Status:
COMPLETED
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04340193
Start Date
September 14 2020
End Date
December 12 2023
Last Update
November 26 2024
Active Locations (107)
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1
Local Institution - 0189
Coronado, California, United States, 92118
2
Local Institution
Washington D.C., District of Columbia, United States, 20007
3
Local Institution - 0005
Louisville, Kentucky, United States, 40202
4
Local Institution - 0059
Louisville, Kentucky, United States, 40217