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- TiNivo-2: Estudio en fase III, aleatorizado, controlado, multicéntrico y abierto para comparar Tivozanib en combinación con Nivolumab con Tivozanib en monoterapia en sujetos con carcinoma de células renales que han progresado tras una o dos líneas de tratamiento en las que una línea tiene un inhibidor del punto de control inmunitario.
TiNivo-2: Estudio en fase III, aleatorizado, controlado, multicéntrico y abierto para comparar Tivozanib en combinación con Nivolumab con Tivozanib en monoterapia en sujetos con carcinoma de células renales que han progresado tras una o dos líneas de tratamiento en las que una línea tiene un inhibidor del punto de control inmunitario.
Dades bàsiques
- Protocol:
- AV-951-20-304
- EURDRACT:
- 2021-000050-26
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
- 2025
Objectius del projecte
Objetivo Principal: Comparar la supervivencia sin progresión (SSP) de tivozanib en combinación con nivolumab frente a tivozanib en sujetos con carcinoma de células renales (CCR) que han progresado después de 1 o 2 líneas de tratamiento entre las que se incluye un inhibidor del punto de control inmunitario (ICI), según lo evaluado mediante una revisión radiológica independiente (RRI) enmascarada. Objetivos Secundarios: a) Comparar la supervivencia general (SG) de los sujetos aleatorizados para recibir tratamiento con tivozanib en combinación con nivolumab en comparación con tivozanib. b) Comparar la tasa de respuesta global(TRG) y la duración de la respuesta (DR) de los sujetos aleatorizados para recibir tratamiento con tivozanib en combinación con nivolumab en comparación con tivozanib, según lo evaluado mediante una RRI enmascarada. c) Evaluar la seguridad y tolerabilidad de tivozanib en combinación con nivolumab en comparación con tivozanib.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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 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
Advances in Transversal Topics Applicable to the Care of Bladder Cancer Patients in the Real-World Setting
Garrido Siles, Marga; (...); Angel Climent, Miguel
Review. 10.3390/cancers14163968. 2022
Artificial Intelligence on FDG PET Images Identifies Mild Cognitive Impairment Patients with Neurodegenerative Disease.
Prats-Climent, Joan; (...); Marti-Bonmati, Luis
Article. 10.1007/s10916-022-01836-w. 2022
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Automatic etiological classification of stroke thrombus digital photographs using a deep learning model
Lucero-Garofano, Alvaro; (...); Manjon, Jose V.
Article. 10.3389/fneur.2025.1534845. 2025
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
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
Correction: Update on the management of elderly patients with colorectal cancer.
Soler-González G; (...); Gironés-Sarrió R
Correction. 10.1007/s12094-023-03351-x. 2024
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
DeepCERES: A deep learning method for cerebellar lobule segmentation using ultra-high resolution multimodal MRI.
Morell-Ortega, Sergio; (...); Manjon, Jose V
Article. 10.1016/j.neuroimage.2025.121063. 2025
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
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
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
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
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
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
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
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 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
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
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
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
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
SEOM-GEINO clinical guidelines for high-grade gliomas of adulthood (2022).
Segura, Pedro Perez; (...); Losada, Estela Pineda
Article. 10.1007/s12094-023-03245-y. 2023
SIOG COVID-19 Working Group recommendations on COVID-19 therapeutic approaches in older adults with cancer.
Russo, Chiara; (...); Battisti NML
Article. 10.1016/j.jgo.2023.101564. 2023
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
State of the scientific evidence and recommendations for the management of older patients with gastric cancer.
Paredero-Perez, Irene; (...); Girones-Sarrio, Regina
Article. 10.1016/j.jgo.2023.101657. 2023
Strategies to enhance management of HER2-positive breast cancer in the elderly: an expert consensus perspective.
Del Barco, Sonia; (...); Servitja, Sonia
Article. 10.1007/s12094-024-03838-1. 2025
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of brain volume to explain autonomous imbalance during recovery from acute stress in batterers.
Romero-Martinez, Angel; (...); Moya-Albiol, Luis
Letter. 10.1007/s00429-024-02772-w. 2024
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
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
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Update on the management of elderly patients with colorectal cancer.
Soler-Gonzalez, Gemma; (...); Girones-Sarrio, Regina
Article. 10.1007/s12094-023-03243-0. 2023
Update on the management of older patients with pancreatic adenocarcinoma: a perspective from medical oncology.
Guillot Morales M; (...); Gironés Sarrió R
Article. 10.1007/s12094-024-03386-8. 2024
Updated SIOG COVID-19 working group recommendations on COVID-19 vaccination among older adults with cancer.
Soto-Perez-de-Celis, Enrique; (...); Battisti, Nicolo Matteo Luca
Article. 10.1016/j.jgo.2022.07.005. 2022
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