CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 959 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03867084
NCT03867084Phase 3Completed

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)

Merck Sharp & Dohme LLC·interventional·Posted Mar 7, 2019·Updated Apr 24, 2026

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 7, 2019
Enrollment StartMay 28, 2019
Primary CompletionMar 20, 2025
Study CompletionSep 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 7.3 years ago

Interventions

Pembrolizumabbiological

IV infusion of Pembrolizumab 200 mg.

Placebodrug

IV infusion of 0.9% normal saline.