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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04472767
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Given IV
  • Ipilimumab — DRUG
    Given IV
  • Cabozantinib — DRUG
    Given PO
  • Transarterial Chemoembolization — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Aug 7, 2020
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib with Ipilimumab/Nivolumab and TACE
    Subjects receive Cabozantinib 40 mg daily on days 1-28 of a 28 day cycle, this is to be started 7-14 days after the last TACE procedure. Nivolumab 480 mg IV on day 1 of a 28 day cycle (cycle 2 and beyond), this is to be started 7-14 days after the last TACE procedure. Nivolumab: 3mg/kg IV on day 1 of a 21 day cycle x 1 dose. Ipilimumab: 1 mg/kg on day 1 of a 21 day cycle x 1 dose TACE: Within 3-4 weeks of cycle 1 day 1; may be done up to 3 times (9-12 weeks total), the intervals between each TACE treatment can vary based on investigator's discretion

Primary Outcome Measure

Percentage of Participants with Progression-free Survival at 6 Months [ Time Frame: 6 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-7883
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Farshid Dayanni, MD, PhD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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