Directed by Cristina Saura, the main area of expertise of VHIO’s Breast Cancer Group is clinical research focused on drug development and associated translational research. In addition to maintaining high patient recruitment in our studies, we also play a leading role in many of the clinical trials that we run. This enables us to apply translational data to guide and accelerate drug development:

• HER2-positive disease: we participate in major trials assessing novel therapies and the most promising agents in the field including trastuzumab deruxtecan, tucatinib and many others currently under development. We have initiated recruitment for the first trial with cell therapy in this area, and are translating the clinical benefit of novel agents in both the metastatic and early disease settings to potentially increase the number of patients cured at first diagnosis. 

• Luminal disease: in partnership with VHIO's Experimental Therapeutics and Cancer Cell Cycle Groups, headed by Violeta Serra and Marcos Malumbres, respectively, we are working to advance insights into the mechanisms of resistance to several therapies, and how they may be reversed through treatment with PI3K, AKT, CDK4/6, and BET inhibitors, as well as novel oral SERDs and different PARP inhibitors. This year, a new wave of PI3K inhibitors have been developed as a treatment opportunity for patients with tumors harboring PI3K mutations, and we are proud to have the most promising clinical trials available for our patients. We are also starting new projects using predictive spatial transcriptomics to identify minimal residual disease after surgery in estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+ HER2-) breast cancer to ultimately better tailor adjuvant treatment toward curing more patients in this setting. 

• Triple negative disease: in addition to our participation in clinical trials testing combinations of immunotherapies and promising antibody drug conjugates, we have created an in-house integrative multi-omics platform to identify predictive biomarkers of response to chemotherapy and immune checkpoint inhibitors (ICI) in early triple-negative breast cancer (TNBC) with more than 40 patients already recruited. We are now starting to analyze the collected samples to identify novel biomarkers. We are also collaborating in pioneering projects focused on cell-based therapies directed by Alena Gros, head of VHIO’s Tumor Immunology and Immunotherapy Group, to develop novel personalized T-cell therapies.

• Circulating tumor DNA (ctDNA): in collaboration with VHIO's Cancer Genomics Group led by Ana Vivancos, we are leading several projects to address the challenging scenario of early disease as well as identify ctDNA in unexplored biological samples including breast milk. This has been one of our standout projects in 2023, with the publication of our first results (Saura et al. 2023), as well as securing funding for this research through several competitive projects. Having generated important interest among patients, we will continue to assess the utility of our in-house developed test for breast cancer screening in the postpartum period. In addition, we continue to screen patients with metastatic breast cancer to identify targetable molecular alterations for personalized medicine as well as opportunities for patients to be included in matched clinical trials.

• Optimize therapies by introducing novel anti-cancer treatments and adding rational combinations to combat mechanisms of resistance.
• Incorporate proteomics, genomics, and ctDNA platforms in translational research to advance insights into tumor biology.
• Apply preclinical and predictive data to help guide innovative clinical trial design in early and advanced disease.

• Relevant contributions in drug approval. Thanks to the leadership of our investigators, we continue to contribute to the approval of therapies including capivasertib for HR+/HER2-negative breast cancer for patients with 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, intratumoral treatments and new immunotherapies that will lead to new approvals in the near future.
• Precision medicine. Thanks to VHIO’s Molecular Prescreening Program, driven by one of our Institutional Programs, the Advanced Molecular Diagnostics Program – DIAMAV supported by Fundación FERO, we continue to identify potentially matched patients with molecular alterations as an enrichment strategy for clinical trials in breast cancer with PI3KCA, ESR1 or HER2 mutations.
• VHIO’s proteomics and ctDNA platforms have also helped us to advance insights into tumor biology. Published this year (Saura et al. 2023), promising results in the detection of ctDNA in breast milk have led us to embark on a prospective study for the early diagnosis of breast cancer using this technique in healthy women (MMATERNA trial).

• 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.

• Saura C, Ortiz C, Matito J, Arenas EJ, Suñol A, Martín Á, Córdoba O, Martínez-Sabadell A, García-Ruiz I, Miranda I, Morales-Comas C, Carrasco E, Viaplana C, Peg V, Nuciforo P, Bayó-Puxan N, Gonzalez-Medina A, Miquel JM, Gómez-Rey M, Villacampa G, Arévalo S, Espinosa-Bravo M, Balmaña J, Dienstmann R, Arribas J, Tabernero J, Vivancos A, Sansó M. Early-Stage Breast Cancer Detection in Breast Milk. Cancer Discov. 2023 Oct 5;13(10):2180-2191. 
• Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. 
• Partridge AH, Niman SM, Ruggeri M, Peccatori FA, Azim HA Jr, Colleoni M, Saura C, Shimizu C, Sætersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Ruíz-Borrego M, Moore HCF, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Smith KL, Ferreiro T, Ribi K, Ruddy K, Kammler R, El-Abed S, Viale G, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O; International Breast Cancer Study Group; POSITIVE Trial Collaborators. Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer. N Engl J Med. 2023 May 4;388(18):1645-1656.
• Loibl S, Azim HA Jr, Bachelot T, Berveiller P, Bosch A, Cardonick E, Denkert C, Halaska MJ, Hoeltzenbein M, Johansson ALV, Maggen C, Markert UR, Peccatori F, Poortmans P, Saloustros E, Saura C, Schmid P, Stamatakis E, van den Heuvel-Eibrink M, van Gerwen M, Vandecaveye V, Pentheroudakis G, Curigliano G, Amant F. ESMO Expert Consensus Statements on the management of breast cancer during pregnancy (PrBC). Ann Oncol. 2023 Oct;34(10):849-866.

1. ctDNA in breast milk for early detection of pregnancy associated breast cancer – Instituto de Salud Carlos III (ISCIII).
2. ctDNA in breast milk for early detection of pregnancy associated breast cancer- Intensificación FIS – Instituto de Salud Carlos III (ISCIII).
3.  ctDNA in breast milk for early detection of pregnancy associated breast cancer Ayudas PFIS for a PhD Student – Instituto de Salud Carlos III (ISCIII).
4. Plataforma integrativa multiómica para la identificación de biomarcadores predictivos de respuesta a quimioterapia e inmunoterapia en cáncer de mama triple negativo temprano (PORTRAIT-TNBC) – Instituto de Salud Carlos III (ISCIII).
5. Caracterización multiómica del cáncer de mama en mujeres jóvenes: impacto de la lactancia y el embarazo en su mal pronóstico– Instituto de Salud Carlos III (ISCIII).
6. Clonal hematopoiesis of indeterminate potential in cancer patients: impact on immune dysfunction, tratment response and therapy related malignancies– Instituto de Salud Carlos III (ISCIII).
7. 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 – Sociedad Española de Oncología Médica (SEOM).
8. Impacto de la microbiota mamaria e intestinal en el pronóstico y en la respuesta al tratamiento con inhibidores de checkpoint inmunitario en cáncer de mama– Sociedad Española de Oncología Médica (SEOM).
9. ctDNA in breast milk for early detection of pregnancy associated breast cancer – Sociedad Española de Oncología Médica (SEOM).
10. Terapia celular adoptiva mediante transferencia de linfocitos CD3+/PD1+ infiltrantes de tumor en pacientes con cáncer de mama avanzado – Asociación Española Contra el Cáncer (AECC).
11. MMATERNA: maternal breast milk ctDNA detection for early diagnosis of pregnancy associated breast cancer– CaixaImpulse.
12. 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– Premio M. Chiara Giorgetti-Asociación Cáncer de Mama Metastático.
13. Predictive spatial transcriptomics to identify minimal residual disease in ER+ HER2- breast cancer– Premio M. Chiara Giorgetti- Asociación Cáncer de Mama Metastático.
14. 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) – Metapremio M. Chiara Giorgetti- Asociación Cáncer de Mama Metastático.
15. OPTimizing adjuvant prescription of PEMbrolizumab in patients with early-stage triple-negative breast cancer achieving pathologic complete response after standard neoadjuvant chemotherapy and pembrolizumab – IGR –CRIS Contra el Cáncer.
16. ETNA: adjuvant single agent immunotherapy in Early Triple Negative BreAst cancer with high stromal tumor-infiltrating lymphocytes (TILs) score- IGR- CRIS Contra el Cáncer.
17. PRECAM: predictores de cardiotoxicidad en cáncer de mama HER2-postivo precoz – Marató de TV3.
18. SPECTA: screening cancer patients for efficient clinical trial access – EORTC 1553.

1. 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) – Funded by el Paseico de la mama.
2. 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 – Funded by el Paseico de la mama.
3. Resonancia nuclear magnètica para mejorar el estiadaje de cáncer de mama en mujeres embarazadas – Funded by el Paseico de la mama.
4. TOTEM: Development of LCMSM for accurate measurement of estradiol in premnenopasual patients receving LHRH agonistis and aromatase inhibitors or tamoxifen – Funded by el Paseico de la mama.
5. MMATERNA: maternal breast milk ctDNA detection for early diagnosis of pregnancy associated breast càncer – Funded by Partners of Choice Astra Zeneca (AZ).
6. Understanding CDK4/6i and SERD resistance in metastatic ER+ breast cancer using patient simples and PDX’s– Funded by Astra Zeneca (AZ).
7. HER-Seq: A blood-based Screening Study to Identify Patients with HER2 Mutations for Enrollment into Clinical Research Studies of Neratinib – Funded by Puma.
8. Detection of Molecular Residual Disease after Neoadjuvant Chemotherapy in Breast Cancer – Funded by Roche.
9. Utilidad 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.
10. Exploiting post-transcriptional regulation to uncover novel vulnerabilities of metastatic cells.
11. Understanding CDK4/6i and SERD resistance in metastatic ER+ breast cancer using patient samples and PDXs.
12. Estudio de biomarcadores circulantes en sangre en pacientes con cáncer de mama.
13. Modulation of androgen receptor signaling as a therapeutic strategy for oestrogen receptor-positive metastatic breast cancer.
14. Patient stratification based on DNA repair functionality for cancer precision medicine.
15. Developing integrated clinical, in vivo and ex vivo platforms to understand platinum response and resistance in breast cancer.
16. 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.
17. 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.
18. PALBOSPAIN: Análisis observacional de tratamiento con palbociclib en pacientes con CM localment avanzado y/o metastásico RH+/HER2- en 1º línia de tratamiento.
19. Impacto y valor pronóstico de vesículas extracelulares tumorales provenientes de células madre cancerígenas en tumores de mama triple negativo-DipEV.

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12. Saura C, Ortiz C, Matito J, Arenas EJ, Suñol A, Martín Á, Córdoba O, Martínez-Sabadell A, García-Ruiz I, Miranda I, Morales-Comas C, Carrasco E, Viaplana C, Peg V, Nuciforo P, Bayó-Puxan N, Gonzalez-Medina A, Miquel JM, Gómez-Rey M, Villacampa G, Arévalo S, Espinosa-Bravo M, Balmaña J, Dienstmann R, Arribas J, Tabernero J, Vivancos A, Sansó M. Early-Stage Breast Cancer Detection in Breast Milk. Cancer Discov. 2023 Oct 5;13(10):2180-2191. doi: 10.1158/2159-8290.CD-22-1340. PMID: 37704212; PMCID: PMC10551665.
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21. Carreras MJ, Tomás-Guillén E, Farriols A, Renedo-Miró B, Valdivia C, Vidal J, Saura C, Carles J, Felip E, Gorgas MQ, Tabernero J, Monterde J. Use of Drugs in Clinical Practice and the Associated Cost of Cancer Treatment in Adult Patients with Solid Tumors: A 10-Year Retrospective Cohort Study. Curr Oncol. 2023 Aug 30;30(9):7984-8004. doi: 10.3390/curroncol30090580. PMID: 37754495; PMCID: PMC10528466.
22. Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. doi: 10.1056/NEJMoa2214131. PMID: 37256976.
23. Oristrell G, Burcet G, Valente F, Escrivá-De-Romaní S, Arumí M, Ferreira-González I. Treatment of mild asymptomatic cardiotoxicity in early-stage HER 2-positive breast cancer. Is it justified? Rev Esp Cardiol (Engl Ed). 2023 Jun;76(6):480-483. English, Spanish. doi: 10.1016/j.rec.2022.11.014. Epub 2023 Feb 15. PMID: 36805384.
24. Lukashchuk, N; Punie, K, Nowecki, Z, Im, SA, Armstrong, AC, Jacot, W, Kim, JH, Webster, MA, Balmaña, J, Delaloge, S, Casson, E, Loembe, B, Dean, E, Armenia, J, Tutt, ANJ. Olaparib (O) + ceralasertib (C) in patients (pts) with metastatic triple-negative breast cancer (mTNBC): Translational analysis of the VIOLETTE trial. J Clin Oncol. Volume 41, Number 16_suppl. https://doi.org/10.1200/JCO.2023.41.16_suppl.1087
25. Sánchez-Heras AB, Ramon Y Cajal T, Pineda M, Aguirre E, Graña B, Chirivella I, Balmaña J, Brunet J; SEOM Hereditary Cancer Working Group and AEGH Hereditary Cancer Committee. SEOM clinical guideline on heritable TP53-related cancer syndrome (2022). Clin Transl Oncol. 2023 Sep;25(9):2627-2633. doi: 10.1007/s12094-023-03202-9. Epub 2023 May 3. PMID: 37133731; PMCID: PMC10425559.
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27. Lozano R, Castro E, Lopez-Campos F, Thorne H, Ramirez-Backhaus M, Aragon IM, Cendón-Florez Y, Gutierrez-Pecharroman A, Salles DC, Romero-Laorden N, Lorente D, González-Peramato P, Calatrava A, Alonso C, Anido U, Arévalo-Lobera S, Balmaña J, Chirivella I, Juan-Fita MJ, Llort G, Y Cajal TR, Almagro E, Alameda D, López-Casas PP, Herrera B, Mateo J, Pritchard CC, Antonarakis ES, Lotan TL, Rubio-Briones J, Sandhu S, Olmos D. Impact of concurrent tumour events on the prostate cancer outcomes of germline BRCA2 mutation carriers. Eur J Cancer. 2023 May;185:105-118. doi: 10.1016/j.ejca.2023.02.022. Epub 2023 Mar 5. PMID: 36972661.
28. Oliveira M, Falato C, Cejalvo JM, Vila MM, Tolosa P, Salvador-Bofill FJ, Cruz J, Arumi M, Luna AM, Guerra JA, Vidal M, Martínez-Sáez O, Paré L, González-Farré B, Sanfeliu E, Ciruelos E, Espinosa-Bravo M, Pernas S, Izarzugaza Y, Esker S, Fan PD, Parul P, Santhanagopal A, Sellami D, Villacampa G, Ferrero-Cafiero JM, Pascual T, Prat A. Patritumab deruxtecan in untreated hormone receptor-positive/HER2-negative early breast cancer: final results from part A of the window-of-opportunity SOLTI TOT-HER3 pre-operative study. Ann Oncol. 2023 Aug;34(8):670-680. doi: 10.1016/j.annonc.2023.05.004. Epub 2023 May 19. PMID: 37211044.
29. Tagliamento M, Gennari A, Lambertini M, Salazar R, Harbeck N, Del Mastro L, Aguilar-Company J, Bower M, Sharkey R, Dalla Pria A, Plaja A, Jackson A, Handford J, Sita-Lumsden A, Martinez-Vila C, Matas M, Miguel Rodriguez A, Vincenzi B, Tonini G, Bertuzzi A, Brunet J, Pedrazzoli P, D'Avanzo F, Biello F, Sinclair A, Lee AJX, Rossi S, Rizzo G, Mirallas O, Pimentel I, Iglesias M, Sanchez de Torre A, Guida A, Berardi R, Zambelli A, Tondini C, Filetti M, Mazzoni F, Mukherjee U, Diamantis N, Parisi A, Aujayeb A, Prat A, Libertini M, Grisanti S, Rossi M, Zoratto F, Generali D, Saura C, Lyman GH, Kuderer NM, Pinato DJ, Cortellini A. Pandemic Phase-Adjusted Analysis of COVID-19 Outcomes Reveals Reduced Intrinsic Vulnerability and Substantial Vaccine Protection From Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Breast Cancer. J Clin Oncol. 2023 May 20;41(15):2800-2814. doi: 10.1200/JCO.22.01667. Epub 2023 Jan 31. PMID: 36720089; PMCID: PMC10414724.
30. Arteaga DP, DeKraker C, Ennis M, Dewey N, Goebel EA, Welch S, Pimentel I, Ippolito JE, Lohmann AE. Body composition and endometrial cancer outcomes. J Natl Cancer Inst Monogr. 2023 May 4;2023(61):49-55. doi: 10.1093/jncimonographs/lgad012. PMID: 37139979.
31. Garcia-Saenz JA, Blancas I, Echavarria I, Hinojo C, Margeli M, Moreno F, Pernas S, Ramon Y Cajal T, Ribelles N, Bellet M. SEOM-GEICAM-SOLTI clinical guidelines in advanced breast cancer (2022). Clin Transl Oncol. 2023 Sep;25(9):2665-2678. doi: 10.1007/s12094-023-03203-8. Epub 2023 May 6. Erratum in: Clin Transl Oncol. 2023 Jun 5;: PMID: 37148499; PMCID: PMC10425299.
32. Luen SJ, Viale G, Nik-Zainal S, Savas P, Kammler R, Dell'Orto P, Biasi O, Degasperi A, Brown LC, Láng I, MacGrogan G, Tondini C, Bellet M, Villa F, Bernardo A, Ciruelos E, Karlsson P, Neven P, Climent M, Müller B, Jochum W, Bonnefoi H, Martino S, Davidson NE, Geyer C, Chia SK, Ingle JN, Coleman R, Solbach C, Thürlimann B, Colleoni M, Coates AS, Goldhirsch A, Fleming GF, Francis PA, Speed TP, Regan MM, Loi S. Genomic characterisation of hormone receptor-positive breast cancer arising in very young women. Ann Oncol. 2023 Apr;34(4):397-409. doi: 10.1016/j.annonc.2023.01.009. Epub 2023 Jan 25. PMID: 36709040; PMCID: PMC10619213.
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35. Errazquin R, Carrasco E, Del Marro S, Suñol A, Peral J, Ortiz J, Rubio JC, Segrelles C, Dueñas M, Garrido-Aranda A, Alvarez M, Belendez C, Balmaña J, Garcia-Escudero R. Early Diagnosis of Oral Cancer and Lesions in Fanconi Anemia Patients: A Prospective and Longitudinal Study Using Saliva and Plasma. Cancers (Basel). 2023 Mar 21;15(6):1871. doi: 10.3390/cancers15061871. PMID: 36980757; PMCID: PMC10046988.
36. Francis PA, Fleming GF, Láng I, Ciruelos EM, Bonnefoi HR, Bellet M, Bernardo A, Climent MA, Martino S, Bermejo B, Burstein HJ, Davidson NE, Geyer CE Jr, Walley BA, Ingle JN, Coleman RE, Müller B, Le Du F, Loibl S, Winer EP, Ruepp B, Loi S, Colleoni M, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 1;41(7):1370-1375. doi: 10.1200/JCO.22.01065. Epub 2022 Dec 9. Erratum in: J Clin Oncol. 2023 Sep 1;41(25):4187. PMID: 36493334; PMCID: PMC10419521.
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38. Nuciforo P, Townend J, Piccart MJ, Fielding S, Gkolfi P, El-Abed S, de Azambuja E, Werutsky G, Bliss J, Moebus V, Colleoni M, Aspitia AM, Gomez H, Gombos A, Coccia-Portugal MA, Tseng LM, Kunz G, Lerzo G, Sohn J, Semiglazov V, Saura C, Kroep J, Ferro A, Cameron D, Gelber R, Huober J, Di Cosimo S. Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer. Eur J Cancer. 2023 Mar;181:92-101. doi: 10.1016/j.ejca.2022.12.020. Epub 2022 Dec 27. PMID: 36641898.
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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.

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.

Published this year (Hernando-Calvo et al. 2023), results of a VHIO-led study support the clinical utility of the Vall d’Hebron immune gene expression signature (VIGex) as a predictive tool to help guide patient selection for immunotherapy. In collaboration with colleagues at the Princess Margaret Centre in Toronto, our VIGex signature has now been validated in an external cohort. These initial findings are currently being prospectively validated in patients treated with immunotherapy across different phase I clinical trials at VHIO.

VHIO is a founding member of both the WIN - Worldwide Innovative Networking in personalized cancer medicine and the Cancer Core Europe (CCE) consortia. These collaborations are academic projects that connect internationally renowned cancer centers to develop cutting-edge cancer diagnostics and new personalized therapies for cancer 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. In 2023, we added a new study module to evaluate the bispecific monoclonal antibody amivantamab in selected patients with MET and EGFR alterations, and we continue to explore new funding opportunities to further expand the number of study modules.

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 aim to accelerate the design and development of a new generation of data rich, dynamic studies in oncology. In 2023, this project reached its halfway point. 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. We also lead CCE's Clinical Trials Task Force.

In collaboration with VHIO’s UITM – CaixaResearch, our teams continue to establish VHIO as a leading reference in cancer drug discovery and development. In 2023, 608 patients were enrolled in our portfolio of 249 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. 

In partnership with colleagues at the Cancer Center Clínica Universidad de Navarra (CIMA), and Cristina Saura, Head of VHIO’s Breast Cancer Group, we are studying allogeneic natural killer (NK) cell therapy combined with HER2-directed therapy in HER2-positive breast cancer. We also work closely with Joaquin Arribas, Head VHIO’s Growth Factors Group, to develop CAR-T cell therapy targeting the tumor-specific antigen p95HER2 in HER2-positive (HER2+) breast cancer. 

