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Projectes i Estudis Clínics
Estudio fase III, abierto, aleatorizado y multicentrico con 3 grupos de tratamiento de savolitinib más durvalumab frente a sunitinib y durvalumab en monoterapia en participantes con carcinoma de células renales papilares (CCRP) irresecable y localmente avanzado o metastásico causado por mutación en MET (SAMETA).

Estudio fase III, abierto, aleatorizado y multicentrico con 3 grupos de tratamiento de savolitinib más durvalumab frente a sunitinib y durvalumab en monoterapia en participantes con carcinoma de células renales papilares (CCRP) irresecable y localmente avanzado o metastásico causado por mutación en MET (SAMETA).

Dades bàsiques

Protocol:: D5086C00001
EURDRACT:: 2021-000336-55
NCT:
Centre:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:: 2021
Any de finalització:: 2025

ENSAYO CLÍNICO

Objectius del projecte

Objetivo Principal: Demostrar la eficacia de savolitinib más durvalumab en relación con sunitinib mediante la evaluación de la SSP en participantes con CCRP irresecable y localmente avanzado o metastásico causado por mutación en MET. Objetivos Secundarios: a.Demostrar la eficacia de savolitinib más durvalumab en relación con sunitinib mediante la evaluación de la: -SG -TRO -DR -TCE a las 24 y 48 semanas -SSP2 b.Demostrar la eficacia de savolitinib más durvalumab en relación con durvalumab en monoterapia mediante la evaluación de: -TRO -SSP -DR c. Evaluar los síntomas notificados por el paciente, el funcionamiento y la CdVRS en participantes con CCRP irresecable y localmente avanzado o metastásico causado por mutación en MET tratados con savolitinib más durvalumab en relación con sunitinib. d. Evaluar la FC de savolitinib y durvalumab en participantes con CCRP irresecable y localmente avanzado o metastásico causado por mutación en MET.

Documents

No hi ha documents

Participants

Carmina Rodrigo Jarque

Data Manager / Study Coordinator
David Ramos Soler

Investigador Colaborador
Irene Torres Espallardo

Investigador Colaborador
Regina Gironés Sarrió

Investigador Principal
Paula Irene Petruskevicius Fernández

Data Manager / Study Coordinator
José Luis Poveda Andrés

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Fernando Aparici Robles

Investigador Colaborador
Carmen Ballester Vallés

Investigador Colaborador
Gema Gimeno Mateu

Data Manager / Study Coordinator
Paula Ballester Martinez

Investigador Colaborador
Alba Torres Martínez

Investigador Colaborador
Begoña Martinez Sanchis

Investigador Colaborador
Carlos Alberto Zac Romero

Investigador Colaborador
Sonia Gines Cardenas

Investigador Colaborador
Africa Almendros Riaza

Investigador Colaborador
Oussama Bardouz Gouguasse

Investigador Colaborador
Silvia Maestro Huguet

Investigador Colaborador
Maria Arnal Rondán

Investigador Colaborador
Elena Teijeiro Vazquez

Investigador Colaborador
Ana Maria Llorca Ibañez

Data Manager / Study Coordinator

Veure tots els Investigadors

Grups d'Investigació

Investigación Clínica y Traslacional en Cáncer

Leader

José Gómez Codina
Unidad Mixta de Investigación Cerebrovascular

Leader

Juan Bautista Salom Sanvalero
Farmacogenética

Investigador Principal

María José Herrero Cervera
Investigacion Biomédica en Imagen (GIBI 2-30)

Investigador Principal

Leonor Cerdá Alberich
Núcleo de investigación traslacional integrado Urológico de Valencia (NITIUV)

Leader

César David Vera Donoso
Endoscopia Digestiva y Hepática

Leader

Vicente Pons Beltrán
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Finançadors - Promotors

ASTRAZENECA AB C/O FORTREA

Resultats de l'Assaig Clínic

Publicacions en Revistes 122

[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

López DF; (...); Ortiz-Romero, P. L.

Article. 10.1016/j.ad.2022.11.013. 2023

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

A combined analysis of two prospective randomised studies exploring the impact of extended post-radiation temozolomide on survival outcomes in newly diagnosed glioblastoma (Dec, 10.1007/s11060-023-04513-1, 2023)

Gately L; (...); Balana C

Correction. 10.1007/s11060-024-04581-x. 2024

A combined analysis of two prospective randomised studies exploring the impact of extended post-radiation temozolomide on survival outcomes in newly diagnosed glioblastoma.

Gately, L.; (...); Balana, C.

