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Experimental bladder cancer drug shows promise but trial halted early

NCT ID NCT03288545

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested an experimental drug called enfortumab vedotin, alone or with other cancer drugs, in people with advanced bladder or urinary tract cancer. The goal was to see if the drug could shrink tumors and control the disease. The trial included 348 participants but was terminated early, so the full results are not yet known.

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 (a drug that targets cancer cells) alone or with pembrolizumab, cisplatin, carboplatin, or gemcitabine
What this could lead to
If successful, this could provide a new treatment option for people with advanced bladder or urinary tract cancer, potentially shrinking tumors and controlling the disease.
What could go wrong
The trial was terminated early, so results may be incomplete. It was also in early phases (1 and 2), meaning it is not yet proven to work or be safe for widespread use.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

348 people

The number who actually took part.

Started

Oct 2017

Finished

Feb 2026

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: * Locally advanced or metastatic urothelial cancer (la/mUC) - Cohorts A, B, D, E, F, G and K. * Histologically documented la/mUC, including squamous differentiation or mixed cell types. * An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2: Participants with ECOG performance status of 2 must meet the following additional criteria: hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure. * Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, G and K Combination Arm). * Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment. * Cohort A: Ineligible for cisplatin-based chemotherapy and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months. * Cohort B: Must have disease progression during/following treatment with at least 1 platinum-containing regimen for la/mUC or disease recurrence. * Cohort D: Eligible for cisplatin-based chemotherapy and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months. * Cohort E: Ineligible for cisplatin-based chemotherapy, eligible for carboplatin, and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months. * Cohort F: Ineligible for platinum-based chemotherapy, or disease progression during/following at least 1 prior treatment for la/mUC. Eligible for gemcitabine. * Cohort G: Eligible for platinum-based chemotherapy (either cisplatin or carboplatin) and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months. * Cohort K: Ineligible for cisplatin-based chemotherapy due to at least 1 of the following: Glomerular filtration rate (GFR) \<60 mL/min and ≥30 mL/min, ECOG performance status of 2, NCI CTCAE Version 4.03 Grade ≥2 hearing loss, New York Heart Association (NYHA) Class III heart failure. No prior systemic treatment for locally advanced or metastatic disease. No adjuvant/neoadjuvant platinum-based therapy within 12 months prior to randomization. * Muscle Invasive Bladder Cancer (MIBC)- Cohorts H, J and L. * Histologically confirmed MIBC with predominant \>50% urothelial histology: Cohorts H and J: Clinical stage cT2-T4aN0M0; Cohort L: Clinical stage cT2-T4aN0M0 or cT1-T4aN1M0: Participants with pT1 disease are eligible only if they have N1 disease on imaging. Mixed cell types are eligible if urothelial cancer is predominant (\>50%); Participants with plasmacytoid and/or neuroendocrine tumors are ineligible regardless of component percentage. Urothelial tumors not originating in the bladder (eg, upper tract tumors, urethral tumors) are ineligible. * Must be cisplatin-ineligible. * Cohort-specific eligibility: Cohort J, H, and L: No prior systemic treatment, chemoradiation, or radiation therapy for MIBC. May have received prior intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy for non-MIBC; Cohort J: Eligible for pembrolizumab. * ECOG performance status of 0, 1, or 2. * Anticipated life expectancy of ≥3 months. * Tumor samples with an associated pathology report from the diagnostic transurethral resection of a bladder tumor done 90 days prior to the first dose of study treatment must be available prior to enrollment and determined to be sufficient for pathology review and biomarker analysis. * Participants must be deemed eligible for RC+PLND. Exclusion Criteria: * la/mUC - Cohorts A, B, D, E, F, G, and K * Received any prior treatment with a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2 inhibitor, except Cohort F. * Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, OX-40 agonists, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (except Cohort F). * Ongoing sensory or motor neuropathy Grade 2 or higher. * Active central nervous system (CNS) metastases. * Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery). * Conditions requiring high doses of steroids or other immunosuppressive medications. * Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs). * Uncontrolled diabetes mellitus. * MIBC - Cohorts H, J, and L * Received prior systemic treatment, chemoradiation, and/or radiation therapy of muscle invasive bladder cancer. * Received any prior treatment with a CPI. * Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists. * For participants in Cohort H, evidence of nodal disease on imaging. For participants in Cohort L, ≥N2 nodal disease on imaging. * Participant has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC. * Ongoing sensory or motor neuropathy Grade 2 or higher. * Conditions requiring high doses of steroids or other immunosuppressive medications. * Prior treatment with enfortumab vedotin or other MMAE-based ADCs for urothelial cancer. * Participants with a history of another invasive malignancy within 3 years before first dose of study drug.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm infiltrating bladder urothelial carcinoma renal pelvis neoplasm transitional cell carcinoma ureter cancer ureter neoplasm urethra neoplasm Urethral Neoplasms urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms urinary system neoplasm urothelial carcinoma

As listed by the trial registrant

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

Carcinoma transitional cell Renal pelvis neoplasms Ureteral neoplasms Urethral neoplasms Urinary bladder neoplasms Urologic neoplasms Urothelial cancer

Contacts and locations

Locations

  • Alaska Urological Institute

    Anchorage, Alaska, 99503, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85710, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Boca Raton Regional Hospital / Lynn Cancer Institute

    Boca Raton, Florida, 33486, United States

  • CMOH Broomall

    Broomall, Pennsylvania, 19008, United States

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Case Western Reserve University / University Hospitals Case Medical Center

    Cleveland, Ohio, 44106, United States

  • Decatur Memorial Hospital - Illinois

    Decatur, Illinois, 62526, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Eastern CT Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Gabrail Cancer Center Research, LLC

    Canton, Ohio, 44718, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308, United States

  • Kaiser Permanente Southern California

    Woodland Hills, California, 91367, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland, 20904, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • McLaren Greater Lansing Hospital

    Lansing, Michigan, 48910, United States

  • Medical College of Wisconsin (Milwaukee)

    Milwaukee, Wisconsin, 53226, United States

  • Medical Oncology Associates

    Spokane, Washington, 99208, United States

  • Medical University of South Carolina/Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10087-9049, United States

  • Memorial Sloan Kettering Cancer Center - Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center - Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center - Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Cancer Center - Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Cancer Center - Westchester

    Harrison, New York, 10604, United States

  • NYU Winthrop Hospital

    Mineola, New York, 11501, United States

  • Nebraska Hematology Oncology P.C.

    Lincoln, Nebraska, 68506, United States

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206, United States

  • New York University (NYU) Cancer Institute

    New York, New York, 10016, United States

  • Northwell Cancer Center / Monter Cancer Center

    Lake Success, New York, 11042, United States

  • Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • OptumCare Cancer Center

    Las Vegas, Nevada, 89102, United States

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30309, United States

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Saint Francis Hospital Cancer Center

    Greenville, South Carolina, 29607, United States

  • Saint Joseph Heritage Medical Group

    Santa Rosa, California, 95403, United States

  • Sarah Cannon Research Institute

    Chattanooga, Tennessee, 37404, United States

  • Site CA11001

    Toronto, Ontario, M5G 2M9, Canada

  • Site CA11002

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Site CA11005

    Montreal, Quebec, H3T1E2, Canada

  • Site CA11008

    East Brampton, Ontario, L6R 3J7, Canada

  • Site CA11011

    Kingston, Ontario, K7L 2V7, Canada

  • Site CA11013

    Montreal, Quebec, H4A3J1, Canada

  • Site ES34001

    Madrid, 28034, Spain

  • Site ES34004

    Santander, 39008, Spain

  • Site ES34005

    Sabadell, 08208, Spain

  • Site ES34006

    Barcelona, 08041, Spain

  • Site ES34007

    Pamplona, 31008, Spain

  • Site ES34008

    Madrid, 28033, Spain

  • Site ES34012

    Madrid, 28041, Spain

  • Site FR33001

    Strasbourg, 67200, France

  • Site FR33002

    Nice, 06189, France

  • Site FR33003

    Lyon, 69008, France

  • Site FR33004

    Marseille, 13273, France

  • Site FR33005

    Dijon, 21000, France

  • Site FR33006

    Pierre-Bénite, 69310, France

  • Site FR33008

    Bordeaux, 33000, France

  • Site FR33010

    Moselle, 54519, France

  • Site IT39002

    Terni, 05100, Italy

  • Site PR78701

    Rio Piedras, 00935, Puerto Rico

  • Southcoast Centers for Cancer Care - Fairhaven Site

    Fairhaven, Massachusetts, 02719, United States

  • Stanford Cancer Center / Blood & Marrow Transplant Program

    Stanford, California, 94305, United States

  • Tennessee Oncology / Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623, United States

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211, United States

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112, United States

  • UC San Diego / Moores Cancer Center

    La Jolla, California, 92093, United States

  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of California Irvine - Newport

    Orange, California, 92868, United States

  • University of California at San Francisco

    San Francisco, California, 94134, United States

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1470, United States

  • University of Colorado Hospital / University of Colorado

    Aurora, Colorado, 80045-0510, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39213, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Vidant Medical Center

    Greenville, North Carolina, 27834, United States

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Winship Cancer Institute / Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States

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