Stopped: Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.
Study consisted 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 was evaluated 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 Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.
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Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Timeframe: Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days)
Double-blind Part: Overall Survival
Timeframe: Time from study day 1 up to data cutoff (assessed up to 609 days)