Importantly, 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 under grant agreement No. 101104684. 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.

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.

• Early clinical drug development of best-in-class targeted therapies. Determine optimal treatment schedules and identify patient populations who would be most likely to derive 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).

• 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. 
• In collaboration with colleagues at the Clínica Universidad de Navarra (CIMA), we are developing allogeneic natural killer (NK )cell therapy, in addition to other cell-based therapies.
• Launched this year, 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.
• We coordinate the Cancer Core Europe (CCE) consortium’s Building Data Rich Clinical Trials (CCE-DART). This EU-funded project focuses on developing interconnected tools to reduce the current complexity of investigator-initiated trials and better guide clinical decision making through the implementation of cutting-edge digital technologies and platforms.
• We also participate two other EU Horizon 2020 projects; canSERV and PCM4EU, to strengthen expertise in personalized medicine and facilitate the design and development of complex trials.

• Sacher A, LoRusso P, Patel MR, Miller WH Jr, Garralda E, Forster MD, Santoro A, Falcon A, Kim TW, Paz-Ares L, Bowyer S, de Miguel M, Han SW, Krebs MG, Lee JS, Cheng ML, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Dharia NV, Schutzman JL, Desai J; GO42144 Investigator and Study Group. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. N Engl J Med. 2023 Aug 24;389(8):710-721. 
• Marin I, Boix O, Garcia-Garijo A, Sirois I, Caballe A, Zarzuela E, Ruano I, Attolini CS, Prats N, López-Domínguez JA, Kovatcheva M, Garralda E, Muñoz J, Caron E, Abad M, Gros A, Pietrocola F, Serrano M. Cellular Senescence Is Immunogenic and Promotes Antitumor Immunity. Cancer Discov. 2023 Feb 6;13(2):410-431. 
• Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, Ivy P, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change - MDICT Guidelines 2022. Ann Oncol. 2023 Jan;34(1):48-60. 
• Drilon A, Subbiah V, Gautschi O, Tomasini P, de Braud F, Solomon BJ, Shao-Weng Tan D, Alonso G, Wolf J, Park K, Goto K, Soldatenkova V, Szymczak S, Barker SS, Puri T, Bence Lin A, Loong H, Besse B. Selpercatinib in Patients With RET Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial. J Clin Oncol. 2023 Jan 10;41(2):385-394. 

Over recent years, several advances have led to the more effective treatment of genitourinary (GU) malignancies. Immunotherapy (IO) is proving 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. We are proud to have participated in the EV-302 study (NCT04223856), results of which showed that enfortumab vedotin plus pembrolizumab almost doubled median overall survival compared to standard of care platinum-based chemotherapy. 

In kidney cancer, immune-based combination therapy, or IO plus antiangiogenics, are now considered as standard first-line treatment. We are now studying novel combinations including HIF2α inhibitors and other immunomodulators.

In close collaboration with the Urology Department at the Vall d’Hebron University Hospital (HUVH), we participate in different phase I studies with drugs targeting FGFR. We are also evaluating ADCs in patients with non-muscle invasive bladder cancer who relapse or progress despite sufficient intravesical Bacillus Calmette-Guerin (BCG) therapy, for whom early radical cystectomy is recommended. Aimed at bladder preservation, these new treatments are administered via intravesical drug delivery. 

Theranosis represents an innovative treatment approach in prostate cancer based on administering radioligands using beta emitters. New radioligands using α-emitters are currently being developed. We have participated in phase III trials involving patients with metastatic hormone-naïve and castration resistant prostate cancer. This type of therapy requires close collaboration with nuclear medicine teams to coordinate the administration and follow-up of patients.

Also in collaboration with HUVH's Urology Department, we have participated in recent studies that have demonstrated the utility of immune checkpoint inhibitors (ICIs) in the adjuvant setting for patients with bladder and kidney cancers at high risk of disease recurrence.

We also work together with other renowned research centers including the Cleveland Clinic (Ohio, USA), University of California, San Francisco (California, USA), 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). 

This year we have continued to expand our translational research program in prostate cancer, working alongside VHIO’s Prostate Cancer Translational Research Group led by Joaquin Mateo, as well as other hospitals in Catalonia. 

We are also developing new methods to identify tumor characteristics using exosomes, and continue to participate in the IRONMAN project directed by the Memorial Sloan Kettering Cancer Center (MSKCC – New York, USA), as the Spanish national repository. This international registry is building a comprehensive bank of clinical data and biospecimens from patients with metastatic prostate cancer. Our involvement in this project is supported by the Movember Foundation and Fundación FERO. 

In March of this year, we launched a collaborative project with the SOLTI Group and prostate cancer societies in Spain, focused on empowering patients with metastatic castration-resistant prostate cancer (mCRPC). To facilitate this, we have developed a dedicated website that integrates next-generation sequencing (NGS) of tumor samples and liquid biopsy data obtained through the Guardant Health platform. As part of our initiative, we request patients to participate in a survey to assess their expectations before and after the NGS analysis. This feedback helps us understand their perception regarding the treatments recommended by a panel of specialists. This study is endorsed by the Spanish Association Against Cancer (AECC) and the Movember Foundation. In the first year of the project, we have enrolled over 100 patients.

In collaboration with VHIO’s Radiomics Group led by Raquel Perez-Lopez, we have started another new project using PET MRI to define functional imaging-based response biomarkers in prostate cancer. This study is funded by the RETOS Program of the Spanish Ministry of Science.

Initiated in May this year, CARE1 is a European project coordinated by Gustave Roussy. Focused on pragmatic clinical trials and by 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 coordinate a national study to identify predictive biomarkers of response to first-line therapy for renal cell carcinoma (RCC). Funded by a grant received from the Spanish Genitourinary Oncology Group (SOGUG), we also participate in a project devoted to paried 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. 

We are founders and coordinators of the Adolescent Working Group of the GEINO Spanish cooperative group for research in neuro-oncology, and have participated in the first GEINO-SEOM clinical guidelines for adult medulloblastoma. 

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

We have set up the first Unit for Adolescent and Younger Adults (AYAs) in Spain 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.

Regarding tumors of unknown primary (CUP), we are working with investigators at the Josep Carreras Leukaemia Research Institute led by Manel Esteller. Using multi-omics (genomics, transcriptomics and epigenomics) to characterize the molecular features of 500 cancer cases of CUP, 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 also lead and coordinate the IMPaCT-GENóMICA precision medicine program to advance the diagnosis of CUP tumors.

Dedicated to promoting education and exchange, in 2023 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.
• Conduct clinical trials at different stages of disease with emphasis on a histology-tailored design and multidisciplinary approach.
• Continue developing our biopsy program for metastatic castration-resistant prostate cancer (mCRPC) patients to target genomic alterations including PI3K pathways, DNA repair genes, and androgen receptor alterations.
• Further consolidate 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 our translational research platform for glioblastoma in collaboration with VHIO's Gene Expression & Cancer Group.
• 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).
• Develop new tools and techniques including liquid biopsy and exosomes for the personalized treatment of mCRPC, GIST, and kidney cancer.
• We have initiated several quality of life and patient perspective academic studies. We also collaborate with patient advocacy groups to put patient perspectives a the heart of cancer care as well as our research into sarcoma.

• In 2023, we have consolidated our prostate cancer Task Force and Serum Bank, and have collected more than 900 blood and saliva samples. These efforts enable us to participate in different translational studies including our lead of the IRONMAN project in Spain. At the end of this year, more than 450 patients in Spain were included in this program, representing 13% of all patients included from around the world.
• We have also expanded our serum bank to include other tumor types and now have 188 kidney cancer samples and 81 sarcoma and GIST tumor samples.
• 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 continue to foster and develop new collaborations with different VHIO groups and external partners.

• Our prostate cancer Task Force will continue identify new opportunities to expand our translational research lines.

• We will continue to incorporate different community hospitals in our research programs to expand precision medicine in prostate cancer.
• Over the next few years, we will continue to develop radioligand therapy is an innovative approach to treat tumor types under our scope.
• 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.
• We aim to further incorporate patient perspectives in regular practice and research.

• Pook D, Geynisman DM, Carles J, de Braud F, Joshua AM, Pérez-Gracia JL, Llácer Pérez C, Shin SJ, Fang B, Barve M, Maruzzo M, Bracarda S, Kim M, Kerloeguen Y, Gallo JD, Maund SL, Harris A, Huang KC, Poon V, Sutaria DS, Gurney H. A Phase Ib, Open-label Study Evaluating the Safety and Efficacy of Ipatasertib plus Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer. Clin Cancer Res. 2023 Sep 1;29(17):3292-3300. 
• Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Heinrich D, Szczylik C, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschäbitz S, Oldenburg J, Lin X, Healy CG, Di Santo N, Zohren F, Fizazi K. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Jul 22;402(10398):291-303. 
• Carles J, Medina-Lopez RA, Puente J, Gómez-Ferrer Á, Nebra JC, Sáez Medina MI, Ribal MJ, Antolín AR, Álvarez-Ossorio JL, Suárez Novo JF, Agut CM, Srinivasan S, Ortiz J, Fizazi K. Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis. Future Oncol. 2023 Apr;19(12):819-828. 
• Yu EY, Piulats JM, Gravis G, Fong PCC, Todenhöfer T, Laguerre B, Arranz JA, Oudard S, Massard C, Heinzelbecker J, Nordquist LT, Carles J, Kolinsky MP, Augustin M, Gurney H, Tafreshi A, Li XT, Qiu P, Poehlein CH, Schloss C, de Bono JS. Pembrolizumab plus Olaparib in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort A Study. Eur Urol. 2023 Jan;83(1):15-26. 

• Gene mutation profiling of patients with Metastatic renal cell carcinoma treated with mTOR inhibitors. CRISTINA SUAREZ ROGRIGUEZ. Entity: FERO.
• BECA APRO 2019 Dra. C. Suarez. Entity: Associació per la Recerca Oncològica. From 7/2/2020 to 12/31/2024.
• DIVAS-Dissecting VAsculas Sarcomas. CLAUDIA VALVERDE MORALES. Entity: Grupo Español de Investigación en Sarcomas (GEIS). From 8/6/2020 to 12/31/2024.
• Avaluant l'efectivitat de teràpies de precisió dirigides a alteracions genètiques recurrents en Tumors Malignes de la Beina del Nervi Perifèric. JOAN CARLES GALCERAN. Entity: MARATÓ TV3. From 7/1/2020 to 1/31/2024.
• Title: Validación del valor predictivo de la firma de expresión génica Vigex-RCC en pacientes con cáncer renal metastásico tratados con combinaciones basadas en inmunoterapia en primera línea. CRISTINA SUAREZ ROGRIGUEZ. Entity: BRISTOL-MYERS SQUIBB. From 1/1/2023 to 12/31/2024.
• First line randomized study platform to optimize treatment in patients with metastatic renal cell carcinoma. CRISTINA SUAREZ RODRIGUEZ.Entity: EUROPEAN COMMISSION. From 5/1/2023 to 4/30/2028.
• Comparison of IO-IO vs IO-TKI strategy in metastic clear cell Renal Cell Carcinoma (CARE1).  CRISTINA SUAREZ ROGRIGUEZ. Entity: Fundación CRIS de Investigación para vencer el Cáncer. From 3/1/2023 to 2/28/2026.
• Defining the Landscape and Clinical Relevance of ATM Defects in Lethal Prostate Cancer. IP: JOAQUIN MATEO VALDERRAMA.Entity: PROSTATE CANCER FOUNDATION. From 11/21/2017 to 12/31/2024.
• IRONMAN-ES: Estudio prospectivo observacional de parámetros clinicos y biomarcadores en cáncer de próstata avanzado en hospitales de España. IP: JOAQUIN MATEO VALDERRAMA. Entity: The Movember Group PTY LTD. From 5/15/2019 to 12/31/2024.
• Title: Estudio de la interacción entre las vías de señalización de andrógenos y reparación del ADN en cáncer de próstata metastásico y tratamiento con combinaciones con inhibidores de PARP. IP: JOAQUIN MATEO VALDERRAMA. Entity: Fundación Científica de la Asociación Española Contra el Cáncer. From 12/1/2020 to 11/24/2024.
• Title: Prostate Cancer genomic evolution and signatures of DNA damage repair deficiencies  JOAQUIN MATEO VALDERRAMA. Entity: Fundación CRIS de Investigación para vencer el Cáncer. From 9/1/2021 to 9/1/2026.
• Title: RAD51 immunofluorescence to identify homologous recombination deficient (HRD) metastatic prostate cancers in a real-world population” IP: JOAQUIN MATEO VALDERRAMA Entity: AstraZeneca Farmacéutica Spain, S.A. From 11/24/2021 to 8/31/2024.
• Title: 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 in Spain. JOAQUIN MATEO VALDERRAMA & JOAN CARLES GALCERAN. Entity: SOLTI. From 11/24/2022 to 12/31/2024.
• Analysis of concurrent KIT and PI3K signaling inhibition as front-line tratment in GIST. IP: CESAR SERRANO GARCIA Entity: BAYER PHARMA AG. From 8/1/2015 to 12/31/2024.
• Apoptosis induction of DCC 2618 in imatinib sensitive and imatinib resistant Gist cell lines IP: CESAR SERRANO GARCIA. Entity: Deciphera Pharmaceuticals, LLC. From 2/22/2016 to 12/31/2024.
• Determinantes clínicos y moleculares de respuesta y progresión a la inhibición de KIT en pacientes con tumores del estroma gastrointestinal (GIST) con respuesta prolongada a Imatinib. CESAR SERRANO GARCIA Entity: Grupo Español de Investigación en Sarcomas (GEIS). From 2/1/2017 to 12/31/2024.
•  Caracterización del potencial predictivo y terapéutico del FBXO32 como mediador crítico de la señalización oncogénica de KIT/PDGFRA en tumores del estroma gastrointestinal. IP: CESAR SERRANO GARCIA. Entity: Fundación Mari Paz Jiménez Casado (FMPJC). From 12/18/2017 to 12/31/2024.
• Perfiles de resistencia molecular a la inhibición de KIT/PDGFRA en tumores del estroma gastrointestinal IP: CESAR SERRANO GARCIA. Entity: Fundación Científica de la Asociación Española Contra el Cáncer. From 12/1/2020 to 11/30/2024.
• Title: Role of centralization of pathological diagnosis and implementation of precision medicine strategies in sarcoma. IP: CESAR SERRANO GARCIA. Entity: Fundación Científica de la Asociación Española Contra el Cáncer. From 12/1/2022 to 11/30/2027.

• GEINO Group Secretary, 2023-2025. María Vieito
• Premio Jóvenes Investigadores Fundación AstraZeneca 2023: Joaquin Mateo.

1. DM Geynisman; M Burotto; C Porta; C Suarez; MT Bourlon; V Del Tejo; EX Du; X Yang; SR Sendhil; KA Betts; S Huo. Grade 3/4 Adverse Event Costs of Immuno-oncology Combination Therapies for Previously Untreated Advanced Renal Cell Carcinoma. Oncologist.28 - 1, pp. 72 - 79. 18/01/2023. ISSN 1549490X. DOI: 10.1093/oncolo/oyac186
2. Matthew S. Ernst; Vishal Navani; J. Connor Wells; Frede Donskov; Naveen Basappa; Chris Labaki; Sumanta K. Pal; Luis Meza; Lori A. Wood; D. Scott Ernst; Bernadett Szabados; Rana R. McKay; Francis Parnis; Cristina Suarez; Takeshi Yuasa; Aly-Khan Lalani; Ajjai Alva; Georg A Bjarnason; Toni K. Choueiri; Daniel Y.C. Henga. Outcomes for International Metastatic Renal Cell Carcinoma Database Consortium Prognostic Groups in Contemporary First-line Combination Therapies for Metastatic Renal Cell Carcinoma.  European Urology. 26/01/2023. ISSN 0302-2838. DOI: 10.1016/j.eururo.2023.01.001
3. Suarez, Cristina; Vieito, Maria; Valdivia, Augusto; Gonzalez, Macarena; Carles, Joan. Selective HIF2A Inhibitors in the Management of Clear Cell Renal Cancer and Von Hippel-Lindau-Disease-Associated Tumors. Med Sci (Basel, Switzerland). 11 - 3, 01/01/2023. ISSN 2076-3271
4. Pestana RC, Serrano C.  Analysis of histology-agnostic targets among soft tissue and bone sarcomas in the AACR GENIE database. Front Oncol. 2023 Jan 18;12:1079909. doi: 10.3389/fonc.2022.1079909. eCollection 2022.
5. RJ Motzer; M Schmidinger; M Eto; C Suarez; R Figlin; Y Liu; R Perini; Y Zhang; DY. Heng. LITESPARK-011: Belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy. Future Oncol.08/02/2023. ISSN 1479-6694. DOI: 10.2217/fon-2022-0802
6. Yu, Evan Y.; Piulats, Josep M.; Gravis, Gwenaelle; Fong, Peter C. C.; Todenhoefer, Tilman; Laguerre, Brigitte; Arranz, Jose A.; Oudard, Stephane; Massard, Christophe; Heinzelbecker, Julia; Nordquist, Luke T.; Carles, Joan; Kolinsky, Michael P.; Augustin, Marinela; Gurney, Howard; Tafreshi, Ali; Li, Xin Tong; Qiu, Ping; Poehlein, Christian H.; Schloss, Charles; de Bono, Johann S.Pembrolizumab plus Olaparib in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort A Study (vol 83, pg 15, 2023). Eur Urol. 83 - 3, pp. E87 - E87. 16/02/2023. ISSN 0302-2838, ISSN 1873-7560
7. Moreno V, Vieito M, Sepulveda JM, Galvao V, Hernández-Guerrero T, Doger B, Saavedra O, Carlo-Stella C, Michot JM, Italiano A, Magagnoli M, Carpio C, Pinto A, Sarmiento R, Amoroso B, Aronchik I, Filvaroff E, Hanna B, Wei X, Nikolova Z, Braña I. BET inhibitor trotabresib in heavily pretreated patients with solid tumors and diffuse large B-cell lymphomas. Nat Commun. 2023 Mar 13;14(1):1359. doi: 10.1038/s41467-023-36976-1. PMID: 36914652 Free PMC article. Clinical Trial.
8. He W, Xu L, Ding J, Song L, Yang W, Klooster I, Pilco-Janeta DF, Serrano C, Fang H, Jiang G, Wang X, Yu J, Ou WB. Co-targeting of ACK1 and KIT triggers additive anti-proliferative and -migration effects in imatinib-resistant gastrointestinal stromal tumors. Biochim Biophys Acta Mol Basis Dis. 2023 Jun;1869(5):166690. doi: 10.1016/j.bbadis.2023.166690. Epub 2023 Mar 13.
9. Gillessen S, Bossi A, Davis ID, de Bono J, Fizazi K, James ND, Mottet N, Shore N, Small E, Smith M, Sweeney CJ, Tombal B, Antonarakis ES, Aparicio AM, Armstrong AJ, Attard G, Beer TM, Beltran H, Bjartell A, Blanchard P, Briganti A, Bristow RG, Bulbul M, Caffo O, Castellano D, Castro E, Cheng HH, Chi KN, Chowdhury S, Clarke CS, Clarke N, Daugaard G, De Santis M, Duran I, Eeles R, Efstathiou E, Efstathiou J, Ekeke ON, Evans CP, Fanti S, Feng FY, Fonteyne V, Fossati N, Frydenberg M, George D, Gleave M, Gravis G, Halabi S, Heinrich D, Herrmann K, Higano C, Hofman MS, Horvath LG, Hussain M, Jereczek-Fossa BA, Jones R, Kanesvaran R, Kellokumpu-Lehtinen PL, Khauli RB, Klotz L, Kramer G, Leibowitz R, Logothetis C, Mahal B, Maluf F, Mateo J, Matheson D, Mehra N, Merseburger A, Morgans AK, Morris MJ, Mrabti H, Mukherji D, Murphy DG, Murthy V, Nguyen PL, Oh WK, Ost P, O'Sullivan JM, Padhani AR, Pezaro CJ, Poon DMC, Pritchard CC, Rabah DM, Rathkopf D, Reiter RE, Rubin MA, Ryan CJ, Saad F, Sade JP, Sartor O, Scher HI, Sharifi N, Skoneczna I, Soule H, Spratt DE, Srinivas S, Sternberg CN, Steuber T, Suzuki H, Sydes MR, Taplin ME, Tilki D, Türkeri L, Turco F, Uemura H, Uemura H, Ürün Y, Vale CL, van Oort I, Vapiwala N, Walz J, Yamoah K, Ye D, Yu EY, Zapatero A, Zilli T, Omlin A. Management of patients with advanced prostate cancer-metastatic and/or castration-resistant prostate cancer: Report of the Advanced Prostate Cancer Consensus Conference (APCCC) 2022. Eur J Cancer. 2023 May;185:178-215. doi: 10.1016/j.ejca.2023.02.018. Epub 2023 Mar 3. PMID: 37003085.
10. Moreno V, Vieito M, Sepulveda JM, Galvao V, Hernández-Guerrero T, Doger B, Saavedra O, Carlo-Stella C, Michot JM, Italiano A, Magagnoli M, Carpio C, Pinto A, Sarmiento R, Amoroso B, Aronchik I, Filvaroff E, Hanna B, Wei X, Nikolova Z, Braña I. BET inhibitor trotabresib in heavily pretreated patients with solid tumors and diffuse large B-cell lymphomas. Nat Commun. 2023 Mar 13;14(1):1359. doi: 10.1038/s41467-023-36976-1. PMID: 36914652 Free PMC article. Clinical Trial.
11. Pérez-Fidalgo JA, Ortega E, Ponce J, Redondo A, Sevilla I, Valverde C, Isern Verdum J, de Alava E, Galera López M, Marquina G, Sebio A. Uterine sarcomas: clinical practice guidelines for diagnosis, treatment, and follow-up, by Spanish group for research on sarcomas (GEIS). Ther Adv Med Oncol. 2023 Mar 28;15:17588359231157645. doi: 10.1177/17588359231157645. PMID: 37007636; PMCID: PMC10052607.
12. T Powles; M Kockx; A Rodriguez-Vida; I Duran; SJ Crabb; MS Van Der Heijden; B Szabados; AF Pous; G Gravis; UA Herranz; A Protheroe; A Ravaud; D Maillet; MJ Mendez; C Suarez; M Linch; A Prendergast; PJ van Dam; D Stanoeva; S Daelemans; S Mariathasan; JS Tea; K Mousa; R Banchereau; D Castellano. Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial. Nat Med. 29 - 12, pp. 3271. 21/03/2023. DOI: 10.1038/s41591-019-0628-7
13. C Loo Gan; J Huang; E Pan; W Xie; AL Schmidt; C Labaki; L Meza; G Bouchard; H Li; F Jackson-Spence; C Sánchez-Ruiz; T Powles; SA Kumar; N Weise; WA Hall; BS Rose; B Beuselinck; C Suarez; SK Pal; TK Choueiri; DYC Heng; RR. McKay. Real-world Practice Patterns and Safety of Concurrent Radiotherapy and Cabozantinib in Metastatic Renal Cell Carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium. Eur Urol Oncol. 6 - 2, pp. 204 - 211. 01/04/2023. DOI: 10.1016/j.euo.2022.10.004
14. Serrano C, Bauer S, Gómez-Peregrina D, Kang YK, Jones RL, Rutkowski P, Mir O, Heinrich MC, Tap WD, Newberry K, Grassian A, Shi H, Bialick S, Schöffski P, Pantaleo MA, von Mehren M, Trent JC, George S. Circulating tumor DNA analysis of the phase III VOYAGER trial: KIT mutational landscape and outcomes in patients with advanced gastrointestinal stromal tumor treated with avapritinib or regorafenib.  Ann Oncol. 2023 Jul;34(7):615-625. doi: 10.1016/j.annonc.2023.04.006. Epub 2023 Apr 25.
15. Ruiz-Demoulin S, Trenquier E, Dekkar S, Deshayes S, Boisguérin P, Serrano C, de Santa Barbara P, Faure S. LIX1 Controls MAPK Signaling Reactivation and Contributes to GIST-T1 Cell Resistance to Imatinib. Int J Mol Sci. 2023 Apr 12;24(8):7138. doi: 10.3390/ijms24087138.
16. Carles, Joan; Medina-Lopez, Rafael A.; Puente, Javier; Gomez-Ferrer, Alvaro; Nebra, Javier Casas; Medina, Maria Isabel Saez; Ribal, Maria J.; Antolin, Alfredo Rodriguez; Alvarez-Ossorio, Jose Luis; Novo, Jose Francisco Suarez; Agut, Cristina Moretones; Srinivasan, Shankar; Ortiz, Jorge; Fizazi, Karim. Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis. Fut Oncol. 19 - 12, pp. 819 - 828. Fut Med LTD, 24/05/2023. ISSN 1479-6694, ISSN 1744-8301
17. Morales-Barrera, Rafael; Villacampa, Guillermo; Vidal, Natalia; Figols, Mariona; Giner, Julia; Bonfill, Teresa; Suarez, Cristina; Diaz, Nely; Mateo, Joaquin; Gonzalez, Macarena; Domenech, Montserrat; Puente, Javier; Carles, Joan. Prevalence of immune-related adverse events and anti-tumor efficacy in advanced/metastatic urothelial carcinoma following immune-checkpoint inhibitor treatment. Clin & Trans Oncol. 25 - 12, pp. 3556 - 3564. SPRINGER INT PUBL AG, 22/05/2023. ISSN 1699-048X, ISSN 1699-3055
18. C Suárez; JMG Larkin; P Patel; BP Valderrama; A Rodriguez-Vida; H Glen; F Thistlethwaite; C Ralph; G Srinivasan; MJ Mendez-Vidal; R Hartmaier; A Markovets; A Prendergast; B Szabados; K Mousa; T Powles. Phase II Study Investigating the Safety and Efficacy of Savolitinib and Durvalumab in Metastatic Papillary Renal Cancer (CALYPSO). J Clin Oncol.41 - 14, pp. 2493 - 2502. 10/05/2023. ISSN 2394-6520. DOI: 10.1200/JCO.22.01414
19. Hernando-Calvo A, Mirallas O, Marmolejo D, Saavedra O, Vieito M, Assaf Pastrana JD, Aguilar S, Bescós C, Lorente J, Giralt J, Benavente S, Temprana-Salvador J, Alberola M, Dienstmann R, Garralda E, Felip E, Villacampa G, Brana I. Nutritional status associates with immunotherapy clinical outcomes in recurrent or metastatic head and neck squamous cell carcinoma patients. Oral Oncol. 2023 May;140:106364. doi: 10.1016/j.oraloncology.2023.106364. Epub 2023 Mar 28. PMID: 36989964 Free article.
20. TK Choueiri; T Powles; L Albiges; M Burotto; C Szczylik; B Zurawski; E Yanez Ruiz; M Maruzzo; A Suarez Zaizar; LE Fein; FA Schutz; DYC Heng; F Wang; F Mataveli; YL Chang; M van Kooten Losio; C Suarez; RJ Motzer. Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma. N. Engl J Med.388 - 19, pp. 1767 - 1778. 11/05/2023. DOI: 10.1056/NEJMoa2212851
21. AB McGregor; DM Geynisman; M Burotto; C Suárez; MT Bourlon; PC Barata; S Gulati; S Huo; F Ejzykowicz; SI Blum; V Del Tejo; M Hamilton; JR May; EX Du; A Wu; P Kral; C Ivanescu; A Chin; KA Betts; CH Lee; TK Choueiri; D Cella; C Porta. Matching-adjusted Indirect Comparison of Nivolumab Plus Cabozantinib Versus Pembrolizumab Plus Axitinib in Patients with Advanced Renal Cell Carcinoma. Eur. Urol. Oncol.6 - 3, pp. 339 - 348. 01/06/2023. ISSN 2588-9311. DOI: 10.1016/j.euo.2023.01.012
22. Suárez C, Vieito M, Valdivia A, González M, Carles J. Med Sci (Basel). Selective HIF2A Inhibitors in the Management of Clear Cell Renal Cancer and Von Hippel-Lindau-Disease-Associated Tumors. 2023 Jun 30;11(3):46. doi: 10.3390/medsci11030046. PMID: 37489462 Free PMC article. Review.
23. Agarwal, N.; Azad, A. A.; Carles, J. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial (vol 402, pg 291, 2023). LANCET. 402 - 10398, pp. 290 - 290. 22/07/2023. ISSN 0140-6736, ISSN 1474-547X
24. MS Ernst; V Navani; JC Wells; F Donskov; N Basappa; C Labaki; SK Pal; L Meza; LA Wood; DS Ernst; B Szabados; RR McKay; F Parnis; C Suarez; T Yuasa; AK Lalani; A Alva; GA Bjarnason; TK Choueiri; DYC Heng. Outcomes for International Metastatic Renal Cell Carcinoma Database Consortium Prognostic Groups in Contemporary First-line Combination Therapies for Metastatic Renal Cell Carcinoma. Eur. Urol  2023; 84 (1): 109 - 116. 07/2023. DOI: 10.1016/j.eururo.2023.01.001
25. Gelderblom H, Jones RL, Blay JY, George S, 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, Harrow B, Becker C, Reichmann W, Sherman ML, Ruiz-Soto R, Heinrich MC, Bauer S; INTRIGUE investigators. Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study. Eur J Cancer. 2023 Oct;192:113245. doi:  10.1016/j.ejca.2023.113245. Epub 2023 Jul 20. PMID: 37598656 Free article. Clinical Trial.
26. SK Pal; L Albiges; P Tomczak; C Suárez; MH Voss; G de Velasco; J Chahoud; A Mochalova; G Procopio; H Mahammedi; F Zengerling; C Kim; T Osawa; M Angel; S Gupta; O Khan; G Bergthold; B Liu; M Kalaitzidou; M Huseni; C Scheffold; T Powles; TK Choueiri. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomized, open-label, phase 3 trial. Lancet, 402, pp. 185 - 195. 15/07/2023. DOI: 10.1016/S0140-6736(23)00922-4.
27. Serrano C, Martín-Broto J, Asencio-Pascual JM, López-Guerrero JA, Rubió-Casadevall J, Bagué S, García-Del-Muro X, Fernández-Hernández JÁ, Herrero L, López-Pousa A, Poveda A, Martínez-Marín V. 2023 GEIS Guidelines for gastrointestinal stromal tumors.  Ther Adv Med Oncol. 2023 Aug 24;15:17588359231192388. doi: 10.1177/17588359231192388. eCollection 2023. PMID: 37655207 Free PMC article. Review.
28. Laurence Albiges; Howard Gurney; Vagif Atduev; Cristina Suarez; Miguel A Climent; David Pook; Piotr Tomczak; Philippe Barthelemy; Jae Lyun Lee; Viktor Stus; Thomas Ferguson; Erhan Gokmen; Louis Lacombe; Craig Gedye; Rodolfo F Perini; Manish Sharma; Xiang Peng; Lee Chung-Han. Pembrolizumab plus lenvatinib as first-line therapy for advanced nonclear-cell renal cell carcinoma (KEYNOTE-B61): a single-arm, multicentre, phase 2 trial. The Lancet. 24 - 8, pp. 881 - 891. 01/08/2023. DOI: 10.1016/S1470-2045(23)00276-0
29. Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF; INDIGO Trial Investigators. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. doi: 10.1056/NEJMoa2304194. Epub 2023 Jun 4. PMID: 37272516 Clinical Trial.
30. Tabernero J, Bedard PL, Bang YJ, Vieito M, Ryu MH, Fagniez N, Chadjaa M, Soufflet C, Masson N, Gazzah A. Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens. Cancer Res Commun. 2023 Aug 28;3(8):1662-1671. doi: 10.1158/2767-9764.CRC-23-0284. eCollection 2023 Aug. PMID: 37645622 Free PMC article. Clinical Trial.
31. Di Vito A, Ravegnini G, Gorini F, Aasen T, Serrano C, Benuzzi E, Coschina E, Monesmith S, Morroni F, Angelini S, Hrelia P. The multifaceted landscape behind imatinib resistance in gastrointestinal stromal tumors (GISTs): A lesson from ripretinib. Pharmacol Ther. 2023  Aug; 248:108475. doi: 10.1016/j.pharmthera.2023.108475. Epub 2023 Jun 10.
32. Martin-Broto J, Valverde C, Hindi N, Vincenzi B, Martinez-Trufero J, Grignani G, Italiano A, Lavernia J, Vallejo A, Tos PD, Le Loarer F, Gonzalez-Campora R, Ramos R, Hernández-Jover D, Gutierrez A, Serrano C, Monteagudo M, Letón R, Robledo M, Moura DS, Martin-Ruiz M, López-Guerrero JA, Cruz J, Fernandez-Serra A, Blay JY, Fumagalli E, Martinez-Marin V. REGISTRI: Regorafenib in first-line of KIT/PDGFRA wild type metastatic GIST: a collaborative Spanish (GEIS), Italian (ISG) and French Sarcoma Group (FSG) phase II trial. Mol Cancer. 2023 Aug 9;22(1):127.
33. Carreras, Maria-Josep; Tomas-Guillen, Elena; Farriols, Anna; Renedo-Miro, Berta; Valdivia, Carolina; Vidal, Jana; Saura, Cristina; Carles, Joan; Felip, Enriqueta; Gorgas, Maria-Queralt; Tabernero, Josep; Monterde, Josep. Use of Drugs in Clinical Practice and the Associated Cost of Cancer Treatment in Adult Patients with Solid Tumors: A 10-Year Retrospective Cohort Study. Curr Oncol. 30 - 9, pp. 7984 - 8004. MDPI, 01/09/2023. ISSN 1198-0052, ISSN 1718-7729
34. Pook, David; Geynisman, Daniel M.; Carles, Joan; de Braud, Filippo; Joshua, Anthony M.; Perez-Gracia, Jose Luis; Perez, Casilda Llacer; Shin, Sang Joon; Fang, Bruno; Barve, Minal; Maruzzo, Marco; Bracarda, Sergio; Kim, Miso; Kerloeguen, Yannick; Gallo, Jorge Daniel; Maund, Sophia L.; Harris, Adam; Huang, Kuan-Chieh; Poon, Victor; Sutaria, Dhruvitkumar S.; Gurney, Howard. A Phase Ib, Open-label Study Evaluating the Safety and Efficacy of Ipatasertib plus Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer. Clin Can Res 2023; 29 - 17, AMER ASSOC CANCER RESEARCH, 01/09/2023. ISSN 1078-0432, ISSN 1557-3265
35. Serrano C, Álvarez R, Carrasco JA, Marquina G, Martínez-García J, Martínez-Marín V, Sala MÁ, Sebio A, Sevilla I, Martín-Broto J. SEOM-GEIS clinical guideline for gastrointestinal stromal tumors (2022). Clin Transl Oncol. 2023 Sep;25(9):2707-2717. doi: 10.1007/s12094-023-03177-7. Epub 2023 May 2. PMID: 37129716 Free PMC article.
36. Giacomo Nuvola; Veronica Mollica; Francesco Massari; Cristina Suárez. SEP The future of immunotherapy in advanced renal cell carcinoma: beyond PD-1/PD-L1 inhibitors.  Future Medicine. 18/09/2023. DOI: 10.2217/imt-2023-021
37. Vieito M, Moreno V, Spreafico A, Brana I, Wang JS, Preis M, Hernández T, Genta S, Hansen AR, Doger B, Galvao V, Lenox L, Brown RJ, Kalota A, Mehta J, Pastore F, Patel B, Mistry P, Gu J, Lauring J, Patel MR. Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors.  Clin Cancer Res. 2023 Sep 15;29(18):3592-3602. doi: 10.1158/1078-0432.CCR-23-0092. PMID: 37491846 Clinical Trial.
38. Hernando-Calvo A, Vila-Casadesús M, Bareche Y, Gonzalez-Medina A, Abbas-Aghababazadeh F, Lo Giacco D, Martin A, Saavedra O, Brana I, Vieito M, Fasani R, Stagg J, Mancuso F, Haibe-Kains B, Han M, Berche R, Pugh TJ, Mirallas O, Jimenez J, Gonzalez NS, Valverde C, Muñoz-Couselo E, Suarez C, Diez M, Élez E, Capdevila J, Oaknin A, Saura C, Macarulla T, Carles Galceran J, Felip E, Dienstmann R, Bedard PL, Nuciforo P, Seoane J, Tabernero J, Garralda E, Vivancos A. A pan-cancer clinical platform to predict immunotherapy outcomes and prioritize immuno-oncology combinations in early-phase trials.  Med. 2023 Oct 13;4(10):710-727.e5. doi: 10.1016/j.medj.2023.07.006. Epub 2023 Aug 11. PMID: 37572657 Free article.
39. Drakaki A, Powles T, Bamias A, Martin-Liberal J, Shin SJ, Friedlander T, Tosi D, Park C, Gomez-Roca C, Joly Lobbedez F, Castellano D, Morales-Barrera R, Moreno-Candilejo I, Fléchon A, Yuen K, Rishipathak D, DuPree K, Young F, Michielin F, Shemesh CS, Steinberg EE, Williams P, Lee JL. Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma). Clin Cancer Res. 2023 Nov 1;29(21):4373-4384. 
40. Kokkali S, Georgaki E, Mandrakis G, Valverde C, Theocharis S. Genomic Profiling and Clinical Outcomes of Targeted Therapies in Adult Patients with Soft Tissue Sarcomas. Cells. 2023 Nov 15;12(22):2632. doi: 10.3390/cells12222632. PMID: 37998367; PMCID: PMC10670373.
41. 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. 2023 Nov 14:JCO2300339. doi: 10.1200/JCO.23.00339.
42. Serrano, Cesar; Rothschild, Sara; Villacampa, Guillermo; Heinrich, Michael C; George, Suzanne; Blay, Jean-Yves; Sicklick, Jason K; Schwartz, Gary K; Rastogi, Sameer; Jones, Robin L; Rutkowski, Piotr; Somaiah, Neeta; Navarro, Victor; Evans, Denisse; Trent, Jonathan C. Rethinking placebos: embracing synthetic control arms in clinical trials for rare tumors. Nat Med 2023; 29 (11): 2689 – 2692
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• Phase 1 Dose-Escalation Study of LY2157299 Monotherapy and in Combination with Lomustine in Patients with Recurrent Malignant Glioma. H9H-MC-JBAH. PI: María Vieito
• A Phase 1 Study of LY3200882 in Patients with Solid Tumors. I8X-MC-JECA. PI: María Vieito
• A Phase 1b Dose Escalation Study of Cabozantinib (XL184) Administered in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors. XL184-021. PI: Cristina Suárez
• 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). C2321001. PI: Joan Carles
• Ensayo clínico de fase I con Olaratumab más Trabectedina en pacientes con sarcoma de tejidos blandos avanzado". GEIS 58 OLATRASTS. PI: Claudia Valverde
• 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 Barrera
• A Phase I First Time in Human Open Label Study of GSK3745417 administered with and without Anticancer Agents in Participants with Advanced Solid Tumors. 208850. PI: María Vieito
• A multicenter, Open-Label, first-in-human, Phase Ib/IIa Trial of EO2401, a novel multipeptide therapeutic vaccine, with and without PD-1 check point inhibitor, following standard treatment in patients with progressive glioblastoma (Rosalie study). EOGBM1-18. PI: María Vieito
• A Phase 1B, open-label, dose-finding study of CC-90010 in combination with temozolomide with or without radiation therapy in subjects with newly diagnosed glioblastoma. CC-90010-GBM-002. PI: María Vieito
• A Multicenter Phase 1, Open-Label study of DCC-3014 to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced tumors. DCC-3014-01-001. PI: César Serrano
• A Phase 1 study of JNJ-70218902, a T Cell redirecting agent, in advanced stage solid tumors. 70218902EDI1001. PI: Joan Carles
• A phase I/II, open-label, multi-center study of the safety and efficacy of BLZ945 as single agent and in combination with PDR001 in adults patients with advanced solid tumors.  BLZ945X2101. PI: María Vieito
• 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. CBT307-1. PI: Joan Carles
• A Phase I/Ib, open-label, multi-center study of DFF332 as a single agent and in combination with Everolimus or IO agents in patients with  advanced/relapsed ccRCC and other malignancies with HIF2α stabilizing mutation. CDFF332A12101. PI: Cristina Suárez
• 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: María Vieito
• 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. PI: María Vieito
• 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
• A dose-escalation and expansion study of the safety and pharmacokinetics of XL092 as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors. XL092-001. PI: Cristina Suárez
• An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours. CCS1477-01. PI: Joan Carles
• 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
• Ensayo clínico aleatorizado Fase I/II de selinexor más gemcitabina en determinados sarcomas de partes blandas y osteosarcomas avanzados. GEIS-67. PI: Claudia Valverde
• 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. BP42573. PI: María Vieito
• 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. PI: Claudia Valverde
• 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. 1403-0002. PI: Claudia Valverde
• 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
• 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: María Vieito
• A Phase 1, multicenter, open-label, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of intravenously administered FHD-609 in subjects with advanced synovial sarcoma. FHD-609-C-001. PI: Claudia Valverde
• 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. EDO-S101-1006. PI: María Vieito
• 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
• First-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery. CEB-01-RLS01-CT. PI: César Serrano
• A Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of AMG 509 in subjects with metastatic castration-resistant prostate cancer. 20180146. PI: Joan Carles
• 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
• 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. PI: Rafael Morales Barrera
• 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. MK-3475-U04/MK-3475-04A. PI: Rafael Morales Barrera
• 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. Debio 0123-GBM-105. PI: María Vieito
• 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: María Vieito
• A Multicenter Phase 1, open-label study of NB003 to assess safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies. NB003-001. PI: César Serrano
• 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)". AMX-500-001. PI: Joaquín Mateo
• Sarcomas de partes blandas localizados de alto riesgo de extremidades y pared de tronco en adultos:  un enfoque integrador que incluye quimioterapia estándar vs histotipo-dirigida neoadyuvante. ISG-GEIS 10-01. PI: Claudia Valverde
• SPARTAN: A multicenter, randomized, double-blind, placebo-controlled, Phase III study of ARN-509 in men with non-metastatic (M0) castration-resistant prostate cancer. ARN-509-003. PI: Joan Carles
• Estudio Clínico en Fase II aleatorizado de radioterapia, hormonoterapia y quimioterapia con docetaxel versus  radioterapia y hormonoterapia, en pacientes afectados de cáncer de próstata localizado de alto riesgo (Estadio III Y IV). QRT-SOGUG. PI: Claudia Valverde
• Ensayo clínico Fase II de tratamiento neoadyuvante con ifosfamida a dosis altas y radioterapia concomitante en sarcomas de partes blandas e identificación de marcadores predictores de respuesta. GEIS 15. PI: Claudia Valverde
• A randomized Phase III, factorial design, of cabazitaxel and pelvic radiotherapy in patients with localized prostate cancer and high-risk features of relapse. GETUG-AFU 23. PI: Joan Carles
• Efficacy of Cabazitaxel, Abiraterone and doceTaxel Sequence in men with metastatic castration-resistant prostate cancer: a European, retrospective, observational study (CATS). ART-CAB-2013-01. PI: Rafael Morales Barrera
• 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. PI: Claudia Valverde
• A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma. CA209-214. PI: Cristina Suárez
• 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. PI: Claudia Valverde
• Estudio de fase III, aleatorizado, controlado con placebo y doble ciego de JNJ-56021927 en combinación con acetato de abiraterona y prednisona en comparación con acetato de abiraterona y prednisona en sujetos con cáncer de próstata metastásico resistente a la castración (CPRCm) que no han recibido nunca quimioterapia. 56021927PCR3001. PI: Cristina Suárez
• A Phase 2, two-arm multicenter, open-label study to determine the efficacy and the safety of two different dose regimens of a pan-FGFR tyrosine kinase inhibitor JNJ-42756493 in subjects with metastatic or surgically unresectable urothelial cancer with FGFR genomic alterations. 42756493BLC2001. PI: Macarena González
• An international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma. RG-13-277 (rEECur). PI: Claudia Valverde
• Phase II, multicenter, open label, prospective trial for the use of regorafenib as first line treatment for patients with KIT/PDGFR Wild Type GIST. GEIS 40. PI: Claudia Valverde
• Three versus five years of adjuvant imatinib as treatment of patients with operable GIST with a high risk for recurrence: A randomised phase III study. SSGXXII. PI: Claudia Valverde
• A Phase III, multicenter, randomized, placebo-controlled, double-blind study of Atezolizumab (ANTI−PD-L1 ANTIBODY) in combination with Gemcitabine/Carboplatin versus Gemcitabine/Carboplatin alone in patients with untreated locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-based therapy . WO30070. PI: Rafael Morales Barrera
• Determinantes clínicos y moleculares de respuesta y progresión a la inhibición de KIT en pacientes con tumores del estroma gastrointestinal (GIST) con respuesta prolongada a Imatinib. GEIS 45. PI: César Serrano
• Estudio de fase 3 aleatorizado, doble ciego, multicéntrico, de nivolumab como tratamiento adyuvante frente a placebo en sujetos con Carcinoma urotelial invasivo de alto riesgo. CA209-274. PI: Rafael Morales Barrera
• Estudio de fase III, aleatorizado y abierto para evaluar la eficacia y la seguridad de pembrolizumab (MK-3475) en combinación con axitinib frente a sunitinib en monoterapia como tratamiento de primera línea del carcinoma renal metastásico (CRm) o localmente avanzado (KEYNOTE-426). MK-3475-426. PI: Cristina Suárez
• 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). MK-3475-365. PI: Joan Carles
• A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR). E7080-G000-307. PI: Cristina Suárez
• MEDI4736 combinations in metastatic renal cell carcinoma (CALYPSO). 010580QM. PI: Cristina Suárez
• A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib or Nivolumab and Ipilimumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma. CA2099ER. PI: Cristina Suárez
• Phase I-II trial of sunitinib plus nivolumab after standard treatment in advanced soft tissue and bone sarcomas. GEIS-52. PI: Claudia Valverde
• Ensayo fase II de nab-paclitaxel para el tratamiento de tumores desmoides y tumores desmoplásicos de células pequeñas y redondas y sarcoma de Ewing en recaída múltiple o refractarios”. GEIS 39. PI: Claudia Valverde
• A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study. 9785-CL-0123. PI: Joan Carles
• Identificacion de biomarcadores pronósticos en el osteosarcoma de alto grado. GEIS 44. PI: Claudia Valverde
• Ensayo clínico fase II, aleatorizado, multicéntrico, doble ciego, internacional, comparativo para determinar la eficacia y la seguridad de durvalumab en combinación con olaparib para el tratamiento en primera línea, en pacientes con cáncer urotelial irresecable en estadio IV inelegibles para tratamiento con cisplatino. D933IC00003. PI: Rafael Morales Barrera
• A Phase 3, randomized, double-blind, placebo-controlled study of Talazoparib with Enzalutamide in metastatic castration-resistant prostate cancer. C3441021. PI: Joan Carles
• Ensayo fase III, aleatorizado, abierto, controlado, multicéntrico, internacional de Durvalumab en combinación con el tratamiento estándar con quimioterapia y Durvalumab en combinación con Tremelimumab y el tratamiento estándar con quimioterapia frente al tratamiento estándar con quimioterapia solo, en primera línea en pacientes con cáncer urotelial localmente avanzado irresecable o metastásico. D933SC00001. PI: Rafael Morales Barrera
• 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. 1333-GUCG. PI: Macarena González
• A Phase 2, Randomized, double-blind, placebo-controlled study of Abiraterone acetate plus Prednisone with or without Abemaciclib in patients with metastatic castration-resistant prostate cancer. I3Y-MC-JPCM. PI: Joan Carles
• A Phase 2, randomized, open-label study of nivolumab combined with Ipilimumab versus standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma. SUNNIFORECAST. PI: Cristina Suárez
• A Phase 3, Interventional, randomized, multicenter, open-label Study of DCC-2618 vs Sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with Imatinib. DCC-2618-03-002. PI: César Serrano
• A Phase III, Randomized, open-label, multi-center, global study to determine the efficacy and safety of Durvalumab in combination with Gemcitabine+Cisplatin for neoadjuvant treatment followed by Durvalumab alone for adjuvant treatment in patients with muscle-invasive bladder cancer (NIAGARA). D933RC00001. PI: Cristina Suárez
• A Phase 3, randomized, study of neoadjuvant and adjuvant Nivolumab plus NKTR-214, versus Nivolumab alone versus standard of care in participants with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible. CA045009. PI: Rafael Morales Barrera
• A Phase 3b, randomized, double-blind study of Nivolumab combined with Ipilimumab versus Nivolumab monotherapy for patients with previously untreated advanced renal cell carcinoma and intermediate- or poor-risk factors. CA209-8Y8. PI: Cristina Suárez
• A randomized, open-label phase 2 Study evaluating Ramucirumab in pediatric patients and young adults with relapsed, recurrent, or refractory desmoplastic small round cell tumor. J1S-MC-JV01. PI: Claudia Valverde
• Ensayo en fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo de olaparib y abiraterona en comparación con placebo y abiraterona como tratamiento de primera línea en varones con cáncer de próstata metastásico resistente a la castración. D081SC00001. PI: Joaquín Mateo
• 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. MIN-003-1806. PI: María Vieito
• IRONMAN-ES: Estudio prospectivo observacional de parámetros clinicos y biomarcadores en cáncer de próstata avanzado en hospitales de España". IRONMAN-ES. PI: Joaquín Mateo
• Retrospective study of Cabozantinib in patients with metastic or unresectable renal cell carcinoma (RCC) in spain.SRWEC study (Spanish Real World Evidence Cabozantinib). SOGUG-2017-A-IEC REN-7. PI: Rafael Morales Barrera
• A Phase 3, multicenter, randomized, double-blind, placebo-controlled study of AG-881 in subjects with  residual/recurrent grade 2 Glioma with an IDH1 or IDH2 Mutation. AG881-C-004. PI: María Vieito
• A multicenter, Phase Ib/II trial of Selinexor in combination with Imatinib in patients with metastatic and/or unresectable gastrointestinal Stromal Tumors (GISTs) . GEIS 41. PI: César Serrano
• A phase II, open-label, biomarker-guided study of carboplatin efficacy in pre-treated metastatic castration- resistant prostate cancer (CRPC). CNIO-CP-2019-01. PI: Joaquín Mateo
• 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. ADP-0044-002. PI: Claudia Valverde
• A Randomized, double-blind, controlled Phase 3 study of Cabozantinib in combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in subjects with previously untreated advanced or metastatic renal cell carcinoma of intermediate or poor risk. XL184-313. PI: Cristina Suárez
• An Open-label, randomized Phase 3 Study of MK-6482 versus Everolimus in participants with advanced renal cell carcinoma that has progressed after prior PD- 1/L1 and VEGF-targeted therapies. MK-6482-005. PI: Cristina Suárez
• An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer. SGN22E-003. PI: Rafael Morales Barrera
• A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse. CA209-914. PI: Cristina Suárez
• A Phase III, multicenter, randomized, open-label study to evaluate the efficacy and safety of Atezolizumab given in combination with Cabozantinib versus Cabozantinib alone in patients with inoperable, locally advanced, or metastatic renal cell carcinoma who experienced diographic tumor progression during or after immune checckpoiny inhibitor treatment.WO41994. PI: Cristina Suárez
• A Modular Phase 2a multicentre open-label study to investigate DNA-damage response agents (or combinations) in patients with advanced cancer whose tumours contain molecular alterations (PLANETTE). D5339C00001. PI: Joaquín Mateo
• A Phase 1b/2 Study of immune and targeted combination therapies in participants with RCC (U03): substudy 03A. MK-3475-03A. PI: Cristina Suárez
• Estudio de fase 1b/2 de terapias inmunitarias y dirigidas combinadas en participantes con carcinoma renal (CR) (U03): subestudio 03B. MK-3475-03B. PI: Cristina Suárez
• A Phase 2, Single-arm, open-label clinical trial of Pembrolizumab plus lenvatinib in participants with first-line advanced/metastatic non-clear cell renal cell carcinoma (nccRCC) (KEYNOTE-B61). MK-3475-B61. PI: Cristina Suárez
• A Phase 2 study evaluating Futibatinib (TAS-120) plus pembrolizumab in the treatment of advanced or metastatic urothelial carcinoma. TAS-120-203. PI: Rafael Morales Barrera
• A Phase 3, randomized, open-label, controlled study of Cabozantinib (XL184) in combination with Atezolizumab vs second novel hormonal therapy (NHT) in subjects with metastatic castration-resistant prostate cancer. XL184-315. PI: Joan Carles
• An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies. BAY1841788/20321. PI: Joan Carles
• Randomized Phase II trial to evaluate the antitumor activity of Enzalutamide and Talazoparib (PF-06944076) for the treatment of metastatic hormone-naïve prostate cancer. MEDOPP234. PI: Joaquín Mateo
• Nivolumab in mRCC patients: Treg function, T-cell Access and nk interactions to predict and improve efficacy. REVOLUTION. PI: Joan Carles
• PSMAfore: Estudio de fase III, multicéntrico, aleatorizado y abierto en el que se compara 177Lu-PSMA-617 frente a un cambio de terapia dirigida al receptor de andrógenos en el tratamiento de hombres con cáncer de próstata metastásico progresivo resistente a la castración que no hayan recibido taxanos. CAAA617B12302. PI: Joan Carles
• 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. 17000139BLC3001. PI: Rafael Morales Barrera
• Phase III study of Sacituzumab Govitecan (IMMU-132) in metastatic or locally advanced unresectable urothelial cancer. iMMU-132-13. PI: Rafael Morales Barrera
• A Phase 2 Study of Abemaciclib in metastatic castration- resistant prostate cancer patients previously treated with a novel hormonal agent and Taxane-based Chemotherapy. I3Y-MC-JPCY. PI: Macarena González
• Phase II multicohort trial of trabectedin and low-dose radiation therapy in advanced/metastatic sarcomas (SYNERGIAS). GEIS-75. PI: Claudia Valverde
• 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. BAY 88-8223 / 20510. PI: Joan Carles
• A Phase III, double-blind, multicenter, randomized study of Atezolizumab (antipd-l1 antibody) versus placebo as adjuvant therapy in patients with high-risk muscle-invasive bladder cancer who are ctdna-positive following cystectomy. BO42843. PI: Rafael Morales Barrera
• 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. PI: Rafael Morales Barrera
• Phase 3, randomized, double-blind, study of Talazoparib with Enzalutamide versus placebo with Enzalutamide in men with ddr gene mutated metastatic castration-sensitive prostate cancer. C3441052. PI: Joaquín Mateo
• 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). D5086C00001. PI: Cristina Suárez
• Renal adjuvant multiple arm randomised trial (RAMPART): An international investigator-led Phase III multi-arm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse. RE06 RAMPART. PI: Cristina Suárez
• Estudio de fase 2 de neoadyuvancia con inhibidores de puntos de control inmunitario en cáncer urotelial (ABACUS-2). ABACUS-2. PI: Rafael Morales Barrera
• A Phase 3, randomized, placebo-controlled, double-blind study of Vimseltinib to assess the efficacy and safety in patients with tenosynovial giant cell tumor (MOTION). DCC-3014-03-001. PI: César Serrano
• An Open-label, randomized, phase 3 Study of MK-6482 in combination with Lenvatinib (MK-7902) vs Cabozantinib for second-line or third-line treatment in participants with advanced renal cell carcinoma who have progressed after prior Anti-PD-1/L1 Therapy. MK-6482-011. PI: Cristina Suárez
• A Phase 2, Randomized, Open-Label Study of Trilaciclib administered with first-line platinum-based chemotherapy and Avelumab maintenance therapy in patients with untreated, locally advanced or metastatic urothelial carcinoma (PRESERVE-3). G1T28-209. PI: Rafael Morales Barrera
• A Phase 3, randomized, controlled, multicenter, open-label study to compare Tivozanib in combination with Nivolumab to Tivozanib monotherapy in subjects with renal cell carcinoma who have progressed following one or two lines of therapy where one line has an immune checkpoint inhibitor. AV-951-20-304. PI: Cristina Suárez
• Estudio observacional multicéntrico de pacientes que reciben tratamiento sistémico para sarcoma sinovial avanzado y mixoide/ liposacroma de células redondas. 212342. PI: Claudia Valverde

• 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. PI: Claudia Valverde
• A Phase 2/3, Randomized, multicenter study to evaluate AL102 in patients with progressing desmoid tumors. AL-DES-01. PI: Claudia Valverde
• A Phase 3, randomized, open-label study to evaluate perioperative Enfortumab Vedotin plus Pembrolizumab (MK-3475) versus neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible participants with muscle-invasive bladder cancer (KEYNOTE-B15 / EV-304). MK-3475-B15. PI: Rafael Morales Barrera
• Impacto de la quimioterapida neoadyuvante con variantes histológicas en el carcinoma uroterial de vejiga: análisis retrospectivo. SOGUG-2017-IEC(VEJ)-3. PI: Rafael Morales Barrera
• Neo-adjuvant versus adjuvant chemotherapy in upper tract urothelial carcinoma: A feasibility Phase II randomized clinical trial (“URANUS”). EUOG-2016-003. PI: Macarena González
• A randomized, blinded, placebo-controlled, Phase 2 Study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma. INBRX109. PI: Claudia Valverde
• Phase 3 study of Belzutifan plus Pembrolizumab as adjuvant treatment in RCC. MK-6482-022. PI: Cristina Suárez
• An overarching study for children and adults with frontline and relapsed RhabdoMyoSarcoma. FaR-RMS. PI: Claudia Valverde
• A Phase 2, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Pemigatinib in participants with previously treated glioblastoma or other primary CNS tumors harboring activating FGFR mutations or translocations (FIGHT-209). INCB54828-209. PI: María Vieito
• 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. D361EC00001. PI: Joan Carles
• Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma. 1403-0008. PI: Claudia Valverde
• 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. IMMU-132-06. PI: Rafael Morales Barrera
• Phase 2/3 study to evaluate the efficacy and safety of unesbulin in unresectable or metastatic, relapsed or refractory leiomyosarcoma. PTC596-ONC-008-LMS. PI: Claudia Valverde
• A Randomized, Open-Label Phase 2 study evaluating Abemaciclib in combination with Irinotecan and Temozolomide in participants with relapsed or Refractory Ewing’s Sarcoma. J1S-MC-JP04. PI: Claudia Valverde
• 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. BO43936. PI: Cristina Suárez
• 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. PH-L19TNFSARC-03/18. PI: Claudia Valverde
• 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. CGT9486-21-301. PI: César Serrano
• A Phase 3 study for the treatment of newly diagnosed H3 K27M-mutant diffuse glioma. ONC-201-108. PI: María Vieito
• Avelumab master protocol (B9991046): an open-label continuation study for participants continuing from Pfizer-sponsored avelumab clinical studies, substudy B9991001C: an open-label study for continued treatment access for participants from the B9991001 Avelumab study. B9991046/B9991001C. PI: Rafael Morales Barrera
• 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
• 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 BarreraO44157, 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. BO44157. PI: David Marmolejo
• A randomized open-label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in subjects with advanced or metastatic non-clear cell renal cell carcinoma. XL092-304. PI: Cristina Suárez
• A phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety in patients with Tenosynovial giant cell tumor. ABSK021-301. PI: César Serrano
• Estudio observacional, multicéntrico, retrospectivo y prospectivo, para evaluar la efectividad y seguridad de la inmunoterapia en pacientes con cáncer y enfermedades inflamatorias inmunomediadas. CHECKIMID. PI: Cristina Suárez
• Exploración de reordenamiento génico NTRK 1/2/3 en GIST y sarcoma de hueso. GIBOTREK. GEIS 66. PI: Claudia Valverde
• Phase I/II randomized clinical trial of Selinexor plus gemcitabine in selected advanced soft-tissue sarcomas. SELNET-7-1. PI: Claudia Valverde

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 continued to pioneer anti-PD1 therapies in head and neck carcinoma.
• The advancement of precision oncology in head and neck cancers.
• Translational and clinical research in rare head and neck malignancies.
• 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).

• Harrington KJ, Burtness B, Greil R, Soulières D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023 Feb 1;41(4):790-802. 
• Hernando-Calvo A, Mirallas O, Marmolejo D, Saavedra O, Vieito M, Assaf Pastrana JD, Aguilar S, Bescós C, Lorente J, Giralt J, Benavente S, Temprana-Salvador J, Alberola M, Dienstmann R, Garralda E, Felip E, Villacampa G, Brana I. Nutritional status associates with immunotherapy clinical outcomes in recurrent or metastatic head and neck squamous cell carcinoma patients. Oral Oncol. 2023 May;140:106364. 
• Vieito M, Moreno V, Spreafico A, Brana I, Wang JS, Preis M, Hernández T, Genta S, Hansen AR, Doger B, Galvao V, Lenox L, Brown RJ, Kalota A, Mehta J, Pastore F, Patel B, Mistry P, Gu J, Lauring J, Patel MR. Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors. Clin Cancer Res. 2023 Sep 15;29(18):3592-3602. 

1. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Harrington KJ, Burtness B, Greil R, Soulières D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Lin J, Gumuscu B, Swaby RF, Rischin D. J Clin Oncol. 2023 Feb 1;41(4):790-802. doi: 10.1200/JCO.21.02508. Epub 2022 Oct 11. PMID: 36219809.

1. Nutritional status associates with immunotherapy clinical outcomes in recurrent or metastatic head and neck squamous cell carcinoma patients. Hernando-Calvo A, Mirallas O, Marmolejo D, Saavedra O, Vieito M, Assaf Pastrana JD, Aguilar S, Bescós C, Lorente J, Giralt J, Benavente S, Temprana-Salvador J, Alberola M, Dienstmann R, Garralda E, Felip E, Villacampa G, Brana I. Oral Oncol. 2023 May;140:106364. doi: 10.1016/j.oraloncology.2023.106364. Epub 2023 Mar 28. PMID: 36989964.

1. Recommendations for the use of biomarkers for head and neck cancer, including salivary gland tumours: A Consensus of the Spanish Society of Medical Oncology and the Spanish Society of Pathology. Pérez JMT, García-Cosío M, García-Castaño A, Gomà M, Mesia-Nin R, Ruiz-Bravo E, Soria-Rivas A, Castillo P, Braña-García I, Alberola-Ferranti M. Rev Esp Patol. 2023 Jan-Mar;56(1):45-57. doi: 10.1016/j.patol.2022.06.003. Epub 2022 Aug 27. PMID: 36599600.

1. Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors. Vieito M, Moreno V, Spreafico A, Brana I, Wang JS, Preis M, Hernández T, Genta S, Hansen AR, Doger B, Galvao V, Lenox L, Brown RJ, Kalota A, Mehta J, Pastore F, Patel B, Mistry P, Gu J, Lauring J, Patel MR. Clin Cancer Res. 2023 Sep 15;29(18):3592-3602. doi: 10.1158/1078-0432.CCR-23-0092. PMID: 37491846.
2. Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. Leary A, Oaknin A, Trigo JM, Moreno V, Delord JP, Boni V, Braña I, Fernández C, Kahatt C, Nieto A, Cullell-Young M, Zeaiter A, Subbiah V. Eur J Cancer. 2023 Oct;192:113259. doi: 10.1016/j.ejca.2023.113259. Epub 2023 Jul 28. PMID: 37634282 Free article.
3. Phase I/II sequencing study of azacitidine, epacadostat, and pembrolizumab in advanced solid tumors. Luke JJ, Fakih M, Schneider C, Chiorean EG, Bendell J, Kristeleit R, Kurzrock R, Blagden SP, Brana I, Goff LW, O'Hayer K, Geschwindt R, Smith M, Zhou F, Naing A. Br J Cancer. 2023 Jun;128(12):2227-2235. doi: 10.1038/s41416-023-02267-1. Epub 2023 Apr 22. PMID: 37087488.
4.  BET inhibitor trotabresib in heavily pretreated patients with solid tumors and diffuse large B-cell lymphomas. Moreno V, Vieito M, Sepulveda JM, Galvao V, Hernández-Guerrero T, Doger B, Saavedra O, Carlo-Stella C, Michot JM, Italiano A, Magagnoli M, Carpio C, Pinto A, Sarmiento R, Amoroso B, Aronchik I, Filvaroff E, Hanna B, Wei X, Nikolova Z, Braña I. Nat Commun. 2023 Mar 13;14(1):1359. doi: 10.1038/s41467-023-36976-1. PMID: 36914652.

