SummaryThis trial will consist of a safety run-in section and an experimental section. During the safety run-in section all eligible participants will receive intravenous infusions of 2400 mg of Bintrafusp Alfa once every 3 weeks and Gemcitabine and Cisplatin on Days 1 and 8 of a 21-day cycle for 8 cycles. In the experimental phase intravenous infusions of Gemcitabine and Cisplatin will continue for all patients, in addition to either Bintrafusp Alfa or a placebo.
This trial is treating patients with Biliary Tract Cancer.
Upper gastrointestinal tract
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Gemcitabine plus cisplatin with or without Bintrafusp Alfa (M7824) in participants with 1L Biliary Tract Cancer (BTC)