Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07566156 | Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) | PHASE3 | RECRUITING | 390 | — | — | May 11, 2026 | Feb 29, 2032 | Jun 8, 2026 | 9 | United States |
BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment confirmed by BICR, histologically confirmed recurrent MIBC by BICR, disease progression by BICR, cystectomy, or death from any cause.
Time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Enfortumab vedotin + pembrolizumab (EV + P) |
| Arm B | ACTIVE_COMPARATOR | Concurrent Chemoradiotherapy (cCRT) |
| Name | Type | Description |
|---|---|---|
| Enfortumab vedotin | DRUG | Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9. |
| Conventional Radiotherapy | RADIATION | 64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes. |
| Hypofractionated Radiotherapy | RADIATION | 55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only. |
| Cisplatin | DRUG | 40 mg of cisplatin per meter squared of body surface area, administered once weekly via IV infusion during radiation OR 20 mg of cisplatin per meter squared of body surface area per day on Days 1 and 2 weekly via IV infusion during radiation. |
| Fluorouracil | DRUG | 500 mg per meter squared of body surface area per day on Days 1-5 (week 1) and Days 22 26 (week 3) administered as continuous IV infusion during radiation in combination with mitomycin C. |
| Mitomycin C | DRUG | 12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil. |
| Gemcitabine | DRUG | 100 mg per meter squared of body surface area administered once weekly via IV infusion during radiation OR 27 mg per meter squared of body surface area administered twice weekly via IV infusion during radiation |
| Pembrolizumab | DRUG | IV infusion on Day 1 of every 3-week cycle up to cycle 17. |
Inclusion Criteria: * Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0 * Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline * Eligible for and agree to...