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Active, Not Recruiting

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer - CA209-040

Updated: 13 December, 2023   |   ClinicalTrials.gov

Print Friendly Summary

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.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Child-Pugh B
Biological: Nivolumab
Experimental: HBV-infected: Nivolumab
Biological: Nivolumab
Experimental: HCV-infected: Nivolumab
Biological: Nivolumab
Experimental: Nivolumab
Biological: Nivolumab
Experimental: Nivolumab plus Cabozantinib Combination
Drug: Cabozantinib
Experimental: Nivolumab plus Ipilimumab Combination
Biological: Nivolumab Drug: Ipilimumab
Experimental: Nivolumab plus Ipilimumab plus Cabozantinib
Drug: Cabozantinib
Experimental: Non-infected: Nivolumab
Biological: Nivolumab
Active Comparator: Sorafenib
Drug: Sorafenib

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 - Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less Exclusion Criteria: - History of autoimmune disease - Any prior or current clinically significant ascites - Any history of hepatic encephalopathy

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? Email Us

Have questions?
Email Us