Bladder Cancer Clinical Trial

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

Summary

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

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Full Description

Eligible patients will receive 6 once-weekly intravesical instillations of UGN-102.

All patients will return to the clinic approximately 3 months after the first instillation for determination of response to treatment. Assessment of response will be 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 confirmed to 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. Patients confirmed to have a non-complete response (NCR) will undergo Investigator designated standard of care (SOC) treatment of remaining lesions and then enter the Follow-up Period of the study.

During the Follow-up Period, patients will return to the clinic every 3 months for up to 24 months (ie, 27 months after the first instillation) for evaluation of response. Patients who remain disease free at the 27-month Visit will continue to return to the clinic every 6 months for up to 36 months (ie, 63 months after the first instillation) or until disease recurrence, disease progression, death, or the study is closed by the Sponsor, whichever occurs first.

Patients confirmed to have a disease recurrence during the Follow-up Period or a disease progression at the 3-month Visit or during the Follow-up Period will undergo Investigator designated SOC treatment and have a separate End of Study (EOS) Visit performed. The timing of the EOS Visit will be approximately 3 months after SOC treatment of disease recurrence or progression.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 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 (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
Estimated glomerular filtration rate (eGFR) ≥ 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.

Exclusion Criteria:

Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
History of HG bladder cancer (papillary or carcinoma in situ [CIS]) 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 urothelial carcinoma (UTUC).
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.
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.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

220

Study ID:

NCT05243550

Recruitment Status:

Active, not recruiting

Sponsor:

UroGen Pharma Ltd.

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There are 79 Locations for this study

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Arizona Urology Specialists
Tucson Arizona, 85704, United States
Loma Linda University Medical Center
Loma Linda California, 92350, United States
American Institute of Research
Los Angeles California, 90017, United States
Tower Urology
Los Angeles California, 90048, United States
Genesis Research
San Diego California, 92123, United States
Wichita Urology Group
Wichita Kansas, 67226, United States
Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States
John Hopkins University
Baltimore Maryland, 21218, United States
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States
The Brigham and Women's Hospital, Inc.
Boston Massachusetts, 02115, United States
Michigan Urology
Troy Michigan, 48084, United States
University of Missouri
Columbia Missouri, 65212, United States
Urology Center Las Vegas
Las Vegas Nevada, 89144, United States
New Jersey Urology
Bloomfield New Jersey, 07003, United States
New Jersey Urology
Englewood New Jersey, 07631, United States
Atlantic Health System
Morristown New Jersey, 07960, United States
Great Lakes Physician dba WNY Urology Associates
Cheektowaga New York, 14225, United States
AccuMed Research Associates
Garden City New York, 11530, United States
Manhattan Medical Research
New York New York, 10016, United States
NYU Langone Health
New York New York, 10016, United States
Mount Sinai
New York New York, 10029, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie New York, 12603, United States
University of Rochester
Rochester New York, 14620, United States
Stony Brook Cancer Center
Stony Brook New York, 11794, United States
TriState Urologic Services PSC INC., dba The Urology Group
Cincinnati Ohio, 45212, United States
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Penn State Health Milton S. Hershey Medical Center and College of Medicine
Hershey Pennsylvania, 17033, United States
Urology Associates, P.C.
Nashville Tennessee, 37209, United States
Houston Methodist Research Institute
Houston Texas, 77030, United States
Spokane Urology, P.S.
Spokane Washington, 99202, United States
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Urology
Linz , 4020, Austria
Salzburg Regional Hospital, University Hospital of Urology and Andrology
Salzburg , 5020, Austria
Medical University Vienna, Department of Urology
Vienna , 1090, Austria
Hospital Wels-Grieskirchen, Department of Urology and Andrology
Wels , 4600, Austria
Multiprofile Hospital for Active Treatment - Blagoevgrad
Blagoevgrad , 2700, Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo , 5300, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
Lom , 3600, Bulgaria
Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
Montana , 3400, Bulgaria
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, Plovdiv
Plovdiv , 4003, Bulgaria
Multiprofile Hospital for Active Treatment Park Hospital
Plovdiv , 4109, Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Ruse , 7000, Bulgaria
Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
Shumen , 9700, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia
Sofia , 1527, 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 "Prof. Dr. Stoyan Kirkovich"
Stara Zagora , 6000, Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte
Targovishte , 7700, Bulgaria
Multiprofile Hospital for Active Treatment "Life Hospital" Burgas
Varna , 8008, Bulgaria
Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
Varna , 9000, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
Varna , 9002, Bulgaria
First Private Hospital Vratsa, Department of Urology
Vratsa , 3001, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
Yambol , 8600, Bulgaria
East Viru Central Hospital, Surgery Clinic
Kohtla-Järve , 31025, Estonia
East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
Tallinn , 10138, Estonia
West Tallinn Central Hospital Ltd., Department of Urology
Tallinn , 10617, Estonia
North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
Tallinn , 13419, Estonia
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu , 50406, Estonia
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi , 0160, Georgia
JSC Jerarsi, Department of Urology
Tbilisi , , Georgia
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
Tbilisi , , Georgia
LTD Gidmedi, Urology Department
Tbilisi , , Georgia
LTD L. Managadze National Center of Urology, Department of Urology
Tbilisi , , Georgia
LTD MMT Hospital, Urology Department
Tbilisi , , Georgia
Pineo Medical Ecosystem Ltd., Department of Urology
Tbilisi , , Georgia
Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
Tbilisi , , Georgia
Liepajas Regional Hospital, Urology Department
Liepāja , LV-34, Latvia
P. Stradins Clinical University Hospital, Center for Urology
Riga , LV-10, Latvia
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga , LV-10, Latvia
Daugavpils Regional Hospital, Urology Department
Riga , LV-54, Latvia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas , LT-50, Lithuania
Klaipeda University Hospital
Klaipėda , LT-92, Lithuania
National Cancer Institute
Vilnius , LT-08, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius , LT-08, Lithuania
AKMED
Gliwice , 44-10, Poland
SCM sp. z o.o. (LLC)
Kraków , 31-55, Poland
Clinical Research Center Limited liability company Medic-R Limited partnership
Poznań , 61-73, Poland
Mazovian Oncology Hospital, Subdepartment of Urology
Wieliszew , 05-13, Poland
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 Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
Kragujevac , 34000, Serbia
Hospital del Mar
Barcelona , 08003, Spain
Hospital de Basurto
Bilbao , 48013, Spain
University Hospital Foundation Jimenez Diaz
Madrid , 28040, Spain
University Hospital 12 de Octubre
Madrid , 28041, Spain
La Paz University Hospital
Madrid , 28046, Spain
Central University Hospital de Asturias (HUCA)
Oviedo , 33006, Spain
Navarra University Hospital
Pamplona , 31008, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

220

Study ID:

NCT05243550

Recruitment Status:

Active, not recruiting

Sponsor:


UroGen Pharma Ltd.

How clear is this clinincal trial information?

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