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Trial ID CA209-040  |   NCT01658878

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

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

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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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Child-Pugh B

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: HBV-infected: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: HCV-infected: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Nivolumab plus Cabozantinib Combination

ASSIGNED INTERVENTION
  • Drug: Cabozantinib

Study Arms

Experimental: Nivolumab plus Ipilimumab Combination

ASSIGNED INTERVENTION
  • Drug: Ipilimumab
  • Biological: Nivolumab

Study Arms

Experimental: Nivolumab plus Ipilimumab plus Cabozantinib

ASSIGNED INTERVENTION
  • Drug: Cabozantinib

Study Arms

Experimental: Non-infected: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Active Comparator: Sorafenib

ASSIGNED INTERVENTION
  • Drug: Sorafenib