Testing the Addition of the Drug Nivolumab Before and after Surgery for Renal Cell Cancer
Lay Title: Testing the Addition of the Drug Nivolumab Before and after Surgery for Renal Cell Cancer
Technical Title: PROSPER RCC: EA8143: A Phase 3 RandOmizedStudy Comparing PERioperative Nivolumab vs. Observation in Patients with Localized RenalCell Carcinoma Undergoing Nephrectomy
Disease Type:Patients with renal cell carcinoma (a type of kidney cancer) who are planned to have a nephrectomy (surgical removal of the kidney)
Basic information: The purpose of this study is to compare the effects of a drug called 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 nivolumabto the usual surgery could prevent your cancer from returning but it could also cause side effects.
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.
If you participate in the study, you will be randomized to one of two groups: (1) receive nivolumab before and after your scheduled kidney cancer surgery, or (2) observation after kidney cancer surgery (which is the routine approach taken for this early stage of kidney cancer).
Research Procedures (not a complete list):
If you are randomized to receive nivolumab, you will receive 2 doses of nivolumab – once every two weeks – before surgery. Starting 4 weeks after surgery, you will receive 12 doses of nivolumab over 9 months. The first 6 doses will be given every 2 weeks, and the last 6 doses will be given every 4 weeks. During study visits, you will undergo a physical exam and have blood drawn for safety and research tests.
If you are randomized to receive usual care, you will undergo routine monitoring after surgery.
Eligibility Criteria (Not a complete list):
Inclusion Criteria:
Exclusion Criteria:
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