A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy
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.
View this trial on ClinicalTrials.gov
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