Clinical Trials /

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

NCT03383458

Description:

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

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
  • Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Clinical Trial IDs

  • ORG STUDY ID: CA209-9DX
  • NCT ID: NCT03383458

Conditions

  • Hepatocellular Carcinoma
  • Liver Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Arm A

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimental
  • Nivolumab
Arm BPlacebo Comparator

    Eligibility Criteria

            For more information regarding Bristol Myers Squibb Clinical Trial participation, please
            visit www.BMSStudyConnect.com
    
            Inclusion Criteria:
    
              -  Participants with a first diagnosis of HCC who have undergone a curative resection or
                 ablation
    
              -  Participants are eligible to enroll if they have non-viral related-HCC, or if they
                 have HBV-HCC, or HCV-HCC
    
              -  Child-Pugh Score 5 or 6
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
    
            Exclusion Criteria:
    
              -  Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
    
              -  Any evidence of tumor metastasis or co-existing malignant disease
    
              -  Participants previously receiving any prior therapy for HCC, including loco-regional
                 therapies
    
              -  Participants who have undergone a liver transplant or those who are in the waiting
                 list for liver transplantation
    
            Other protocol defined inclusion/exclusion criteria could apply
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Recurrence-free Survival (RFS)
    Time Frame:Up to 49 months
    Safety Issue:
    Description:defined as the time from randomization to the first documented disease recurrence or death (by any cause), whichever occurs first

    Secondary Outcome Measures

    Measure:Overall Survival (OS)
    Time Frame:Up to 7 years
    Safety Issue:
    Description:defined by the time between the date of randomization and the date of death
    Measure:Time to recurrence (TTR)
    Time Frame:Up to 49 months
    Safety Issue:
    Description:defined as the time from randomization to the first documented disease recurrence

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated