18 and older, any sex, with Mesothelioma; Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To Evaluate the Efficacy of the TreatmentPrimary· From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.
To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm.
Group
Value
95% CI
Experimental: Bintrafusp Alfa (M7824)
1.9
1.7 – 5.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open-label, non-randomized, phase II, single arm, multi-center controlled clinical trial.
47 patients will be enrolled in this trial to determine the efficacy and safety of Bintrafusp alfa (M7824) in advanced malignant pleural mesothelioma patients previously treated with platinum-based chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05445882 — N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resi
· Phase 2
· withdrawn
NCT04648826 — Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With U
· Phase 1, PHASE2
· withdrawn
NCT05061823 — Bintrafusp Alfa Program Rollover Study
· Phase 3
· completed
NCT04727541 — Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer
· Phase 2
· terminated
NCT04481256 — TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY
· NA
· recruiting
Other recruiting trials for Mesothelioma; Lung
Currently open trials in the same condition.
NCT07126509 — Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma
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· recruiting
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· recruiting
NCT04300244 — Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma
· Phase 2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundación GECP
Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05005429.