A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

Completed · Phase 3

Conditions studied: Cancer, Hepatocellular

In brief

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.

Key facts

Study ID

NCT04340193

Run by

Bristol-Myers Squibb

People needed

26

Starts

2020-09-14

Expected to finish

2023-12-12

Last updated by the study team

2024-11-26

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution - 0005 — Louisville, Kentucky, United States
• Local Institution - 0059 — Louisville, Kentucky, United States
• Local Institution - 0109 — Dallas, Texas, United States
• Local Institution — Wollongong, New South Wales, Australia
• Local Institution - 0037 — Birtinya, Queensland, Australia
• Local Institution - 0010 — Adelaide, South Australia, Australia
• Local Institution - 0001 — Melbourne, Victoria, Australia
• Local Institution - 0139 — Murdoch, Western Australia, Australia
• Local Institution - 0026 — Graz, Austria
• Local Institution - 0013 — Sankt Pölten, Austria
• Local Institution — Vienna, Austria
• Local Institution - 0078 — West Springfield, Austria
• Local Institution - 0048 — Wiener Neustadt, Austria
• Local Institution - 0020 — Brussels, Belgium
• Local Institution — Federal District, Belgium
• Local Institution - 0053 — Ghent, Belgium
• Local Institution - 0050 — Plainfield, Belgium
• Local Institution - 0039 — Québec, Quebec, Canada
• Local Institution - 0184 — Beijing, Beijing Municipality, China
• Local Institution — Guangzhou, Guangdong, China
• Local Institution — Guangzhou, Guangdong, China
• Local Institution — Tianjin, Hebei, China
• Local Institution - 0196 — Nanjing, Jiangsu, China
• Local Institution - 0189 — Coronado, California, United States

Full record on ClinicalTrials.gov

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