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 70 Locations for this study

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Arizona Urology Specialists
Tucson Arizona, 85704, United States More Info
Kalpesh Patel, MD
Contact
520-784-7019
[email protected]
Kalpesh Patel, MD
Principal Investigator
Loma Linda University Medical Center
Loma Linda California, 92350, United States More Info
Brian Hu, MD
Contact
909-558-0702
[email protected]
Brian Hu, MD
Principal Investigator
American Institute of Research
Los Angeles California, 90017, United States More Info
John Kowalczyk, DO
Contact
213-481-7142
[email protected]
John Kowalczyk, DO
Principal Investigator
Tower Urology
Los Angeles California, 90048, United States More Info
David Josephson
Contact
310-854-9898
[email protected]
UCLA - University of California, Los Angeles
Los Angeles California, 90095, United States More Info
Chamie Karim, MD
Contact
310-206-8183
[email protected]
Contact
(310)794-5929
Genesis Research
San Diego California, 92123, United States More Info
Amirali Salmasi, MD
Contact
858-430-1101
[email protected]
Providence Saint John's Health Center
Santa Monica California, 90404, United States More Info
Jennifer Linehan, MD
Contact
310-582-7137
[email protected]
Jennifer Linehan, MD
Principal Investigator
University of Chicago Hospital
Chicago Illinois, 60637, United States More Info
Piyush Agarwal, MD
Contact
777-702-3080
[email protected]
Piyush Agarwal, MD
Principal Investigator
Indiana University School of Medicine
Indianapolis Indiana, 46202, United States More Info
Hristos Kaimakliotis, M.D.
Contact
[email protected]
Courtney Dhondt
Contact
317-274-1791
[email protected]
Wichita Urology Group
Wichita Kansas, 67226, United States More Info
Fadi Nabih Joudi, MD
Contact
316-636-6141
[email protected]
Amanda Ho
Contact
316-636-6141
[email protected]
Fadi Nabih Joudi, MD
Principal Investigator
Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States More Info
Brian Nueman, MD
Contact
410-825-5454
[email protected]
John Hopkins University
Baltimore Maryland, 21218, United States More Info
Max Kates, MD
Contact
[email protected]
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States More Info
Rian Dickstein, MD
Contact
443-471-5763
[email protected]
Rian Dickstein, MD
Principal Investigator
The Brigham and Women's Hospital, Inc.
Boston Massachusetts, 02115, United States More Info
Mark Preston
Contact
[email protected]
Michigan Urology
Troy Michigan, 48084, United States More Info
Jason Hafron
Contact
[email protected]
Minnesota Urology
Woodbury Minnesota, 55125, United States More Info
Aaron Milbank
Contact
651-999-6800
[email protected]
University of Missouri
Columbia Missouri, 65212, United States More Info
Katie Murray, DO, MS, SACS
Contact
573-884-4057
[email protected]
Katie Murray, DO, MS, SACS
Principal Investigator
Urology Center Las Vegas
Las Vegas Nevada, 89144, United States More Info
Michael Verni, MD
Contact
702-212-3428
[email protected]
Michael Verni, MD
Principal Investigator
New Jersey Urology
Bloomfield New Jersey, 07003, United States More Info
Gordon A Brown, DO
Contact
856-673-1613
[email protected]
Jennifer Pilallis
Contact
856-673-1613
[email protected]
Gordon Brown, DO
Principal Investigator
New Jersey Urology
Englewood New Jersey, 07631, United States More Info
Christopher Wright, MD
Contact
201-487-8866
[email protected]
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Sandip Prasad, MD
Contact
973-437-6744
[email protected]
Sandip Prasad, MD
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States More Info
Saum Ghodoussipour
Contact
Great Lakes Physician dba WNY Urology Associates
Cheektowaga New York, 14225, United States More Info
Kent Chevli, MD
Contact
716-844-5550
[email protected]
Kent Chevli, MD
Principal Investigator
AccuMed Research Associates
Garden City New York, 11530, United States More Info
Mitchell Efros, MD
Contact
516-746-2190
[email protected]
Leanne Cossu
Contact
516-746-2190
[email protected]
Mitchell Efros, MD
Principal Investigator
Manhattan Medical Research
New York New York, 10016, United States More Info
William Huang, MD
Contact
212-480-3333
[email protected]
William Huang, MD
Principal Investigator
NYU Langone Health
New York New York, 10016, United States More Info
William Huang, MD
Contact
