Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-025
Prinicipal Investigator
Joshi, Monika
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EA8143
Title
A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Objective
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
Applicable Disease Sites
Kidney
Status
Open
Participating Institutions
Hershey Medical Center