A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer (CheckMate 74W)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Cancer, Hepatocellular

Treatments: Drug: ipilimumab; Drug: nivolumab; Procedure: TACE

Study type: Interventional

Funder types: Industry

Identifiers

NCT04340193

CA209-74W

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Nivolumab + Ipilimumab + TACE

Experimental group

Description:

TACE (Trans-arterial ChemoEmbolization)

Treatment:

Procedure: TACE

Drug: nivolumab

Drug: ipilimumab

Nivolumab + TACE

Experimental group

Treatment:

Procedure: TACE

Drug: nivolumab

TACE

Active Comparator group

Treatment:

Procedure: TACE