Table 1.
Trial | Drug | Study Design | Line | Overall pts n, UTUC pts n. (%) | Outcomes (Primary Endpoint) |
---|---|---|---|---|---|
IMvigor 010 [61] | Atezolizumab | Phase 3 RCT | Adjuvant | 809; 54 (6.7%) | Median disease-free survival, 19.4 months (95% CI 15.9–24.8) |
Checkmate 274 [62] | Nivolumab | Phase 3 RCT | Adjuvant | 709; 149 (21%) | Median disease-free survival 20.8 months (95% confidence interval [CI], 16.5 to 27.6) |
NCT02690558 [63] | Cisplatin, gemcitabine, pembrolizumab | Phase 2 | Neoadjuvant | 39; na | pCR:36% |
POUT [43] | Cisplatin or carboplatin + gemcitabine | Phase 3 RCT | Adjuvant | 261 | Disease-free survival (hazard ratio 0.45, 95% CI 0.30–0.68; p = 0.0001) |
Abbreviations: RCT: randomized controlled trial, pts: patients; na: non available; pCR: pathologic complete response.