A Phase II Study of Nivolumab Immunotherapy plus Cabozantinib in Patients with Non-Clear Cell Renal Cell Cancer

Full Title

A Phase 2 Open-Label Study of Nivolumab Combined with Cabozantinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (CA209-9KU)

Purpose

Nivolumab and cabozantinib are both treatments used for patients with metastatic kidney cancer. In this study, researchers are evaluating the safety and effectiveness of giving them together in patients with metastatic non-clear cell renal cell carcinoma.

Nivolumab inhibits a protein that normally puts the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells. It is given intravenously (by vein). Cabozantinib inhibits the development of the blood vessels that tumors need to grow and spread. It is taken orally (by mouth). Patients in this study will receive both medications.

Eligibility

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

  • Patients must have inoperable or metastatic non-clear cell renal cell cancer that has not been treated or has been treated with no more than one regimen of therapy.
  • At least 4 weeks must pass since the completion of prior therapies (2 weeks for kinase inhibitors) and entry into the study.
  • Patients may not have previously received immunotherapy or cabozantinib.
  • 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 and to inquire about eligibility for this study, please contact Dr. Chung-Han Lee at 646-888-5418.

Protocol

18-254

Phase

II

Investigator