Article. 10.1007/s11060-023-04513-1. 2023

A COMBINED ANALYSIS OF TWO RANDOMISED STUDIES EXPLORING THE IMPACT OF EXTENDED POST-RADIATION TEMOZOLOMIDE ON SURVIVAL OUTCOMES IN NEWLY DIAGNOSED GLIOBLASTOMA

Gately, Lucy; (...); Balana, Carmen

Meeting Abstract. 2023

A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.

Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose

Article. 10.3390/ijms25042112. 2024

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro

Article. 10.33393/grhta.2022.2333. 2022

A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022

Addressing the challenges of cancer care in older adults: The unique benefits of oncogeriatric evaluation and management.

Martinez-Peromingo, Javier; (...); Girones, Regina

Letter. 10.1016/j.regg.2023.03.002. 2023

Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022

Bladder cancer patients have increased NETosis and impaired DNaseI-mediated NET degradation that can be therapeutically restored in vitro.

Herranz R; (...); Medina P

Article. 10.3389/fimmu.2023.1171065. 2023

Bladder Preservation with Durvalumab plus Tremelimumab and Concurrent Radiotherapy in Patients with Localized Muscle-Invasive Bladder Cancer (IMMUNOPRESERVE): A Phase II Spanish Oncology GenitoUrinary Group Trial.

Garcia-Del-Muro, Xavier; (...); Alemany, Ramon

Article. 10.1158/1078-0432.CCR-24-2636. 2025

Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2021.07.009. 2021

Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.

Martinez-Movilla, Andrea; (...); Carles, Montserrat

Article. 10.1186/s40658-022-00509-4. 2022

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

Salinas P; (...); Escaned J

Article. 10.1016/j.carrev.2021.11.015. 2021

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Distal Access Catheter Improves Balloon Guide and Stent Retriever Thrombectomy Outcomes in Nonagenarians.

Puig, Josep; (...); Blasco, Jordi

Article. 10.1111/jon.70012. 2025

Drug load and memory during intracarotid amobarbital procedure in epilepsy

Lozano-García A; (...); Villanueva V

Editorial Material. 10.1111/ane.13491. 2021

Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment

Palanques-Pastor T; (...); Poveda Andrés JL

Article. 10.1159/000517813. 2021

Enhancing Prostate Tumor Biobanking Reliability with Improved Sampling Technique and Histological Characterization.

Giner Moreno E; (...); Ramos Soler D

Article. 10.3791/65635. 2023

Enhancing the First-Pass Effect in Acute Stroke: The Impact of Stent Retriever Characteristics

Murias, Eduardo; (...); Vega, Pedro

Article. 10.3390/jcm13113123. 2024

Executive dysfunction and cortical variations among intimate partner violence perpetrators and the association with sexism.

Romero-Martinez, Angel; (...); Moya-Albiol, Luis

Article. 10.1093/scan/nsae046. 2024

Experience of GEINO (Spanish cooperative group for research in neuro-oncology) oncologists in the management of adult medulloblastoma

Villar, MV; (...); Santos, JD

Meeting Abstract. 10.1016/j.annonc.2021.08.008. 2021

Expert consensus to optimize the management of older adult patients with advanced EGFR-mutated non-small cell lung cancer.

Nadal E; (...); Gironés R

Article. 10.1007/s12094-023-03286-3. 2023

Expert consensus to optimize the treatment of elderly patients with luminal metastatic breast cancer.

Torregrosa-Maicas MD; (...); Gironés-Sarrió R

Article. 10.1007/s12094-021-02766-8. 2022

Exploring management and outcomes of elderly patients with glioblastoma using data from two randomised trials (GEINO1401/EX-TEM).

Gately L; (...); Balana C

Article. 10.1007/s11060-024-04668-5. 2024

Extra-Skeletal Osteosarcoma of the Prostate After Treated Prostatic Acinar Adenocarcinoma: A Case Report and Review of the Literature.

García CR; (...); Segura FG

Article. 10.1177/10668969241283735. 2024

Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report

Fernandez-Sanchez, M; (...); Poveda-Andres, JL

Article. 10.1002/bdr2.1942. 2021

Final database lock results of the phase 2 cohort of lenvatinib plus pembrolizumab for progressive disease after a PD-1/PD-L1-containing therapy in metastatic clear cell renal cell carcinoma

Lee, Chung-Han; (...); Motzer, Robert J.

Meeting Abstract. 2023

Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.

Saborido-Moral, Juan D.; (...); Carles, Montserrat

Article. 10.1016/j.ejmp.2023.103153. 2023

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Glasdegib in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma: Phase Ib/II GEINO 1602 trial

Vaz, M. A.; (...); Girones, R.

