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Closed (no longer recruiting)Last updated: 14 May 2024

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)

Clinical summary


This 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 Cancers Upper gastrointestinal tract





Trial Acronym


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Trial Identifiers

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Trial sponsor

EMD Serono

Scientific Title

Gemcitabine plus cisplatin with or without Bintrafusp Alfa (M7824) in participants with 1L Biliary Tract Cancer (BTC)



  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC
  • Participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment
  • At least 1 measurable lesion according to RECIST 1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing
  • Life expectancy of >= 12 weeks, as judged by the Investigator
  • Adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
  • Other protocol defined inclusion criteria could apply


  • 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


  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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