Spots Global Cancer Trial Database for A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
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Trial Identification
Brief Title: A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
Official Title: A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
Study ID: NCT05243550
Interventions
Study Description
Brief 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).
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Urology Specialists, Tucson, Arizona, United States
Loma Linda University Medical Center, Loma Linda, California, United States
American Institute of Research, Los Angeles, California, United States
Tower Urology, Los Angeles, California, United States
Genesis Research, San Diego, California, United States
Wichita Urology Group, Wichita, Kansas, United States
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
John Hopkins University, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Hanover, Maryland, United States
The Brigham and Women's Hospital, Inc., Boston, Massachusetts, United States
Michigan Urology, Troy, Michigan, United States
University of Missouri, Columbia, Missouri, United States
Urology Center Las Vegas, Las Vegas, Nevada, United States
New Jersey Urology, Bloomfield, New Jersey, United States
New Jersey Urology, Englewood, New Jersey, 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
Premier Medical Group of the Hudson Valley PC, Poughkeepsie, New York, United States
University of Rochester, Rochester, New York, United States
Stony Brook Cancer Center, Stony Brook, New York, United States
TriState Urologic Services PSC INC., dba The Urology Group, Cincinnati, Ohio, United States
Clinical Research Solutions, Middleburg Heights, Ohio, United States
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology, Bala-Cynwyd, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center and College of Medicine, Hershey, Pennsylvania, 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
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Urology, Linz, , Austria
Salzburg Regional Hospital, University Hospital of Urology and Andrology, Salzburg, , Austria
Medical University Vienna, Department of Urology, Vienna, , Austria
Hospital Wels-Grieskirchen, Department of Urology and Andrology, Wels, , 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
Multiprofile Hospital for Active Treatment Park Hospital, Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology, Ruse, , Bulgaria
Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology, Shumen, , Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich", Stara Zagora, , Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte, Targovishte, , Bulgaria
Multiprofile Hospital for Active Treatment "Life Hospital" Burgas, Varna, , Bulgaria
Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology, Varna, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic, Varna, , Bulgaria
First Private Hospital Vratsa, Department of Urology, Vratsa, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology, Yambol, , Bulgaria
East Viru Central Hospital, Surgery Clinic, Kohtla-Järve, , Estonia
East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology, Tallinn, , Estonia
West Tallinn Central Hospital Ltd., Department of Urology, Tallinn, , Estonia
North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre, Tallinn, , Estonia
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation, Tartu, , Estonia
LTD Central University Clinic After Academic N. Kipshidze, Tbilisi, , 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, , Latvia
P. Stradins Clinical University Hospital, Center for Urology, Riga, , Latvia
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology, Riga, , Latvia
Daugavpils Regional Hospital, Urology Department, Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas, , Lithuania
Klaipeda University Hospital, Klaipėda, , Lithuania
National Cancer Institute, Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos, Vilnius, , Lithuania
AKMED, Gliwice, , Poland
SCM sp. z o.o. (LLC), Kraków, , Poland
Clinical Research Center Limited liability company Medic-R Limited partnership, Poznań, , Poland
Mazovian Oncology Hospital, Subdepartment of Urology, Wieliszew, , Poland
Clinical Center of Serbia, Clinic of Urology, Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology, Belgrade, , Serbia
Clinical Hospital Center Zemun, Urology unit, Belgrade, , Serbia
Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis, Kragujevac, , Serbia
Hospital del Mar, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
University Hospital Foundation Jimenez Diaz, Madrid, , Spain
University Hospital 12 de Octubre, Madrid, , Spain
La Paz University Hospital, Madrid, , Spain
Central University Hospital de Asturias (HUCA), Oviedo, , Spain
Navarra University Hospital, Pamplona, , Spain
Contact Details
Name: Sandip Prasad, MD
Affiliation: Atlantic Health System
Role: PRINCIPAL_INVESTIGATOR
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