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NCT06809140 · ClinicalTrials.gov record · last posted 2026-08-05

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

StatusRecruiting
PhasePhase 2
Started2025-04-07
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-06
critical
Primary endpoint(s) modified
WasComplete response rate with enfortumab vedotin plus pembrolizumab for MIBC
NowBladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response, Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC
2026-08-06
notable
Enrollment increased: 47 → 75 participants
Trial Details
NCT Number NCT06809140
Lead Sponsor Matthew Galsky
Collaborators: Seagen Inc., Astellas Pharma Inc, Merck Sharp & Dohme LLC, Icahn School of Medicine at Mount Sinai
Conditions Muscle Invasive Bladder Urothelial Carcinoma
Enrollment 75 participants
Start Date 2025-04-07
Primary Completion 2027-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-05