Study Evaluating Nivolumab (Anti-PD-1 Antibody) Alone Versus Nivolumab Plus Ipilimumab (Anti-CTLA-4 Antibody) in Patients With Resectable and Potentially Resectable Hepatocellular Carcinoma (HCC) (CA209-956)

• Status: Not yet recruiting
• Trial end date: 0000-00-00

Summary

Objectives:

Primary Objective:

1. To evaluate the safety and tolerability of therapy with nivolumab alone or nivolumab + ipilimumab in resectable HCC in the context of presurgical therapy; to evaluate the safety and tolerability of therapy with nivolumab + ipilimumab in potentially resectable HCC in the context of pre-biopsy therapy.

Secondary Objectives:

1. To assess the efficacy of presurgical nivolumab alone or nivolumab + ipilimumab therapy in HCC by estimating the objective response rate (ORR) and time to progression (TTP) per RECIST 1.1 progression-free survival (PFS).

2. To estimate the conversion rate to surgery for arm 3 potentially resectable patients.

• Phase: Phase 2

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies; Antibodies, Monoclonal; Nivolumab