A Phase III Study of Nivolumab and Ipilimumab Immunotherapy with or without Cabozantinib in Patients with Previously Untreated Advanced or Metastatic Kidney Cancer

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Full Title

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk (WIRB)

Purpose

This study will determine whether cabozantinib in combination with nivolumab plus ipilimumab immunotherapy is more effective than nivolumab plus ipilimumab alone to treat patients with advanced renal cell carcinoma (kidney cancer) who have not received prior treatment and whose risk of recurrence is considered intermediate or poor. Cabozantinib is already used to treat advanced kidney cancer. Nivolumab is also used to treat advanced kidney cancer, but its use in combination with ipilimumab is only for patients with advanced melanoma. The combination of cabozantinib, nivolumab, and ipilimumab is considered investigational.

Cabozantinib inhibits the development of the blood vessels that tumors need to grow and spread. Nivolumab and ipilimumab inhibit proteins that normally put the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells.

Cabozantinib is taken orally (by mouth) and nivolumab and ipilimumab are given intravenously (by vein). Patients in this study will be randomly assigned to receive nivolumab and ipilimumab with cabozantinib or with a placebo (inactive tablets).

Eligibility

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

  • Patients must have intermediate-risk or poor-risk renal cell carcinoma that is inoperable or metastatic and has not yet been treated.
  • 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. Robert Motzer at 646-888-4722.

Protocol

19-291

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators