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  • NCT05337137

Recruiting

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer - CA224-106

Updated: 12 November, 2024   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
Print this page CA224-106
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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 35

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Relatlimab + Nivolumab + Bevacizumab
Drug: Relatlimab, Nivolumab, Bevacizumab
Experimental: Arm B: Placebo + Nivolumab + Bevacizumab
Drug: Nivolumab, Bevacizumab Other: Placebo

Key Eligibility Criteria

Inclusion Criteria: - Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC) - Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team) - Child-Pugh score of 5 or 6 (ie, Child-Pugh A) - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC - Prior allogenic stem cell or solid organ transplantation - Untreated symptomatic central nervous system (CNS) metastases - Clinically significant ascites as defined by: i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment Other protocol-defined inclusion/exclusion criteria apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001