Table 3:
Trial | Treatments | Setting (doses) | Stage for Inclusion | Histology | Primary Endpoint |
---|---|---|---|---|---|
Checkmate 914 NCT03138512 |
Ipilimumab + Nivolumab | Adjuvant (24 weeks) | pT2a (G3/4), ≥pT2b TanyN1M0 |
Primarily clear cell | DFS |
RAMPART NCT03288532 |
Durvalumab ± Tremelimumab | Adjuvant D only (13 cycles) D+T (13+2 cycles) |
Leibovich score 3–11 | Any RCC histology | DFS, OS |
KEYNOTE-564 NCT03142334 |
Pembrolizumab | Adjuvant (17 cycles) | pT2 (G3, sarcomatoid) ≥pT3, pTanyN+M0 (any G) M1 NED |
Clear cell RCC (including sarcomatoid) | DFS |
IMmotion010 NCT03024996 |
Atezolizumab | Adjuvant (16 cycles) | pT2 (G4), pT3 (G3/4), ≥pT3b, pTxN+, M1 NED | Clear cell RCC (including sarcomatoid) | DFS |
NEOAVAX NCT03341845 |
Axitinib + Avelumab | Neoadjuvant (12 weeks) | High-risk nonmetastatic RCC | Clear cell RCC | Partial response |
PROSPER NCT03055013 |
Nivolumab | Neoadjuvant (1 dose) Adjuvant (9 doses) |
≥T2Nx or TanyN+ or M1* | Any RCC histology | RFS |
G: Grade; DFS: disease-free survival; OS: overall survival; RFS: recurrence-free survival
M1 disease has be resected/definitively treat at the same time or within 12-week window of surgical intervention such as that patient is considered “No Evidence of Disease”