Cabozantinib + Nivolumab + Ipilimumab for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+35 other locations

Overseen byBhavana Konda

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 trial studies how well a combination of cabozantinib, nivolumab, and ipilimumab works in patients with thyroid cancer that hasn't responded to other treatments. Cabozantinib stops cancer growth by blocking certain enzymes, while nivolumab and ipilimumab help the immune system fight the cancer.

Eligibility Criteria

Adults with advanced differentiated thyroid cancer that's resistant to radioactive iodine and has worsened after VEGFR-targeted therapy. They must have measurable disease, not be pregnant, agree to use contraception, and be able to swallow pills. Excludes those with certain other cancers within the last 2 years or specific health conditions.

Inclusion Criteria

I have someone legally authorized to make decisions for me due to my impaired decision-making capacity.

I have HIV, am on treatment, and my viral load is undetectable.

My thyroid cancer does not respond to radioactive iodine treatment.

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Exclusion Criteria

I am not on any medications that are not allowed in the study.

My cancer has not spread to major blood vessels or the GI tract.

I do not have untreated brain or spinal cord cancer spread.

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Treatment Details

Interventions

Cabozantinib S-malate (Tyrosine Kinase Inhibitor)
Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing a combination of three drugs: Cabozantinib (blocks enzymes for cell growth), Nivolumab, and Ipilimumab (both boost the immune system against cancer). It aims to see if this trio is more effective than standard chemotherapy treatments for this type of thyroid cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (cabozantinib S-malate, nivolumab, ipilimumab)Experimental Treatment6 Interventions

Patients receive cabozantinib S-malate PO QD on days -14 to -1 prior to cycle 1, days 1-42 of cycles 1-4 and days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1, 15, and 29 of cycles 1-4 and day 1 of subsequent cycles and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Treatment repeats every 42 days for cycles 1-4 and every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening, and blood sample collection throughout the study.

Cabozantinib S-malate is already approved in United States, United States, European Union for the following indications:

🇺🇸 Approved in United States as Cabometyx for: