Study of Pembrolizumab (MK-3475) vs. Best Supportive Care in Participants With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-240/KEYNOTE-240)

This is a study of pembrolizumab (MK-3475) in participants with previously systemically treated advanced hepatocellular carcinoma (HCC).

The primary objectives of this study are to determine 1) Progression-Free Survival (PFS) and 2) Overall Survival (OS) of pembrolizumab plus best supportive care (BSC) compared with placebo plus BSC. The primary hypotheses of this study are: 1) pembrolizumab plus BSC prolongs PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, assessed by a blinded central imaging vendor compared to placebo plus BSC, and 2) pembrolizumab plus BSC improves OS compared with placebo plus BSC.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240)
Actual Study Start Date: May 26, 2016
Estimated Primary Completion Date: February 1, 2019
Estimated Study Completion Date: February 1, 2019

Arm:
- Experimental: Pembrolizumab+Best Supportive Care
- Placebo Comparator: Placebo+Best Supportive Care