Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

  • STATUS
    Recruiting
  • End date
    Jul 24, 2023
  • participants needed
    512
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 5 May 2021
renal function
cancer
measurable disease
kidney function tests
antivirals
gemcitabine
bintrafusp alfa
cisplatin/gemcitabine
m7824
biliary tract cancer
gemcitabine/cisplatin

Summary

Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study will evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-nave participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.

Details
Condition Adenocarcinoma, Cholangiocarcinoma, Biliary neoplasm, Malignant neoplasm of gallbladder, Gallbladder Disease, Gallbladder Carcinoma, Urothelial Tract Cancer, Gall Bladder Disorders, Malignant Adenoma, Gall Bladder Cancer, Biliary Tract Cancer, gallbladder cancer, biliary cancer
Treatment cisplatin, Placebo, Gemcitabine, M7824, Bintrafusp Alfa
Clinical Study IdentifierNCT04066491
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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