MS0055: This phase II/III trial is evaluating the effectiveness of a novel immunotherapy (Bintafusp Alfa) in combination with the standard of care chemotherapy (Gemcitabine and Cisplatin) to treat patients with locally advanced or metastatic Biliary Tract CancerGemcitabine plus cisplatin with or without Bintrafusp Alfa (M7824) in participants with 1L Biliary Tract Cancer (BTC)

Exclusion

• Previous and/or intercurrent cancers
• Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
• Participants with symptomatic central nervous system (CNS) metastases
• Significant acute or chronic infection including known history of positive test for human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 Day 1 prior to dosing.
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
• History of or concurrent interstitial lung disease
• History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
• Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints)
• Other protocol defined exclusion criteria could apply