PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Renal Cell Cancer (PDIGREE)
Objective
To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab. To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib To evaluate the 12-month complete response rate in patients treated with ipilimumabnivolumab followed by cabozantinb-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have CR and relapse before 12 months will not be counted as a CR at 12-months) To evaluate the rates of discontinuing therapy at 1 year To compare objective response rates (ORR, assessed by RECIST 1.1 and irRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinb-nivolumab versus ipilimumab-nivolumab followed by nivolumab. To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinbnivolumab.
