At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating pembrolizumab, placebo, and 1 other intervention for Carcinoma, Hepatocellular. Completed, enrolled 453 participants across 41 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Normal saline solution administered as an IV infusion Q3W
BSC will include pain management and management of other potential complications including ascites per local standards of care.