Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment
University of California, Irvine
Summary
This is a phase 2 single-arm, open-label clinical trial determining efficacy of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologic or radiographic diagnosis of hepatocellular carcinoma * At least one lesion amenable to TACE treatment * Child-Pugh A-B7 (B7 based on Albumin allowed) * Not a candidate for resection or transplantation * Age ≥ 18 years. * Performance status: ECOG performance status ≤2 * Must have at least one measurable lesion (either untreated or progressed after previous locoregional treatment) * Adequate organ and marrow function as defined below: 1. Leukocytes ≥ 2,000/mcL 2. absolute neutrophil count ≥ 1000/mcL 3. platelets ≥ 60,000/mcl 4. total bilirubin within n…
Interventions
- DrugNivolumab
Given IV
- DrugIpilimumab
Given IV
- DrugCabozantinib
Given PO
- ProcedureTransarterial Chemoembolization
TACE treatment will be administered using either the DEB-TACE or cTACE modality in a series of up to 3 individual procedures within the 9-12 weeks following Day 21 (= cycle 1 day 21) of a patient's first infusion of nivolumab/ipilimumab. The first TACE treatment should start no more than 7 working days after being cycle 1 day 21.
Location
- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California