Table 3. Selected trials in muscle-invasive bladder cancer with available results.
| Trial | Phase | Inclusion criteria | Experimental
arm(s) |
Patients
treated |
Patients
undergoing RC |
pCR,
percentage |
<pT2,
percentage |
Median
follow-up, months |
One-year
RFS, percentage |
Status |
|---|---|---|---|---|---|---|---|---|---|---|
|
PURE-01
NCT02736266 |
II | cT2-3bN0M0 MIBC,
plan for RC, any cisplatin eligibility |
Neoadjuvant
pembrolizumab |
50 | 50 | 42 | 54 | Results
published |
||
|
ABACUS
NCT02662309 |
II | cT2-4aN0M0 MIBC,
plan for RC, cisplatin- ineligible or refuses |
Neoadjuvant
atezolizumab |
95 | 88 | 31 | 13.1 | 79% | Results
published |
|
|
BLASST-1
NCT03294304 |
II | cT2-4aN0-1M0 MIBC,
plan for RC, cisplatin- eligible |
Neoadjuvant
nivolumab + gem/cis |
41 | 41 | 49 | 66 | Results
presented |
||
|
HCRN GU14-188
NCT02365766 |
Ib/II | Cohort 1: cT2-4aN0M0
MIBC, plan for RC, cisplatin-eligible Cohort 2: cT2-4aN0M0 MIBC, plan for RC, cisplatin-ineligible |
Cohort 1:
neoadjuvant pembrolizumab + gem/cis Cohort 2: neoadjuvant pembrolizumab + gemcitabine |
40 | 36 | 44.4 | 60 | 14 | 80% | Cohort 1:
results presented Cohort 2: completed accrual |
cTNM, clinical tumor node metastasis stage; gem/cis, gemcitabine + cisplatin; MIBC, muscle-invasive bladder cancer; pCR, pathologic complete response; <pT2, downstaging to non-muscle-invasive disease; RC, radical cystectomy; RFS, relapse-free survival.