drugset / Trial / NCT07566156
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.
Timeline
- Start
- 2026-05-11
- Primary completion
- 2030-03-31
- Completion
- 2032-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Enfortumab Vedotin | Other / unclassified | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | 27 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Mitomycin C | Other / unclassified | 12 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |