47
Participants
Start Date
September 20, 2021
Primary Completion Date
February 1, 2024
Study Completion Date
February 1, 2024
Bintrafusp alfa
"Bintrafusp alfa (M7824) is a bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β) receptor II (a TGF-β trap) fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1).~Day 1 of week 1 of treatment will start within 1-5 days from enrollment. Cycles will be administered every 2 weeks (±3 days) until progression or other reason to discontinue. If a pseudoprogression is suspected patient is allowed to continue treatment until loss of clinical benefit as judged by principal investigator and after the permission from the trial chair is granted.~On Day 1 of each cycle (QW2), all eligible patients will receive:~Bintrafusp alfa (M7824): 1200mg, IV infusion over 60 minutes Current experience revealed that IRRs to bintrafusp alfa occur seldomly and are generally mild to moderate in severity. Therefore, administration of a premedication is generally not required."
Hospitalario Universitario A Coruña, A Coruña
ICO Girona, Hospital Josep Trueta, Girona
Hospital Universitario Lucus Augusti, Lugo
Hospital Universitario Fundación Jiménez Díaz, Madrid
Hospital Universitario Puerta de Hierro, Majadahonda
Hospital Universitario Virgen De La Victoria, Málaga
Hospital Universitario Central de Asturias, Oviedo
Hospital Clínico de Valencia, Valencia
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital de Basurto, Bilbao
Hospital General Universitario de Alicante, Alicante
ICO Badalona, Hospital Germans Trias i Pujol, Badalona
Hospital Universitari Vall d' Hebron, Barcelona
Hospital Parc Taulí, Barcelona
ICO Hospitalet, L'Hospitalet de Llobregat
Fundación GECP
OTHER