RecruitingPhase IIEN originalBladder cancer

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Diagnoza raka pęcherza moczowego w zaawansowanym stadium (T2-T3), bez przerzutów do węzłów chłonnych
  • •Przebyta operacja usunięcia guza z pęcherza (TURBT) w ostatnich 90 dniach
  • •Dostępne próbki tkanki tumorowej do badań
  • •Stan ogólny pacjenta pozwalający na przeprowadzenie zabiegu chirurgicznego usunięcia pęcherza
  • •Prawidłowe wyniki badań laboratoryjnych funkcji narządów

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 5, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (5)

City of Hope

Duarte, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, United States

Icahn School of Medicine at Mount Sinai

New York, United States

Columbia University Irving Medical Center

New York, United States

Fox Chase Cancer Center

Philadelphia, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/29/2026.

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