[email protected]
Mount Sinai
New York New York, 10029, United States More Info
John Sfakianos
Contact
[email protected]
Premier Medical Group of the Hudson Valley PC
Poughkeepsie New York, 12603, United States More Info
Evan Goldfischer
Contact
University of Rochester
Rochester New York, 14620, United States More Info
William Tabayoyong
Contact
Stony Brook Cancer Center
Stony Brook New York, 11794, United States More Info
David Golombos, MD
Contact
[email protected]
David Golombos, MD
Principal Investigator
Associated Medical Professionals of NY
Syracuse New York, 13210, United States More Info
Chris Pieczonka
Contact
315-478-4185
[email protected]
SUNY Upstate Medical University
Syracuse New York, 13210, United States More Info
Joseph Jacob
Contact
[email protected]
TriState Urologic Services PSC INC., dba The Urology Group
Cincinnati Ohio, 45212, United States More Info
Marc Pliskin, DO
Contact
513-841-7550
William Corbett
Contact
(513) 841-7555
[email protected]
Marc Pliskin, DO
Principal Investigator
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States More Info
Lawrence Gervasi
Contact
440-845-0900
[email protected]
Lawrence Gervasi, MD
Principal Investigator
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Laurence Belkoff, DO
Contact
610-667-0458
[email protected]
Laurence Belkoff, DO
Principal Investigator
Penn State Health Milton S. Hershey Medical Center and College of Medicine
Hershey Pennsylvania, 17033, United States More Info
Jay Raman, MD
Contact
717-531-8848
[email protected]
Jay Raman, MD
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Daniel Lee
Contact
[email protected]
Urology Associates, P.C.
Nashville Tennessee, 37209, United States More Info
David Morris, MD
Contact
[email protected]
David Morris, MD
Principal Investigator
Urology Austin
Austin Texas, 78745, United States More Info
Brian Mazzarella, MD
Contact
512-410-3773
[email protected]
Houston Methodist Research Institute
Houston Texas, 77030, United States More Info
Raj Satkunasivam
Contact
713-441-6455
[email protected]
Spokane Urology, P.S.
Spokane Washington, 99202, United States More Info
Shane Pearce
Contact
[email protected]
Multiprofile Hospital for Active Treatment - Blagoevgrad
Blagoevgrad , 2700, Bulgaria More Info
Petar Uzunov, MD
Contact
Petar Uzunov, MD
Principal Investigator
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo , 5300, Bulgaria More Info
Georgi Atanasov, MD
Contact
Georgi Atanasov, MD
Principal Investigator
Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
Lom , 3600, Bulgaria More Info
Sasho Tsvetkov, MD
Contact
Sasho Tsvetkov, MD
Principal Investigator
Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
Montana , 3400, Bulgaria More Info
Georgi Chakarov, MD
Contact
Georgi Chakarov, MD
Principal Investigator
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
Pleven , 5800, Bulgaria More Info
Nikolay Kolev, MD
Contact
Nikolay Kolev, MD
Principal Investigator
University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
Pleven , 5800, Bulgaria More Info
Assoc. Prof. Boyan Atanasov, MD
Contact
Assoc. Prof. Boyan Atanasov, MD
Principal Investigator
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
Plovdiv , 4002, Bulgaria More Info
Petar Antonov, MD
Contact
University Multiprofile Hospital for Active Treatment, Plovdiv
Plovdiv , 4003, Bulgaria More Info
Dimitar Shishkov, MD
Contact
Multiprofile Hospital for Active Treatment Park Hospital
Plovdiv , 4109, Bulgaria More Info
Angel Dimitrov, MD
Contact
Angel Dimitrov, MD
Principal Investigator
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Ruse , 7000, Bulgaria More Info
Assoc. Prof. Pencho Genov, MD
Contact
Assoc. Prof. Pencho Genov, MD
Principal Investigator
Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
Shumen , 9700, Bulgaria More Info
Dobri Marchev, MD
Contact
Dobri Marchev, MD
Principal Investigator
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia
Sofia , 1527, Bulgaria More Info
Chavdar Slavov, MD
Contact
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
Sofia , 1606, Bulgaria More Info
Boris Mladenov, MD
Contact
Boris Mladenov, MD
Principal Investigator
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
Stara Zagora , 6000, Bulgaria More Info
Ilija Kolevski, MD
Contact
Multiprofile Hospital for Active Treatment - Targovishte
