A Phase 3 Study of XL092 and Nivolumab Immunotherapy Compared to Sunitinib in People With Kidney Cancer


Full Title

A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma


Researchers in this study are comparing two different treatments for advanced non-clear cell renal cell carcinoma (nccRCC). This is a type of kidney cancer. The people in this study have nccRCC that has metastasized (spread to other parts of the body). It is also inoperable (cannot be removed with surgery).

If you join this study, you will be randomly assigned to get one of these treatments:

  • The investigational treatment, XL092 in combination with nivolumab immunotherapy
  • The standard treatment, sunitinib

XL092 and sunitinib are drugs called tyrosine kinase inhibitors (TKIs). TKIs block certain proteins found in or on cancer cells. When these proteins are blocked, your cancer may stop growing, or it may grow more slowly or shrink. XL092 and sunitinib are taken orally (by mouth).

Nivolumab works by taking the brakes off the immune response. It boosts the power of the immune system to find and kill cancer cells. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have nccRCC that is inoperable and metastatic.
  • Not have had treatment for advanced nccRCC.
  • Have recovered from the serious side effects of any prior anti-cancer therapies.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please call Dr. Darren Feldman’s office at 646-888-4740.




Phase III (phase 3)



ClinicalTrials.gov ID