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Study identifier: NCT06809140 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Muscle Invasive Bladder Urothelial Carcinoma  ·  Sponsor: Matthew Galsky

PhasePhase 2
Planned participants47
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Matthew Galsky, MD  ·  212-659-5452  ·  matthew.galsky@mssm.edu

Ahran Lee  ·  317-634-5842  ·  alee@hoosiercancer.org

Always discuss trial participation with your own doctor first.

Locations (5)

City of HopeDuarte, California, United StatesRecruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana, United StatesRecruiting
Icahn School of Medicine at Mount SinaiNew York, New York, United StatesRecruiting
Columbia University Irving Medical CenterNew York, New York, United StatesRecruiting
Fox Chase Cancer CenterPhiladelphia, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06809140