Overview

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

Status:
Active, not recruiting

Trial end date:
2024-01-29

Target enrollment:
0

Participant gender:
All

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 with intermediate liver cancer.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Ipilimumab
Nivolumab

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:

- 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