A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
NCT ID: NCT06331299
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
99 participants
INTERVENTIONAL
2024-08-29
2026-09-30
Brief Summary
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Detailed Description
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Efficacy will be assessed by the complete response rate (CRR) at the 3-month Visit (approximately 3 months after the first instillation). Response will be determined based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab.
Patients who have a complete response (CR) at the 3-month Visit, defined as having no detectable disease (NDD) in the bladder, will enter the Follow-up Period of the study. During the Follow-up Period, patients will return to the clinic every 3 months for evaluation of response. Patients will remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (ie, 12 months after the 3-month Visit), whichever occurs first.
Patients who have a non-complete response (NCR) at the 3-month Visit will undergo investigator designated standard of care (SOC) and have a separate End of Study (EOS) Visit performed.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UGN-103
Patients will receive UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses).
UGN-103
UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
Interventions
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UGN-103
UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
3. History of at least 1 prior episode of NMIBC. 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:
* Leukocytes ≥ 3,000/μL.
* Absolute neutrophil count ≥ 1,500/μL.
* Platelets ≥ 100,000/μL.
* Hemoglobin ≥ 9.0 g/dL.
* Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
* Alkaline phosphatase (ALP) ≤ 2.5 × ULN.
* Estimated glomerular filtration rate (eGFR) ≥ 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
2. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
3. Known allergy or sensitivity to any component of the study treatment (including excipients) 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 stage of T1.
8. Concurrent upper tract urothelial carcinoma (UTUC).
9. Evidence of active urinary tract infection (UTI) 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 transurethral resection of bladder tumors (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.
17. Where applicable per country regulation, the patient must not be currently committed to an institution by virtue of an order issued by either judicial or administrative authorities.
18 Years
ALL
No
Sponsors
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UroGen Pharma Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sebastian Mirkin, MD
Role: STUDY_DIRECTOR
UroGen Pharma
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Genesis Research, LLC
San Diego, California, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Peachtree Clinical Solutions
Powder Springs, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Minnesota Urology - Metro Urology - Woodbury
Woodbury, Minnesota, United States
Garden State Urology
Morristown, New Jersey, United States
Great Lakes Physician dba WNYU
Cheektowaga, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Crystal Run Healthcare
Middletown, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates P.C. - Nashville
Nashville, Tennessee, United States
Houston Metro Urology (HMU) - Southwest Location
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Spokane Urology, P.S.
Spokane, Washington, United States
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo, Gabrovo, Bulgaria
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
Pleven, Pleven Province, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology
Plovdiv, Plovdiv Province, Bulgaria
University Multiprofile Hospital for Active Treatment, Plovdiv, Clinic of Urology
Plovdiv, Plovdiv Province, Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Rousse, Ruse Province, Bulgaria
Multiprofile Hospital for Active Treatment - Shumen, Department of Urology
Shumen, Shumen Province, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
Sofia, Sofia-Grad, Bulgaria
West Tallinn Central Hospital Ltd., Department of Urology
Tallinn, Harju, Estonia
North Estonia Medical Centre Foundation Ltd.
Tallinn, Harju, Estonia
East Viru Central Hospital, Surgery Clinic
Kohtla-Järve, Ida-Virumaa, Estonia
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu, Tartu County, Estonia
LLC "Todua Clinic"
Tbilisi, , Georgia
Geo Hospitals LLC
Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, , Georgia
LTD MMT Hospital
Tbilisi, , Georgia
JSC Jerarsi
Tbilisi, , Georgia
Daugavpils Regional Hospital, Urology Department
Daugavpils, , Latvia
Liepajas Regional Hospital, Urology Department
Liepāja, , Latvia
P. Stradins Clinical University Hospital, Center for Urology
Riga, , Latvia
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga, , Latvia
Bihor County Emergency Clinical Hospital
Oradea, Bihor County, Romania
Brasov County Emergency Clinical Hospital, Department of Urology
Brasov, Brașov County, Romania
Craiova County Emergency Clinical Hospital, Department of Urology
Craiova, Dolj, Romania
SC Clinica Polisano Hospital
Sibiu, Sibiu County, Romania
Colentina Clinical Hospital, Department of Urology
Bucharest, , Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Department of Urology III
Bucharest, , Romania
University Hospital Virgen de la Victoria
Málaga, Andalusia, Spain
Puigvert Foundation
Barcelona, Catalonia, Spain
University Hospital Foundation Jimenez Diaz
Madrid, Madrid, Spain
University Hospital 12 de Octubre
Madrid, Madrid, Spain
La Paz University Hospital
Madrid, Madrid, Spain
Countries
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Other Identifiers
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BL013
Identifier Type: -
Identifier Source: org_study_id
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