At a glance
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A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab and Placebo for Hepatocellular Carcinoma. Completed, enrolled 959 participants across 249 sites in 31 countries.
Detailed Summary
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Study Details
Timeline
Interventions
IV infusion of Pembrolizumab 200 mg.
IV infusion of 0.9% normal saline.