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New drug combo aims to spare bladders in cancer patients

NCT ID NCT07475806

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 11 times

Summary

This phase 2 trial tests whether a combination of enfortumab vedotin and pembrolizumab can help people with muscle-invasive bladder cancer avoid bladder removal. About 240 adults who are candidates for surgery will receive the drugs intravenously. The main goals are to see how many achieve a complete response and keep their bladder for at least 2 years.

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 and pembrolizumab
What this could lead to
If successful, this could offer a way to treat muscle-invasive bladder cancer without removing the bladder, preserving quality of life.
What could go wrong
This is a mid-stage trial with no control group, so results are uncertain. The treatment may not work for everyone, and side effects like nerve damage or uncontrolled diabetes could occur.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

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

Started

Mar 2026

Expected to finish

Apr 2031

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: * Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0. NOTE: urothelial carcinomas (UCs) not originating from the bladder (e.g., upper tract \[ureters, renal pelvis\], urethra) are not eligible. UCs invading into the prostatic stroma with no histologic muscle invasion is allowed, provided that the extent of disease is confirmed via imaging. * Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50% (participants whose tumors contain predominant \[≥ 50%\] plasmacytoid variant are not eligible). Participants whose tumors contain any neuroendocrine histology are not eligible. * Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection. * Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention. If no archival tumor tissue is available, the participant will have a biopsy to obtain tumor tissue prior to study intervention. * Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Have a transurethral resection of a bladder tumor within 60 days (+14 days) prior to, or during screening (from the date of informed consent form signature). Exclusion Criteria: * Participant has preexisting sensory or motor neuropathy Grade ≥ 2. * Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging * Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7% and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility. * Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed. * Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated. * Participant has a history of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. * Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. * Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency. * Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Brief (\< 7 days) use of systemic corticosteroids is allowed when use is considered standard of care. * Participant with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded. * Participant requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded. * Participant with hypothyroidism that is stable with hormone replacement therapy or Sjögren's syndrome will not be excluded. * Participant has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). * Participant has received prior systemic anti-cancer therapy for MIBC/non-muscle invasive bladder cancer (NMIBC), or received prior systemic anti-cancer therapy including investigational agents (including enfortumab vedotin or other monomethyl auristatin E-based antibody-drug conjugates) within 3 years prior to screening. NOTE: Prior treatment for NMIBC with intravesical instillation therapy such as Bacillus Calmette-Guérin or intravesical chemotherapy is permitted. Prior systemic treatment (including, but not limited to, anti-PD-1/PD-L1 treatment with pembrolizumab, etc.) received for NMIBC is not permitted. * Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC. * Participant has received any prior radiotherapy to the bladder.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma

As listed by the trial registrant

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

Muscle invasive bladder cancer

How to take part

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

  1. The places running it

    33 sites in 6 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

  • Accellacare of Duly

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Arkansas Urology Associates

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Centers for Advanced Urology, LLP

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Gifu University Hospital

    RECRUITING

    Gifu, Gifu, Japan

  • Institute of Science Tokyo Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, Japan

  • KR82008

    RECRUITING

    Seoul, South Korea

  • Kobe City Hospital Organization - Kobe City Medical Center General Hospital

    RECRUITING

    Kobe, Hyōgo, Japan

  • Kyoto University Hospital

    RECRUITING

    Kyoto, Japan

  • NYU Langone Urology Associates

    RECRUITING

    New York, New York, 10017, United States

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, Japan

  • Profound Research LLC at Michigan Hematology and Oncology Consultants

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Sidney Kimmel Comprehensive Cancer - Asplundh Cancer Pavilion

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Sidney Kimmel Comprehensive Cancer Center (SKCC) Washington Township

    RECRUITING

    Washington Township, New Jersey, 08080, United States

  • Sidney Kimmel Comprehensive Cancer Center (SKCCC) Cherry Hill

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Site DE49009

    RECRUITING

    Herne, Germany

  • Site ES34002

    RECRUITING

    Ourense, Spain

  • Site ES34011

    RECRUITING

    Granada, Spain

  • Site GB44005

    RECRUITING

    London, United Kingdom

  • Site KR82001

    RECRUITING

    Seoul, South Korea

  • Site KR82002

    RECRUITING

    Seongnam-si, Gyeonggi-do, South Korea

  • Site KR82003

    RECRUITING

    Seoul, South Korea

  • Site KR82004

    RECRUITING

    Hwasun, Jeollanam-do, South Korea

  • Site KR82005

    RECRUITING

    Seoul, South Korea

  • Site KR82007

    RECRUITING

    Gyeonggi-do, South Korea

  • St. Marianna University Hospital

    RECRUITING

    Kawasaki, Kanagawa, Japan

  • The Cancer Institute Hospital-Japanese Foundation for Cancer

    RECRUITING

    Koto-ku, Tokyo, Japan

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tokyo Metropolitan Hospital Organization-Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, Japan

  • University of Illinois College of Medicine - UIC Cancer Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Tsukuba Hospital

    RECRUITING

    Tsukuba, Ibaraki, Japan

  • Urology San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Yamaguchi University Hospital - Center For Clinical Research

    RECRUITING

    Ube, Yamaguchi, Japan

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