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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT03867084•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
•Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation.
•Has no radiologic evidence of disease prior to enrollment.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
•Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.
•Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.
•Has controlled hepatitis B (Hep B).
•Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment.
•If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).
•If undergoing surgical resection, has submitted a tumor tissue sample during Screening.
+1 more criteria

Exclusion Criteria

•Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.
•Has had esophageal or gastric variceal bleeding within the last 6 months.
•Has clinically apparent ascites on physical examination.
•Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
•Has received local therapy to liver ablation other than with radiofrequency or microwave ablation.
•Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
•Has an active infection requiring systemic therapy.
•Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry.
•Has a known history of human immunodeficiency virus (HIV) infection.
•Has known active tuberculosis (TB; Bacillus tuberculosis).
+10 more criteria

Locations (249)

Banner MD Anderson Cancer Center ( Site 0026)

Gilbert, Arizona, United States

The University of Arizona Cancer Center - North Campus ( Site 0039)

Tucson, Arizona, United States

City of Hope Medical Center ( Site 0027)

Duarte, California, United States

Smilow Cancer Hospital at Yale New Haven ( Site 0042)

New Haven, Connecticut, United States

Regional Cancer Center ( Site 0054)

Fort Myers, Florida, United States

Indiana University Simon Cancer Center ( Site 0075)

Indianapolis, Indiana, United States

University of Iowa ( Site 0067)

Iowa City, Iowa, United States

James Graham Brown Cancer Center ( Site 0088)

Louisville, Kentucky, United States

University of Louisville ( Site 0059)

Louisville, Kentucky, United States

University Medical Center New Orleans ( Site 0014)

New Orleans, Louisiana, United States

Key Dates

Start Date

May 28, 2019

Primary Completion Date

March 20, 2025

Completion Date

September 30, 2025

Last Updated

February 4, 2026

Enrollment

959

ACTUAL participants

Conditions

Hepatocellular Carcinoma

Interventions

Pembrolizumab

BIOLOGICAL

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Early Detection of Liver Cancer by QUS

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

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A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)