NCT04003636

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,069 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Pembrolizumab by intravenous (IV) infusion
DRUG	Gemcitabine	Gemcitabine by IV infusion
DRUG	Cisplatin	Cisplatin by IV infusion
DRUG	Placebo	Placebo to pembrolizumab

Timeline

• Start date: 2019-09-24
• Primary completion: 2022-12-15
• Completion: 2025-04-01
• First posted: 2019-07-01
• Last updated: 2026-03-24
• Results posted: 2023-12-22

Locations

185 sites across 24 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study