Overview

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

Status:
Active, not recruiting

Trial end date:
2022-12-31

Target enrollment:

Participant gender:

Summary

Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study will evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

EMD Serono Research & Development Institute, Inc.

Collaborator:

Merck KGaA, Darmstadt, Germany

Treatments:

Cisplatin
Gemcitabine