A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Running, not enrolling · Phase 3

Conditions studied: Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder

In brief

This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Key facts

Study ID: NCT05243550
Run by: UroGen Pharma Ltd.
People needed: 240
Starts: 2022-03-01
Expected to finish: 2028-03-01
Last updated by the study team: 2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
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.
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).
Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
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.
Has an anticipated life expectancy of at least the duration of the trial.
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.

You may not qualify if…

Received Bacillus Calmette-Guérin treatment for urothelial carcinoma (UC) within previous 1 year.
History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed.
Clinically significant urethral stricture that would preclude passage of a urethral catheter.
History of:
Neurogenic bladder;
Active urinary retention;
Any other condition that would prohibit normal voiding.
Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC.
Current tumor grading of T1.
Concurrent upper tract UC.
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.
Is pregnant or breastfeeding.
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.
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.
Has participated in a study with an investigational agent or device within 30 days of enrollment.
Has previously participated in a study in which they received UGN-102.
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.
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.

Where it is running

Loma Linda University Medical Center — Loma Linda, California, United States
Genesis Research — San Diego, California, United States
Wichita Urology Group — Wichita, Kansas, United States
John Hopkins University — Baltimore, Maryland, United States
Chesapeake Urology Research Associates — Hanover, Maryland, United States
University of Missouri — Columbia, Missouri, United States
Atlantic Health System — Morristown, New Jersey, United States
Great Lakes Physician dba WNY Urology Associates — Cheektowaga, New York, United States
AccuMed Research Associates — Garden City, New York, United States
Manhattan Medical Research — New York, New York, United States
NYU Langone Health — New York, New York, United States
Mount Sinai — New York, New York, United States
Urology Associates, P.C. — Nashville, Tennessee, United States
Houston Methodist Research Institute — Houston, Texas, United States
Spokane Urology, P.S. — Spokane, Washington, United States
Medical University Vienna, Department of Urology — Vienna, Austria
Multiprofile Hospital for Active Treatment - Blagoevgrad — Blagoevgrad, Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology — Gabrovo, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom — Lom, Bulgaria
Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi" — Montana, Bulgaria
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic — Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology — Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv — Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment, Plovdiv — Plovdiv, Bulgaria
Arizona Urology Specialists — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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