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. Moreover, over the last 5 years we have established our Unit as a reference in tackling these diseases, with one of the largest therapeutic arsenals against skin cancers. 

Melanoma research is led by Eva Muñoz and our group is a consolidated research team incorporating clinical investigators, dermatologists, other medical specialists, and cancer researchers. It is thanks to our purely multidisciplinary and translational research model that we lead one of the largest melanoma networks in Spain and in Europe. We are one of the most active groups in metastatic and neoadjuvant/adjuvant clinical trials in melanoma and other skin cancers. 

Over the past few years, we have made significant progress by (co) leading and participating in several phase I, II and III studies in melanoma and other skin cancers to study various novel therapies in the metastatic, neoadjuvant and adjuvant settings. We have also participated in different preclinical and clinical projects, mainly focused on resistance to standard targeted therapies and immunotherapies.

In collaboration with other medical departments including internal medicine, cardiology, neurology, nephrology, hepatology, and endocrinology, we have established 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 promote research into the mechanisms underlying adverse events associated with immunotherapy during treatment.

• 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 clinical trial design and sourcing strategies.
• Enhance clinical care for patients suffering from cutaneous or ocular melanoma, and advance insights into melanoma development and progression.
• 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 deepen our understanding of tumor immunology and the biology of skin tumors.
• Translate preclinical discovery into improved outcomes for patients. Unveil the molecular mechanisms implicated in the genesis and progression of other cutaneous tumors, especially squamous and basal cell skin cancer. 
• The discovery of effective molecular targets for metabolic therapies to broaden the therapeutic arsenal against skin tumors.

• Our Unit continues to lead one of the largest melanoma research networks in Spain and Europe, and 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. 
• 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.
• The expansion of 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.
• Apply for and obtain academic grants.

• Continue to (co) lead early clinical drug development and the design of different clinical trials in melanoma.
• Continue to offer certain patients novel and personalized treatment options (clinical trials).
• Optimize the recruitment of patients with skin tumors at our institution and referral centers.
• Maintain regular contact with referral centers regarding trials and resources available at our unit.
• Promote collaborative circuits with other centers at national and international level.
• Consolidation of a Seroteca for the collection of samples for future national collaborations.

• Lozano-Rabella M, Garcia-Garijo A, Palomero J, Yuste-Estevanez A, Erhard F, Farriol-Duran R, Martín-Liberal J, Ochoa-de-Olza M, Matos I, Gartner JJ, Ghosh M, Canals F, Vidal A, Piulats JM, Matías-Guiu X, Brana I, Muñoz-Couselo E, Garralda E, Schlosser A, Gros A. Exploring the Immunogenicity of Noncanonical HLA-I Tumor Ligands Identified through Proteogenomics. Clin Cancer Res. 2023 Jun 13;29(12):2250-2265. 
• de Braud F, Dooms C, Heist RS, Lebbe C, Wermke M, Gazzah A, Schadendorf D, Rutkowski P, Wolf J, Ascierto PA, Gil-Bazo I, Kato S, Wolodarski M, McKean M, Muñoz Couselo E, Sebastian M, Santoro A, Cooke V, Manganelli L, Wan K, Gaur A, Kim J, Caponigro G, Couillebault XM, Evans H, Campbell CD, Basu S, Moschetta M, Daud A. Initial Evidence for the Efficacy of Naporafenib in Combination With Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase Ib, Open-Label Study. J Clin Oncol. 2023 May 10;41(14):2651-2660. 
• Diab A, Gogas H, Sandhu S, Long GV, Ascierto PA, Larkin J, Sznol M, Franke F, Ciuleanu TE, Pereira C, Muñoz Couselo E, Bronzon Damian F, Schenker M, Perfetti A, Lebbe C, Quéreux G, Meier F, Curti BD, Rojas C, Arriaga Y, Yang H, Zhou M, Ravimohan S, Statkevich P, Tagliaferri MA, Khushalani NI. Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. J Clin Oncol. 2023 Oct 20;41(30):4756-4767. 
• Bratland Å, Munoz-Couselo E, Mortier L, Roshdy O, González R, Schachter J, Arance AM, Grange F, Meyer N, Joshi AJ, Billan S, Hughes BGM, Grob JJ, Ramakrishnan K, Ge J, Gumuscu B, Swaby RF, Gutzmer R. Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629. Dermatol Ther (Heidelb). 2023 Dec;13(12):3165-3180. 

1. Wong SK, Blum SM, Sun X, Da Silva IP, Zubiri L, Ye F, Bai K, Zhang K, Ugurel S, Zimmer L, Livingstone E, Schadendorf D, Serra-Bellver P, Muñoz-Couselo E, Ortiz C, Lostes J, Huertas RM, Arance A, Pickering L, Long GV, Carlino MS, Buchbinder EI, Vázquez-Cortés L, Jara-Casas D, Márquez-Rodas I, González-Espinoza IR, Balko JM, Menzies AM, Sullivan RJ, Johnson DB. Efficacy and safety of immune checkpoint inhibitors in young adults with metastatic melanoma. Eur J Cancer. 2023 Mar;181:188-197. 
2.  Lozano-Rabella M, Garcia-Garijo A, Palomero J, Yuste-Estevanez A, Erhard F, Farriol-Duran R, Martín-Liberal J, Ochoa-de-Olza M, Matos I, Gartner JJ, Ghosh M, Canals F, Vidal A, Piulats JM, Matías-Guiu X, Brana I, Muñoz-Couselo E, Garralda E, Schlosser A, Gros A. Exploring the Immunogenicity of Noncanonical HLA-I Tumor Ligands Identified through Proteogenomics. Clin Cancer Res. 2023 Jun 13;29(12):2250-2265. 
3. de Braud F, Dooms C, Heist RS, Lebbe C, Wermke M, Gazzah A, Schadendorf D, Rutkowski P, Wolf J, Ascierto PA, Gil-Bazo I, Kato S, Wolodarski M, McKean M, Muñoz Couselo E, Sebastian M, Santoro A, Cooke V, Manganelli L, Wan K, Gaur A, Kim J, Caponigro G, Couillebault XM, Evans H, Campbell CD, Basu S, Moschetta M, Daud A. Initial Evidence for the Efficacy of Naporafenib in Combination With Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase Ib, Open-Label Study. J Clin Oncol. 2023 May 10;41(14):2651-2660. 
4. Gonzalez-Cao M, Puertolas T, Martinez-Vila C, Carrera C, Maldonado Seral C, Rodríguez-Jiménez P, Sequero S, Cerezuela-Fuentes P, Feltes Ochoa R, Muñoz E, Antoñanzas Basa M, Martín-Liberal J, Soria A, Francisco Rodriguez Moreno J, Marquez-Rodas I, Lopez Criado P, Luis Manzano J, Lopez-Castro R, Ayala de Miguel P, Villalobos L, Martin Algarra S, Gonzalez-Barrallo I, Boada A, García Castaño A, Puig S, Crespo G, Luna Fra P, Aguayo Zamora C, Feito Rodríguez M, Valles L, Drozdowskyj A, Gardeazabal J, Antonio Fernandez-Morales L, Rodrigo A, Cruz R, Yelamos O, Rubio B, Mujica K, Provencio M, Berrocal A; Spanish Melanoma Group (GEM). SARS-CoV-2 infection in patients with melanoma: results of the Spanish Melanoma Group registry. Clin Transl Oncol. 2023 Mar;25(3):768-775. 
5. Hernando-Calvo A, Vila-Casadesús M, Bareche Y, Gonzalez-Medina A, Abbas-Aghababazadeh F, Lo Giacco D, Martin A, Saavedra O, Brana I, Vieito M, Fasani R, Stagg J, Mancuso F, Haibe-Kains B, Han M, Berche R, Pugh TJ, Mirallas O, Jimenez J, Gonzalez NS, Valverde C, Muñoz-Couselo E, Suarez C, Diez M, Élez E, Capdevila J, Oaknin A, Saura C, Macarulla T, Galceran JC, Felip E, Dienstmann R, Bedard PL, Nuciforo P, Seoane J, Tabernero J, Garralda E, Vivancos A. A pan-cancer clinical platform to predict immunotherapy outcomes and prioritize immuno-oncology combinations in early-phase trials. Med. 2023 Oct 13;4(10):710-727.e5. d
6. Riveiro-Barciela M, Barreira-Díaz A, Callejo-Pérez A, Muñoz-Couselo E, Díaz-Mejía N, Díaz-González Á, Londoño MC, Salcedo MT, Buti M. Retreatment With Immune Checkpoint Inhibitors After a Severe Immune-Related Hepatitis: Results From a Prospective Multicenter Study. Clin Gastroenterol Hepatol. 2023 Mar;21(3):732-740. 
7. Diab A, Gogas H, Sandhu S, Long GV, Ascierto PA, Larkin J, Sznol M, Franke F, Ciuleanu TE, Pereira C, Muñoz Couselo E, Bronzon Damian F, Schenker M, Perfetti A, Lebbe C, Quéreux G, Meier F, Curti BD, Rojas C, Arriaga Y, Yang H, Zhou M, Ravimohan S, Statkevich P, Tagliaferri MA, Khushalani NI. Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. J Clin Oncol. 2023 Oct 20;41(30):4756-4767. 
8. Clingan P, Ladwa R, Brungs D, Harris DL, McGrath M, Arnold S, Coward J, Fourie S, Kurochkin A, Malan DR, Mant A, Sharma V, Shue H, Tazbirkova A, Berciano-Guerrero MA, Charoentum C, Dalle S, Dechaphunkul A, Dudnichenko O, Koralewski P, Lugowska I, Montaudié H, Muñoz-Couselo E, Sriuranpong V, Oliviero J, Desai J. Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. J Immunother Cancer. 2023 Oct;11(10):e007637. 
9. Bratland Å, Munoz-Couselo E, Mortier L, Roshdy O, González R, Schachter J, Arance AM, Grange F, Meyer N, Joshi AJ, Billan S, Hughes BGM, Grob JJ, Ramakrishnan K, Ge J, Gumuscu B, Swaby RF, Gutzmer R. Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629. Dermatol Ther (Heidelb). 2023 Dec;13(12):3165-3180.
10. Schmid P, Lipatov O, Im SA, Goncalves A, Muñoz-Couselo E, Lee KS, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia JA, Zhou X, Haiderali A, Nguyen AM, Cortes J, Winer EP. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. Eur J Cancer. 2023 Dec;195:113393. 

• 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. 
• Estudio de fase III multicéntrico, aleatorizado y doble ciego de HBI-8000 combinado con nivolumab frente a placebo con nivolumab en pacientes con melanoma irresecable o metastásico no tratados previamente con inhibidores de PD-1 o PD-L1.
• Phase I trial: abierto y multicéntrico, para evaluar el efecto de la disfunción hepática moderada y grave en la farmacocinética y la seguridad del encorafenib en combinación con binimetinib, en pacientes adultos con tumores sólidos irresecables o metastásicos y mutación BRAF V600.
•  A Phase 1/2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR- 707) combined with cemiplimab for the treatment of participants with advanced unresectable or metastatic skin cancers.
• Phase II trial: Open label, multicenter phase II study of the C5a antibody IFX-1 alone or IFX-1 + pembrolizumab in patients with PD-1 or PD-L1 resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC).
• Phase I/II IGNYTE RPL-00-16: single agent and in combination with anti-PD1 blockade in patietns with solis tumors.
•  A 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. 
• Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple treatment combinations in patients with melanoma (MORPHEUS-MELANOMA).
• Phase IB trial: An open-label, phase I study of neo-ptc-01 in patients with advanced or metastatic melanoma, NTC-001.
• Phase III clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma.
• An open label, multicentre, phase I study to evaluate the impact of moderate and severe hepatic impairments on the pharmacokinetics and safety of encorafenib in combination with binimetinib in adult patients with unresectable or metastatic BRAF V600-mutant solid tumors.
• COMBI-AD: Estudio de fase III, aleatorizado y doble ciego de dabrafenib (GSK2118436) en COMBInación con trametinib (GSK1120212) frente a dos placebos en el tratamiento ADyuvante del melanoma de alto riesgo con la mutación BRAF V600 tras resección quirúrgica.
• KN-8701 A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants with BRAF and/or NRAS Mutation-positive Solid Tumors.
• Phase III trial: 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.
• Phase II trial BP43963 - A randomized, open-label, multicenter, phase ii study of multiple doses of RO7247669 in participants with previously untreated unresectable or metastatic melanoma.
• Phase II trial CA221023 – 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-PD1 therapy.
• Phase III trial 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.
•  Phase III trial: abierto, 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. 
• Phase III trial: 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.
• Phase I/II trial: An open-label, multicenter Phase I/II 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.
• Phase III trial: A 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.
• Phase II Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma.

At the Vall d'Hebron University Hospital's Department of Radiation Oncology and VHIO, our clinicians and researchers are committed to enhancing patient care through research. Alongside our own research initiatives, we actively engage in numerous national and international projects. As active members of internationally recognized research organizations, such as the European Organisation for Research and Treatment of Cancer (EORTC), the International Society of Paediatric Oncology (SIOP), the GETUG radiation oncology group, and the Radiogenomics consortium, we collaborate to drive advancements in the field.

We mainly focus on clinical research, but also support translational research projects led by different VHIO groups. In 2023, we (co) authored 26 articles, and have collaborated in more than 40 clinical trials.

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

We treat over 80% of pediatric patients in Catalonia requiring radiotherapy. We also manage very complex cases from other autonomous regions in Spain that do not have the necessary technology in-house. We also offer treatment to patients coming to us from abroad.

Technology:

In tertiary care, we provide complex irradiation techniques including volumetric modulated arc therapy (VMAT), image-guided radiation therapy (IGRT), stereotactic ablative radiotherapy (SABR), radiosurgery or re-irradiation. In this regard, we are participating in clinical trials to evaluate dose escalation in head and neck tumors, fiducial markers in both prostate and breast cancer IGRT, and stereotactic body radiotherapy (SBRT) in breast cancer. We are also assessing response to toxicity based on genomic polymorphisms. We have also established our department as a reference in radiosurgery and sarcoma.

Techniques:

• SABR. This complex technique consists of delivering high dose radiation to localized tumors in three or five fractions. While this treatment approach achieves a high tumor control rate with fewer secondary side effects, quality parameters are essential since even small variations can lead to high toxicity or poor tumor control. We use this technique in lung, pancreatic, and adrenal tumors, as well as liver, lymph node, and bone metastases.

• Breathing control for the treatment of tumors that are located in moving body regions such as the lungs and liver. Therapy is synchronized with respiratory rhythm. This technique is especially indicated in SBRT.

• Deep inspiration breath hold (DIBH). Deep breathing ensures that the heart moves away from the chest. This reduces the dose received by the heart.

• For prostate cancer treatment with hypofractionated therapy, we apply real-time tumor-tracking radiotherapy (RTRT). This technique involves placing markers on the prostate, which the system identifies and tracks during treatment.

• We utilize Adaptive Radiotherapy (ART) for treating gynecological and bladder tumors, as they can shift and change position during treatment.

• Radiosurgery for the treatment of small brain tumors and/or metastases.

• We employ Stereotactic Radiotherapy (SRT) to treat refractory ventricular arrhythmias. For treatment planning, a 4-dimensional CT scan is used to monitor respiratory and cardiac movements, while the defibrillator maintains a constant heart rate of 100 beats per minute. Through using an ADAS 3D image processing tool, we are able to integrate available images with Electroanatomic Mapping (EAM) and radiotherapy planning to deliver optimal personalized treatment to patients.

• Holocranial irradiation with hippocampal protection allows us to reduce long-term toxicity associated to treatment.

• Technology development: acquiring new equipment to implement cutting-edge radiation oncology techniques, including rotational radiotherapy with volumetric modulated arc therapy (VMAT), respiratory control radiotherapy (RT4D), and image-guided radiotherapy (IGRT), in the clinic.
• Translational research: translate new mechanistic insights into personalized radiation therapy and biomarker-driven strategies tailored to each patient's clinical and molecular features.
• Quality & safety: renewal of 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 oncohematology program at the Vall d'Hebron University Hospital.
• Clinical research: advance clinical research in radiogenomics, nanoparticles, polymorphisms and radioimmunotherapy (RIT).

• Over 90% of our patients undergoing radical radiotherapy have been treated with highly complex, advanced techniques.
• We have continued to increase our participation in international clinical trials. These include clinical 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 have implemented stereotactic radiotherapy for the treatment of patients with refractory ventricular arrhythmias.
• We continue to participate in a project combining radiotherapy with nanoparticles in head and neck cancer.
• We have implemented the deep inspiration breath hold (DIBH) technique and are treating some of our patients using this approach.
• We continue to serve as national representatives of radiation oncology at the International Society of Paediatric Oncology (SIOP).
• We have obtained ISO 9001/2015 quality management as well as UNE 179003:2013 safety certification in radiation oncology.

• SBRT program for primary kidney cancer.
• Adaptive radiotherapy in cervical uteri, with a dedicated radiotherapy unit.
• Consolidate the VMAT technique  to TBI in adults and children.
• Start the RDC of movement disorders.
• Work at the nexus of digital health and data science for research and clinical applications.
• Closely collaborate with VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) - CaixaResearch directed by Elena Garralda, Molecular Oncology Group led by Paolo Nuciforo, and Radiomics Group headed by Raquel Perez-Lopez to accelerate the research and implementation of cutting-edge data science models and technology platforms in the healthcare domain for the personalization of patient care at Vall d’Hebron.
• Cross-training and education in computational oncology, development of digital health solutions and web-based/mobile phone applications for investigators, care providers, and patients.
• Closely collaborate with our Clinical Research Support Unit (CRSU) in the design and implementation of investigator-initiated clinical trials (IITs) and registries, providing support for electronic data capture and statistical analyses.
• Radiosurgery of small lesions is applied for the treatment of small brain tumors and/or metastases, and for some non-oncological conditions such as trigeminal neuralgia that no longer respond to standard therapy, and some Parkinsonism conditions. A very high dose is administered at a very small volume (5-10 mm in diameter), requiring extremely precise techniques
• Proton therapy is a type of external beam radiation therapy where a proton beam is used to irradiate a very well-defined volume. The main benefit of protons over photons is the reduction of irradiated tissue; a fact that is clinically manifested in the reduction of adverse effects. We are planning to install two proton therapy units and envisage that these will be operational for the treatment of patients in 2026.
   

• Kroeze SGC, Pavic M, Stellamans K, Lievens Y, Becherini C, Scorsetti M, Alongi F, Ricardi U, Jereczek-Fossa BA, Westhoff P, But-Hadzic J, Widder J, Geets X, Bral S, Lambrecht M, Billiet C, Sirak I, Ramella S, Giovanni Battista I, Benavente S, Zapatero A, Romero F, Zilli T, Khanfir K, Hemmatazad H, de Bari B, Klass DN, Adnan S, Peulen H, Salinas Ramos J, Strijbos M, Popat S, Ost P, Guckenberger M. Metastases-directed stereotactic body radiotherapy in combination with targeted therapy or immunotherapy: systematic review and consensus recommendations by the EORTC-ESTRO OligoCare consortium. Lancet Oncol. 2023 Mar;24(3):e121-e132. 
• Ma TM, Sun Y, Malone S, Roach M 3rd, Dearnaley D, Pisansky TM, Feng FY, Sandler HM, Efstathiou JA, Syndikus I, Hall EC, Tree AC, Sydes MR, Cruickshank C, Roy S, Bolla M, Maingon P, De Reijke T, Nabid A, Carrier N, Souhami L, Zapatero A, Guerrero A, Alvarez A, Gonzalez San-Segundo C, Maldonado X, Romero T, Steinberg ML, Valle LF, Rettig MB, Nickols NG, Shoag JE, Reiter RE, Zaorsky NG, Jia AY, Garcia JA, Spratt DE, Kishan AU; Meta-Analysis of Randomized Trials in Cancer of the Prostate (MARCAP) Consortium Investigators. Sequencing of Androgen-Deprivation Therapy of Short Duration With Radiotherapy for Nonmetastatic Prostate Cancer (SANDSTORM): A Pooled Analysis of 12 Randomized Trials. J Clin Oncol. 2023 Feb 1;41(4):881-892. 
• Jandu HK, Veal CD, Fachal L, Luccarini C, Aguado-Barrera ME, Altabas M, Azria D, Baten A, Bourgier C, Bultijnck R, Colciago RR, Farcy-Jacquet MP, Chang-Claude J, Choudhury A, Dunning A, Elliott RM, Green S, Gutiérrez-Enríquez S, Herskind C, Lambrecht M, Monten C, Rancati T, Reyes V, Rosenstein BS, De Ruysscher D, Carmen De Santis M, Seibold P, Sperk E, Veldwijk M, Paul Symonds R, Stobart H, Taboada-Valladares B, Vega A, Veldeman L, Webb AJ, Weltens C, West CM, Rattay T, Talbot CJ; REQUITE consortium. Genome-wide association study of treatment-related toxicity two years following radiotherapy for breast cancer. Radiother Oncol. 2023 Oct;187:109806. 
• Giraldo A, Geng AAA, Ramos M, Recalde E, Garre J, Maldonado X, Giralt J. et al. Evaluation of Pulmonary Functions by Spirometry after Stereotactic Body Radiotherapy in Lung Tumors. Medical Research Archives, [S.l.], v. 11, n. 6, june 2023. ISSN 2375-1924.

1. IRAD-FEOR -IPSEN 2023 Grant for  prostate cancer research projects based on exosomes.
2. 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.
3. PA(AG)04/2018(5428) Study of genomic, transcriptomic and molecular profiles of advanced prostate cancer.
4. EPA (AG) 69/2018 (5413) IRONMAN-ES: Prospective observational study of clinical parameters and biomarkers in advanced prostate cancer in hospitals in Spain.
5. RAPIDO (Rectal cancer And Pre-operative Induction therapy followed by Dedicated Operation): central review of radiotherapy. RAPIDO Radiotherapy data collection (IRBd22-309)
6. PR/AG 191/2019. Identification of novel prognostic biomarkers in high-risk cutaneous squamous cell carcinoma patients by NGS strategy
7. UMBRELLA SIOP-RTSG 2016 protocol. Registry of the treatment of all pediatric kidney tumors
8. 2021-2023. FIS PI20/556. New therapeutic approaches in head and neck cancer. Fundació Institut de Recerca de l'Hospital Univ. Vall d'Hebron.
9. EURopeAn MEDical application and Radiation prOteCtion Concept: strategic research agenda aNd ROadmap interLinking to heaLth and digitisation aspects - EURAMED rocc-n-roll. EU Horizon 2020 research and innovation programme. Grant agreement no: 899995.
10. 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.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.
11. COGNITO: Evaluation of long-term cognitive effects in childhood cancer survivors. Reference: PR(AMI)389/2017. PI: Monica Ramos. EU project 899995 – EURAMED.
12. OLIGOCARE. “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.
13. EORTC Research Project 2011. E2RADIatE – ReCare. A prospective observational cohort on high-dose re-irradiation. ReCare Consortium. 
14. 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

1. Adaptive radiation therapy based on PET functional imaging for H&N cancer patients.
2. Breast irradiation, comparisons and analysis of dose distribution and reproducibility in supine versus prone position.
3. Instrumentation radiotherapy of the spine and paraspinal tumors and metastases.
4. Extracranial stereotactic radiotherapy in pancreatic cancer, commissioning and validation of the technique.
5. Techniques for reducing toxicity: radiotherapy treatment in the pediatric patients with brain tumors.
6. Total marrow irradiation program for bone marrow transplantation in patients with multiple myeloma; dosimetric studies.
7. A feasibility trial evaluating anti-PD1 nivolumab consolidation after standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B NSCLC.
8. REQUITE project. Inclusion and monitoring of lung cancer patients.
9. Adaptive radiotherapy in the treatment of patients with non-small cell lung neoplasia in stages IIA and IIB.(AG) 288/216.
10. Extracranial stereotactic radiotherapy (SBRT) as a treatment for unresectable liver metastases.
11. Prospective Observational study on radioresistance mediated by S100A9 in patients with brain metastases. Red Nacional de Metástasis Cerebral (RENACER). CNIO 
12. Development in PROMs as a clinical and research tool.

• The Vall d’Hebron Radiation Oncology Department achieved first place in the Spanish Health Reputation Ranking.

1. Kroeze SGC, Pavic M, Stellamans K, Lievens Y, Becherini C, Scorsetti M, Alongi F, Ricardi U, Jereczek-Fossa BA, Westhoff P, But-Hadzic J, Widder J, Geets X, Bral S, Lambrecht M, Billiet C, Sirak I, Ramella S, Giovanni Battista I, Benavente S, Zapatero A, Romero F, Zilli T, Khanfir K, Hemmatazad H, de Bari B, Klass DN, Adnan S, Peulen H, Salinas Ramos J, Strijbos M, Popat S, Ost P, Guckenberger M. Metastases-directed stereotactic body radiotherapy in combination with targeted therapy or immunotherapy: systematic review and consensus recommendations by the EORTC-ESTRO OligoCare consortium. Lancet Oncol. 2023 Mar;24(3):e121-e132. doi: 10.1016/S1470-2045(22)00752-5. PMID: 36858728.  
2.  Hernando-Calvo A, Mirallas O, Marmolejo D, Saavedra O, Vieito M, Assaf Pastrana JD, Aguilar S, Bescós C, Lorente J, Giralt J, Benavente S, Temprana-Salvador J, Alberola M, Dienstmann R, Garralda E, Felip E, Villacampa G, Brana I. Nutritional status associates with immunotherapy clinical outcomes in recurrent or metastatic head and neck squamous cell carcinoma patients. Oral Oncol. 2023 Mar 27;140:106364. doi: 10.1016/j.oraloncology.2023.106364. Epub ahead of print. PMID: 36989964. 
3.  Benavente S. Remodeling the tumor microenvironment to overcome treatment resistance in HPV-negative head and neck cancer. Cancer Drug Resist. 2023 May 30;6(2):291-313. doi: 10.20517/cdr.2022.141. PMID: 37457128; PMCID: PMC10344731. 
4. 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. Epub 2023 Oct 31. PMID: 37908014.
5. Jaikuna T, Osorio EV, Azria D, Chang-Claude J, De Santis MC, Gutiérrez-Enríquez S, van Herk M, Hoskin P, Lambrecht M, Lingard Z, Seibold P, Seoane A, Sperk E, Symonds RP, Talbot CJ, Rancati T, Rattay T, Reyes V, Rosenstein BS, de Ruysscher D, Vega A, Veldeman L, Webb A, West CML, Aznar MC. Contouring variation affects estimates of normal tissue complication probability for breast fibrosis after radiotherapy. Breast. 2023 Dec;72:103578. doi: 10.1016/j.breast.2023.103578. Epub 2023 Sep 11. PMID: 37713940.
6. 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. Pre treatment risk factors for late fatigue and fatigue trajectories following radiotherapy for breast cancer. Int J Cancer. 2023 Nov 1;153(9):1579-1591. doi: 10.1002/ijc.34640. Epub 2023 Jul 5. PMID: 37403702.
7. Naderi E, Aguado-Barrera ME, Schack LMH, Dorling L, Rattay T, Fachal L, Summersgill H, Martínez-Calvo L, Welsh C, Dudding T, Odding Y, Varela-Pazos A, Jena R, Thomson DJ, Steenbakkers RJHM, Dennis J, Lobato-Busto R, Alsner J, Ness A, Nutting C, Gómez-Caamaño A, Eriksen JG, Thomas SJ, Bates AM, Webb AJ, Choudhury A, Rosenstein BS, Taboada-Valladares B, Herskind C, Azria D, Dearnaley DP, de Ruysscher D, Sperk E, Hall E, Stobart H, Chang-Claude J, De Ruyck K, Veldeman L, Altabas M, De Santis MC, Farcy-Jacquet MP, Veldwijk MR, Sydes MR, Parliament M, Usmani N, Burnet NG, Seibold P, Symonds RP, Elliott RM, Bultijnck R, Gutiérrez-Enríquez S, Mollà M, Gulliford SL, Green S, Rancati T, Reyes V, Carballo A, Peleteiro P, Sosa-Fajardo P, Parker C, Fonteyne V, Johnson K, Lambrecht M, Vanneste B, Valdagni R, Giraldo A, Ramos M, Diergaarde B, Liu G, Leal SM, Chua MLK, Pring M, Overgaard J, Cascallar-Caneda LM, Duprez F, Talbot CJ, Barnett GC, Dunning AM, Vega A, Andreassen CN, Langendijk JA, West CML, Alizadeh BZ, Kerns SL; Radiogenomics Consortium. Large-scale meta-genome-wide association study reveals common genetic factors linked to radiation-induced acute toxicities across cancer types. JNCI Cancer Spectr. 2023 Oct 31;7(6):pkad088. doi: 10.1093/jncics/pkad088.PMID: 37862240.
8.  Jandu HK, Veal CD, Fachal L, Luccarini C, Aguado-Barrera ME, Altabas M, Azria D, Baten A, Bourgier C, Bultijnck R, Colciago RR, Farcy-Jacquet MP, Chang-Claude J, Choudhury A, Dunning A, Elliott RM, Green S, Gutiérrez-Enríquez S, Herskind C, Lambrecht M, Monten C, Rancati T, Reyes V, Rosenstein BS, De Ruysscher D, Carmen De Santis M, Seibold P, Sperk E, Veldwijk M, Paul Symonds R, Stobart H, Taboada-Valladares B, Vega A, Veldeman L, Webb AJ, Weltens C, West CM, Rattay T, Talbot CJ; REQUITE consortium. Genome-wide association study of treatment-related toxicity two years following radiotherapy for breast cancer. Radiother Oncol. 2023 Oct;187:109806. doi: 10.1016/j.radonc.2023.109806. Epub 2023 Jul 10.PMID: 37437607.
9. Vakaet V, Deseyne P, Bultijnck R, Post G, West C, Azria D, Bourgier C, Farcy-Jacquet MP, Rosenstein B, Green S, de Ruysscher D, Sperk E, Veldwijk M, Herskind C, De Santis MC, Rancati T, Giandini T, Chang-Claude J, Seibold P, Lambrecht M, Weltens C, Janssens H, Vega A, Taboada-Valladares MB, Aguado-Barrera ME, Reyes V, Altabas M, Gutiérrez-Enríquez S, Monten C, Van Hulle H, Veldeman L Comparison of prone and supine positioning for breast cancer radiotherapy using REQUITE data: dosimetry, acute and two years physician and patient-reported outcomes. Acta Oncol. 2023 Sep;62(9):1036-1044. doi: 10.1080/0284186X.2023.2240486. Epub 2023 Aug 7.PMID: 37548182.
10. AJ, Harper E, Rattay T, Aguado-Barrera ME, Azria D, Bourgier C, Brengues M, Briers E, Bultijnck R, Chang-Claude J, Choudhury A, Cicchetti A, De Ruysscher D, De Santis MC, Dunning AM, Elliott RM, Fachal L, Gómez-Caamaño A, Gutiérrez-Enríquez S, Johnson K, Lobato-Busto R, Kerns SL, Post G, Rancati T, Reyes V, Rosenstein BS, Seibold P, Seoane A, Sosa-Fajardo P, Sperk E, Taboada-Valladares B, Valdagni R, Vega A, Veldeman L, Ward T, West CM, Symonds RP, Talbot CJ; REQUITE Treatment time and circadian genotype interact to influence radiotherapy side-effects. A prospective European validation study using the REQUITE cohort.Webb Consortium. EBioMedicine. 2022 Oct;84:104269. doi: 10.1016/j.ebiom.2022.104269. Epub 2022 Sep 18.PMID: 36130474.
11. Eraso A, Sanz J, Mollà M, Reyes V, Pedro A, Arenas M, Martinez E, Ballester R, Cambra MJ, García V, Prades JL, Borras JM, Algara M. Evidence-based guidelines for hypofractionated radiation in breast cancer: conclusions of the Catalan expert working group.Clin Transl Oncol. 2022 Aug;24(8):1580-1587. doi: 10.1007/s12094-022-02798-8. Epub 2022 Feb 21. PMID: 35190961.
12. Aldraimli M, Osman S, Grishchuck D, Ingram S, Lyon R, Mistry A, Oliveira J, Samuel R, Shelley LEA, Soria D, Dwek MV, Aguado-Barrera ME, Azria D, Chang-Claude J, Dunning A, Giraldo A, Green S, Gutiérrez-Enríquez S, Herskind C, van Hulle H, Lambrecht M, Lozza L, Rancati T, Reyes V, Rosenstein BS, de Ruysscher D, de Santis MC, Seibold P, Sperk E, Symonds RP, Stobart H, Taboada-Valadares B, Talbot CJ, Vakaet VJL, Vega A, Veldeman L, Veldwijk MR, Webb A, Weltens C, West CM, Chaussalet TJ, Rattay T; REQUITE consortiumDevelopment and Optimization of a Machine-Learning Prediction Model for Acute Desquamation After Breast Radiation Therapy in the Multicenter REQUITE Cohort. Adv Radiat Oncol. 2022 Jan 3;7(3):100890. doi: 10.1016/j.adro.2021.100890. eCollection 2022 May-Jun. PMID: 35647396.
13. Giraldo A, Geng AAA, Ramos M, Recalde E, Garre J, Maldonado X, Giralt J.  et al. Evaluation of Pulmonary Functions by Spirometry after Stereotactic Body Radiotherapy in Lung Tumors. Medical Research Archives, [S.l.], v. 11, n. 6, june 2023. ISSN 2375-1924. 
14. Rosas JC, Aguado-Barrera ME, Azria D, Erik Briers, Rebecca Elliott, Marie-Pierre Farcy-Jacquet, Alexandra Giraldo, et al. (Pre) treatment risk factors for late fatigue and fatigue trajectories following radiotherapy for breast cancer. Int J Cancer. 2023;1‐13. doi:10.1002/ijc.34640.
15. Soumyajit Roy, Tahmineh Romero,Jeff M. Michalski, Felix Y. Feng, Jason Efstathiou, Colleen A.F. Lawton,Michel Bolla, Philippe Maingon,Theo de Reijke,David Joseph, Wee Loon Ong, Matthew R. SydesDavid P. Dearnaley, Alison C. Treep ; Nathalie Carrierp Abdenour Nabid, p Luis Souhami,Luca Incrocci,Wilma D. Heemsbergen, p Floris J. Pos,pAlmudena Zapatero,Araceli Guerrero, Ana Alvarez,Carmen Gonzalez San-Segundo, Xavier Maldonado, Robert E. Reiter,Matthew B. Rettig,Nicholas G. Nickols, Michael L. Steinberg, Luca F. Valle, T. Martin Ma, Matthew J. Farrell, Beth K. Neilsen, Jesus E. Juarez, Jie Deng, Sitaram Vangala, Norbert Avril, Angela Y. Jia, Nicholas G. Zaorsky, Yilun Sun, Daniel Spratt and Amar U. Kishan, on behalf of the Meta-Analysis of Randomized Trials in Cancer of the Prostate (MARCAP) Consortium Investigators. Biochemical Recurrence Surrogacy for Clinical Outcomes After Radiotherapy for Adenocarcinoma of the Prostate. J Clin Oncol. 2023, jul. 12. doi:10.1200/JCO.23.00617.
16. Gómez-Aparicio MA, López-Campos F, Lozano AJ, Maldonado X, Caballero B, Zafra J, Suarez V, Moreno E, Arcangeli S, Scorsetti M, Couñago F. Novel Approaches in the Systemic Management of High-Risk Prostate Cancer. Clin Genitourin Cancer. 2023 Dec;21(6):e485-e494. doi: 10.1016/j.clgc.2023.06.001.
17. Bonet M, González D, Baquedano JE, García E, Altabas M, Casas F, Feltes N,Ferrer F, Foro P, Fuentes R, Galdeano M, Gomez D, Henriquez I, Jové J, Lozano J,Maldonado X, Mases J, Membrive I, Paredes S, Roselló À, Sancho G, Mira M. Management of high-risk and post-operative non-metastatic prostate cancer in Catalonia: an expert Delphi consensus. Clin Transl Oncol. 2022 Nov 27. doi: 10.1007/s12094-022-03005-4. Epub ahead of print. PMID: 36436177.
18. Ting Martin Ma, MD, Yilun Sun,Shawn Malone, Mack Roach III, David Dearnaley,; Thomas M. Pisansky, Felix Y. Feng, Howard M. Sandler, Jason A. Efstathiou, Isabel Syndikus, Emma C. Hall , Alison C. Tree, Matthew R. Sydes, Claire Cruickshank, Soumyajit Roy, Michel Bolla, Philippe Maingon, Theo De Reijke, Abdenour Nabid, Nathalie Carrier, Luis Souhami, Almudena Zapatero, Araceli Guerrero, Ana Alvarez, Carmen Gonzalez San-Segundo, Xavier Maldonado, Tahmineh Romero, Michael L. Steinberg, Luca F. Valle,; Matthew B. Rettig, Nicholas G. Nickols, Jonathan E. Shoag, Robert E. Reiter, Nicholas G. Zaorsky, Angela Y. Jia, Jorge A. Garcia, Daniel E. Spratt, and Amar U. Kishan, on behalf of the Meta-Analysis of Randomized Trials in Cancer of the Prostate (MARCAP) Consortium Investigator. Sequencing of Androgen-Deprivation Therapy of Short Duration With Radiotherapy for Nonmetastatic Prostate Cancer (SANDSTORM): A Pooled Analysis of 12 Randomized. J Clin Oncol. 2023 Feb 1;41(4):881-892. doi: 10.1200/JCO.22.00970.
19. Sánchez-Artuñedo D, Reyes López V, Granado Carrasco R, Beltran-Vilagrasa M, Duch-Guillen MA, Hermida-López M.Gamma passing rates of daily EPID transit images correlate to PTV coverage for breast cancer IMRT treatment plans. J Appl Clin Med Phys. 2023;24:e13913.

• GICOR-SEOR 01-21/ URONCOR 06-24. Short- or long-term Androgen Deprivation Therapy in combination with rescue radiotherapy in patients with prostate cancer with biochemical recurrence after surgery: a randomized, controlled, multicenter phase III trial.
• BAY 1841788/21492. Phase III, randomized, placebo-controlled, double-blind study of Darolutamide plus androgen deprivation treatment (ADT) compared to placebo plus ADT in patients with high-risk biochemically recurrent prostate cancer.
• (PR-AG 34/2016) Extracerebral stereoatacic radiotherapy as treatment of liver metastases
• EORTC 22114-40111: Trial of preoperative therapy for gastric and esophagogastric junction adenocarcinoma. A randomized phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer. Registro interno AC/U(AG)159/2013(3829) (IP Dra.Navalpotro)
• Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial) EudraCT No: 2018-004835-56. GEMCAD-1703
• International phase III, randomized, double-blind, placebo-controlled, multicenter trial of durvalumab administered concurrently with definitive chemoradiation therapy in patients with locally advanced, inoperable squamous cell carcinoma of the esophagus (KUMLUN).
• A Phase II, Multicenter, Two Stage, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Alone and in Combination with Focal Radiation Therapy in Adults with Unresectable or Metastatic Melanoma Protocol Number: APX005M-010. IND Number: 122725. EudraCT Number: 2018-003864-30
• Multicentre phase II clinical trial to evaluate the activity of encorafenib and binimetinib before local treatment in patients with BRAF mutated melanoma with metastasis to the brain. Protocol Number: GEM-1802 EudraCT: 2018-002530-20
• 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. EudraCT Number: 2019-000566-38. IND Number:127100608315
• KEYNOTE-630 . Phase 3 study of adjuvant pembrolizumab versus placebo in patients with high-risk, locally advanced cutaneous squamous cell carcinoma. 
• Protocol ID: hCCA-LT. Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study. Approval Number: PR(AG)223/2019
• Phase II study of Atezolizumab plus Tiraglolumab in combination with chemoradiotherapy in localized squamous cell carcinoma of the anal canal. TIRANUS trial Código: GEMCAD 2103//MO44170 Nº EudraCT:2021-005887-24
• Xray vision - MS202359_002: A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplatin.
• Keynote MK-689: Fase III. Pacientes con tumor de cabeza y cuello localmente avanzado, tributarios a cirugía evalúa pembro neoadyuvante y adyuvante + RT vs cirugía directa y RT +/- cisplatino adyuvante en función de resultados de cirugía.
• Nanoray -312: A Phase 3 (Pivotal Stage) 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
• 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).
• MK012:  A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
• MK006: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK- 7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC
• PACIFIC9: 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
• M14-360: A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in Combination with Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC
• MORPHEUS.  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)
• MK 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
• MK 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)
• STEREO. A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancer
• SIOP-Ependymoma-II trial. An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma (Phase II-III).
• FaR-RMS. An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma (FaR-RMS). 
• High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) (HR-NBL2)

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 and combinations through clinical trials.
• Determine the complexities of genetic profiling in cancer.
• Identify baseline 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).
• Demonstrate the clinical utility of liquid biopsy to:
  • Monitor response to therapy in advanced non-small cell lung cancer (NSCLC).
  • Study disease relapse in early-stage NSCLC patients.
• Study intratumor heterogeneity in matched primary and metastatic lesions from the cancer genome to the tumor microenvironment.

• 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.
• Provide patients with opportunities to participate in clinical trials that are developing innovative cancer therapies.
• Consolidation of our interdisciplinary group comprising oncologists, molecular biologists, a bioinformatician, and a nurse.
• National and international collaborations of excellence.

• Expand clinical research in KRAS-G12C and EGFR exon 20 insertions molecular subtypes.
• Establish the role of antibody drug conjugates in the management of NSCLC and small cell lung cancer (SCLC).
• Determine the potential role of immunotherapy in mesothelioma and thymic malignancies.
• Develop a medical device through artificial inteligence-based models to predict immunotherapy efficacy in NSCLC patients by integrating multisource data.

• Unravel the value of somatic copy number alterations burden to predict benefit to different therapies beyond ICIs as monotherapy in NSCLC (chemotherapy and ICIs in combination, EGFR-mutated NSCLC).
• Incorporate the analysis of ‘fragmentomics’ in liquid biopsy studies.
• Characterize acquired resistance to ICIs and targeted agents in NSCLC using liquid biopsy.
• Develop new in vitro and in vivo models to test response to targeted therapies and to ICIs.
• Determine intratumoral heterogeneity levels in paired primary and metastatic samples in NSCLC.
• Spatial and temporal characterization of intratumor heterogeneity in lung cancer

• Felip E, Altorki N, Zhou C, Vallières E, Martínez-Martí A, Rittmeyer A, Chella A, Reck M, Goloborodko O, Huang M, Belleli R, McNally V, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial. Ann Oncol. 2023 Oct;34(10):907-919. 
• Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Bustamante Alvarez J, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L; DeLLphi-301 Investigators. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 30;389(22):2063-2075.
• Carbonell C, Frigola J, Pardo N, Callejo A, Iranzo P, Valdivia A, Priano I, Cedrés S, Martinez-Marti A, Navarro A, Lenza L, Soleda M, Gonzalo-Ruiz J, Vivancos A, Sansó M, Carcereny E, Morán T, Amat R, Felip E. Dynamic changes in circulating tumor DNA assessed by shallow whole-genome sequencing associate with clinical efficacy of checkpoint inhibitors in NSCLC. Mol Oncol. 2023 May;17(5):779-791. 
• Solomon BJ, Bauer TM, Mok TSK, Liu G, Mazieres J, de Marinis F, Goto Y, Kim DW, Wu YL, Jassem J, López FL, Soo RA, Shaw AT, Polli A, Messina R, Iadeluca L, Toffalorio F, Felip E. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med. 2023 Apr;11(4):354-366. 

1. Caracterización espacial y temporal de la heterogeneidad intratumoral en cáncer de pulmón.
   Instituto de Salud Carlos III (FIS – ISCIII) 
   2023– 2026 
   PI: Enriqueta Felip. 
2. PREDICT-Meso: PRE-malignant Drivers Combined with Target-Drug validation in Mesothelioma.
   CRUK/AECC.
   2019 – 2023.
   PI: Susana Cedrés   Collaborator: Enriqueta Felip.
3. Inestabilidad cromosòmica e infiltración immune del tumor como factores determinantes del potencial metastásico en cáncer de pulmón.
   Instituto de Salud Carlos III (FIS – ISCIII).
   PI20/00987.
   2021 – 2023.
   PI: Enriqueta Felip.
4. Ayudas para contratos Juan de la Cierva-Formación convocatoria 2020.
   Entitat Finançadora: Agencia Estatal de Investigación.
   Durada: 2022 – 2023.
   PI: Enriqueta Felip. 
5. A Machine learning approach to Identify patients with resected non-small-cell lung cancer with high risk of relapse (MIRACLE).
   Instituto de Salud Carlos III (FIS – ISCIII).
   2022 – 2024.
   PI: Enriqueta Felip.
6. Integrative science, Intelligent data platform for Individualized LUNG cancer care with Immunotherapy Horizon Europe – European Commission 101057695.
   2022 – 2026.
   PI: Enriqueta Felip.
7. Diseccionando el papel de las alteraciones en el número de copia como biomarcador molecular en NSCLC avanzado.
   Instituto de Salud Carlos III (FIS – ISCIII).
   PI22/01585.
   2023 – 2025.

• Enriqueta Felip was recognized as a Clarivate Highly Cited Researcher 2023 under the category of Clinical Medicine for a sixth year running.

