drugset / Trial / NCT05879653
Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)
Phase 2
Recruiting
30 enrolled
Kyoto University Hospital
Astellas Pharma Inc · collabKobe City Medical Center General Hospital · collabMerck Sharp & Dohme LLC · collabOsaka Metropolitan University · collabUniversity of Tsukuba · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy.
Timeline
- Start
- 2023-10-01
- Primary completion
- 2025-09-30
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enfortumab Vedotin | Other / unclassified | 1.25 mg/kg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | — |