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New bladder cancer drug delivered directly into bladder shows early promise

NCT ID NCT05014139

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 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.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

37 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease) * Predominant histologic component (\>50 percent) must be urothelial (transitional cell) carcinoma * Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as (where adequate BCG therapy is defined as one of the following: 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course): * Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. * Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy, or * T1 high-grade disease at the first evaluation following an induction BCG course (at least 5 or 6 doses) * Participant must be ineligible for or refusing a radical cystectomy * All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment. * Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2. Exclusion Criteria: * Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease. * Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months prior to study treatment * Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed within 3 months prior to study treatment * Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months prior to study treatment * Participants with tumor-related hydronephrosis * Participant has received other systemic anticancer therapy including chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational agent within 4 weeks or intravesical therapy within 6 weeks of first dose of study treatment * Participant has had any prior radiation to the bladder for urothelial cancer

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.