Table 3.
Main clinical trials of neoadjuvant immunotherapy for MIBC.
| Trial (ref.) | Phase | N of patients | Regimen | Cycles of NAC | pCR (pT0N0) rates, % | Downstaging (<pT2), % |
| PURE-01 (57, 58) | II | 114 | Pembrolizumab | 3 | 39 | 56 |
| ABACUS (59) | II | 95 | Atezolizumab | 2 | 31 | 39 |
| NABUCCO (60) | I | 24 | Ipilimumab/nivolumab | 2 | 46 | 58 |
| DUTRENEO (61) | II | 61 | Durvalumab/tremelimumab | 3 | 35 | 57 |
| BLASST-1 (62) | II | 41 | Nivolumab + GC | 4 | 49 | 66 |
| HCRN GU14-188 (63, 64) | Ib/II | 12/70 | Pem + GC (cohort 1) Pem + Gem (cohort 2) |
4 | 44 54 |
61 52 |
Neoadjuvant chemotherapy (NAC), number (N), muscle-invasive bladder cancer (MIBC), gemcitabine-cisplatin (GC), pathologic complete response (pCR), pembrolizumab (Pem), gemcitabine (Gem).