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

Primary Objectives To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives To evaluate for differences in recurrence-free survival associated with perioperative nivolumab compared to surgery alone among the subset of patients with clear cell histology. To compare the overall survival between patients randomized to perioperative nivolumab in addition to resection to patients randomized to primary tumor resection alone. To describe the safety and tolerability of perioperative nivolumab Correlative Objectives To correlate the primary tumor s expression of PD-L1 with outcome. To correlate the expression of PD-L1 on tumor tissue at recurrence with outcome. To archive images for potential central confirmation of recurrence and for future correlative work with ACRIN, including markers predicting outcome or response. To prospectively collect tumor and biologic specimens (e.g., serum, PMBCs) for future correlative studies. To characterize the pharmacokinetics of nivolumab and explore exposure response relationships with respect to safety and efficacy. To characterize the immunogenicity of nivolumab. Quality of Life Objective To evaluate differences in change from baseline in patient-reported symptoms and toxicities among patients randomized to treatment with nivolumab compared to surgery alone.

Primary Objectives To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives To evaluate for differences in recurrence-free survival associated with perioperative nivolumab compared to surgery alone among the subset of patients with clear cell histology. To compare the overall survival between patients randomized to perioperative nivolumab in addition to resection to patients randomized to primary tumor resection alone. To describe the safety and tolerability of perioperative nivolumab Correlative Objectives To correlate the primary tumor s expression of PD-L1 with outcome. To correlate the expression of PD-L1 on tumor tissue at recurrence with outcome. To archive images for potential central confirmation of recurrence and for future correlative work with ACRIN, including markers predicting outcome or response. To prospectively collect tumor and biologic specimens (e.g., serum, PMBCs) for future correlative studies. To characterize the pharmacokinetics of nivolumab and explore exposure response relationships with respect to safety and efficacy. To characterize the immunogenicity of nivolumab. Quality of Life Objective To evaluate differences in change from baseline in patient-reported symptoms and toxicities among patients randomized to treatment with nivolumab compared to surgery alone.