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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

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.

Conditions

This trial is treating patients with Biliary Tract Cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II/III

Trial Acronym

MS0055

More information

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)

Eligibility

Inclusion

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

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.