A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer

Official Title

A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer With Disease Progression or Recurrence Following Treatment With a Platinum Agent

Summary:

The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy

Trial Description

Primary Outcome:

• Confirmed overall response rate (ORR) - Investigator assessment

• Duration of Response (DOR) - Investigator assessment
• Progression-free Survival (PFS) - Investigator assessment
• Confirmed overall response rate- Independent Review Committee (IRC)
• Duration of Response - IRC
• Progression free survival - IRC
• Overall survival (OS)
• Number of participants with adverse events (AEs) and serious adverse events (SAEs)
• Number of participants with AEs by their severity
• Concentration observed immediately at the end of infusion (Ceoi) for bintrafusp alfa
• Concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing) (Ctrough) for bintrafusp alfa.
• Number of participants with positive anti-drug antibodies (ADAs) against bintrafusp alfa
• Percentage of participants with positive ADAs against bintrafusp alfa

View this trial on ClinicalTrials.gov