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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

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
    1. Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
      1. Child-Pugh Score 5 or 6
        1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
            1. Any evidence of tumor metastasis or co-existing malignant disease
              1. Participants previously receiving any prior therapy for HCC, including loco-regional therapies
                1. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
                  1. 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
                    Additional Information *

                    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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