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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

Conditions
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Cancer, Hepatocellular

Intervention / Treatment
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* Drug: nivolumab
* Drug: ipilimumab
* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab + Ipilimumab + TACE<br>TACE (Trans-arterial ChemoEmbolization) | Drug: nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;Procedure: TACE<br>* TACE (Trans-arterial ChemoEmbolization)<br>|
| Experimental: Nivolumab + TACE<br> | Drug: nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Procedure: TACE<br>* TACE (Trans-arterial ChemoEmbolization)<br>|
| Active Comparator: TACE<br> | Procedure: TACE<br>* TACE (Trans-arterial ChemoEmbolization)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treated participants with adverse events (AEs) |  | Up to 2 years and 4 months | 
| Number of deaths in all treated patients |  | Up to 2 years and 4 months | 
| Number of treated participants with laboratory abnormalities |  | Up to 2 years and 4 months |