Table 2 Phase 3 immune checkpoint inhibitor-based adjuvant therapy trials in advanced RCC
Trial | Description | Primary 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 relapse | Blinded 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 nephrectomy | Independent 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 ccRCC | Safety and efficacy and investigator-assessed DFS. |
PROSPER RCC (NCT03055013) | Perioperative nivolumab vs. nephrectomy alone in treating patients with high-risk RCC | Recurrence-free survival (RFS). |
RAMPART (NCT03288532) | 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 relapse | DFS and OS. |