A Phase III Study of Immunotherapy versus Placebo in Patients with Localized Kidney Cancer at High Risk of Relapse After Cancer Surgery

Full Title

CA209914: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse (CheckMate 914)


The standard treatment for early-stage renal cell carcinoma is surgery to remove part or all of the affected kidney. Yet patients with some cancers, such as those with stage II and III tumors, may still have a high risk of the cancer returning. In this study, researchers want to see if giving immunotherapy with the drugs nivolumab and ipilimumab after kidney cancer surgery is effective for reducing the risk of relapse in these patients.

Nivolumab and ipilimumab target proteins that cancer cells use to evade detection by the immune system. They boost the power of the immune system to find and kill cancer cells. Both drugs are given intravenously (by vein).

Patients in this study will be randomly assigned to receive nivolumab and ipilimumab or a placebo (inactive drug).


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

  • Patients must have localized clear cell renal cell carcinoma that was surgically removed through either partial or total nephrectomy (removal of the kidney) at least 4 weeks but no more than 12 weeks before entering the study.
  • Patients must have a high risk of kidney cancer relapse.
  • 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.