PCRC_EA8143

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

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). Monoclonal antibodies, such as nivolumab, 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.

Inclusion Criteria:
* Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four (4) months prior to randomization
* Patients must have no clinical or radiological evidence of distant metastases (M0)
* No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Phase III
NCT03055013
Oncology
Genitourinary
Alison Conlin, M.D.
ECOG-ACRIN
Scot Lary

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.