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A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Protocol No
ECOG-EA8143-PROSPER
Principal Investigator
Deepak Kilari
Phase
III
Summary
The purpose of this study is to compare any good and bad effects of using nivolumab (also known as OPDIVO®), before and after the kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring. Nivolumab is a drug that may help stimulate your immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent your cancer from returning but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for kidney cancer that has been removed but is at risk for coming back The study drug, nivolumab, is already FDA-approved for patients who have kidney cancer that has spread outside of the kidney to other organs or lymph nodes. The use of nivolumab in this study is investigational (not approved by the FDA) for your early stage of cancer where we do not know for sure if the disease has spread outside of the kidney. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live without any signs or symptoms of your cancer compared to the usual approach There will be about 766 people taking part in this research study.
Description
Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL