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New bladder cancer drug delivered directly into bladder shows early promise

NCT ID NCT05014139

First seen Nov 20, 2025 · Last updated Jun 19, 2026 · Updated 30 times

Summary

This early-phase trial tested enfortumab vedotin, a drug placed directly into the bladder via a catheter, in 37 people with a type of bladder cancer that did not respond to standard BCG therapy. The main goals were to check safety and side effects, and to see if the drug could help control the cancer. The study was terminated early, so full results are not yet available.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erlanger Oncology and Hematology

    Chattanooga, Tennessee, 37403, United States

  • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington, 98195, United States

  • James Cancer Hospital / Ohio State University

    Columbus, Ohio, 43221, United States

  • Johns Hopkins Medical Center

    Baltimore, Maryland, 21287, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Markey Cancer Center / University of Kentucky

    Lexington, Kentucky, 40508, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Northwestern University-Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 98682, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107, United States

  • Site CA11001

    Toronto, Ontario, M5G 2C1, Canada

  • Site DE49001

    Göttingen, 37075, Germany

  • Site DE49002

    Tübingen, 72076, Germany

  • Site ES34001

    Barcelona, 08025, Spain

  • Site ES34002

    Madrid, 28041, Spain

  • Site ES34003

    Barcelona, 08036, Spain

  • Site ES34004

    Barcelona, 08035, Spain

  • Site FR33001

    Paris, 75013, France

  • Site FR33002

    Lyon, 69003, France

  • Site FR33003

    Rennes, 35000, France

  • Site UK44002

    London, EC1A 7BE, United Kingdom

  • Stanford Health Care

    Stanford, California, 94305, United States

  • UCLA Department of Medicine - Hematology & Oncology

    Los Angeles, California, 90095, United States

  • University of California at San Francisco

    San Francisco, California, 94134, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

enfortumab vedotin (PADCEV)

What this could lead to

If it works, this could offer a new treatment option for people with bladder cancer that hasn't responded to standard therapy, potentially avoiding the need for bladder removal.

What could go wrong

This is a very early (Phase 1) trial that was terminated early, so results are limited. The drug may cause side effects and may not effectively control the cancer.

Conditions

The condition(s) this trial relates to.

in situ carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma transitional cell carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.