Table 4. Selected ongoing clinical trials for patients with muscle-invasive bladder cancer.
| Trial | Phase | Inclusion criteria | Experimental arm(s) | Comparator arm | Status |
|---|---|---|---|---|---|
| KEYNOTE-905
NCT03924895 |
III | Cisplatin-ineligible MIBC, fit
for RC |
Perioperative pembrolizumab + RC
+ PLND |
RC + PLND | Recruiting |
| AMBASSADOR
NCT03244384 |
III | Muscle invasive or locally
advanced urothelial carcinoma post-surgery, ineligible for or declines cisplatin |
Adjuvant pembrolizumab | Observation | Recruiting |
| CheckMate 274
NCT02632409 |
III | Invasive urothelial cancer
post-surgery at high risk of recurrence |
Adjuvant nivolumab | Placebo | Completed
accrual |
| IMvigor010
NCT02450331 |
III | Invasive urothelial cancer
post-surgery at high risk of recurrence |
Adjuvant atezolizumab | Observation | Awaiting final
results (press release stating DFS endpoint not met 26) |
| NCT02845323 | II | Cisplatin-ineligible/refusing
MIBC, fit for RC |
Neoadjuvant nivolumab +
urelumab |
Neoadjuvant
nivolumab |
Recruiting |
| EV-103
NCT03288545 |
I/II | Cisplatin-ineligible MIBC, fit
for RC |
Cohort H: Neoadjuvant EV
Cohort J: Neoadjuvant EV + pembrolizumab |
Recruiting | |
| ENERGIZE | III | Cisplatin-eligible MIBC, fit for
RC |
Arm B: Neoadjuvant nivolumab
+ chemo + placebo followed by adjuvant nivolumab + placebo Arm C: Neoadjuvant nivolumab + chemo + BMS-986205 (IDO inhibitor) followed by adjuvant nivolumab + BMS-986205 |
Arm A:
Gemcitabine + cisplatin followed by RC |
Recruiting |
| NCT02690558 | II | Cisplatin-eligible MIBC, fit for
RC |
Neoadjuvant pembrolizumab +
gemcitabine + cisplatin |
Completed
accrual |
|
| NEMIO
NCT03549715 |
I/II | Cisplatin-eligible MIBC, fit for
RC |
Arm A: Neoadjuvant durvalumab
+ ddMVAC Arm B: Neoadjuvant durvalumab + tremelimumab + ddMVAC |
Recruiting | |
| NIAGARA
NCT03732677 |
III | Cisplatin-eligible MIBC, fit for
RC |
Neoadjuvant durvalumab +
gemcitabine + cisplatin followed by adjuvant durvalumab |
Neoadjuvant
gemcitabine + cisplatin |
Recruiting |
| NCT04228042 | I/II | Low-grade UTUC or high-
grade UTUC and cisplatin- ineligible |
Neoadjuvant infigratinib | Recruiting | |
| NCT02621151 | II | Localized MIBC, not a
candidate for or declines RC |
Tri-modality therapy with maximal
TURBT and gemcitabine + pembrolizumab concurrent with EBRT |
Recruiting | |
| SWOG 1806
NCT03775265 |
III | Localized MIBC | Concurrent chemotherapy +
atezolizumab + radiation |
Concurrent
chemotherapy + radiation |
Recruiting |
| KEYNOTE-992
NCT04241185 |
III | Localized MIBC, opting for
bladder preservation |
Pembrolizumab + CRT | Placebo + CRT | Recruiting |
| PROOF 302
NCT04197986 |
III | Invasive urothelial carcinoma
with FGFR3 alteration at high risk for recurrence following RC or nephrectomy |
Adjuvant infigratinib | Placebo | Recruiting |
CRT, chemoradiation; ddMVAC, dose-dense methotrexate, vinblastine, doxorubicin, cisplatin; DFS, disease-free survival; EBRT, external beam radiation therapy; EV, enfortumab vedotin; MIBC, muscle-invasive bladder cancer; PLND, pelvic lymph node dissection; RC, radical cystectomy; TURBT, transurethral resection of bladder tumor; UTUC, upper tract urothelial carcinoma.