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New drug combo may help bladder cancer patients keep their bladder

NCT ID NCT07566156

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 4 times

Summary

This study tests whether two drugs, enfortumab vedotin and pembrolizumab, can control muscle-invasive bladder cancer without needing to remove the bladder. About 390 adults whose cancer hasn't spread outside the bladder will receive either the drug combo or standard chemoradiation. The goal is to see if the combo helps patients live longer and keeps the bladder cancer-free.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Feb 2032

An estimate. End dates often move.

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: * Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0 * Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline * Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens * Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Exclusion Criteria: * Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta/T1/CIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy * Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC * Prior pelvic radiation for any reason * Inadequate bladder function * Other active malignancies within 3 years prior to randomization * Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs) * Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor * Uncontrolled diabetes * Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted * Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection * Received major surgery (defined as requiring general anesthesia and \>24 hour inpatient hospitalization) within 4 weeks prior to randomization * Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin * Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome) * Active keratitis or corneal ulcerations * History of autoimmune disease that has required systemic treatment in the past 2 years * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Prior allogeneic stem cell or solid organ transplant * Received a live attenuated vaccine within 30 days prior to randomization

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm Female Urogenital Diseases infiltrating bladder urothelial carcinoma Male Urogenital Diseases neoplasm Neoplasms by Site transitional cell carcinoma urinary bladder disorder urinary bladder neoplasm Urinary Bladder Neoplasms urinary system disorder Urogenital Diseases Urogenital Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Urinary bladder neoplasms Urothelial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Compass Oncology - West

    RECRUITING

    Tigard, Oregon, 97223, United States

  • Fort Wayne Medical Oncology and Hematology

    RECRUITING

    Fort Wayne, Indiana, 46825, United States

  • Illinois Cancer Specialists

    RECRUITING

    Niles, Illinois, 60714, United States

  • Medical Oncology Hematology Consultants

    RECRUITING

    Newark, Delaware, 19713, United States

  • Missouri Cancer Associates

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Oncology Hematology Care Clinical Trials, LLC

    RECRUITING

    Fairfield, Ohio, 45014, United States

  • Rocky Mountain Cancer Center

    RECRUITING

    Aurora, Colorado, 80012, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsun Clinic - Ridley-Tree Cancer Center

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Site CA01071

    RECRUITING

    Montreal, Quebec, Canada

  • Texas Oncology

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology - Northeast Texas

    RECRUITING

    Tyler, Texas, 75702, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Williamette Valley Cancer Institute and Research Center

    RECRUITING

    Eugene, Oregon, 97401, United States

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