Meeting Abstract. 10.1016/j.annonc.2023.09.1695. 2023

Gray matter volume differences in intimate partner violence perpetrators and its role in explaining dropout and recidivism

Romero-Martinez, Angel; (...); Moya-Albiol, Luis

Article. 10.1016/j.jpsychires.2024.09.019. 2024

Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022

Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

Impact of a comprehensive geriatric assessment to manage elderly patients with locally advanced non-small-cell lung cancers: a multicenter prospective study.

Rondan, Maria Arnal; (...); Sarrio, Regina Girones

Article. 10.1007/s12094-024-03657-4. 2024

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Leave no one behind: A global survey of the current state of geriatric oncology practice by SIOG national representatives.

Mizutani, Tomonori; (...); Kanesvaran, Ravindran

Article. 10.1016/j.jgo.2024.101709. 2024

Lenvatinib plus Pembrolizumab Following Immune Checkpoint Inhibitor Treatment in Patients with Metastatic Clear Cell Renal Cell Carcinoma: Results from Study 111/KEYNOTE-146.

Lee, Chung-Han; (...); Motzer, Robert J

Letter. 10.1016/j.eururo.2024.05.003. 2024

Lenvatinib plus pembrolizumab in patients with either treatment-naive or previously treated metastatic renal cell carcinoma (Study 111/KEYNOTE-146): a phase 1b/2 study

Lee, CH; (...); Motzer, JR

Article. 10.1016/S1470-2045(21)00241-2. 2021

Local detection of microvessels in IDH-wildtype glioblastoma using relative cerebral blood volume: an imaging marker useful for astrocytoma grade 4 classification.

Álvarez-Torres MDM; (...); Garcia-Gomez, Juan Miguel

Article. 10.1186/s12885-021-09117-4. 2022

Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.

Megías-Vericat JE; (...); Poveda-Andrés JL

Article. 2021

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A

Bonanad, S; (...); Santos, S

Article. 10.1007/s12325-021-01853-0. 2021

Medical imaging clinical trials unit: A professional need.

Penades-Blasco, Ana; (...); Marti-Bonmati, Luis

Article. 10.1016/j.ejrad.2021.110099. 2022

Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Article. 10.3390/cancers14030596. 2022

Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021

National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)

Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel

Correction. 10.7399/fh.11740. 2021

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

P25.03.B RWD OF IDH MUTANT GLIOMAS IN SPAIN, A RETSINE - GEINO STUDY

Mazariegos, M.; (...); Pineda, E.

Meeting Abstract. 10.1093/neuonc/noae144.446. 2024

Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Correction. 10.3389/fped.2021.834454. 2022

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Morillo-Verdugo, R; (...); Diaz-Olmo, J

Article. 10.7399/fh.11719. 2021

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

Morillo-Verdugo R; (...); Díaz-Olmo J

Article. 2021

Phase II trial evaluating olaparib maintenance in patients with metastatic castration resistant prostate cancer (mCRPC) after docetaxel treatment, reaching partial or stable response: SOGUG-IMANOL study.

Juan Fita, Maria Jose; (...); Heras, Lucia

Meeting Abstract. 2023

Phase II Trial Evaluating Olaparib Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer Responsive or Stabilized on Docetaxel Treatment: SOGUG-IMANOL Study.

Juan Fita, Maria Jose; (...); Angel Climent, Miguel

Article. 10.3390/cancers15215223. 2023

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

Falkenhain-Lopez, D; (...); Ortiz-Romero, P L

Article. 10.1016/j.ad.2022.11.010. 2023

Prognostic role of geriatric assessment (GA) in patients with metastatic prostate cancer (MPCaP) attended in medical oncology.

Girones, Regina, Arnal, Maria, Forcano, Silvia

Meeting Abstract. 2023

Safety and efficacy of glasdegib in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma: Phase Ib/II GEINO 1602 trial

Vaz, Maria Angeles; (...); Martinez-Garcia, Maria

Meeting Abstract. 2022

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

SOGUG-AVELUMAB_RWD: Comprehensive analysis of real-word data to evaluate the effectiveness and safety of avelumab maintenance therapy in patients with stage IV urothelial carcinoma conducted in Spain.

Juan Fita, Maria Jose; (...); Molina Diaz, Aurea

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.e1656. 2024

The role of intimate partner violence perpetrators' resting state functional connectivity in treatment compliance and recidivism.

Romero-Martinez, Angel; (...); Moya-Albiol, Luis

Article. 10.1038/s41598-024-52443-3. 2024

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

vol2Brain: A New Online Pipeline for Whole Brain MRI Analysis

Manjón JV; (...); Coupé P

Article. 10.3389/fninf.2022.862805. 2022

Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.

Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene

Article. 10.1007/s13246-024-01452-7. 2024