RecruitingPhase 2NCT04472767

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


Sponsor

University of California, Irvine

Enrollment

35 participants

Start Date

Aug 7, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — cabozantinib (a targeted therapy), ipilimumab and nivolumab (two immunotherapy drugs), and TACE (a procedure that delivers chemotherapy directly into tumors in the liver) — in patients with hepatocellular carcinoma (liver cancer) who are not candidates for surgery or transplant. **You may be eligible if:** - You have liver cancer confirmed by biopsy or imaging - You have at least one tumor that can be treated with TACE (a procedure delivering chemo directly to the liver) - Your liver function is relatively preserved (Child-Pugh A or B7) - You are 18 or older with a good performance status (ECOG 0-2) - You have at least one measurable tumor - Your blood counts and organ function meet required levels - You are willing to use contraception if of childbearing potential **You may NOT be eligible if:** - You have had a prior liver transplant - You have uncontrolled infections - You are pregnant or breastfeeding - You have serious autoimmune disease - Your liver disease is severe (Child-Pugh C) - You have significant heart, kidney, or other organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

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NCT04472767


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