of Lacutamab with GemOx versus GemOx alone in relapsed/refractory patients with peripheral Tcell lymphoma. II
CGT9486-20-201 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
64407564MMY1001 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
KER050-MF-301 A Phase 2, Open-label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Participants with Myelofibrosis (MF). II
KER050-MD-201 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
AG946-C-002 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
4202-HEM-301 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
PKRPC001 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
MPOH08 (PHOEBUS) A multi-center randomized, double blinded phase IIb trial evaluating oral pooled fecal microbiotherapy Maa7033 to prevent allogenic hematopoietic cell transplantation complications. II
CCTL019A2205B Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CAR T-Cell Therapy. II
CPI-0209-01 A Phase 1/2 Study of CPI-0209 Monotherapy and in Combination with Other Therapy in Patients with Advanced Tumors. II
KT-US-982-5968 Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells. II
ANT-010 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
C3731003 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
NN7415-4616 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
B7841007 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
Sobi.BIVV001-001 A phase 3b open-label, multicenter study evaluating physical activity and joint health in previously treated patients ≥12 years of age with severe haemophilia A treated with intraveneous recombinant coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN;  efanesoctocog alfa) for 24 months. III
FRONTIER-4 (NN7769-4532) Open-label, long-term safety and efficacy study of Mim8 in participants with haemophilia A with or without inhibitors. III
C0371002 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
ATA129-EBV-302 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
NEOD001-301 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
GO43878 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
MK-4280A-008 A Phase 3 Randomized Clinical Study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Physician’s Choice Chemotherapy in PD-1/L1-refractory Relapsed or Refractory Classical Hodgkin Lymphoma. III
GLA 2017-R2 (Pola-R-ICE) Estudio fase III abierto, prospectivo, para comparar polatuzumab vedotin más rituximab, ifosfamida, carboplatino y etopósido (Pola-R-ICE) y rituximab, ifosfamida, carboplatino y etopósido (R-ICE) solo como terapia de rescate en pacientes con linfoma difuso de célula B grande (LDCBG) primariamente refractarios o en recaída III
BGB-3111-LTE1 Estudio abierto, multicéntrico y de extensión a largo plazo con pautas de zanubrutinib (BGB-3111) en pacientes con neoplasias malignas de linfocitos B. III
M20-621 A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with R-CHOP Compared to R-CHOP in Subjects with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL). III
GO44145 (Skyglo) A PHASE III, MULTICENTER, RANDOMIZED, OPEN‑LABEL TRIAL COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB , CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLA‑R‑CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA. III
KT-US-484-0136 F 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
PCI-32765CAN3001 A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study. III
KTE-US-473-0133 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
M22-003 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
CCTL019E2301 A randomized, open-label, multicenter phase III trial comparing tisagenlecleucel to standard of care in adult patients with relapsed or refractory follicular lymphoma. III
R1979-HM-2298 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
LOXO-BTK-20022 (LOXO-305) - BRUIN CLL-322 A Phase 3 Open-Label, Randomized Study of Fixed Duration LOXO-305 plus Venetoclax and Rituximab versus Venetoclax and Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322). III
LOXO-BTK-20030 A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314) III
MK-1026-011 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
20190360 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
AB15003 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
R1979-ONC-22102 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
CC-220-MM-002 A Phase 3, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) - EXCALIBER-RRMM. III
C1071007 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
64407564MMY3002 A Phase 3 Randomized Study Comparing Talquetamab SC in Combination with Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination with Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy. III
CA057-008 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
64407564MMY3009 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
64007957MMY3005 (MajesTEC-7) 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
EMN29 Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone (SPd) versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Patients with Re-lapsed or Refractory Multiple Myeloma (RRMM). III
HOVON-150 A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy. III
DIM-95031-006 (ALIDHE) 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
M20-178 Estudio de fase 3 aleatorizado y abierto para evaluar la eficacia y la seguridad de navitoclax combinado con ruxolitinib en comparación con el mejor tratamiento disponible en pacientes con mielofibrosis en recaída/refractario (TRANSFORM-2). III
