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. Author manuscript; available in PMC: 2020 Jun 24.
Published in final edited form as: Med Res Arch. 2020 May 25;8(5):2091. doi: 10.18103/mra.v8i5.2091

Table 3:

Clinical trials evaluating neoadjuvant, perioperative, & adjuvant immunotherapies for renal cell carcinoma.

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”