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

Phase 2/3 Terminated 309 enrolled EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2019-09-20
Primary completion: 2021-05-20
Completion: 2022-11-10

Publications

Results Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bintrafusp alfa	Protein / enzyme biologic	2400 mg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications