Table 3

Ongoing phase III clinical trials of immunotherapy for MIBC

TrialImmunotherapy and control armsAgent descriptionPrimary outcome(s) for assessment
Neoadjuvant/adjuvant, cisplatin-eligible
KEYNOTE-866 (NCT03924856)Pembrolizumab+gemcitabine+cisplatinICI, chemotherapypCR rate, EFS
Placebo+gemcitabine+cisplatinChemotherapy
KEYNOTE-B15/EV-304 (NCT04700124)Pembrolizumab+EVICI, ADCpCR rate, EFS
Gemcitabine+cisplatinChemotherapy
NIAGARA (NCT03732677)Cisplatin+gemcitabine+durvalumabICI, chemotherapypCR rate at time of surgery, EFS
Cisplatin+gemcitabineChemotherapy
ENERGIZE CA017078 (NCT03661320)Gemcitabine+cisplatinChemotherapypCR rate, EFS
Placebo+nivolumab+cisplatin+gemcitabineICI, chemotherapy
Linrodostat+nivolumab+cisplatin+gemcitabineIDO1 inhibitor, ICI, chemotherapy
Neoadjuvant/adjuvant, cisplatin-ineligible
KEYNOTE-905 (NCT03924895)PembrolizumabICIpCR rate, EFS
Surgery aloneNone
Pembrolizumab+EVICI, ADC
PIVOT IO 009 (NCT04209114)Nivolumab+bempegaldesleukinICI, CD122-biased agonistpCR rate, EFS
NivolumabICI
Surgery aloneNone
Adjuvant
IMvigor010 (NCT02450331)AtezolizumabICIDFS
ObservationNone
CheckMate 274 (NCT02632409)NivolumabICIDFS
PlaceboNone
AMBASSADOR (NCT03244384)PembrolizumabICIOS, DFS
ObservationNone
  • 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.