Table 4

Phase II clinical trials of immunotherapy for MIBC

TrialInterventionsAgent descriptionRate of downstaging at time of surgeryRate of ypT0 at time of surgery
ABACUS (NCT02662309)41AtezolizumabICINR31%
PURE-01 (NCT02736266)151PembrolizumabICI54% (to non-invasive disease)42%
NABUCCO (NCT03387761)152Nivolumab+ipilimumabICI58% (to non-invasive disease)45%
NCT02812420153Durvalumab+tremelimumabICI58% (to ypT1 or less)38%
BLASST-1 (NCT03294304)90Nivolumab+gemcitabine+cisplatinICI+chemotherapy66%34%
HCRN GU14-188 (NCT02365766)154 155Pembrolizumab+gemcitabine+cisplatin (eligible cohort) Pembrolizumab+gemcitabine (cisplatin-ineligible cohort)ICI+chemotherapyCisplatin-eligible cohort I: 53% (to ypT0/Tis)
Cisplatin-ineligible cohort II: 52% (to ypT0/Tis)
Cisplatin-eligible cohort I: 44%
Cisplatin-ineligible cohort II: 45%
DUTRENEO (NCT03472274)91Durvalumab+tremelimumabICINR35%
  • ICI, immune checkpoint inhibitor; MIBC, muscle-invasive bladder cancer; NR, not reported.