NCT03867084

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 (MK-3475-937 / KEYNOTE-937)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 959 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion of Pembrolizumab 200 mg.
DRUG	Placebo	IV infusion of 0.9% normal saline.

Timeline

• Start date: 2019-05-28
• Primary completion: 2025-03-20
• Completion: 2025-09-30
• First posted: 2019-03-07
• Last updated: 2026-02-04

Locations

249 sites across 31 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Malaysia, New Zealand, Norway, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study