Table 3.
Ongoing phase III clinical trials of immunotherapy for MIBC
| Trial | Immunotherapy and control arms | Agent description | Primary outcome(s) for assessment |
| Neoadjuvant/adjuvant, cisplatin-eligible | |||
| KEYNOTE-866 (NCT03924856) | Pembrolizumab+gemcitabine+cisplatin | ICI, chemotherapy | pCR rate, EFS |
| Placebo+gemcitabine+cisplatin | Chemotherapy | ||
| KEYNOTE-B15/EV-304 (NCT04700124) | Pembrolizumab+EV | ICI, ADC | pCR rate, EFS |
| Gemcitabine+cisplatin | Chemotherapy | ||
| NIAGARA (NCT03732677) | Cisplatin+gemcitabine+durvalumab | ICI, chemotherapy | pCR rate at time of surgery, EFS |
| Cisplatin+gemcitabine | Chemotherapy | ||
| ENERGIZE CA017078 (NCT03661320) | Gemcitabine+cisplatin | Chemotherapy | pCR rate, EFS |
| Placebo+nivolumab+cisplatin+gemcitabine | ICI, chemotherapy | ||
| Linrodostat+nivolumab+cisplatin+gemcitabine | IDO1 inhibitor, ICI, chemotherapy | ||
| Neoadjuvant/adjuvant, cisplatin-ineligible | |||
| KEYNOTE-905 (NCT03924895) | Pembrolizumab | ICI | pCR rate, EFS |
| Surgery alone | None | ||
| Pembrolizumab+EV | ICI, ADC | ||
| PIVOT IO 009 (NCT04209114) | Nivolumab+bempegaldesleukin | ICI, CD122-biased agonist | pCR rate, EFS |
| Nivolumab | ICI | ||
| Surgery alone | None | ||
| Adjuvant | |||
| IMvigor010 (NCT02450331) | Atezolizumab | ICI | DFS |
| Observation | None | ||
| CheckMate 274 (NCT02632409) | Nivolumab | ICI | DFS |
| Placebo | None | ||
| AMBASSADOR (NCT03244384) | Pembrolizumab | ICI | OS, DFS |
| Observation | None | ||
ADC, antibody-drug conjugate; DFS, disease-free survival; EFS, event-free survival; EV, enfortumab vedotin; ICI, immune checkpoint inhibitor; MIBC, muscle-invasive bladder cancer; OS, overall survival; pCR, pathologic complete response.