A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
About the study
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
- Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
EXCLUSION CRITERIA
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant or participants who are on the waiting list for liver transplantation
- Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Cancer, Hepatocellular
Age (in years)
18+
Phase
Phase 3
Participants needed
26
Est. Completion Date
Dec 15, 2023
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04340193
Study number
CA20974W
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