NCT06809140

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Invasive Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Enfortumab vedotin	1.25 mg/kg (maximum dose 125 mg)
DRUG	Pembrolizumab	200 mg

Timeline

• Start date: 2025-04-07
• Primary completion: 2027-11-01
• Completion: 2029-11-01
• First posted: 2025-02-05
• Last updated: 2026-02-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study