A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03383458
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Placebo — OTHER
    specified dose on specified days

Study Details

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Key Dates

Start date
Apr 18, 2018
Status verified
Nov 2025
Primary completion
Feb 27, 2026
Completion
Feb 27, 2031

Study Design

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

Arms

  • Experimental: Arm A
  • Placebo Comparator: Arm B

Primary Outcome Measure

Recurrence-free Survival (RFS) [ Time Frame: Up to 49 months ]

Locations (28)

FacilityCityStateZIPSite coordinators
Local Institution - 0081AnnistonAlabama36207-
Mayo Clinic in Arizona - PhoenixPhoenixArizona85054-
Arizona Oncology Associates, PC - HOPETucsonArizona85711-
Local Institution - 0135Los AngelesCalifornia90095-
Local Institution - 0088Palo AltoCalifornia94304-
Local Institution - 0085San FranciscoCalifornia94115-
Local Institution - 0235AuroraColorado80045-
Local Institution - 0267MiamiFlorida33125-
Sylvester Comprehensive Cancer Center/ UMHCMiamiFlorida33136-
Local Institution - 0163TampaFlorida33612-
Local Institution - 0009AtlantaGeorgia30322-
Local Institution - 0025WestwoodKansas66205-
Local Institution - 0086New OrleansLouisiana70112-
University of MichiganAnn ArborMichigan48109-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
Local Institution - 0209St LouisMissouri63110-
Local Institution - 0045New YorkNew York10065-
Local Institution - 0075New YorkNew York10016-
Local Institution - 0208New YorkNew York10029-
Local Institution - 0219White PlainsNew York10601-
MetroHealth Medical CenterClevelandOhio44109-
Local Institution - 0206PortlandOregon97225-
Local Institution - 0272AustinTexas78705-
Local Institution - 0156DallasTexas75390-
Local Institution - 0270DallasTexas75246-
Local Institution - 0273TylerTexas75702-
McGuire VA Medical CenterRichmondVirginia23249-
Local Institution - 0154SeattleWashington98109-

Related coverage on Hipa.ai

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Local Institution - 0081· Anniston, ALMayo Clinic in Arizona - Phoenix· Phoenix, AZArizona Oncology Associates, PC - HOPE· Tucson, AZLocal Institution - 0135· Los Angeles, CALocal Institution - 0088· Palo Alto, CALocal Institution - 0085· San Francisco, CA

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