Portal de investigación
Ensayo aleatorizado de fase III en pacientes con cáncer de endometrio con deficiencia de MMR que compara quimioterapia sola versus Dostarlimab en primera línea en un cáncer avanzado/metastásico: ESTUDIO DOMENICA (estudio GINECO-EN105b/ENGOT-en13).
Datos básicos
- Protocolo:
- GINECO-EN105b
- EUDRACT:
- 2021-002124-21
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Supervivencia libre de progresión (SLP) definida como el tiempo transcurrido desde la fecha de aleatorización hasta la progresión objetiva del tumor según RECIST 1.1, o la muerte por cualquier causa, lo que ocurra primero Objetivos Secundarios: • Calidad de vida • Tasa de respuesta objetiva (RO) • Supervivencia global (SG) • Tasa de duración de la respuesta (DoR) • Seguridad y tolerabilidad evaluada por CTCAE v5.0 (por los investigadores) y evaluada por NCI PRO-CTCAE (por los pacientes) • Tiempo hasta el primer y segundo tratamiento posterior (TPTP y TSTP)
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[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 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 Smart Digital Health Platform to Enable Monitoring of Quality of Life and Frailty in Older Patients with Cancer: A Mixed-Methods, Feasibility Study Protocol.
Papachristou, Nikolaos; (...); Bamidis, Panagiotis D.
Article. 10.1016/j.soncn.2023.151437. 2023
Analysis of Tumor Microenvironment Changes after Neoadjuvant Chemotherapy with or without Bevacizumab in Advanced Ovarian Cancer (GEICO-89T/MINOVA Study).
Tavira B; (...); González-Martín A
Article. 10.1158/1078-0432.CCR-23-0771. 2024
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
Atezolizumab (atezo) combined with platinum-based chemotherapy (CT) and maintenance niraparib for recurrent ovarian cancer (rOC) with a platinum-free interval (TFIp) >6 months: Primary analysis of the double-blind placebo (pbo)controlled ENGOT-Ov41/GEICO 69-O/ANITA phase III trial
Martin, A. Gonzalez; (...); Selle, F.
Meeting Abstract. 10.1016/j.annonc.2023.10.031. 2023
Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial.
Gonzalez-Martin, Antonio; (...); Selle, Frederic
Article. 10.1200/JCO.24.00668. 2024
Clinical and molecular signature of survival and resistance to olaparib plus pegylated liposomal doxorubicin in platinum-resistant ovarian cancer: a stratified analysis from the phase II clinical trial ROLANDO, GEICO-1601.
Perez-Fidalgo, Jose Alejandro; (...); Gonzalez-Martin, Antonio
Article. 10.1136/ijgc-2022-004028. 2023
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
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
Cyclin E cytoplasmatic isoform to predict outcome and benefit to capecitabine treatment in patients with HR+/HER2-metastatic breast cancer from the GEICAM/2013-02 PEARL study
Guerrero, Angel; (...); Martin, Miguel
Meeting Abstract. 2023
Characterization of the gene expression profile of breast cancer tumours in patients undergoing ovarian stimulation for fertility preservation purposes
Soriano, M. J.; (...); Diaz-Garcia, C.
Meeting Abstract. 2022
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
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Hypertension as predictive factor for bevacizumab-containing first-line therapy in metastatic breast and colorectal cancer in BRECOL (GEICAM/2011-04) study.
Rodríguez-Lescure Á; (...); de la Haba-Rodriguez J
Article. 10.1007/s12094-024-03411-w. 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
Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry.
Martin, Miguel; (...); Aguiar-Bujanda, David
Article. 10.1007/s10549-023-07002-1. 2023
Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study.
Kristeleit, Rebecca; (...); Subbiah, Vivek
Article. 10.1007/s10637-023-01383-2. 2023
Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study.
Longo-Munoz, Federico; (...); Subbiah, Vivek
Article. 10.1016/j.ejca.2022.06.024. 2022
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
Molecular characterization of pregnancy-associated breast cancer and insights on timing from GEICAM-EMBARCAM study.
Pena-Enriquez, Regina; (...); de la Haba-Rodriguez, Juan
Article. 10.1038/s41523-025-00718-x. 2025
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
Open-label phase II clinical trial of ketoconazole as CYP17 inhibitor in metastatic or advanced non-resectable granulosa cell ovarian tumors: the GREKO (GRanulosa Et KetOconazole) trial, GETHI 2011-03.
Garcia-Donas, Jesus; (...); Grande, Enrique
Article. 10.1007/s12094-023-03085-w. 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
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 clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01).
García-Donas J; (...); Navarro P
Article. 10.1016/j.ygyno.2024.10.019. 2024
Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+/HER2-metastatic breast cancer (MBC) enrolled in the GEICAM/2014-12 FLIPPER trial
Gustavo, Federico; (...); Albanell, Joan
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.1029. 2024
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
Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial.
Tibau, Ariadna; (...); Albanell, Joan
Article. 10.1177/17588359221148921. 2023
Real-world safety and effectiveness of maintenance niraparib for platinum-sensitive recurrent ovarian cancer: A GEICO retrospective observational study within the Spanish expanded-access programme.
Cueva, Juan F.; (...); Gonzalez-Martin, Antonio
Article. 10.1016/j.ejca.2022.12.023. 2022
Role of the receptor for advanced glycation end products (RAGE) in blood as a potential biomarker for progression to olaparib: A post hoc analysis of patients with platinum-resistant ovarian cancer (PROC) treated in the ROLANDO-GEICO 1601 trial
Perez-Fidalgo, Jose Alejandro; (...); Gonzalez-Martin, Antonio
Meeting Abstract. 2024
Rucaparib for PARP inhibitor-pretreated ovarian cancer: A GEICO retrospective subgroup analysis from the Spanish Rucaparib Access Program.
Yubero, Alfonso; (...); Gonzalez-Martin, Antonio
Case Reports. 10.1016/j.gore.2023.101211. 2023
Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain - A GEICO study
Yubero, Alfonso; (...); Gonzalez-Martin, Antonio
Article. 10.1186/s12885-022-10191-5. 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 Prognostic Significance of Tumor-Infiltrating Lymphocytes, PD-L1, BRCA Mutation Status and Tumor Mutational Burden in Early-Stage High-Grade Serous Ovarian Carcinoma-A Study by the Spanish Group for Ovarian Cancer Research (GEICO).
Pizarro, David; (...); Palacios, Jose
Article. 10.3390/ijms241311183. 2023
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
Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial
Albanell, Joan; (...); Rojo Todo, Federico Gustavo
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.1028. 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