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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Treatments: Cisplatin; Gemcitabine

Criteria

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