PAC 303 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
XPORT-MF-034 (KPTBEP11-0D1OQL) 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
PTG-300-11 A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera. III
SY-1425-301 A Randomized, Double-blind, Placebo-controlled Phase 3 Study of SY-1425 Plus Azacitidine Versus Placebo Plus Azacitidine in Newly diagnosed, RARA-positive Adult Participants with Higher-risk Myelodysplastic Syndrome. III
LUSPLUS 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
CA056-025 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
CA056-1060 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
BO42161 A Phase III, Randomized, Open Label, Active-Controlled, multicenter study evaluating the efficacy and safety of Crovalimab vs Eculizumab in Adult and Adolescent patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently treated with compliment inhibitors. III
CVAY736O12301 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
RODEX A multicenter, randomized, open-label study of dexamethasone plus romiplostim vs dexamethasone in patients with newly diagnosed primary immune thrombocytopenia. III
CVAY736I12301 A phase 3, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia. III
PRN1008-018 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
2022-523-GLOB1 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
CSL964-2001 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
ALXN-1210-TMA-313 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
CD101.IV.3.08 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
MC-MSC.1/aGvHD 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
TRACE Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial. III
MK-3543-007 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
MK-3543-006 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
GENA-25 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
Sobi.Alprolix-002 (B-MORE) Estudio observacional y multicéntrico de 48 meses para evaluar la eficacia a largo plazo de Elocta en la salud articular. IV
HEM-POWR HEM-POWR: Estudio observacional para evaluar la eficacia y la seguridad del tratamiento con damoctocog alfa pegol en la vida real en pacientes con hemofilia A tratados previamente. IV
TAK-660-403 Evaluation of long-term safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, rurioctocog alfa pegol) in patients with haemophilia A – An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS). IV
MOTIVATE MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial. IV
ML42270 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
NN7088-4928 Non-Interventional Study of the Change in Joint Health in Adult Patients with Haemophilia A after Switching to Prophylaxis with Turoctocog Alfa Pegol (N8-GP). IV
AP-0105 A Global, Non-interventional Study to Prospectively Evaluate Bleeding Episodes and Treatment Use in Patients with Hemophilia. IV
ML44186 (LEMON) OBSERVATIONAL STUDY TO DESCRIBE THE CLINICAL IMPACT OF TREATMENT PATTERNS IN PEOPLE WITH MILDMODERATE HEMOPHILIA A IN SPAIN (STUDY LEMON). IV
SL45088 Cross-sectional Study to evaluate the perception with hemophilia a treated with emicizumab. Hemo-Act. IV
R1979-ONC-2090 (ORCHID) R1979-ONC-2090 Outcomes in Patients with Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated with Systemic Therapy from Real-World Experience (ORCHID). IV
R1979-ONC-20103 (FLORA) Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated with Systemic Therapy in a Real-World Assessment (FLORA). IV
KTE-iNHL-RW2020 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
D8221R00003 (PICAROS) 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
CEL-MIE-2012-01 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
CEL-MIE-2016-01 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 progenitoreshematopoyéticos en España. Estudio QoLMMBuS. IV
JAN-DAR-2019-02 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
CEL-BEN-2019-01 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
GEM-MIE-2014-01 Estudio observacional prospectivo para identificar los aspectos clínicos que conducen a la toma de decisiones terapéuticas en pacientes con mielofibrosis. IV
CC-5013-MDS-010 (216900) A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide. IV
DNO-IBR-2018-01 Virología e inmunología de la infección por el citomegalovirus (CMV) en el paciente con neoplasias hematológicas en la era de las nuevas bioterapias. IV
AG348-C008 Pyruvate Kinase Deficiency Global Longitudinal Registry. IV
AIE-ART-2016-01 Estudio retrospectivo para evaluar el uso de agonistas de los receptores de trombopoyetina en pacientes adultos con trombocitopenia inmune primaria en España. IV
GRI1007-GC2001 Post-Authorization Long Term Safety Surveillance Study of Fostamatinib in Adult Patients with Chronic Immune Thrombocytopenia (cITP) who are Refractory to Previous Treatments. IV
SOBI-Doptelet 001 Estudio observacional, multicéntrico para evaluar el uso y la eficacia de Doptelet® (Avatrombopag) en pacientes adultos con Trombocitopenia Inmune (PTI). IV
TAK-705-3003 Natural History and Treatment Outcomes of Congenital and Immune Thrombotic Thrombocytopenic Purpura: a Retrospective Chart Review Study. IV
MSD-CMV-2017-01 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
AA_00117 Real-World Comparative Effectiveness of Belumosudil vs. Physician’s Choice of Best Available Therapy for the Treatment of Chronic Graft vs. Host Disease: A Retrospective Study Using Patient Medical Records. IV
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