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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 47
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Matthew GalskyUpdated: Feb 23, 2026Locations: 5
Eligibility criteria

Written informed consent and HIPAA authorization for release of personal health... [+15]

Pre-existing sensory or motor neuropathy Grade ≥ 2 [+19]