drugset / Trial / NCT06809140
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Phase 2
Recruiting
47 enrolled
Matthew Galsky
Astellas Pharma Inc · collabIcahn School of Medicine at Mount Sinai · collabMerck Sharp & Dohme LLC · collabSeagen Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.
Timeline
- Start
- 2025-04-07
- Primary completion
- 2027-11
- Completion
- 2029-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enfortumab Vedotin | Other / unclassified | 1.25 mg/kg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |