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Clinical Trials/NCT03383458
NCT03383458
Active, not recruiting
Phase 3

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

Bristol-Myers Squibb175 sites in 7 countries545 target enrollmentApril 18, 2018
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ConditionsHepatocellular CarcinomaLiver Cancer
InterventionsNivolumabPlacebo

Overview

Phase
Phase 3
Intervention
Nivolumab
Conditions
Hepatocellular Carcinoma
Sponsor
Bristol-Myers Squibb
Enrollment
545
Locations
175
Primary Endpoint
Recurrence-free Survival (RFS)
Status
Active, not recruiting
Last Updated
5 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 18, 2018
End Date
February 27, 2031
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • •Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).
  • •Other protocol defined inclusion/exclusion criteria apply

Arms & Interventions

Arm A

Intervention: Nivolumab

Arm B

Intervention: Placebo

Outcomes

Primary Outcomes

Recurrence-free Survival (RFS)

Time Frame: Up to 49 months

Secondary Outcomes

  • Time to recurrence (TTR)(Up to 49 months)
  • Overall Survival (OS)(Up to 7 years)

Study Sites (175)

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