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  • NCT04340193

Active, Not Recruiting

A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer - CA209-74W

Updated: 5 September, 2023   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab + Ipilimumab + TACE
Drug: nivolumab Drug: ipilimumab Procedure: TACE
Experimental: Nivolumab + TACE
Drug: nivolumab Procedure: TACE
Active Comparator: TACE
Procedure: TACE

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

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