NCT04472767

Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• HCC

Interventions

Type	Name	Description
DRUG	Nivolumab	Given IV
DRUG	Ipilimumab	Given IV
DRUG	Cabozantinib	Given PO
PROCEDURE	Transarterial 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.

Timeline

• Start date: 2020-08-07
• Primary completion: 2026-06-01
• Completion: 2027-09-01
• First posted: 2020-07-15
• Last updated: 2025-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study