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

Recruiting in Palo Alto (17 mi)

+112 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: EMD Serono Research & Development Institute, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility 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

Treatment Details

Interventions

• Bintrafusp alfa (Monoclonal Antibodies)
• Cisplatin (Chemotherapy)
• Gemcitabine (Chemotherapy)
• Placebo (Immunotherapy)

Participant Groups

Group I: Safety Run-In Part: M7824 + Gemcitabine + Cisplatin Experimental Treatment 3 Interventions

Group II: Double-blinded Part: M7824 + Gemcitabine + Cisplatin Experimental Treatment 3 Interventions

Group III: Double-blinded Part: Placebo + Gemcitabine + Cisplatin Placebo Group 3 Interventions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Massachusetts Memorial Medical Center - Pediatrics Worcester, MA

Northwestern Center for Clinical Research Chicago, IL

Yale Cancer Center - Hematology New Haven, CT

Inova Dwight and Martha Schar Cancer Institute Fairfax, VA

More Trial Locations

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc. Lead Sponsor

Merck KGaA, Darmstadt, Germany Industry Sponsor

References