1. Sotorasib versus docetaxel for previously treated non-small- cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial.de Langen, Adrianus Johannes ; Johnson, Melissa L ; Mazieres, Julien ; Dingemans, Anne-Marie C ; Mountzios, Giannis ; Pless, Miklos ; Wolf, Jürgen ; Schuler, Martin ; Lena, Hervé ; Skoulidis, Ferdinandos ; Yoneshima, Yasuto ; Kim, Sang-We ; Linardou, Helena ; Novello, Silvia ; van der Wekken, Anthonie J ; Chen, Yuanbin ; Peters, Solange ; FELIP FONT, ENRIQUETA; Solomon, Benjamin J ; Ramalingam, Suresh S ; Dooms, Christophe ; Lindsay, Colin R ; Ferreira, Carlos Gil ; Blais, Normand ; Obiozor, Cynthia C ; Wang, Yang ; Mehta, Bhakti ; Varrieur, Tracy ; Ngarmchamnanrith, Gataree ; Stollenwerk, Björn ; Waterhouse, David ; Paz-Ares, Luis ; CodeBreaK 200 Investigators.LANCET.1.1.168,9.49.10.1016/S0140-6736(23)00221-0.1.1
2. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions..Zhou, Caicun ; Tang, Ke-Jing ; Cho, Byoung Chul ; Liu, Baogang ; Paz-Ares, Luis ; Cheng, Susanna ; Kitazono, Satoru ; Thiagarajan, Muthukkumaran ; Goldman, Jonathan W ; Sabari, Joshua K ; Sanborn, Rachel E ; Mansfield, Aaron S ; Hung, Jen-Yu ; Boyer, Michael ; Popat, Sanjay ; Mourão Dias, Josiane ; FELIP FONT, ENRIQUETA; Majem, Margarita ; Gumus, Mahmut ; Kim, Sang-We ; Ono, Akira ; Xie, John ; Bhattacharya, Archan ; Agrawal, Trishala ; Shreeve, S Martin ; Knoblauch, Roland E ; Park, Keunchil ; Girard, Nicolas ; PAPILLON Investigators.NEW ENGLAND JOURNAL OF MEDICINE.1.1.158,5.6.10.1056/NEJMoa2306441.1.1
3. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer..Ahn, Myung-Ju ; Cho, Byoung Chul ; FELIP FONT, ENRIQUETA; Korantzis, Ippokratis ; Ohashi, Kadoaki ; Majem, Margarita ; Juan-Vidal, Oscar ; Handzhiev, Sabin ; Izumi, Hiroki ; Lee, Jong-Seok ; Dziadziuszko, Rafal ; Wolf, Jürgen ; Blackhall, Fiona ; Reck, Martin ; Bustamante Alvarez, Jean ; Hummel, Horst-Dieter ; Dingemans, Anne-Marie C ; Sands, Jacob ; Akamatsu, Hiroaki ; Owonikoko, Taofeek K ; Ramalingam, Suresh S ; Borghaei, Hossein ; Johnson, Melissa L ; Huang, Shuang ; Mukherjee, Sujoy ; Minocha, Mukul ; Jiang, Tony ; Martinez, Pablo ; Anderson, Erik S ; Paz-Ares, Luis ; DeLLphi-301 Investigators.NEW ENGLAND JOURNAL OF MEDICINE.1.1.158,5.3.10.1056/NEJMoa2307980.1.1
4. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell  lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results..Gutierrez, Martin ; Lam, Wei-Sen ; Hellmann, Matthew D ; Gubens, Matthew A ; Aggarwal, Charu ; Tan, Daniel Shao Weng ; FELIP FONT, ENRIQUETA; Chiu, Joanne W Y ; Lee, Jong-Seok ; Yang, James Chih-Hsin ; Garon, Edward B ; Finocchiaro, Giovanna ; Ahn, Myung-Ju ; Luft, Alexander ; Landers, Gregory A ; Basso, Andrea ; Ma, Hua ; Kobie, Julie ; Palcza, John ; Cristescu, Razvan ; Fong, Lawrence ; Snyder, Alexandra ; Yuan, Jianda ; Herbst, Roy S.NATURE MEDICINE.1.1.82,9.0.10.1038/s41591-023-02385-6.1.1
5. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with  advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from  the phase 3, randomised, open-label CROWN study..Solomon, Benjamin J ; Bauer, Todd M ; Mok, Tony S K ; Liu, Geoffrey ; Mazieres, Julien ; de Marinis, Filippo ; Goto, Yasushi ; Kim, Dong-Wan ; Wu, Yi-Long ; Jassem, Jacek ; López, Froylán López ; Soo, Ross A ; Shaw, Alice T ; Polli, Anna ; Messina, Rossella ; Iadeluca, Laura ; Toffalorio, Francesca ; FELIP FONT, ENRIQUETA.LANCET RESPIRATORY MEDICINE.1.1.76,2.31.10.1016/S2213-2600(22)00437-4.1.1
6. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining  the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab  subcutaneous versus intravenous administration in previously treated locally  advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison  with other approved indications..Burotto, M ; Zvirbule, Z ; Mochalova, A ; Runglodvatana, Y ; Herraez-Baranda, L ; Liu, S N ; Chan, P ; Shearer-Kang, E ; Liu, X ; Tosti, N ; Zanghi, J A ; Leutgeb, B ; FELIP FONT, ENRIQUETA.ANNALS OF ONCOLOGY.1.1.50,5.2.10.1016/j.annonc.2023.05.009.1.1
7. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage  II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre,  open-label, phase III trial..FELIP FONT, ENRIQUETA; Altorki, N ; Zhou, C ; Vallieres, E ; MARTINEZ MARTI, ALEXANDRE; Rittmeyer, A ; Chella, A ; Reck, M ; Goloborodko, O ; Huang, M ; Belleli, R ; McNally, V ; Srivastava, M K ; Bennett, E ; Gitlitz, B J ; Wakelee, H A.ANNALS OF ONCOLOGY.1.1.50,5.9.10.1016/j.annonc.2023.07.001.1.1
8. Randomized open-label controlled study of cancer vaccine OSE2101 versus  chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer  with resistance to immunotherapy: ATALANTE-1..Besse, B ; FELIP FONT, ENRIQUETA; Garcia Campelo, R ; Cobo, M ; Mascaux, C ; Madroszyk, A ; Cappuzzo, F ; Hilgers, W ; Romano, G ; Denis, F ; Viteri, S ; Debieuvre, D ; Galetta, D ; Baldini, E ; Razaq, M ; Robinet, G ; Maio, M ; Delmonte, A ; Roch, B ; Masson, P ; Schuette, W ; Zer, A ; REMON MASIP, JORDI; Costantini, D ; Vasseur, B ; Dziadziuszko, R ; Giaccone, G ; ATALANTE-1 study group ; Zemanová, M ; Besse, B ; Bonnet, C ; Cadranel, J ; Chouaid, C ; Cortot, A ; Debieuvre, D ; Delclaux, B ; Denis, F ; Duchemann, B ; El Kouri, C ; Ferrand, F R ; Ginoux, M ; Hilgers, W ; Madroszyk, A ; Masson, P ; Mazieres, J ; Molinier, O ; Moro-Sibilot, D ; Pichon, E ; Mascaux, C ; Robinet, G ; Roch, B ; Zalcman, G ; Schmidtke-Schrezenmeier, G ; Schuette, W ; Urban, L ; Gottfried, M ; Nechushtan, H ; Peled, N ; Wollner, M ; Zer, A ; Baldini, E ; Bonanno, L ; Bonetti, A ; Cappuzzo, F ; Delmonte, A ; Galetta, D ; Maio, M ; Minotti, V ; Rea, A ; Romano, G ; Tassinari, D ; Tonini, G ; Dziadziuszko, R ; Karaszewska, B ; Szczesna, A ; Cobo, M ; De Castro, J ; FELIP FONT, ENRIQUETA; Garcia Campelo, M R ; Hernández, A ; Moran, T ; Provencio, M ; Viteri, S ; Dasgupta, A ; Gabrail, N ; Giaccone, G ; Harshad, A ; Liu, S ; Oubre, D ; Panikkar, R ; Razaq, M ; Sanborn, R.ANNALS OF ONCOLOGY.1.1.50,5.3.10.1016/j.annonc.2023.07.006.1.1
9. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in  Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After  Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and  Platinum-Based Chemotherapy..Yu, Helena A ; Goto, Yasushi ; Hayashi, Hidetoshi ; FELIP FONT, ENRIQUETA; Chih-Hsin Yang, James ; Reck, Martin ; Yoh, Kiyotaka ; Lee, Se-Hoon ; Paz-Ares, Luis ; Besse, Benjamin ; Bironzo, Paolo ; Kim, Dong-Wan ; Johnson, Melissa L ; Wu, Yi-Long ; John, Thomas ; Kao, Steven ; Kozuki, Toshiyuki ; Massarelli, Erminia ; Patel, Jyoti ; Smit, Egbert ; Reckamp, Karen L ; Dong, Qian ; Shrestha, Pomy ; Fan, Pang-Dian ; Patel, Parul ; Sporchia, Andrea ; Sternberg, David W ; Sellami, Dalila ; Jänne, Pasi A.JOURNAL OF CLINICAL ONCOLOGY.1.1.45,4.6.10.1200/JCO.23.01476.1.1
10. Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non-Small-Cell Lung  Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study..Garassino, Marina C ; Gadgeel, Shirish ; Speranza, Giovanna ; FELIP FONT, ENRIQUETA; Esteban, Emilio ; Dómine, Manuel ; Hochmair, Maximilian J ; Powell, Steven F ; Bischoff, Helge G ; Peled, Nir ; Grossi, Francesco ; Jennens, Ross R ; Reck, Martin ; Hui, Rina ; Garon, Edward B ; Kurata, Takayasu ; Gray, Jhanelle E ; Schwarzenberger, Paul ; Jensen, Erin ; Pietanza, M Catherine ; Rodríguez-Abreu, Delvys.JOURNAL OF CLINICAL ONCOLOGY.1.1.45,4.39.10.1200/JCO.22.01989.1.1
11. Phase II Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for  Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated  Brain Metastases (Atezo-Brain, GECP17/05)..Nadal, Ernest ; Rodríguez-Abreu, Delvys ; Simó, Marta ; Massutí, Bartomeu ; Juan, Oscar ; Huidobro, Gerardo ; López, Rafael ; De Castro, Javier ; Estival, Anna ; Mosquera, Joaquín ; Sullivan, Ivana ; FELIP FONT, ENRIQUETA; Blasco, Ana ; Guirado, Maria ; Pereira, Eva ; Vilariño, Noelia ; Navarro, Valentín ; Bruna, Jordi.JOURNAL OF CLINICAL ONCOLOGY.1.1.45,4.2.10.1200/JCO.22.02561.1.1
12. Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With  BRAF(V600)-Mutant Metastatic Non-Small-Cell Lung Cancer..Riely, Gregory J ; Smit, Egbert F ; Ahn, Myung-Ju ; FELIP FONT, ENRIQUETA; Ramalingam, Suresh S ; Tsao, Anne ; Johnson, Melissa ; Gelsomino, Francesco ; Esper, Raymond ; Nadal, Ernest ; Offin, Michael ; Provencio, Mariano ; Clarke, Jeffrey ; Hussain, Maen ; Otterson, Gregory A ; Dagogo-Jack, Ibiayi ; Goldman, Jonathan W ; Morgensztern, Daniel ; Alcasid, Ann ; Usari, Tiziana ; Wissel, Paul ; Wilner, Keith ; Pathan, Nuzhat ; Tonkovyd, Svitlana ; Johnson, Bruce E.JOURNAL OF CLINICAL ONCOLOGY.1.1.45,4.4.10.1200/JCO.23.00774.1.1
13. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in  Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study..Paz-Ares, Luis ; Champiat, Stephane ; Lai, W Victoria ; Izumi, Hiroki ; Govindan, Ramaswamy ; Boyer, Michael ; Hummel, Horst-Dieter ; Borghaei, Hossein ; Johnson, Melissa L ; Steeghs, Neeltje ; Blackhall, Fiona ; Dowlati, Afshin ; Reguart, Noemi ; Yoshida, Tatsuya ; He, Kai ; Gadgeel, Shirish M ; FELIP FONT, ENRIQUETA; Zhang, Yiran ; Pati, Amrita ; Minocha, Mukul ; Mukherjee, Sujoy ; Goldrick, Amanda ; Nagorsen, Dirk ; Sadraei, Nooshin Hashemi ; Owonikoko, Taofeek K.JOURNAL OF CLINICAL ONCOLOGY.1.1.45,4.33.10.1200/JCO.22.02823.1.1
14. Dynamic changes in circulating tumor DNA assessed by shallow whole-genome  sequencing associate with clinical efficacy of checkpoint inhibitors in NSCLC..CARBONELL NUÑEZ, CATERINA CECILIA; FRIGOLA RISSECH, JOAN; PARDO ARANDA, NURIA; CALLEJO PEREZ, ANA; IRANZO GOMEZ, PATRICIA; VALDIVIA, AUGUSTO; Priano, Ilaria ; CEDRES PEREZ, SUSANA; MARTINEZ MARTI, ALEXANDRE; NAVARRO MENDIVIL, ALEJANDRO; Lenza, Laura ; SOLEDA PALOU, MIREIA; GONZALO RUIZ, JAVIER; VIVANCOS PRELLEZO, ANA; Sansó, Miriam ; Carcereny, Enric ; Morán, Teresa ; AMAT FERRER, RAMON; FELIP FONT, ENRIQUETA.MOLECULAR ONCOLOGY.1.3.6,6.0.10.1002/1878-0261.13409.1.1
15. Tepotinib Treatment in Patients With MET Exon 14-Skipping Non-Small Cell Lung  Cancer: Long-term Follow-up of the VISION Phase 2 Nonrandomized Clinical Trial..Mazieres, Julien ; Paik, Paul K ; Garassino, Marina C ; Le, Xiuning ; Sakai, Hiroshi ; Veillon, Remi ; Smit, Egbert F ; Cortot, Alexis B ; Raskin, Jo ; Viteri, Santiago ; Wu, Yi-Long ; Yang, James C H ; Ahn, Myung-Ju ; Ma, Rui ; Zhao, Jun ; O'Brate, Aurora ; Berghoff, Karin ; Bruns, Rolf ; Otto, Gordon ; Johne, Andreas ; FELIP FONT, ENRIQUETA; Thomas, Michael.JAMA oncology.1.1.28,4.7.10.1001/jamaoncol.2023.1962.1.1
16. Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed  Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial..Cho, Byoung Chul ; Lee, Jong Seok ; Wu, Yi-Long ; Cicin, Irfan ; Dols, Manuel Cobo ; Ahn, Myung-Ju ; Cuppens, Kristof ; Veillon, Rémi ; Nadal, Ernest ; Dias, Josiane Mourão ; Martin, Claudio ; Reck, Martin ; Garon, Edward B ; FELIP FONT, ENRIQUETA; Paz-Ares, Luis ; Mornex, Francoise ; Vokes, Everett E ; Adjei, Alex A ; Robinson, Clifford ; Sato, Masashi ; Vugmeyster, Yulia ; Machl, Andreas ; Audhuy, Francois ; Chaudhary, Surendra ; Barlesi, Fabrice.JOURNAL OF THORACIC ONCOLOGY.1.1.20,4.2.10.1016/j.jtho.2023.08.018.1.1
17. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in  Programmed Cell Death-(Ligand)1-Monotherapy Pretreated, Advanced NSCLC: Results  From a Phase 1b Clinical Trial..Garon, Edward B ; Spira, Alexander I ; Goldberg, Sarah B ; Chaft, Jamie E ; Papadimitrakopoulou, Vassiliki ; Cascone, Tina ; Antonia, Scott J ; Brahmer, Julie R ; Camidge, D Ross ; Powderly, John D ; Wozniak, Antoinette J ; FELIP FONT, ENRIQUETA; Wu, Song ; Ascierto, Maria L ; Elgeioushi, Nairouz ; Awad, Mark M.JOURNAL OF THORACIC ONCOLOGY.1.1.20,4.0.10.1016/j.jtho.2023.04.020.1.1
18. First-Line Nivolumab Plus Ipilimumab With Chemotherapy Versus Chemotherapy Alone for Metastatic NSCLC in CheckMate 9LA: 3-Year Clinical Update and Outcomes in Patients With Brain Metastases or Select Somatic Mutations.Paz-Ares, Luis G. ; Ciuleanu, Tudor-Eliade ; Cobo, Manuel ; Bennouna, Jaafar ; Schenker, Michael ; Cheng, Ying ; Juan-Vidal, Oscar ; Mizutani, Hideaki ; Lingua, Alejo ; Reyes-Cosmelli, Felipe ; Reinmuth, Niels ; Menezes, Juliana ; Jassem, Jacek ; Protsenko, Svetlana ; Richardet, Eduardo ; FELIP FONT, ENRIQUETA; Feeney, Kynan ; Zurawski, Bogdan ; Alexandru, Aurelia ; Jimenez, Emmanuel de la Mora ; Dakhil, Shaker ; Lu, Shun ; Reck, Martin ; John, Thomas ; Hu, Nan ; Zhang, Xiaoqing ; Sylvester, Judi ; Eccles, Laura J. ; Grootendorst, Diederik J. ; Balli, David ; Neely, Jaclyn ; Carbone, David P..JOURNAL OF THORACIC ONCOLOGY.1.1.20,4.23.10.1016/j.jtho.2022.10.014.1.1
19. RET-MAP: An International Multicenter Study on Clinicobiologic Features and Treatment Response in Patients With Lung Cancer Harboring a RET Fusion.Aldea, Mihaela ; Marinello, Arianna ; Duruisseaux, Michael ; Zrafi, Wael ; Conci, Nicole ; Massa, Giacomo ; Metro, Giulio ; Monnet, Isabelle ; Gomez Iranzo, Patricia ; Tabbo, Fabrizio ; Bria, Emilio ; Guisier, Florian ; Vasseur, Damien ; Lindsay, Colin R ; Ponce-Aix, Santiago ; Cousin, Sophie ; Citarella, Fabrizio ; Fallet, Vincent ; Minatta, Jose Nicolas ; Eisert, Anna ; de Saint Basile, Hortense ; Audigier-Valette, Clarisse ; Mezquita, Laura ; Calles, Antonio ; Mountzios, Giannis ; Tagliamento, Marco ; Remon Masip, Jordi ; Raimbourg, Judith ; Terrisse, Safae ; Russo, Alessandro ; Cortinovis, Diego ; Rochigneux, Philippe ; Pinato, David James ; Cortellini, Alessio ; Leonce, Camille ; Gazzah, Anas ; Ghigna, Maria-Rosa ; Ferrara, Roberto ; Dall'Olio, Filippo Gustavo ; Passiglia, Francesco ; Ludovini, Vienna ; Barlesi, Fabrice ; FELIP FONT, ENRIQUETA; Planchard, David ; Besse, Benjamin.JOURNAL OF THORACIC ONCOLOGY.1.1.20,4.4.10.1016/j.jtho.2022.12.018.1.1
20. PTEN Loss Confers Resistance to Anti-PD-1 Therapy in Non-Small Cell Lung Cancer  by Increasing Tumor Infiltration of Regulatory T Cells..Exposito, Francisco ; Redrado, Miriam ; Houry, Maeva ; Hastings, Katherine ; Molero-Abraham, Magdalena ; Lozano, Teresa ; Solorzano, Jose Luis ; Sanz-Ortega, Julian ; Adradas, Vera ; AMAT FERRER, RAMON; Redin, Esther ; Leon, Sergio ; Legarra, Naroa ; Garcia, Javier ; Serrano, Diego ; Valencia, Karmele ; Robles-Oteiza, Camila ; Foggetti, Giorgia ; Otegui, Nerea ; FELIP FONT, ENRIQUETA; Lasarte, Juan J ; Paz-Ares, Luis ; Zugazagoitia, Jon ; Politi, Katerina ; Montuenga, Luis ; Calvo, Alfonso.CANCER RESEARCH.1.2.11,2.2.10.1158/0008-5472.CAN-22-3023.1.1
21. Comparison of SP263 and 22C3 immunohistochemistry PD-L1 assays for clinical  efficacy of adjuvant atezolizumab in non-small cell lung cancer: results from the  randomized phase III IMpower010 trial..Zhou, Caicun ; Srivastava, Minu K ; Xu, Hao ; FELIP FONT, ENRIQUETA; Wakelee, Heather ; Altorki, Nasser ; Reck, Martin ; Liersch, Rüdiger ; Kryzhanivska, Anna ; Oizumi, Satoshi ; Tanaka, Hiroshi ; Hamm, John ; McCune, Steven L ; Bennett, Elizabeth ; Gitlitz, Barbara ; McNally, Virginia ; Ballinger, Marcus ; McCleland, Mark ; Zou, Wei ; Das Thakur, Meghna ; Novello, Silvia.Journal for ImmunoTherapy of Cancer.1.2.10,9.0.10.1136/jitc-2023-007047.1.1
22. First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer,  including patients with ECOG performance status 2 and other special populations:  CheckMate 817..Ready, Neal E ; Audigier-Valette, Clarisse ; Goldman, Jonathan W ; FELIP FONT, ENRIQUETA; Ciuleanu, Tudor-Eliade ; Rosario García Campelo, María ; Jao, Kevin ; Barlesi, Fabrice ; Bordenave, Stéphanie ; Rijavec, Erika ; Urban, Laszlo ; Aucoin, Jean-Sébastien ; Zannori, Cristina ; Vermaelen, Karim ; Arén Frontera, Osvaldo ; Curioni Fontecedro, Alessandra ; Sánchez-Gastaldo, Amparo ; Juan-Vidal, Oscar ; Linardou, Helena ; Poddubskaya, Elena ; Spigel, David R ; Ahmed, Samreen ; Maio, Michele ; Li, Sunney ; Chang, Han ; Fiore, Joseph ; Acevedo, Angelic ; Paz-Ares, Luis.Journal for ImmunoTherapy of Cancer.1.2.10,9.11.10.1136/jitc-2022-006127.1.1
23. Reducing MYC's transcriptional footprint unveils a good prognostic gene signature  in melanoma..ZACARIAS FLUCK, MARIANO FEDERICO; MASSO VALLES, DANIEL; GIUNTINI, FABIO; GONZALEZ LARREATEGUI, IÑIGO; KAUR, JASTRINJAN; CASACUBERTA SERRA, SILVIA; JAUSET GONZALEZ, ANTONIO; MARTINEZ MARTI, SANDRA; MARTIN FERNANDEZ, IMMACULADA GENESIS; SERRANO DEL POZO, ERIKA; FORADADA FELIP, LAIA; GRUESO GRAGERA, JUDIT; NONELL MAZELON, LARA; BEAULIEU, MARIE-EVE; WHITFIELD, JONATHAN RICHARD; SOUCEK, LAURA.GENES & DEVELOPMENT.1.1.10,5.0.10.1101/gad.350078.122.1.1
24. First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus  chemotherapy alone (four cycles) in metastatic non-small cell lung cancer:  CheckMate 9LA 2-year patient-reported outcomes..Reck, Martin ; Ciuleanu, Tudor-Eliade ; Cobo, Manuel ; Schenker, Michael ; Zurawski, Bogdan ; Menezes, Juliana ; Richardet, Eduardo ; Bennouna, Jaafar ; FELIP FONT, ENRIQUETA; Juan-Vidal, Oscar ; Alexandru, Aurelia ; Cheng, Ying ; Sakai, Hiroshi ; Paz-Ares, Luis ; Lu, Shun ; John, Thomas ; Sun, Xiaowu ; Moisei, Aniela ; Taylor, Fiona ; Lawrance, Rachael ; Zhang, Xiaoqing ; Sylvester, Judi ; Yuan, Yong ; Blum, Steven I ; Penrod, John R ; Carbone, David P.EUROPEAN JOURNAL OF CANCER.1.2.8,4.3.10.1016/j.ejca.2023.01.015.1.1
25. Challenges in oncology career: are we closing the gender gap? Results of the new  ESMO Women for Oncology Committee survey..Linardou, H ; Adjei, A A ; Bajpai, J ; Banerjee, S ; Berghoff, A S ; Mathias, C Cerqueira ; Choo, S P ; Dent, R ; FELIP FONT, ENRIQUETA; Furness, A J S ; Garassino, M C ; GARRALDA CABANAS, ELENA; Konsoulova-Kirova, A ; Letsch, A ; Menzies, A M ; Mukherji, D ; Peters, S ; Sessa, C ; Tsang, J ; Yang, J C-H ; Garrido, P.ESMO open.1.2.7,3.4.10.1016/j.esmoop.2023.100781.1.2
26. Expression of TILs and Patterns of Gene Expression from Paired Samples of  Malignant Pleural Mesothelioma (MPM) Patients..CEDRES PEREZ, SUSANA; SERNA ALONSO, GARAZI; Gonzalez-Medina, Alberto ; VALDIVIA, AUGUSTO; Assaf-Pastrana, Juan David ; IRANZO GOMEZ, PATRICIA; CALLEJO PEREZ, ANA; PARDO ARANDA, NURIA; NAVARRO MENDIVIL, ALEJANDRO; MARTINEZ MARTI, ALEXANDRE; Priano, Ilaria ; FASANI, ROBERTA; Guardia, Xavier ; GONZALO RUIZ, JAVIER; CARBONELL NUÑEZ, CATERINA CECILIA; FRIGOLA RISSECH, JOAN; AMAT FERRER, RAMON; NAVARRO GARCES, VICTOR; DIENSTMANN, RODRIGO; VIVANCOS PRELLEZO, ANA; NUCIFORO, PAOLO GIOVANNI; FELIP FONT, ENRIQUETA.Cancers.2.3.5,2.0.10.3390/cancers15143611.1.3
27. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-ß and PD-L1, in  Patients With Non-Small Cell Lung Cancer Resistant or Refractory to Immune  Checkpoint Inhibitors..Barlesi, Fabrice ; Isambert, Nicolas ; FELIP FONT, ENRIQUETA; Cho, Byoung Chul ; Lee, Dae Ho ; Peguero, Julio ; Jerusalem, Guy ; Penel, Nicolas ; Saada-Bouzid, Esma ; Garrido, Pilar ; Helwig, Christoph ; Locke, George ; Ojalvo, Laureen S ; Gulley, James L.ONCOLOGIST.1.3.5,8.5.10.1093/oncolo/oyac253.1.1
28. Current State-of-the-Art Therapy for Malignant Pleural Mesothelioma and Future  Options Centered on Immunotherapy..CEDRES PEREZ, SUSANA; VALDIVIA, AUGUSTO; IRANZO GOMEZ, PATRICIA; CALLEJO PEREZ, ANA; PARDO ARANDA, NURIA; NAVARRO MENDIVIL, ALEJANDRO; MARTINEZ MARTI, ALEXANDRE; Assaf-Pastrana, Juan David ; FELIP FONT, ENRIQUETA; Garrido, Pilar.Cancers.2.3.5,2.0.10.3390/cancers15245787.1.3
29. Human Metastatic Cholangiocarcinoma Patient-Derived Xenografts and Tumoroids for  Preclinical Drug Evaluation..SERRA, QUERALT; VERDAGUER MATA, HELENA; Oliveros, Winona ; Lupión-Garcia, Núria ; LLOP GUEVARA, ALBA; Molina, Cristina ; Vila-Casadesús, Maria ; Turpin, Anthony ; Neuzillet, Cindy ; FRIGOLA RISSECH, JOAN; QUEROL PAÑOL, JESSICA; Yáñez-Bartolomé, Mariana ; CASTET, FLORIAN; FABREGAT FRANCO, CARLES; Escudero-Iriarte, Carmen ; ESCORIHUELA BAEZ, MARTA; ARENAS LAHUERTA, ENRIQUE HUERTA; Bernado-Morales, Cristina ; Haro, Noemí ; Giles, Francis J ; Pozo, Oscar J ; MIQUEL AYMAR, JOSEP MARIA; NUCIFORO, PAOLO GIOVANNI; VIVANCOS PRELLEZO, ANA; Melé, Marta ; SERRA ELIZALDE, VIOLETA; Arribas, Joaquín ; TABERNERO CATURLA, JOSEP; Peiró, Sandra ; MACARULLA MERCADE, TERESA; TIAN, TIAN.CLINICAL CANCER RESEARCH.1.1.11,5.1.10.1158/1078-0432.CCR-22-2551.1.1
30. A transcriptomics approach to expand therapeutic options and optimize clinical  trials in oncology..Lazar, Vladimir ; Zhang, Baolin ; Magidi, Shai ; Le Tourneau, Christophe ; Raymond, Eric ; Ducreux, Michel ; Bresson, Catherine ; Raynaud, Jacques ; Wunder, Fanny ; Onn, Amir ; FELIP FONT, ENRIQUETA; TABERNERO CATURLA, JOSEP; Batist, Gerald ; Kurzrock, Razelle ; Rubin, Eitan ; Schilsky, Richard L.THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY.2.4.4,9.1.10.1177/17588359231156382.1.2
31. Nutritional status associates with immunotherapy clinical outcomes in recurrent  or metastatic head and neck squamous cell carcinoma patients..HERNANDO CALVO, ALBERTO; MIRALLAS VIÑAS, ORIOL; MARMOLEJO CASTAÑEDA, DAVID HUMBERTO; SAAVEDRA SANTAGADEA, OMAR; VIEITO VILLAR, MARIA; Assaf Pastrana, Juan David ; AGUILAR IZQUIERDO, SUSANA; Bescós, Coro ; Lorente, Juan ; GIRALT, JORDI; BENAVENTE, SERGIO; Temprana-Salvador, Jordi ; Alberola, Margarita ; DIENSTMANN, RODRIGO; GARRALDA CABANAS, ELENA; FELIP FONT, ENRIQUETA; VILLACAMPA JAVIERRE, GUILLERMO; BRAÑA GARCIA, IRENE.ORAL ONCOLOGY.1.1.4,8.1.10.1016/j.oraloncology.2023.106364.1.1
32. Editorial: Multidisciplinary management of cancer patients with immune-related  adverse events from checkpoint inhibitors..Riveiro-Barciela, Mar ; FELIP FONT, ENRIQUETA; Suarez-Almazor, María E.Frontiers in Medicine.2.4.3,9.1.10.3389/fmed.2022.1104382.1.3
33. The EU-funded I(3)LUNG Project: Integrative Science, Intelligent Data Platform  for Individualized LUNG Cancer Care With Immunotherapy..Prelaj, Arsela ; Ganzinelli, Monica ; Trovo', Francesco ; Roisman, Laila C ; Pedrocchi, Alessandra Laura Giulia ; Kosta, Sokol ; Restelli, Marcello ; Ambrosini, Emilia ; Broggini, Massimo ; Pravettoni, Gabriella ; Monzani, Dario ; Nuara, Alessandro ; AMAT FERRER, RAMON; Spathas, Nikos ; Willis, Michael ; Pearson, Alexander ; Dolezal, James ; Mazzeo, Laura ; Sangaletti, Sabina ; Correa, Ana Maria ; Aguaron, Alfonso ; Watermann, Iris ; Popa, Crina ; Raimondi, Giulia ; Triulzi, Tiziana ; Steurer, Stefan ; Lo Russo, Giuseppe ; Linardou, Helena ; Peled, Nir ; FELIP FONT, ENRIQUETA; Reck, Martin ; Garassino, Marina Chiara.CLINICAL LUNG CANCER.2.5.3,6.2.10.1016/j.cllc.2023.02.005.1.2
34. A Delphi consensus panel about clinical management of early-stage EGFR-mutated non-small cell lung cancer (NSCLC) in Spain: a Delphi consensus panel study.Isla, Dolores ; FELIP FONT, ENRIQUETA; Garrido, Pilar ; Insa, Amelia ; Majem, Margarita ; Remon, Jordi ; Trigo, Jose M. ; de Castro, Javier.CLINICAL & TRANSLATIONAL ONCOLOGY.3.6.3,4.1.10.1007/s12094-022-02941-5.2.3
35. Current professional standing of young medical oncologists in Spain: a nationwide  survey by the Spanish Society of Medical Oncology + MIR section..Martinez, Domingo Antonio Sanchez ; Quilez-Cutillas, Aliica ; Jimenez-Labaig, Pablo ; Sesma, Andrea ; Tarazona, Noelia ; Pacheco-Barcia, Vilma ; Obispo, Berta ; Paez, David ; Quintanar, Teresa ; Sanchez-Canovas, Manuel ; Montes, Ana Fernandez ; FELIP FONT, ENRIQUETA; Rodriguez-Lescure, Alvaro ; ELEZ FERNANDEZ, MARIA ELENA.CLINICAL & TRANSLATIONAL ONCOLOGY.3.6.3,4.1.10.1007/s12094-022-02989-3.2.3
36. New update to the guidelines on testing predictive biomarkers in non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology.Isla, Dolores ; Lozano, Maria D ; Paz-Ares, Luis ; Salas, Clara ; de Castro, Javier ; Conde, Esther ; FELIP FONT, ENRIQUETA; Gómez-Román, Javier ; Garrido, Pilar ; Enguita, Ana Belén.CLINICAL & TRANSLATIONAL ONCOLOGY.3.6.3,4.6.10.1007/s12094-022-03046-9.2.3
37. Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for <i>EGFR</i> exon 20 insertion-positive non-small cell lung cancer.Yang, James Chih-Hsin ; Zhou, Caicun ; Jänne, Pasi A ; Ramalingam, Suresh S ; Kim, Tae Min ; Riely, Gregory J ; Spira, Alexander I ; Piotrowska, Zofia ; Mekhail, Tarek ; Garcia Campelo, Maria Rosario ; FELIP FONT, ENRIQUETA; Bazhenova, Lyudmila ; Jin, Shu ; Kaur, Manmit ; Diderichsen, Paul M ; Gupta, Neeraj ; Bunn, Veronica ; Lin, Jianchang ; N Churchill, Eric ; Mehta, Minal ; Nguyen, Danny.EXPERT REVIEW OF ANTICANCER THERAPY.3.6.3,3.1.10.1080/14737140.2023.2157815.2.3
38. HERTHENA-Lung01: a phase II study of patritumab deruxtecan (HER3-DXd) in  previously treated metastatic EGFR-mutated NSCLC..Yu, Helena A ; Yang, James Chih-Hsin ; Hayashi, Hidetoshi ; Goto, Yasushi ; FELIP FONT, ENRIQUETA; Reck, Martin ; Vigliotti, Michele ; Dong, Qian ; Cantero, Frédérique ; Fan, Pang-Dian ; Kanai, Masayuki ; Sternberg, David W ; Jänne, Pasi A.FUTURE ONCOLOGY.3.6.3,3.2.10.2217/fon-2022-1250.1.3
39. Plain language summary of the CheckMate 816 study results: nivolumab plus  chemotherapy given before surgery for non-small-cell lung cancer..Forde, Patrick M ; Spicer, Jonathan ; Lu, Shun ; Provencio, Mariano ; Mitsudomi, Tetsuya ; Awad, Mark M ; FELIP FONT, ENRIQUETA; Broderick, Stephen R ; Brahmer, Julie R ; Swanson, Scott J ; Kerr, Keith ; Wang, Changli ; Ciuleanu, Tudor-Eliade ; Saylors, Gene B ; Tanaka, Fumihiro ; Ito, Hiroyuki ; Chen, Ke Neng ; Liberman, Moishe ; Vokes, Everett E ; Taube, Janis M ; Dorange, Cecile ; Cai, Junliang ; Fiore, Joseph ; Jarkowski, Anthony ; Balli, David ; Sausen, Mark ; Pandya, Dimple ; Calvet, Christophe Y ; Girard, Nicolas.FUTURE ONCOLOGY.3.6.3,3.0.10.2217/fon-2023-0007.1.3
40. Plain language summary of the updated results from the CROWN study comparing  lorlatinib with crizotinib in people with advanced non-small-cell lung cancer..Solomon, Benjamin J ; Bauer, Todd M ; K Mok, Tony S ; Liu, Geoffrey ; Mazieres, Julien ; Marinis, Filippo de ; Goto, Yasushi ; Kim, Dong-Wan ; Wu, Yi-Long ; Jassem, Jacek ; López, Froylán López ; Soo, Ross A ; Shaw, Alice T ; Polli, Anna ; Messina, Rossella ; Iadeluca, Laura ; Toffalorio, Francesca ; FELIP FONT, ENRIQUETA.FUTURE ONCOLOGY.3.6.3,3.0.10.2217/fon-2022-1289.1.3
41. TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as  first-line therapy for advanced NSCLC..Levy, Benjamin P ; FELIP FONT, ENRIQUETA; Reck, Martin ; Yang, James Ch ; Cappuzzo, Federico ; Yoneshima, Yasuto ; Zhou, Caicun ; Rawat, Siddhartha ; Xie, Jingdong ; Basak, Priyanka ; Xu, Lu ; Sands, Jacob.FUTURE ONCOLOGY.3.6.3,3.2.10.2217/fon-2023-0230.1.3
42. TRUST-II: a global phase II study of taletrectinib in ROS1-positive  non-small-cell lung cancer and other solid tumors..Nagasaka, Misako ; Ohe, Yuichiro ; Zhou, Caicun ; Choi, Chang-Min ; Yang, Nong ; Liu, Geoffrey ; FELIP FONT, ENRIQUETA; Pérol, Maurice ; Besse, Benjamin ; Nieva, Jorge ; Raez, Luis ; Pennell, Nathan A ; Dimou, Anastasios ; Marinis, Filippo de ; Ciardiello, Fortunato ; Seto, Takashi ; Hu, Zheyi ; Pan, Max ; Wang, Weiqing ; Li, Shuanglian ; Ou, Sai-Hong I.FUTURE ONCOLOGY.3.6.3,3.0.10.2217/fon-2022-1059.1.3
43. A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate  Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors..Hanley, Michael J ; D'Arcangelo, Manolo ; FELIP FONT, ENRIQUETA; Garrido, Pilar ; Zhu, Jiaxi ; Ye, Meng ; Vranceanu, Florin ; Gupta, Neeraj.JOURNAL OF CLINICAL PHARMACOLOGY.3.6.2,9.1.10.1002/jcph.2198.2.4
44. Antibody-Drug Conjugates for Lung Cancer: Payloads and Progress..Rosner, Samuel ; VALDIVIA, AUGUSTO; Hoe, Hui Jing ; Murray, Joseph C ; Levy, Benjamin ; FELIP FONT, ENRIQUETA; Solomon, Benjamin J.American Society Of Clinical Oncology Educational Book / Asco. American Society Of Clinical Oncology. Meeting. . . . .10.1200/EDBK_389968.3.8
45. Use of Drugs in Clinical Practice and the Associated Cost of Cancer Treatment in Adult Patients with Solid Tumors: A 10-Year Retrospective Cohort Study.Carreras, Maria-Josep ; Tomás-Guillén, Elena ; Farriols, Anna ; Renedo-Miró, Berta ; Valdivia, Carolina ; Vidal, Jana ; SAURA MANICH, CRISTINA; CARLES GALCERAN, JOAN; FELIP FONT, ENRIQUETA; Gorgas, Maria-Queralt ; TABERNERO CATURLA, JOSEP; Monterde, Josep.Current Oncology. . . .0.10.3390/curroncol30090580.2.5
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