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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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).

Key facts

Study ID: NCT03867084
Run by: Merck Sharp & Dohme LLC
People needed: 959
Starts: 2019-05-28
Expected to finish: 2025-09-30
Last updated by the study team: 2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Has adequate organ function.

You may not qualify if…

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).
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Has received prior systemic anti-cancer therapy for HCC including investigational agents.
Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology.
Has received a live vaccine within 30 days prior to the first dose of study treatment.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Has had an allogenic tissue/solid organ transplant.

Where it is running

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
Massachusetts General Hospital ( Site 0062) — Boston, Massachusetts, United States
Boston Medical Center ( Site 0025) — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Ctr. ( Site 0033) — Boston, Massachusetts, United States
University of Massachusetts Worcester ( Site 0017) — Worcester, Massachusetts, United States
Henry Ford Hospital-GI/Hepatology Research ( Site 0047) — Detroit, Michigan, United States
University of New Mexico ( Site 0041) — Albuquerque, New Mexico, United States
North Shore-Long Island Jewish Health System ( Site 0068) — Lake Success, New York, United States
Miami Valley Hospital South ( Site 0093) — Centerville, Ohio, United States
University of Cincinnati Medical Center ( Site 0084) — Cincinnati, Ohio, United States
ProMedica Flower Hospital ( Site 0090) — Sylvania, Ohio, United States
Stephenson Cancer Center ( Site 0045) — Oklahoma City, Oklahoma, United States
Vanderbilt Ingram Cancer Center ( Site 0006) — Nashville, Tennessee, United States
Baylor Scott & White Medical Center - Temple ( Site 0089) — Temple, Texas, United States
Virginia Mason Medical Center ( Site 0028) — Seattle, Washington, United States
Hospital Universitario Austral ( Site 0795) — Pilar, Buenos Aires, Argentina
Banner MD Anderson Cancer Center ( Site 0026) — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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