NCT03833661

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

Conditions

• Biliary Tract Cancer
• Cholangiocarcinoma
• Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	M7824	Participants received an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

Timeline

• Start date: 2019-03-26
• Primary completion: 2020-11-09
• Completion: 2022-09-30
• First posted: 2019-02-07
• Last updated: 2023-10-25
• Results posted: 2022-01-10

Locations

33 sites across 9 countries: United States, China, France, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study