Actively Recruiting
Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma Who Are Not Candidates for Curative Intent Treatment
Led by University of California, Irvine · Updated on 2026-04-30
35
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of cabozantinib combined with the drugs ipilimumab and nivolumab along with a procedure called transarterial chemoembolization (TACE) in people with hepatocellular carcinoma (HCC) who cannot have curative treatments like surgery. This phase 2, open-label trial aims to determine how well this combination works in treating this type of liver cancer. Participants receive cabozantinib daily by mouth in 28-day cycles starting 7 to 14 days after their last TACE treatment. Nivolumab and ipilimumab are given intravenously in specific doses and schedules, with nivolumab continuing every 28 days from cycle 2 onward. TACE is done within 3 to 4 weeks after the first doses of nivolumab and ipilimumab and may be repeated up to three times over 9 to 12 weeks depending on the investigator's decision. During the study, participants will have regular assessments including scans and lab tests to measure tumor response, progression-free survival at 6 months, overall survival, and side effects. Safety is closely monitored for about a year after treatment ends. Participants will be followed up for up to 18 months or until death to track outcomes and any adverse events related to the study treatments.
CONDITIONS
Brief Title
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- ECOG performance status 0, 1, or 2
- At least one measurable lesion untreated or progressed after previous locoregional treatment
- Adequate organ and marrow function including leukocytes ≥ 2,000/mcL, absolute neutrophil count ≥ 1000/mcL, platelets ≥ 60,000/mcL, total bilirubin within normal limits, AST/ALT ≤ 3x upper limit of normal or ≤ 5x if liver metastases present, creatinine <1.5 ULN, hemoglobin ≥ 8 g/dL, serum albumin ≥ 2.8 g/dL, urine protein/creatinine ratio ≤ 1 mg/mg
- Use of adequate contraception for women of child-bearing potential and men during and after study as specified
- Life expectancy greater than 3 months
- Ability to swallow tablets
- Willingness and ability to sign informed consent
You will not qualify if you...
- Prior systemic anti-cancer treatment
- Toxicities from prior cancer therapy not resolved to grade 1 or baseline except alopecia
- Locoregional treatment for HCC within 3 months
- Vp4 or Vp3 portal vein thrombus
- Extrahepatic disease
- Receiving other investigational agents
- Allergic reactions to nivolumab, cabozantinib, or similar agents
- Use of certain anticoagulants except low-dose aspirin or low molecular weight heparins under specified conditions
- Prothrombin time or partial thromboplastin time ≥ 1.3 times upper limit of normal
- Uncontrolled illnesses including active infections, congestive heart failure, uncontrolled hypertension, recent stroke or ischemic events, unstable angina, arrhythmia, gastrointestinal conditions, recent major surgery without healing, and others
- Prior treatment with cabozantinib
- Corrected QT interval > 500 ms on ECG
- Recent use of small molecule kinase inhibitors or radiation therapy as specified
- History of other primary cancers within 3 years except certain exceptions
- Inability to comply with study procedures
- Pregnancy or nursing
- Fibrolamellar HCC
- Recent live vaccines
- Immunodeficiency or recent immunosuppressive therapy
- Severe hypersensitivity to study drugs
- Active autoimmune disease requiring systemic treatment
- History or current pneumonitis requiring steroids
- Active infections requiring systemic therapy
- Known HIV or active tuberculosis infection
- Other conditions or lab abnormalities interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 to 12 weeks for TACE plus ongoing drug treatment cycles
Participants receive a combination of cabozantinib, nivolumab, and ipilimumab along with up to 3 Transarterial Chemoembolization (TACE) procedures over 9 to 12 weeks. Cabozantinib and nivolumab treatment starts 7 to 14 days after the last TACE procedure.
Up to 3 TACE procedures within 9 to 12 weeks; drug infusions on specified days of 21- and 28-day cycles
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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