Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

February 1, 2024

Study Completion Date

February 1, 2024

Conditions
Mesothelioma; Lung
Interventions
DRUG

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."

Trial Locations (15)

15006

Hospitalario Universitario A Coruña, A Coruña

17007

ICO Girona, Hospital Josep Trueta, Girona

27003

Hospital Universitario Lucus Augusti, Lugo

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29010

Hospital Universitario Virgen De La Victoria, Málaga

33011

Hospital Universitario Central de Asturias, Oviedo

46010

Hospital Clínico de Valencia, Valencia

47003

Hospital Clínico Universitario de Valladolid, Valladolid

48013

Hospital de Basurto, Bilbao

03010

Hospital General Universitario de Alicante, Alicante

08916

ICO Badalona, Hospital Germans Trias i Pujol, Badalona

08035

Hospital Universitari Vall d' Hebron, Barcelona

08208

Hospital Parc Taulí, Barcelona

08908

ICO Hospitalet, L'Hospitalet de Llobregat

All Listed Sponsors
lead

Fundación GECP

OTHER

NCT05005429 - Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma | Biotech Hunter | Biotech Hunter