Cabozantinib + Immunotherapy for Cancer

Recruiting in Palo Alto (17 mi)

+52 other locations

Overseen byAnteneh A Tesfaye

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab work in treating patients with poorly differentiated neuroendocrine tumors (i.e., neuroendocrine tumor that does not look like the normal tissue it arose from). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab and ipilimumab may shrink the cancer.

Eligibility Criteria

This trial is for adults with poorly differentiated neuroendocrine tumors, excluding small cell lung cancer and merkel cell carcinoma. Participants must have only failed one prior treatment, have measurable disease, and be able to perform daily activities (ECOG <=2). They should not be pregnant or breastfeeding and must agree to use contraception. People who've had major surgery recently, those with active autoimmune diseases or a history of severe allergies to similar drugs are excluded.

Inclusion Criteria

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

Your hemoglobin level must be at least 9 grams per deciliter.

PT/INR and PTT test < 1.3 x ULN

+34 more

Exclusion Criteria

I have previously been treated with cabozantinib or other MET-targeting therapies.

I need treatment with strong medications that change how my body processes drugs.

I haven't had chemotherapy or certain drugs within the last 4 weeks.

+15 more

Participant Groups

The study tests the effectiveness of combining XL184 (cabozantinib), nivolumab, and ipilimumab in treating certain neuroendocrine tumors. Cabozantinib may block enzymes needed for tumor growth while nivolumab and ipilimumab could help the immune system fight cancer by interfering with tumor growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (cabozantinib s-malate, nivolumab, ipilimumab)Experimental Treatment3 Interventions

Patients receive cabozantinib s-malate PO QD on days 1-21 of cycles 1-4 and days 1-28 of subsequent cycles, nivolumab IV over 30 minutes on day 1, and ipilimumab IV over 90 minutes on day 1 of cycles 1-4 only. Treatment repeats every 21 for 4 cycles then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Cabometyx for: