New bladder cancer drug delivered directly into bladder shows early promise

NCT ID NCT05014139

Terminated Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

CARCINOMA IN SITU CARCINOMA, TRANSITIONAL CELL NMIBC NON-MUSCLE INVASIVE BLADDER CANCER URINARY BLADDER NEOPLASMS

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

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