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Table 2 Phase 3 immune checkpoint inhibitor-based adjuvant therapy trials in advanced RCC

From: The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of advanced renal cell carcinoma (RCC)

TrialDescriptionPrimary Outcome to be Assessed
CheckMate 914 (NCT03138512)Nivolumab + ipilimumab vs. placebo as adjuvant therapy in patients with localized RCC who underwent radical or partial nephrectomy and who are at high risk of relapseBlinded Independent Central Review (BICR)-assessed disease-free survival (DFS)
IMmotion010 (NCT03024996)Atezolizumab vs. placebo as adjuvant therapy for 1 year in patients with RCC at high risk of disease recurrence following nephrectomyIndependent review facility (IRF)-assessed DFS.
KEYNOTE 564 (NCT03142334)Pembrolizumab vs. placebo (saline solution) as adjuvant therapy given after nephrectomy on 3-week cycles for up to 17 cycles in patients with resected intermediate or high risk ccRCCSafety and efficacy and investigator-assessed DFS.
PROSPER RCC (NCT03055013)Perioperative nivolumab vs. nephrectomy alone in treating patients with high-risk RCCRecurrence-free survival (RFS).
Durvalumab monotherapy vs. durvalumab + tremelimumab vs. no intervention (active monitoring) as adjuvant therapy for 1 year in patients with resected primary RCC at high or intermediate risk of relapseDFS and OS.