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  3. Estudio aleatorizado, doble ciego y con grupos paralelos para comparar la farmacocinética de GME751 (biosimilar propuesto de pembrolizumab) y Keytruda®, autorizado por la UE y en EE. UU., en participantes con melanoma en estadio II y III que requieren tratamiento complementario con pembrolizumab.

Estudio aleatorizado, doble ciego y con grupos paralelos para comparar la farmacocinética de GME751 (biosimilar propuesto de pembrolizumab) y Keytruda®, autorizado por la UE y en EE. UU., en participantes con melanoma en estadio II y III que requieren tratamiento complementario con pembrolizumab.

Datos básicos

Código:
CGME751A12101
Protocolo:
CGME751A12101
EUDRACT:
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2024
Año de finalización:
ENSAYO CLÍNICO

Documentos

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Participantes

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Grupos

Financiadores - Promotores

HEXAL AG

Resultados del Ensayo Clínico

[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.

Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin

Article. 10.1016/j.farma.2024.08.002. 2024

  • Open Access.

[Translated article] New challenges in advanced therapies.

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

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[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


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

  • Open Access.

An exosome-based liquid biopsy predicts depth of response and survival outcomes to cetuximab and panitumumab in metastatic colorectal cancer: The EXONERATE Study.

Xu, Caiming; (...); Goel, Ajay

Article. 10.1158/1078-0432.CCR-24-1934. 2025


Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.

Pérez-Alenda S; (...); Núñez-Cortés R

Article. 10.1111/hae.14988. 2024

  • Open Access.

Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.

Megias-Vericat, Juan E; (...); Yan, Songkai

Article. 10.1080/13696998.2025.2474886. 2025


Dermatological toxicities of talquetamab, a new bispecific antibody: case series and literature review.

Mansilla-Polo M; (...); Botella-Estrada R

Letter. 10.1111/ddg.15502. 2024


Dermatological toxicities of talquetamab, a new bispecificantibody: case series and literature review

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Letter. 10.1111/ddg.15502_g. 2024


Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.

Megias-Vericat, J E; (...); Poveda Andres, J L

Letter. 10.1016/j.thromres.2024.109122. 2024


Fibrillary glomerulonephritis: more frequent than it seems? The diagnostical importance of immunohistochemistry.

Viejo-Boyano I; (...); Hernández-Jaras J

Letter. 10.1016/j.nefroe.2023.05.022. 2024


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

  • Open Access.

Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.

Rodríguez MA; (...); Chimeno-Hernández A

Article. 10.1016/j.thromres.2024.109181. 2024

  • Open Access.

New challenges of advanced therapies.

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

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

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

  • Open Access.

Pharmacogenetics of Neoadjuvant MAP Chemotherapy in Localized Osteosarcoma: A Study Based on Data from the GEIS-33 Protocol

Salazar, Juliana; (...); Sebio, Ana

Article. 10.3390/pharmaceutics16121585. 2024

  • Open Access.

Precision medicine in metastatic colorectal cancer: targeting KRAS G12C mutation

Aparicio, Jorge

Article. 10.21037/tgh-24-28. 2024

  • Open Access.

Prediction model for major bleeding in anticoagulated patients with cancer-associated venous thromboembolism using machine learning and natural language processing.

Munoz Martin, Andres J; (...); Hernandez-Presa, Miguel Angel

Article. 10.1007/s12094-024-03586-2. 2024

  • Open Access.

Real-world dosing patterns of regorafenib for patients with metastatic colorectal cancer in Spain: the RE-SEARCH study.

López Muñoz AM; (...); Martín Gómez T

Article. 10.1007/s12094-024-03630-1. 2024


Real-world effectiveness and safety of second- or third-line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain

Alvarez-Gallego, Rafael; (...); Cubillo, Antonio

Article. 10.1177/17588359241309828. 2025

  • Open Access.

Redefining radiologic responses in high-risk soft-tissue sarcomas treated with neoadjuvant chemotherapy: final results of ISG-STS 1001, a randomized clinical trial.

Vanzulli, A; (...); Gronchi, A

Article. 10.1016/j.esmoop.2025.104299. 2025

  • Open Access.

SEOM-GG clinical guidelines for the management of germ-cell testicular cancer (2023).

Arranz Arija, Jose Angel; (...); Gonzalez-Billalabeitia, Enrique

Article. 10.1007/s12094-024-03532-2. 2024

  • Open Access.

Sequential RAS mutations evaluation in cell-free DNA of patients with tissue RAS wild-type metastatic colorectal cancer: the PERSEIDA (Cohort 2) study.

Valladares-Ayerbes M; (...); Lloansí Vila A

Article. 10.1007/s12094-024-03487-4. 2024

  • Open Access.

Sustained response to anti-TNF therapy in ASIA syndrome triggered by vaccination and filler.

Martin-Torregrosa, Daniel; (...); Rodriguez-Serna, Mercedes

Letter. 10.1111/ijd.17650. 2025


Tattoo-Associated Common Wart

Mansilla-Polo, M., Llavador-Ros, M., Botella-Estrada, R.

Editorial Material. 10.1016/j.ad.2024.05.001. 2024

  • Open Access.

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


Campos de estudio

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