Table 5.
Overview of adjuvant trials in MIBC testing immunotherapy.
| Drugs | Number of patients | Study Design | Primary endpoint | Status | Trial ID |
|---|---|---|---|---|---|
| ADJUVANT IMMUNOTHERAPY | |||||
| Pembrolizumab | 739 | Phase III Open Label |
OS, DFS | Recruiting | NCT03244384 (AMBASSADOR) |
| Atezolizumab | 809 | Phase III Open Label |
DFS | Active, non recruiting | NCT02450331 (IMvigor010) |
| Nivolumab | 700 | Phase III Open Label |
DFS | Active, non recruiting | NCT02632409 (Checkmate 274) |
| NA Durvalumab + GC and A Durvalumab vs. NA GC | 1050 | Phase III Open Label |
pCR rate, EFS | Recruiting | NCT03732677 (NIAGARA) |
| NA Pembrolizumab + GC and A Pembrolizumab vs. NA GC | 790 | Phase III Double-blind |
pCR rate, EFS | Recruiting | NCT03924856 (KEYNOTE-866) |
| NEOADJUVANT AND ADJUVANT IMMUNOTHERAPY | |||||
| NA Nivolumab/BMS-986205 + GC and A Nivolumab/BMS-986205 vs. NA Nivolumab/BMS-986205 + GC and A Nivolumab/placebo + A BMS-986205/placebo vs. NA GC | 1,200 | Phase III Partially blinded |
pCR rate, EFS | Recruiting | NCT03661320 |
ID, identification number; OS, Overall survival; DFS, Disease Free Survival; NA, Neoadjuvant; GC, gemcitabine, cisplatin; A, Adjuvant; pCR, pathologic complete response; EFS, Event-Free Survival.