Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer

Summary

This phase II trial studies how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. 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 work better than the usual approach consisting of chemotherapy with drugs such as doxorubicin, sorafenib, and lenvatinib for this type of thyroid cancer.

Timeline

Start

2020-02-10

Primary completion

2024-10-17

Completion

2026-12-17

Outcome

Missed primary endpoint

paper ORR within the first 6 months of treatment was 10% (1 partial response). PMID 39133806 ↗

paper The study did not reach its prespecified efficacy threshold. PMID 39133806 ↗

Publications

• Konda B, Sherman EJ, Massarelli E, Nieva J, Muzaffar J, Morris JC 3rd, Ryder M, Ho AL, Agulnik M, Wei L, Handley D, Moses C, Jacob R, Wright J, Streicher H, Carson W, Shah MH. Cabozantinib Plus Ipilimumab/Nivolumab in Patients With Previously Treated Advanced Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2025 Feb 18;110(3):830-837. doi: 10.1210/clinem/dgae512.

Drugs

Indications