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)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03867084
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    IV infusion of Pembrolizumab 200 mg.
  • Placebo — DRUG
    IV infusion of 0.9% normal saline.

Study Details

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 Dates

Start date
May 28, 2019
Status verified
Apr 2026
Primary completion
Mar 20, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
959 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
  • Placebo Comparator: Placebo
    Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.

Primary Outcome Measure

Recurrence-Free Survival (RFS) [ Time Frame: Up to approximately 69 months ]

Locations (24)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Center ( Site 0026)GilbertArizona85234-
The University of Arizona Cancer Center - North Campus ( Site 0039)TucsonArizona85719-
City of Hope Medical Center ( Site 0027)DuarteCalifornia91010-
Smilow Cancer Hospital at Yale New Haven ( Site 0042)New HavenConnecticut06510-
Regional Cancer Center ( Site 0054)Fort MyersFlorida33905-
Indiana University Simon Cancer Center ( Site 0075)IndianapolisIndiana46202-
University of Iowa ( Site 0067)Iowa CityIowa52242-
James Graham Brown Cancer Center ( Site 0088)LouisvilleKentucky40202-
University of Louisville ( Site 0059)LouisvilleKentucky40202-
University Medical Center New Orleans ( Site 0014)New OrleansLouisiana70112-
Beth Israel Deaconess Medical Ctr. ( Site 0033)BostonMassachusetts02215-
Boston Medical Center ( Site 0025)BostonMassachusetts02118-
Massachusetts General Hospital ( Site 0062)BostonMassachusetts02114-
University of Massachusetts Worcester ( Site 0017)WorcesterMassachusetts01655-
Henry Ford Hospital-GI/Hepatology Research ( Site 0047)DetroitMichigan48202-
University of New Mexico ( Site 0041)AlbuquerqueNew Mexico87131-
North Shore-Long Island Jewish Health System ( Site 0068)Lake SuccessNew York11042-
Miami Valley Hospital South ( Site 0093)CentervilleOhio45459-
University of Cincinnati Medical Center ( Site 0084)CincinnatiOhio45219-
ProMedica Flower Hospital ( Site 0090)SylvaniaOhio43560-
Stephenson Cancer Center ( Site 0045)Oklahoma CityOklahoma73104-
Vanderbilt Ingram Cancer Center ( Site 0006)NashvilleTennessee37232-
Baylor Scott & White Medical Center - Temple ( Site 0089)TempleTexas76508-
Virginia Mason Medical Center ( Site 0028)SeattleWashington98101-

Related coverage on Hipa.ai

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