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)

FacilityCityStateZIP
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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Banner MD Anderson Cancer Center ( Site 0026)· Gilbert, AZThe University of Arizona Cancer Center - North Campus ( Site 0039)· Tucson, AZCity of Hope Medical Center ( Site 0027)· Duarte, CASmilow Cancer Hospital at Yale New Haven ( Site 0042)· New Haven, CTRegional Cancer Center ( Site 0054)· Fort Myers, FLIndiana University Simon Cancer Center ( Site 0075)· Indianapolis, IN

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