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

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Gallbladder Cancer; Biliary Tract Cancer; Cholangiocarcinoma

Treatments: Drug: Placebo; Drug: M7824; Drug: Gemcitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04066491

MS200647_0055

2019-001992-35 (EudraCT Number)

Details and patient eligibility

About

Study consisted 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 was evaluated 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 Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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309 participants in 3 patient groups, including a placebo group

Safety Run-In Part: M7824 + Gemcitabine + Cisplatin

Experimental group

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: M7824

Double-blinded Part: M7824 + Gemcitabine + Cisplatin

Experimental group

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: M7824

Double-blinded Part: Placebo + Gemcitabine + Cisplatin

Placebo Comparator group

Treatment:

Drug: Cisplatin

Drug: Placebo

Drug: Gemcitabine