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Tyrosine Kinase Inhibitor

Cabozantinib + Immunotherapy + TACE for Liver Cancer

Phase 2

Recruiting

Led By Farshid Dayyani, MD, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ and marrow function as defined below: Leukocytes ≥ 2,000/mcL, absolute neutrophil count ≥ 1000/mcL, platelets ≥ 60,000/mcl, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present, creatinine <1.5ULN, hemoglobin ≥ 8 g/dL, Serum albumin ≥ 2.8 g/dL, Urine protein/creatinine ration (UPCR) ≤ 1 mg/mg

Not a candidate for resection or transplantation

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a drug called cabozantinib, used together with other drugs, can help people with HCC who are not candidates for curative treatment.

Who is the study for?

Adults with hepatocellular carcinoma (HCC) who can't have curative treatments like surgery or transplantation. They must be physically able to perform daily activities with minimal assistance, have a tumor treatable by TACE, good liver function (Child-Pugh A-B7), and adequate blood and organ function. Women of childbearing potential and men must use contraception during the trial.

What is being tested?

The trial is testing the effectiveness of cabozantinib combined with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in treating HCC. It's an open-label study where all participants receive the same treatment without being compared to a control group.

What are the potential side effects?

Possible side effects include high blood pressure, tiredness, loss of appetite, gastrointestinal symptoms like diarrhea or nausea, skin reactions at injection sites for immunotherapy drugs, potential liver toxicity from TACE procedure, and increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood and organ tests meet the required levels for treatment.

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I cannot have surgery or a transplant for my condition.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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I have been diagnosed with liver cancer.

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I have a tumor that can be treated with TACE.

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My liver function is mildly to moderately impaired.

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I have at least one tumor that can be measured and has not been treated or has grown after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatments that travel through my bloodstream to reach cancer cells anywhere in my body.

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All my side effects from cancer treatment have improved, except for hair loss.

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I am allergic to medications similar to nivolumab or cabozantinib.

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I do not have any uncontrolled illnesses or recent major heart or blood vessel problems.

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I do not have any serious wounds, thyroid issues, severe liver problems, or mental health/social situations that would stop me from following the study's requirements.

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I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.

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I have been treated with cabozantinib before.

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I have had or currently have lung inflammation treated with steroids.

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My cancer has spread outside of the liver.

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I have lung lesions or tumors inside my airways.

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I have not had significant bleeding in the last 3 months.

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I haven't taken any kinase inhibitor medication in the last 2 weeks.

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I have been diagnosed with fibrolamellar hepatocellular carcinoma.

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I have not received a live vaccine in the last 30 days.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I am currently being treated for an infection.

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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response Rate

Percentage of Participants with Progression-free Survival at 6 Months

Secondary study objectives

Conversion Rate to Resectable

Overall Survival of Patients who Received Cabozantinib with Ipilimumab/Nivolumab and TACE

Percentage of Grade 3-5 Adverse Events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cabozantinib with Ipilimumab/Nivolumab and TACEExperimental Treatment4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3420

Cabozantinib

2020

Completed Phase 2

~2360

Transarterial Chemoembolization

2009

Completed Phase 1

~100

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

566 Previous Clinical Trials

1,933,013 Total Patients Enrolled

2 Trials studying Hepatocellular Carcinoma

15 Patients Enrolled for Hepatocellular Carcinoma

ExelixisIndustry Sponsor

121 Previous Clinical Trials

20,123 Total Patients Enrolled

7 Trials studying Hepatocellular Carcinoma

4,707 Patients Enrolled for Hepatocellular Carcinoma

Farshid Dayyani, MD, PhD5.02 ReviewsPrincipal Investigator - Chao Family Comprehensive Cancer Center

University of California, Irvine

3 Previous Clinical Trials

62 Total Patients Enrolled

5Patient Review

Dr. Sayyani is very attuned to the needs of clinical trial patients. He's been great at adjusting my chemotherapeutic drugs to manage side effects. He's also very patient and open to questions, even if he can't answer everything.