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Trial Summary


Protocol No.CTO-MK-3475-937
StatusOPEN TO ACCRUAL
Principal InvestigatorTurk, Anita
ScopeNational
PhasePhase III
Age GroupAdult
TitleA 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)
DescriptionThis 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 EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Has a diagnosis of hepatocellular carcinoma (HCC) by radiological criteria and/or pathological confirmation.
  • Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLiver
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu