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
ClinicalTrials.gov