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

Completed · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT01658878

Run by

Bristol-Myers Squibb

People needed

657

Starts

2012-10-30

Expected to finish

2024-11-12

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of autoimmune disease
• Any prior or current clinically significant ascites
• Any history of hepatic encephalopathy

Where it is running

• Local Institution - 0048 — Washington D.C., District of Columbia, United States
• Local Institution - 0053 — Pensacola, Florida, United States
• Local Institution - 0047 — Atlanta, Georgia, United States
• Local Institution - 0025 — Boston, Massachusetts, United States
• Local Institution - 0002 — Ann Arbor, Michigan, United States
• Local Institution - 0054 — Hackensack, New Jersey, United States
• Local Institution - 0067 — Paterson, New Jersey, United States
• Local Institution - 0001 — Portland, Oregon, United States
• The University Of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Local Institution - 0065 — Halifax, Nova Scotia, Canada
• Local Institution - 0039 — Toronto, Ontario, Canada
• Local Institution - 0022 — Montreal, Quebec, Canada
• Local Institution - 0061 — Angers, France
• Local Institution - 0064 — Créteil, France
• Local Institution - 0062 — Marseille, France
• Local Institution - 0059 — Marseille, France
• Local Institution - 0042 — Paris, France
• Local Institution - 0060 — Reims, France
• Local Institution - 0058 — Vandœuvre-lès-Nancy, France
• Local Institution - 0030 — Essen, Germany
• Local Institution - 0028 — Frankfurt, Germany
• Local Institution - 0029 — Hanover, Germany
• Local Institution - 0031 — Heidelberg, Germany
• Local Institution - 0005 — Hong Kong, Hong Kong
• Local Institution - 0008 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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