MS0055 : Gemcitabine plus cisplatin with or without Bintrafusp Alfa (M7824) in participants with 1L Biliary Tract Cancer (BTC)

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

Two/ThreePhase Two/Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach

Systemic therapy | Stomach and upper gastrointestinal tractBile duct

Trial Overview Read MoreRead more

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 Cancer.

This trial is treating patients with Biliary Tract Cancer.

This is a systemic therapy.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • 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 - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Commercial Sponsor

EMD Serono


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.

Recruiting Hospitals Read MoreRead more

Epworth Freemasons, Medical Oncology
East Melbourne
Mr Dave McKee
03 9936 8043

Monash Health, Medical Oncology
GI Research Study Coordinator

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.