Table 7.
Immunotherapies in development for the treatment of bladder cancer
| Trial | Disease state | Interventions | Agent description | Primary outcome(s) for assessment |
| S1602 (NCT03091660) | NMIBC (first-line) | TICE-BCG (I/M) | BCG strain | Time to high-grade recurrence |
| Tokyo-172 BCG (I/M) | BCG strain | |||
| Tokyo-172 BCG (I/M) with priming | BCG strain | |||
| ALBAN (NCT03799835) | NMIBC (first-line) | BCG (I/M) | BCG | RFS |
| Atezolizumab+BCG (I/M) | ICI, BCG | |||
| POTOMAC (NCT03528694) | NMIBC (high-risk, first-line) | BCG (I/M) | BCG | DFS |
| Durvalumab+BCG (I/M) | ICI, BCG | |||
| Durvalumab+BCG (I) | ICI, BCG | |||
| B8011006 (NCT04165317) | NMIBC (high-risk, first-line) | BCG (I/M) | BCG | EFS |
| PF-06801591+BCG (I/M) | ICI, BCG | |||
| PF-06801591+BCG (I) | ICI, BCG | |||
| CheckMate 7G8 (NCT04149574) | NMIBC (high-risk, R/R to BCG) | BCG (I/M)+nivolumab | ICI, BCG | EFS |
| BCG (I/M)+placebo | BCG | |||
| CheckMate 9UT (NCT03519256) |
NMIBC (high-risk, R/R to BCG) | Nivolumab | ICI | CR rate, duration of CR |
| Nivolumab+BCG | ICI, BCG | |||
| Nivolumab+BMS-986205 | ICI, IDO1 inhibitor | |||
| Nivolumab+BMS-986205+BCG | ICI, IDO1 inhibitor, BCG | |||
| QUILT-3.032 (NCT03022825) | NMIBC (high-risk, R/R to BCG) | BCG+ALT-803 | BCG, IL-15 superagonist | CR rate, disease-free rate |
| ALT-803 | IL-15 superagonist | |||
| MK-3475–676/KEYNOTE-676 (NCT03711032) | NMIBC (high-risk, R/R to BCG) | BCG (I/M)+pembrolizumab | ICI, BCG | CR rate |
| BCG (I/M) | BCG | |||
| S1605 (NCT02844816) | NMIBC (BCG-unresponsive) | Atezolizumab | ICI | CR rate, EFS |
| NCT03661320 | MIBC (NA, A) | Gemcitabine/cisplatin (NA) | Chemotherapy | CR rate, EFS |
| Gemcitabine/cisplatin (NA)+nivolumab (NA, A)+placebo (NA, A) | ICI, chemotherapy | |||
| Gemcitabine/cisplatin (NA)+nivolumab (NA, A)+BMS-986205 (NA, A) | ICI, IDO1 inhibitor, chemotherapy | |||
| NIAGARA (NCT03732677) | MIBC (NA, A) | Gemcitabine/cisplatin (NA)+durvalumab (NA, A) | ICI, chemotherapy |
CR rate, EFS |
| Gemcitabine/cisplatin (NA) | Chemotherapy | |||
| MK-3475–905/KEYNOTE-905 (NCT03924895) | MIBC (NA, A) | Pembrolizumab (NA, A) | ICI | CR rate, EFS |
| Surgery alone | None | |||
| MK-3475–866/KEYNOTE-866 (NCT03924856) | MIBC (NA, A) | Pembrolizumab (NA, A)+gemcitabine/cisplatin (NA) | ICI, chemotherapy | CR rate, EFS |
| Gemcitabine/cisplatin (NA)+placebo (NA, A) | Chemotherapy | |||
| PIVOT IO 009 (NCT04209114) | MIBC (NA, A) | Nivolumab (NA, A)+NKTR-214 (NA, A) | ICI, CD122-biased agonist | CR rate, EFS |
| Nivolumab (NA, A) | ICI | |||
| Surgery alone | None | |||
| INTACT SWOG/NRG 1806 NCT03775265 |
MIBC (bladder preservation) | Radiotherapy+chemotherapy | Chemotherapy | Bladder-intact EFS |
| Radiotherapy+chemotherapy+atezolizumab | ICI, chemotherapy | |||
| MK-3475–992/KEYNOTE-992 (NCT04241185) | MIBC (bladder preservation) | Pembrolizumab+chemotherapy+radiotherapy | ICI, chemotherapy | Bladder-intact EFS |
| Placebo+chemotherapy+radiotherapy | Chemotherapy | |||
| AMBASSADOR (NCT03244384) | MIBC (A) | Pembrolizumab | ICI | OS, DFS |
| Observation | None | |||
| CheckMate 274 (NCT02632409) |
MIBC (A) | Nivolumab | ICI | DFS |
| Placebo | None | |||
| NILE (NCT03682068) | Metastatic (first-line) | Durvalumab+platinum/gemcitabine | ICI, chemotherapy | OS |
| Durvalumab+tremelimumab+platinum/gemcitabine | ICI, chemotherapy | |||
| Platinum/gemcitabine | Chemotherapy | |||
| Checkmate 901 (NCT03036098) | Metastatic (first-line) | Ipilimumab+nivolumab | ICI | OS, PFS |
| Ipilimumab+nivolumab+chemotherapy | ICI, chemotherapy | |||
| Chemotherapy | Chemotherapy | |||
| EV 302 (NCT04223856) |
Metastatic (first-line) | EV+pembrolizumab | ICI, ADC | PFS, OS |
| Gemcitabine+platinum | Chemotherapy | |||
| EV+pembrolizumab+platinum | ICI, ADC, chemotherapy | |||
| LEAP-011 (NCT03898180) |
Metastatic (first-line) | Pembrolizumab+lenvatinib | ICI, tyrosine kinase inhibitor |
PFS, OS |
| Pembrolizumab+placebo | ICI | |||
| THOR (NCT03390504) |
Metastatic (second- or third-line) | Erdafitinib | FGFR kinase inhibitor | OS |
| Pembrolizumab | ICI |
A, adjuvant; ADC, antibody-drug conjugate; AE, adverse event; BCG, Bacillus Calmette-Guérin; CR, complete response; DFS, disease-free survival; EFS, event-free survival; FGFR, fibroblast growth factor receptor; I, induction; ICI, immune checkpoint inhibitor; IL-15, interleukin-15; I/M, induction and maintenance; M, maintenance; MIBC, muscle-invasive bladder cancer; NA, neoadjuvant; NMIBC, non-muscle-invasive bladder cancer; OS, overall survival; PFS, progression-free survival; RFS, recurrence-free survival; R/R, relapsed/refractory.