A Phase I Multiple Ascending Dose Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1)Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Infection.

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.

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
• Dose Escalation Phase: Child-Pugh score of 7 points or less. For all other cohorts Child-Pugh score of 6 points or less
Phase I
Cancer, All Other
Todd Crocenzi, M.D.
BMS (Bristol-Myers Squibb)
Yue-Yun To
  • Oncology and Hematology Care Eastside
  • Providence Portland Medical Center