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

Status:	Active, not recruiting
Conditions:	Liver Cancer, Cancer, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/8/2018
Start Date:	September 26, 2012
End Date:	December 26, 2019

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. 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.

Study Classification: Pharmacokinetics/Pharmacodynamics

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 found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200