Clinical Trial TitleA phase 3 randomized study comparing perioperative nivolumab vs observation in patients with localized renal cell carcinoma undergoing nephrectomy (PROSPER RCC).
Clinical Trial Protocol Description:
This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a renal mass consistent with a clinical stage >= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned.
- Have no clinical or radiological evidence of distant metastases (M0) unless the presumed M1 disease can be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or within a 12 week window from the date of the initial procedure such that the patient is considered "no evidence of disease" (M1 NED).
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior systemic or local anti-cancer therapy for the current RCC.
This is a partial list of inclusion and exclusion criteria.