A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) (SunRISe-5)
Last Updated January 11, 2025
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17000139BLC3004
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Recruiting
SUMMARY
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.
CONDITIONS
- Non-Muscle Invasive Bladder Neoplasms
ELIGIBILITY
Inclusion Criteria:
* Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]
* Part
DETAILS
LOCATIONS
Country (14) | City or Province (98) | Status |
United States | Little Rock Arkansas Urology |
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United States | Los Alamitos Genesis Research LLC |
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United States | Orange University of California Irvine Medical Center |
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United States | Torrance Genesis Research LLC |
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United States | Lakewood Colorado Clinical Research |
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United States | Riverview Florida Urology Partners |
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United States | Chicago Ridge UroPartners |
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United States | Carmel Urology of Indiana |
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United States | Jeffersonville First Urology, PSC |
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United States | Wichita Wichita Urology Group |
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United States | Royal Oak Comprehensive Urology |
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United States | Saint Louis Specialty Clinical Research of St Louis |
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United States | Syracuse Associated Medical Professionals |
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United States | Cincinnati The Urology Group |
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United States | Gahanna Central Ohio Urology Group |
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United States | Bala-Cynwyd Centers for Advanced Urology LLC d b a MidLantic Urology |
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United States | Myrtle Beach Carolina Urologic Research Center |
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United States | North Charleston Low Country Urology Clinics |
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United States | Nashville Urology Associates |
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United States | Austin Urology Austin |
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United States | Dallas Urology Clinics of North Texas |
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United States | Houston Houston Metro Urology |
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United States | Spokane Spokane Urology |
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Argentina | Buenos Aires Clinica Santa Isabel |
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Argentina | Caba Investigaciones Clinico Moleculares (ICM) |
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Argentina | Cordoba Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica |
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Argentina | Córdoba Centro Urologico Profesor Bengio |
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Argentina | Mar del Plata Hospital Privado de la Comunidad |
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Belgium | Brugge AZ Sint-Jan |
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Belgium | Genk Ziekenhuis Oost-Limburg |
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Belgium | Gent Algemeen ziekenhuis Maria Middelares |
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Belgium | Roeselare Algemeen Ziekenhuis Delta |
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Brazil | Barretos Fundacao Pio XII |
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Brazil | Bauru NAIC Nair Antunes Instituto do Cancer |
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Brazil | Curitiba Liga Paranaense de Combate ao Cancer |
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Brazil | Porto Alegre Irmandade Santa Casa de Misericordia de Porto Alegre |
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Brazil | Sao Paulo Real e Benemérita Associação Portuguesa de Beneficência |
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Brazil | Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center |
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China | Beijing Peking University First Hospital |
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China | Cheng Du Shi West China School of Medicine/West China Hospital, Sichuan University |
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China | Chong Qing Chongqing Cancer Hospital |
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China | Guang Zhou Shi Sun Yat-Sen University Cancer Center |
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China | Shen Yang Shi Shengjing Hospital Of China Medical University |
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China | Tianjin Tianjin Medical University Cancer Institute and Hospital |
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China | Tianjin The Second Hospital Of Tianjin Medical University |
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China | Wenzhou The First Affiliated Hospital of Wenzhou Medical University |
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China | Wuhan Tongji Medical College of Huazhong University Science Technology of Medicine Health Management |
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China | XI An Shi Xi an Jiaotong University Hospital |
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France | Limoges Polyclinique de Limoges - Francois Chenieux |
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France | Paris APHP - Hopital Bichat - Claude Bernard |
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France | Quint-Fonsegrives Clinique de la Croix du Sud |
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France | Suresnes Hopital Foch |
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Germany | Halle (Saale) Universitaetsklinikum Halle Saale |
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Germany | Köln Universitaetsklinikum Koeln |
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Germany | Leverkusen Klinikum Leverkusen gGmbH |
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Germany | Lubeck Universitatsklinikum Schleswig Holstein Campus Lubeck |
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Germany | Mettmann Urologie Neandertal Praxis Mettmann |
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Germany | Munchen Klinikum der Universitaet Muenchen |
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Italy | Arezzo Ospedale San Donato |
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Italy | Ravenna Ospedale S. Maria Delle Croci |
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Italy | Roma Istituto Nazionale Tumori Regina Elena |
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Italy | Rozzano Istituto Clinico Humanitas |
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Italy | Torino PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino |
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Japan | Chiba Funabashi Munitiple Medical Center |
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Japan | Hakodate Hakodate Goryoukaku Hospital |
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Japan | Hyogo Hyogo Prefectural Amagasaki General Medical Center |
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Japan | Niigata Niigata Cancer Center Hospital |
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Japan | Okayama National Hospital Organization Okayama Medical Center |
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Japan | Sakura Toho University Sakura Medical Center |
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Japan | Tokyo Toranomon Hospital |
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Japan | Yokohama Yokohama City University Medical Center |
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South Korea | Chungcheongbuk Do Chungbuk National University Hospital |
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South Korea | Daegu Keimyung University Dongsan Hospital |
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South Korea | Gyeonggi-do National Cancer Center |
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South Korea | Jeollanam-do Chonnam National University Hwasun Hospital |
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South Korea | Seoul Seoul National University Hospital |
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South Korea | Seoul Samsung Medical Center |
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South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
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South Korea | Yangsan-si Pusan National University Yangsan Hospital |
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Poland | Bialystok Uniwersytecki Szpital Kliniczny w Bialymstoku |
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Poland | Bydgoszcz IN VIVO Sp. z o.o |
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Poland | Przemysl Wojewodzki Szpital im Sw Ojca Pio w Przemyslu |
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Poland | Tarnow Szpital Wojewodzki im. Sw. Lukasza SP ZOZ |
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Poland | Torun MICS Centrum Medyczne Torun |
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Poland | Wieliszew Mazowiecki Szpital Onkologiczny |
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Poland | Wroclaw Dolnoslaskie Centrum Onkologii |
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Romania | Brasov Centrul Medical Unirea SRL |
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Romania | Bucuresti Ponderas Academic Hospital |
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Romania | Cluj-Napoca Institutul Oncologic Ion Chiricuta |
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Romania | Cluj-Napoca Regina Maria |
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Romania | Timisoara Spitalul Clinic Judetean de Urgenta Pius Brinzeu |
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Spain | Madrid Hosp. Univ. 12 de Octubre |
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Spain | Málaga Hosp Virgen de La Victoria |
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Spain | Sabadell Hosp.Univ.Parc Tauli |
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United Kingdom | London St Bartholomews Hospital |
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United Kingdom | Salford Salford Royal Hospital |
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United Kingdom | Southampton Southampton University Hospital |
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United Kingdom | Stevenage Lister Hospital |
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