University of California, Irvine
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.
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…
Given IV
Given IV
Given PO
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.
Arctuva estimate
Verify or correct the compensation shown for this listing.