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Active, Not Recruiting

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma - CA209-459

Updated: 6 December, 2023   |   ClinicalTrials.gov

Print Friendly Summary

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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
Drug: Nivolumab
Active Comparator: Sorafenib
Drug: Sorafenib

Key Eligibility Criteria

Inclusion Criteria: - Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies - Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan - Child-Pugh Class A - 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 - Active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com