Targovishte , 7700, Bulgaria More Info
Ivan Svetulkov, MD
Contact
Ivan Svetulkov, MD
Principal Investigator
Multiprofile Hospital for Active Treatment "Life Hospital" Burgas
Varna , 8008, Bulgaria More Info
Deyan Anakievski, MD
Contact
Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
Varna , 9000, Bulgaria More Info
Vasyl Terzi, MD
Contact
Vasyl Terzi, MD
Principal Investigator
Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
Varna , 9002, Bulgaria More Info
Assoc. Prof Tosho Ganev, MD, PhD
Contact
Assoc. Prof Tosho Ganev, MD, PhD
Principal Investigator
First Private Hospital Vratsa, Department of Urology
Vratsa , 3001, Bulgaria More Info
Georgi Tatarski, MD
Contact
Georgi Tatarski, MD
Principal Investigator
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
Yambol , 8600, Bulgaria More Info
Emil Milkov, MD
Contact
Emil Milkov, MD
Principal Investigator
East Viru Central Hospital, Surgery Clinic
Kohtla-Järve , 31025, Estonia More Info
Jaak Lind, MD
Contact
Jaak Lind, MD
Principal Investigator
East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
Tallinn , 10138, Estonia More Info
Toomas Tamm, MD
Contact
Toomas Tamm, MD
Principal Investigator
West Tallinn Central Hospital Ltd., Department of Urology
Tallinn , 10617, Estonia More Info
Heino-Enn Arpo, MD
Contact
Heino-Enn Arpo, MD
Principal Investigator
North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
Tallinn , 13419, Estonia More Info
Dmitri Korotots, MD
Contact
Dmitri Korotots, MD
Principal Investigator
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu , 50406, Estonia More Info
Roomet Ots, MD
Contact
Roomet Ots, MD
Principal Investigator
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi , 0160, Georgia More Info
Barnab Nikoladze, MD
Contact
Barnab Nikoladze, MD
Principal Investigator
JSC Jerarsi, Department of Urology
Tbilisi , , Georgia More Info
Nikoloz Gogoladze
Contact
Nikoloz Gogoladze
Principal Investigator
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
Tbilisi , , Georgia More Info
Dr. Zaal Kvirikashvili
Contact
Zaal Kvirikashvili
Principal Investigator
LTD Gidmedi, Urology Department
Tbilisi , , Georgia More Info
Prof. Alexandre Khuskivadze, MD
Contact
Prof. Alexandre Khuskivadze, MD
Principal Investigator
LTD L. Managadze National Center of Urology, Department of Urology
Tbilisi , , Georgia More Info
Zaza Tchanturaia, MD
Contact
Zaza Tchanturaia, MD
Principal Investigator
LTD MMT Hospital, Urology Department
Tbilisi , , Georgia More Info
Guram Karazanashvili, MD
Contact
Guram Karazanashvili, MD
Principal Investigator
Pineo Medical Ecosystem Ltd., Department of Urology
Tbilisi , , Georgia More Info
Dr. Giorgi Adeishvili
Contact
Dr. Giorgi Adeishvili
Principal Investigator
Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
Tbilisi , , Georgia More Info
Prof. Shalva Chovelidze, MD
Contact
Prof. Shalva Chovelidze, MD
Principal Investigator
Liepajas Regional Hospital, Urology Department
Liepāja , LV-34, Latvia More Info
Dzintra Litavniece, MD
Contact
Dzintra Litavniece, MD
Principal Investigator
P. Stradins Clinical University Hospital, Center for Urology
Riga , LV-10, Latvia More Info
Prof. Egils Vjaters, MD, PhD
Contact
Prof. Egils Vjaters, MD, PhD
Principal Investigator
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga , LV-10, Latvia More Info
Vilnis Lietuvietis, MD, PhD
Contact
Vilnis Lietuvietis, MD, PhD
Principal Investigator
Daugavpils Regional Hospital, Urology Department
Riga , LV-54, Latvia More Info
Andrejs Aleksandrovs, MD
Contact
Andrejs Aleksandrovs, MD
Principal Investigator
Clinical Center of Serbia, Clinic of Urology
Belgrade , 11000, Serbia More Info
Prof. Zoran Dzamic, MD, PhD
Contact
Prof. Zoran Dzamic, MD, PhD
Principal Investigator
Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
Belgrade , 11080, Serbia More Info
Zoran Filipovic, MD
Contact
Zoran Filipovic, MD
Principal Investigator
Clinical Hospital Center Zemun, Urology unit
Belgrade , 11080, Serbia More Info
Bora Cvetkovic, MD
Contact
Bora Cvetkovic, MD
Principal Investigator
Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
Kragujevac , 34000, Serbia More Info
Radovan Zaric, MD
Contact
Radovan Zaric, MD
Principal Investigator

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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