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RecruitingLast updated: 23 February 2022

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





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Trial Identifiers

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Commercial Sponsor

EMD Serono

Scientific Title

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



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


  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • 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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