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

Mesothelioma; Lung Clinical Trial

Official title: A Phase II Single Arm Clinical Trial Assessing the Efficacy and Safety of BIntrafusp Alfa (M7824) in Previously Treated Advanced Malignant Pleural MESothelioma (BIMES)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is an open-label, non-randomized, phase II, single arm, multi-center controlled clinical trial.

Patients enrolled will receive Bintrafusp alfa (M7824) 1200mg intravenous. The treatment will be administered at day 1 of 14-day intervals.Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy.

The primary objective is 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.

Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 3-6 months. Treatment and follow-up are expected to extend the study duration to a total of 3.5 years. Patients will be followed 1 month after treatment. The study will end once survival follow-up has concluded. ;

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Mesothelioma; Lung

• NCT number: NCT05005429
• Study type: Interventional
• Source: Fundación GECP
• Contact: Eva Pereira
• Phone: +34934302006
• Email: gecp@gecp.org
• Status: Recruiting
• Phase: Phase 2
• Start date: September 20, 2021
• Completion date: April 30, 2025