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Page last updated: 4/15/2020

A safety run-in followed by a phase 2/3, randomized, placebo-controlled study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).




ClinicalTrials.gov: NCT04066491

Location: Global

Countries: Argentina, Australia, Chile, Japan, Republic of Korea, Spain, Taiwan, and the United States


Now Enrolling

Find a trial site near you at www.clinicaltrials.gov

Key inclusion criteria*

  • Participants must have histologically or cytologically confirmed locally advanced or metastatic BTC, be naive to chemotherapy and immunotherapy, and have an ECOG PS of 0 or 1


Key exclusion criteria*

  • Participants must not have a history of or concurrent interstitial lung disease, and must not have received prior therapy with immune checkpoint inhibitors





Study Design | Global

Are you interested and want to know if this trial is right for you or someone you know?

Please print or email this page.

Speak with a doctor before making a decision regarding whether a clinical trial is the right option.

Bintrafusp alfa is being investigated in this clinical trial. This means that it has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for bintrafusp alfa, and it includes information about how the trial is structured and how EMD Serono, a business of Merck KGaA, Darmstadt, Germany, will determine whether bintrafusp alfa might be safe or effective. Therefore, it is important to understand that bintrafusp alfa is not a treatment or therapy for cancer or any other disease, and it has not been approved to be used by any health authority, such as the European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.

You should speak with your doctor, who can help you decide whether a clinical trial might be right for you. Your doctor will be able to answer questions you might have about the risk of participating in a trial, and what other options may be available to you.

* For a full list of inclusion and exclusion criteria, please visit https://www.clinicaltrials.gov.
1L, first-line; BTC, biliary tract cancer; DLTs, dose-limiting toxicities; DOR, duration of response; DRR, durable response rate; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q3W, every 3 weeks; R, randomized.


ClinicalTrials.gov. Gemcitabine plus cisplatin with or without bintrafusp alfa (M7824) in participants with 1L biliary tract cancer (BTC). http://www.clinicaltrials.gov/ct2/show/NCT04066491. Accessed April 15, 2020.


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