ACTIVE_NOT_RECRUITING

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

Conditions

Bladder Cancer Urothelial Carcinoma Urothelial Carcinoma Bladder Non-muscle invasive bladder cancer Low-grade non-muscle invasive bladder cancer Intermediate-risk non-muscle invasive bladder cancer NMIBC UGN-103 UGN-102 Mitomycin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).

Official Title

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence

Quick Facts

Study Start:2024-08-29

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06331299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 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 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.	1. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within the 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 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.

Inclusion Criteria

Exclusion Criteria

1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 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 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.

1. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within the 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 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.

Contacts and Locations

Principal Investigator

Sebastian Mirkin, MD

STUDY_DIRECTOR

UroGen Pharma

Study Locations (Sites)

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

Genesis Research, LLC

San Diego, California, 92123

United States

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037

United States

Peachtree Clinical Solutions

Powder Springs, Georgia, 30127

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Minnesota Urology - Metro Urology - Woodbury

Woodbury, Minnesota, 55125

United States

Garden State Urology

Morristown, New Jersey, 07962

United States

Great Lakes Physician dba WNYU

Cheektowaga, New York, 14225

United States

AccuMed Research Associates

Garden City, New York, 11530

United States

Crystal Run Healthcare

Middletown, New York, 10941

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

New York, New York, 11501

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

Urology Associates P.C. - Nashville

Nashville, Tennessee, 37209-4035

United States

Houston Metro Urology (HMU) - Southwest Location

Houston, Texas, 77027

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Spokane Urology, P.S.

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: UroGen Pharma Ltd.

Sebastian Mirkin, MD, STUDY_DIRECTOR, UroGen Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-29

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-08-29

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Non-muscle invasive bladder cancer
Low-grade non-muscle invasive bladder cancer
Intermediate-risk non-muscle invasive bladder cancer
NMIBC
UGN-103
UGN-102
Mitomycin

Additional Relevant MeSH Terms

Bladder Cancer
Urothelial Carcinoma
Urothelial Carcinoma Bladder