35 Participants Needed

Cabozantinib + Immunotherapy + TACE for Liver Cancer

Uo
CF
Overseen ByChao Family Comprehensive Cancer Center University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on certain blood thinners like warfarin or certain other investigational drugs. It's best to discuss your current medications with the trial team to see if they are allowed.

Is the combination of Cabozantinib, Immunotherapy, and TACE safe for humans?

The combination of Cabozantinib (Cabometyx) with immunotherapy drugs like Nivolumab (Opdivo) and Ipilimumab (Yervoy) has been studied for safety in liver cancer and other conditions. Common side effects include hand-foot syndrome (skin reaction on palms and soles), high blood pressure, tiredness, and diarrhea. These treatments have been used in advanced liver and kidney cancers, showing a safety profile that includes these manageable side effects.12345

What makes the Cabozantinib + Immunotherapy + TACE treatment unique for liver cancer?

This treatment is unique because it combines cabozantinib, a multikinase inhibitor that targets cancer growth pathways, with immunotherapy drugs like nivolumab and ipilimumab, which help the immune system attack cancer cells, and TACE (transarterial chemoembolization), a procedure that delivers chemotherapy directly to the liver tumor. This combination aims to enhance the immune response and directly target the tumor, offering a potentially more effective approach for advanced liver cancer.23678

What data supports the effectiveness of the treatment Cabozantinib + Immunotherapy + TACE for Liver Cancer?

Research shows that combining cabozantinib with immunotherapy drugs like nivolumab and ipilimumab can improve outcomes for patients with advanced liver cancer. Studies have demonstrated that these combinations can enhance the body's immune response against cancer cells, potentially leading to better treatment results.236910

Who Is on the Research Team?

Farshid Dayyani | UCI Chao Family ...

Farshid Dayyani

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My blood and organ tests meet the required levels for treatment.
I agree to use birth control or abstain from sex during and for 4 months after the study.
I am using effective birth control while being treated with ipilimumab and will continue for 3 months after the last dose.
See 11 more

Exclusion Criteria

You cannot be taking any other experimental drugs.
I have received treatments that travel through my bloodstream to reach cancer cells anywhere in my body.
All my side effects from cancer treatment have improved, except for hair loss.
See 31 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cabozantinib, Ipilimumab/Nivolumab, and TACE. Cabozantinib is administered daily on days 1-28 of a 28-day cycle, Nivolumab on day 1 of a 28-day cycle (cycle 2 and beyond), and Ipilimumab on day 1 of a 21-day cycle. TACE may be done up to 3 times within 9-12 weeks.

9-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of overall survival and adverse events.

4 weeks

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival up to 18 months after the last patient is enrolled.

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cabozantinib
  • Ipilimumab/Nivolumab
  • Transarterial Chemoembolization
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cabozantinib with Ipilimumab/Nivolumab and TACEExperimental Treatment4 Interventions

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Cabometyx for:
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Approved in United States as Cabometyx for:
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Approved in Canada as Cabometyx for:
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Approved in Japan as Cabometyx for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Published Research Related to This Trial

The combination of cabozantinib and anti-PD1 significantly improved antitumor efficacy in experimental models of hepatocellular carcinoma (HCC) compared to either treatment alone, indicating a promising therapeutic strategy.
Cabozantinib alone increased neutrophil infiltration and reduced certain T-cell populations, while its combination with anti-PD1 further enhanced these effects and improved overall T-cell proportions, suggesting a mechanism that boosts both innate and adaptive immune responses against HCC.
Cabozantinib Enhances Anti-PD1 Activity and Elicits a Neutrophil-Based Immune Response in Hepatocellular Carcinoma.Esteban-Fabrรณ, R., Willoughby, CE., Piquรฉ-Gili, M., et al.[2023]
In a phase 1/2 study involving 148 patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib, the combination of nivolumab and ipilimumab showed a promising objective response rate of 32% in one treatment arm, indicating potential efficacy for this patient population.
The treatment regimen was generally manageable in terms of safety, although 94% of patients in one arm experienced treatment-related adverse events, highlighting the need for careful monitoring; notably, this combination therapy received accelerated approval in the US based on these results.
Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial.Yau, T., Kang, YK., Kim, TY., et al.[2022]
In the COSMIC-312 trial involving 837 patients with advanced hepatocellular carcinoma, the combination of cabozantinib and atezolizumab showed a median progression-free survival of 6.8 months, significantly longer than the 4.2 months observed with sorafenib, indicating improved efficacy for the combination treatment.
While the overall survival rates were similar between the combination treatment and sorafenib (15.4 months vs. 15.5 months), the combination was associated with a higher incidence of serious treatment-related adverse events, suggesting a need for careful patient selection and monitoring.
Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial.Kelley, RK., Rimassa, L., Cheng, AL., et al.[2022]

Citations

Cabozantinib Enhances Anti-PD1 Activity and Elicits a Neutrophil-Based Immune Response in Hepatocellular Carcinoma. [2023]
Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial. [2022]
Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. [2022]
Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial. [2023]
CABOSEQ: The Effectiveness of Cabozantinib in Patients With Treatment Refractory Advanced Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). [2023]
Adverse Events of Cabozantinib Plus Nivolumab Versus Ipilimumab Plus Nivolumab. [2023]
Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma. [2023]
Cabozantinib for the Treatment of Advanced Hepatocellular Carcinoma: Current Data and Future Perspectives. [2021]
Cabozantinib plus atezolizumab for the treatment of advanced hepatocellular carcinoma: shedding light on the preclinical rationale and clinical trials. [2022]
Cabozantinib Following Immunotherapy in Patients with Advanced Hepatocellular Carcinoma. [2023]
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