Table 1.
Completed prospective single-arm studies of immunotherapy in nccRCC.
| Trial | Therapy | Sample Size, by Subtype | Prior Systemic Therapy Allowed? | Outcomes |
|---|---|---|---|---|
| CheckMate-374 Phase III/IV |
Nivolumab | Total n = 44 Papillary, n = 24 Chromophobe, n = 7 Unclassified, n = 8 Other, n = 5 |
Yes | ORR 13.6% Papillary, 2 responses Chromophobe, 2 responses Collecting Duct, 1 response Unclassified, 1 response Median PFS 2.2 months Median OS 16.3 months |
| KEYNOTE-427 Cohort B Phase II |
Pembrolizumab | Total n = 165 Papillary, n = 118 Chromophobe, n = 21 Unclassified, n = 26 |
No | ORR 26.7% Papillary—28.8% Chromophobe—9.5% Unclassified—30.8% |
|
NCT02724878 Phase II |
Bevacizumab + Atezolizumab |
Total n = 60 Clear cell w/sarcomatoid, n = 18 Papillary, n = 12 Chromophobe, n = 10 Unclassified, n = 9 TFE3 Translocation, n = 5 Collecting duct, n = 5 Medullary, n = 1 |
Yes | ORR 33% Clear cell w/sarcomatoid—55% Papillary—25% Chromophobe—10% Unclassified—33% TFE3 Translocation—20% Collecting duct—40% Medullary—100% |
| CALYPSO Phase I/II |
Durvalumab + Savolitinib |
Total n = 41 * Papillary, n = 40 * 1 patient did not receive treatment |
Yes | ORR 27% Median PFS 4.9 months Median OS 12.3 months * non-treated patient excluded from analysis |
| COSMIC-021 Phase Ib/II |
Cabozantinib + Atezolizumab |
Total n = 30 Papillary, n = 15 Chromophobe, n = 7 Other, n = 8 |
Yes | ORR 33% Papillary—40% Chromophobe—14% Other—60% |
ORR: Objective response rate; PFS: progression-free survival; OS: overall survival. (*) 1 patient did not receive treatment.