Last updated on November 2019

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


Brief description of study

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 M7824 in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) or progression-free survival (PFS) in chemotherapy and immunotherapy-nave participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.

Clinical Study Identifier: NCT04066491

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