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Phase 2 Study of Cabozantinib, Ipilimumab, Nivolumab, and TACE for Liver Cancer

This study is testing a combination of treatments for hepatocellular carcinoma (HCC), a type of liver cancer, in people who cannot have surgery or a transplant. The treatments include three medications: nivolumab and ipilimumab (given intravenously, meaning into a vein), and cabozantinib (taken by mouth). You would also receive Transarterial Chemoembolization (TACE), a procedure that delivers cancer-fighting drugs directly to the tumor. Researchers want to see how many participants are still alive without their cancer growing after 6 months, and how many have their cancer completely disappear. This is a Phase 2 study, meaning it's looking at how well the treatment works and its safety, and it plans to enroll 35 participants. The current status of the study is unclear.

Study design
This is a Phase 2, single-arm, open-label study, meaning all participants receive the same treatment, and both you and the study team will know which treatments you are receiving. The study plans to enroll 35 participants.
What's involved
You would receive nivolumab and ipilimumab intravenously, and cabozantinib by mouth. TACE treatments would be given in up to 3 procedures within 9-12 weeks after your first nivolumab/ipilimumab infusion.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants live without their disease progressing, and how many achieve a complete response, with an average follow-up of 1 year for complete response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04472767

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Irvine
~35 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:NivolumabIpilimumabCabozantinibTransarterial Chemoembolization

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Progression-free Survival at 6 Months
Measured over 6 months
+1 more outcome measured

Conditions

Hepatocellular Carcinoma
HCC

Explore related trials

Hepatocellular Carcinoma

NCT04472767

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Farshid Dayyani, MD, PhD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-7883
Email the study team

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Eligibility criteria

Inclusion

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:
The effects of cabozantinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Life expectancy of greater than 3 months
Ability to swallow tablets
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Any type of previous systemic anti-cancer treatment
All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
Any locoregional treatment for HCC within 3 months
Vp4 or Vp3 portal vein thrombus
Extrahepatic disease
Patients may not be receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, cabozantinib or other agents used in study.
Concomitant anticoagulation with coumarin agents (eg, warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., rivaroxaban), or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following:
The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 28 days before the first dose of study treatment.
Uncontrolled intercurrent illness including, but not limited to, the following conditions:
Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
Prior treatment with cabozantinib
Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.
Inability to comply with study and follow-up procedures as judged by the Investigator
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Has fibrolamellar HCC
Has received prior cytotoxic, biologic or other systemic anticancer therapy including investigational agents within 4 weeks prior to randomization.
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Has received a live vaccine within 30 days prior to the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Has severe hypersensitivity (Grade ≥ 3) to nivolumab or cabozantinib and/or any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

What this trial measures

  • Percentage of Participants with Progression-free Survival at 6 Months6 months

    This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined death, radiographic progression or clinical deterioration attributed disease progression as judged by an investigator. Radiographic progression is defined using the modified Response Evaluation Criteria in Solid Tumors Criteria (mRECIST), as a 20% increase in the sum of diameters of of viable (enhancing) target lesions and/or appearance of one or new lesions and/or unequivocal progression of existing non-target lesions.

  • Complete Response RateFrom date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

    Complete Response (CR) is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.