Table 2. Selected ongoing clinical trials for patients with locally advanced/metastatic urothelial carcinoma.
| Trial | Phase | Inclusion criteria | Experimental arm(s) | Comparator arm | Status |
|---|---|---|---|---|---|
| CheckMate901NCT03036098 | III | First-line LA/mUC | Arm A: nivolumab +
ipilimumab Arm C: nivolumab + gemcitabine + cisplatin |
Arm B: gemcitabine
+ cis/carboplatin Arm D: gemcitabine + cisplatin |
Recruiting |
|
NILE
NCT03682068 |
III | First-line LA/mUC | Arm 1: Durvalumab
+ gemcitabine + cis/ carboplatin Arm 2: Durvalumab + tremelimumab + gemcitabine + cis/ carboplatin |
Gemcitabine +
cis/carboplatin |
Recruiting |
| KEYNOTE-361 NCT02853305 | III | First-line LA/mUC | Arm 1: Pembrolizumab
Arm 2: Pembrolizumab + chemotherapy |
Gemcitabine +
cis/carboplatin |
Completed accrual (press
release stating co-primary endpoints not met) |
|
DANUBE
NCT02516241 |
III | First-line LA/mUC | Arm 1: Durvalumab
Arm 2: Durvalumab + tremelimumab |
Gemcitabine +
cis/carboplatin |
Completed accrual (press
release stating primary endpoints not met) |
|
PIVOT-10
NCT03785925 |
II | First-line LA/mUC, cisplatin-
ineligible |
NKTR-214 + nivolumab | None | Recruiting |
| NCT03473743 | Ib/II | Phase Ib: LA/mUC with FGFR
alteration and any number of prior lines of therapy Phase 2: LA/mUC with FGFR alteration, no prior systemic therapy, and cisplatin-ineligible |
Erdafitinib +
cetrelimab |
None | Recruiting |
| NCT02122172 | II | LA/mUC treated with prior
platinum-based chemotherapy and alteration in EGFR, HER2, ERBB3, or ERBB4 |
Afatinib | None | Recruiting |
| NCT03854474 | I/II | Arm A: LA/mUC with disease
progression following platinum-based chemotherapy Arm B: LA/mUC with positive PD-L1 expression and cisplatin- ineligible |
Tazemetostat +
pembrolizumab |
None | Undergoing interim
analysis |
|
EV-103
NCT03288545 |
II | Cohort D: 1L LA/mUC, cisplatin-
eligible Cohort E: 1L LA/mUC, platinum-eligible Cohort G: 1L LA/mUC, platinum-eligible Cohort K: 1L LA/mUC, cisplatin- ineligible |
D: EV + cisplatin
E: EV + carboplatin G: EV + pembrolizumab + cis/carboplatin K (randomized): EV + pembrolizumab |
K (randomized): EV
monotherapy |
Recruiting |
| NCT03547973 | II | Cohort 1: LA/mUC with
progression following platinum and anti-PD-(L)1 Cohort 2: LA/mUC cisplatin- ineligible and post anti-PD-(L)1 Cohort 3: LA/mUC with progression following platinum |
1 + 2: sacituzumab
govitecan 3: sacituzumab govitecan + pembrolizumab |
None | Cohort 1 awaiting final
results Cohort 2 and 3 recruiting |
1L, first-line; EV, enfortumab vedotin; LA, locally advanced; mUC, metastatic urothelial cancer.