NCT03062358

Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)

A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of pembrolizumab or placebo given with best supportive care (BSC) in Asian participants with previously systemically treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that overall survival is prolonged in participants who receive pembrolizumab compared to those who receive placebo.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
DRUG	placebo	Normal saline solution administered as an IV infusion Q3W
OTHER	best supportive care (BSC)	BSC will include pain management and management of other potential complications including ascites per local standards of care.

Timeline

• Start date: 2017-04-27
• Primary completion: 2021-06-30
• Completion: 2024-10-15
• First posted: 2017-02-23
• Last updated: 2025-09-30
• Results posted: 2023-03-21

Locations

41 sites across 5 countries: China, Hong Kong, Malaysia, South Korea, Taiwan