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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-9DX  |   NCT03383458

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Placebo Comparator: Arm B

ASSIGNED INTERVENTION
  • Other: Placebo

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