Wednesday, November 07, 2018 The CCTG trial REC.4 (EA8143), A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) has been centrally activated. If you have questions please contact the study coordinator: Max Sherry Eligibility: Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or unknown histology confirmed by biopsy where nephrectomy is planned. Patients must have no distant metastases, history of RCC within the past 5 years and have had no concurrent or prior systemic or local anti-cancer therapy for RCC. Paitents must be over the age of 18 and have no active or suspected autoimmune disease, no ongoing condition requireing systemic treatment with corticosteroids/other immunosuppressants and no history of severe hypersensitivity to a monoclonal antibody. Objectives: Primary Objective: 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 RFS associated with perioperative nivolumab compared to surgery alone among patients with clear cell histology. To compare the overall survival between patients randomized to perioperative nivolumab compared to surgery alone among the subset of patients with clear cell histology. To describe the safety and tolerability of perioperative nivolumab. Visit the trial webpage for more information.
