A Phase II Study of Cabozantinib, Nivolumab, and Ipilimumab Immunotherapy in Patients with Advanced Radioiodine-Resistant Thyroid Cancer

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Full Title

Phase II Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab (CaboNivoIpi) in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Whose Cancer Progressed After One Prior VEGFR-Targeted Therapy (NCI 10240) (CIRB)

Purpose

In this study, researchers are assessing the safety and effectiveness of combining the drug cabozantinib with the immunotherapy drugs nivolumab and ipilimumab to treat patients with advanced differentiated thyroid cancer that cannot be cured with the standard treatment, radioiodine, and have been previously treated with a single drug that targets VEGFR (including but not limited to sorafenib, lenvatinib, pazopanib, sunitinib, vandetanib, or axitinib).

Cabozantinib inhibits an enzyme called tyrosine kinase which can fuel cancer growth; it is already used to treat medullary thyroid cancer. Nivolumab and ipilimumab are immunotherapy drugs that take the brakes off the immune response, enabling immune cells to find and destroy cancer cells. This combination of treatments is investigational. Cabozantinib is taken orally (by mouth) and nivolumab and ipilimumab are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced differentiated thyroid cancer that cannot be successfully treated with radioiodine therapy and has grown despite no more than one VEGFR-targeted therapy (such as sorafenib, sunitinib, vandetanib, pazopanib, or lenvatinib).
  • Patients may not have previously received immunotherapy or cabozantinib.
  • Patients must be able to swallow tablets.
  • Patients may not have untreated or progressive metastases to the brain.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-608-3776.

Protocol

20-337

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators