NCT04924062

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)-China Extension Study

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: 158 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults 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).

Detailed description

The China extension study will include participants previously enrolled in China in the global study for MK-3475-966 (NCT04003636) plus those enrolled during the China extension enrollment period. A total of approximately 158 Chinese participants will be enrolled.

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 by IV infusion

Timeline

• Start date: 2020-07-10
• Primary completion: 2022-12-15
• Completion: 2025-03-25
• First posted: 2021-06-11
• Last updated: 2026-04-15
• Results posted: 2023-12-26

Locations

22 sites across 1 country: China

Regulatory

• FDA-regulated drug study