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Trial ID CA209-74W  |   NCT04340193

A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

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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 purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

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Key Eligibility Criteria

Inclusion Criteria: - Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE) - Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Prior liver transplant or participants who are on the waiting list for liver transplantation - Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab + Ipilimumab + TACE

ASSIGNED INTERVENTION
  • Drug: ipilimumab, nivolumab
  • Procedure: TACE

Study Arms

Experimental: Nivolumab + TACE

ASSIGNED INTERVENTION
  • Procedure: TACE
  • Drug: nivolumab

Study Arms

Active Comparator: TACE

ASSIGNED INTERVENTION
  • Procedure: TACE