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Trial ID CA209-9DW  |   NCT04039607

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

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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

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participants must have a diagnosis of HCC based on histological confirmation
    1. Participants must have an advanced HCC
      1. Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
        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. Prior liver transplant
                1. Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
                  1. Active brain metastases or leptomeningeal metastases Other protocol-defined inclusion/exclusion criteria apply.
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Nivolumab + Ipilimumab

                    ASSIGNED INTERVENTION
                    • Drug: Nivolumab, Ipilimumab

                    Study Arms

                    Active Comparator: Sorafenib/lenvatinib

                    ASSIGNED INTERVENTION
                    • Drug: Sorafenib, lenvatinib

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