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Bladder cancer patients may avoid surgery with new drug

NCT ID NCT05243550

Disease control Sponsor: UroGen Pharma Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a drug called UGN-102 for people with a low-grade type of bladder cancer that hasn't spread into the muscle. The drug is given directly into the bladder to destroy tumors without surgery. The main goal is to see if the cancer disappears completely after 3 months. About 240 adults with recurrent low-grade bladder cancer are taking part.

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

240 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Mar 2028

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: 1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol. 2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening. 3. History of LG-NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened. 4. Has intermediate-risk disease, defined as having 1 or 2 of the following: * Presence of multiple tumors; * Solitary tumor \> 3 cm; * Early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis at the initial Screening Visit). 5. Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening. 6. Has adequate organ and bone marrow function as determined by routine laboratory tests as below: * Leukocytes ≥ 3,000 per μL; * Absolute neutrophil count ≥ 1,500 per μL; * Platelets ≥ 100,000 per μL; * Hemoglobin ≥ 9.0 g/dL; * Total bilirubin ≤ 1.5 x upper limit of normal (ULN); * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN; * Alkaline phosphatase ≤ 2.5 × ULN; * Estimated glomerular filtration rate ≥ 30 mL/min. 7. Has an anticipated life expectancy of at least the duration of the trial. 8. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment. Exclusion Criteria: 1. Received Bacillus Calmette-Guérin treatment for urothelial carcinoma (UC) within previous 1 year. 2. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years. 3. Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed. 4. Clinically significant urethral stricture that would preclude passage of a urethral catheter. 5. History of: * Neurogenic bladder; * Active urinary retention; * Any other condition that would prohibit normal voiding. 6. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC. 7. Current tumor grading of T1. 8. Concurrent upper tract UC. 9. Evidence of active urinary tract infection that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment. 10. Is pregnant or breastfeeding. 11. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol. 12. History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT. 13. Has participated in a study with an investigational agent or device within 30 days of enrollment. 14. Has previously participated in a study in which they received UGN-102. 15. Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed. 16. Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Urothelial carcinoma Urothelial carcinoma bladder

Contacts and locations

Locations

  • AKMED

    Gliwice, 44-100, Poland

  • AccuMed Research Associates

    Garden City, New York, 11530, United States

  • Arizona Urology Specialists

    Tucson, Arizona, 85704, United States

  • Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076, United States

  • Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis

    Kragujevac, 34000, Serbia

  • Clinical Center of Serbia, Clinic of Urology

    Belgrade, 11000, Serbia

  • Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology

    Belgrade, 11080, Serbia

  • Clinical Hospital Center Zemun, Urology unit

    Belgrade, 11080, Serbia

  • Clinical Research Center Limited liability company Medic-R Limited partnership

    Poznan, 61-737, Poland

  • Daugavpils Regional Hospital, Urology Department

    Riga, LV-5417, Latvia

  • East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology

    Tallinn, 10138, Estonia

  • East Viru Central Hospital, Surgery Clinic

    Kohtla-Järve, 31025, Estonia

  • Genesis Research

    San Diego, California, 92123, United States

  • Great Lakes Physician dba WNY Urology Associates

    Cheektowaga, New York, 14225, United States

  • Hospital de Basurto

    Bilbao, 48013, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, LT-50161, Lithuania

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • JSC Jerarsi, Department of Urology

    Tbilisi, Georgia

  • John Hopkins University

    Baltimore, Maryland, 21218, United States

  • Klaipeda University Hospital

    Klaipėda, LT-92288, Lithuania

  • LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology

    Riga, LV-1038, Latvia

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi, 0160, Georgia

  • LTD Gidmedi, Urology Department

    Tbilisi, Georgia

  • La Paz University Hospital

    Madrid, 28046, Spain

  • Liepajas Regional Hospital, Urology Department

    Liepāja, LV-3414, Latvia

  • Loma Linda University Medical Center

    Loma Linda, California, 92350, United States

  • Manhattan Medical Research

    New York, New York, 10016, United States

  • Mazovian Oncology Hospital, Subdepartment of Urology

    Wieliszew, 05-135, Poland

  • Medical University Vienna, Department of Urology

    Vienna, 1090, Austria

  • Mount Sinai

    New York, New York, 10029, United States

  • Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"

    Montana, 3400, Bulgaria

  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology

    Gabrovo, 5300, Bulgaria

  • Multiprofile Hospital for Active Treatment "Life Hospital" Burgas

    Varna, 8008, Bulgaria

  • Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic

    Varna, 9002, Bulgaria

  • Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom

    Lom, 3600, Bulgaria

  • Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology

    Yambol, 8600, Bulgaria

  • Multiprofile Hospital for Active Treatment - Blagoevgrad

    Blagoevgrad, 2700, Bulgaria

  • Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology

    Shumen, 9700, Bulgaria

  • Multiprofile Hospital for Active Treatment - Targovishte

    Targovishte, 7700, Bulgaria

  • Multiprofile Hospital for Active Treatment Park Hospital

    Plovdiv, 4109, Bulgaria

  • Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology

    Varna, 9000, Bulgaria

  • NYU Langone Health

    New York, New York, 10016, United States

  • North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre

    Tallinn, 13419, Estonia

  • P. Stradins Clinical University Hospital, Center for Urology

    Riga, LV-1002, Latvia

  • Pineo Medical Ecosystem Ltd., Department of Urology

    Tbilisi, Georgia

  • SCM sp. z o.o. (LLC)

    Krakow, 31-559, Poland

  • Spokane Urology, P.S.

    Spokane, Washington, 99202, United States

  • Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation

    Tartu, 50406, Estonia

  • Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department

    Tbilisi, Georgia

  • University Hospital 12 de Octubre

    Madrid, 28041, Spain

  • University Hospital Foundation Jimenez Diaz

    Madrid, 28040, Spain

  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic

    Pleven, 5800, Bulgaria

  • University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology

    Pleven, 5800, Bulgaria

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

    Plovdiv, 4002, Bulgaria

  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia

    Sofia, 1527, Bulgaria

  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology

    Rousse, 7000, Bulgaria

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic

    Sofia, 1606, Bulgaria

  • University Multiprofile Hospital for Active Treatment, Plovdiv

    Plovdiv, 4003, Bulgaria

  • University of Missouri

    Columbia, Missouri, 65212, United States

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209, United States

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661, Lithuania

  • West Tallinn Central Hospital Ltd., Department of Urology

    Tallinn, 10617, Estonia

  • Wichita Urology Group

    Wichita, Kansas, 67226, United States

More trials for these conditions

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