A Phase III Study Comparing Nivolumab Immunotherapy plus Cabozantinib, Nivolumab and Ipilimumab plus Cabozantinib, and Sunitinib Alone for Patients with Untreated Advanced Kidney Cancer

Full Title

CA2099ER: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9ER)

Purpose

The purpose of this study is to compare three different regimens of therapy for inoperable or metastatic renal cell carcinoma (kidney cancer) that has not yet been treated with medication. Patients will be randomly assigned to receive one of these treatments:

  • Nivolumab immunotherapy plus cabozantinib
  • Nivolumab and ipilimumab immunotherapy plus cabozantinib
  • Sunitinib alone

Nivolumab and ipilimumab work by taking the brakes off the immune response, boosting the power of the immune system to find and destroy cancer cells. They are given intravenously (by vein). Cabozantinib and sunitinib both inhibit the development of the blood vessels that tumors need to grow and spread. They are taken orally (by mouth).

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 previously untreated renal cell carcinoma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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 646-422-4312.

Protocol

17-520

Phase

III

Investigator

Co-Investigators