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 April 2, 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
Locations in:
United States, Argentina, Belgium, Brazil, China, France, Germany, Italy, Japan, South Korea, Poland, Romania, Spain, United Kingdom
| Country (14) | City or Province (123) | Status |
| United States | Little Rock Arkansas Urology |
RECRUITING
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| United States | Los Alamitos Genesis Research LLC |
RECRUITING
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| United States | Orange University of California Irvine Medical Center |
RECRUITING
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| United States | Torrance Genesis Research LLC |
RECRUITING
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| United States | Lakewood Colorado Clinical Research |
RECRUITING
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| United States | Riverview Florida Urology Partners |
RECRUITING
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| United States | Chicago Ridge UroPartners |
RECRUITING
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| United States | Carmel Urology of Indiana |
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| United States | Jeffersonville First Urology, PSC |
RECRUITING
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| United States | Wichita Wichita Urology Group |
RECRUITING
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| United States | Royal Oak Comprehensive Urology |
RECRUITING
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| United States | Saint Louis Specialty Clinical Research of St Louis |
RECRUITING
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| United States | Syracuse Associated Medical Professionals |
RECRUITING
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| United States | Cincinnati The Urology Group |
RECRUITING
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| United States | Gahanna Central Ohio Urology Group |
RECRUITING
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| United States | Bala-Cynwyd Centers for Advanced Urology LLC d b a MidLantic Urology |
RECRUITING
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| United States | Myrtle Beach Carolina Urologic Research Center |
RECRUITING
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| United States | North Charleston Low Country Urology Clinics |
RECRUITING
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| United States | Nashville Urology Associates |
RECRUITING
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| United States | Austin Urology Austin |
RECRUITING
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| United States | Dallas Urology Clinics of North Texas |
RECRUITING
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| United States | Houston Houston Metro Urology |
RECRUITING
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| United States | Spokane Spokane Urology |
RECRUITING
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| Argentina | Buenos Aires Clinica Santa Isabel |
RECRUITING
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| Argentina | Caba Investigaciones Clinico Moleculares (ICM) |
RECRUITING
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| Argentina | Cordoba Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica |
RECRUITING
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| Argentina | Córdoba Centro Urologico Profesor Bengio |
RECRUITING
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| Belgium | Brugge AZ Sint-Jan |
RECRUITING
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| Belgium | Genk Ziekenhuis Oost-Limburg |
RECRUITING
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| Belgium | Gent Algemeen ziekenhuis Maria Middelares |
RECRUITING
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| Belgium | Roeselare Algemeen Ziekenhuis Delta |
RECRUITING
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| Brazil | Barretos Fundacao Pio XII |
RECRUITING
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| Brazil | Bauru NAIC Nair Antunes Instituto do Cancer |
RECRUITING
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| Brazil | Porto Alegre Irmandade Santa Casa de Misericordia de Porto Alegre |
RECRUITING
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| Brazil | Sao Paulo Real e Benemérita Associação Portuguesa de Beneficência |
RECRUITING
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| Brazil | Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center |
RECRUITING
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| China | Beijing Peking University First Hospital |
RECRUITING
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| China | Cheng Du Shi West China School of Medicine/West China Hospital, Sichuan University |
RECRUITING
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| China | Chong Qing Chongqing Cancer Hospital |
RECRUITING
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| China | Guang Zhou Shi Sun Yat-Sen University Cancer Center |
RECRUITING
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| China | Shen Yang Shi Shengjing Hospital Of China Medical University |
RECRUITING
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| China | Tianjin Tianjin Medical University Cancer Institute and Hospital |
RECRUITING
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| China | Tianjin The Second Hospital Of Tianjin Medical University |
RECRUITING
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| China | Wenzhou The First Affiliated Hospital of Wenzhou Medical University |
RECRUITING
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| China | Wuhan Tongji Medical College of Huazhong University Science Technology of Medicine Health Management |
RECRUITING
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| China | XI An Shi Xi an Jiaotong University Hospital |
RECRUITING
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| France | Limoges Polyclinique de Limoges - Francois Chenieux |
RECRUITING
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| France | Paris APHP - Hopital Bichat - Claude Bernard |
RECRUITING
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| France | Quint-Fonsegrives Clinique de la Croix du Sud |
RECRUITING
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| France | Suresnes Hopital Foch |
RECRUITING
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| Germany | Halle (Saale) Universitaetsklinikum Halle Saale |
RECRUITING
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| Germany | Köln Universitaetsklinikum Koeln |
RECRUITING
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| Germany | Leverkusen Klinikum Leverkusen gGmbH |
RECRUITING
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| Germany | Lubeck Universitatsklinikum Schleswig Holstein Campus Lubeck |
RECRUITING
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| Germany | Mettmann Urologie Neandertal Praxis Mettmann |
RECRUITING
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| Germany | Munchen Klinikum der Universitaet Muenchen |
RECRUITING
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| Italy | Arezzo Ospedale San Donato |
RECRUITING
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| Italy | Ravenna Ospedale S. Maria Delle Croci |
RECRUITING
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| Italy | Roma Istituto Nazionale Tumori Regina Elena |
RECRUITING
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| Italy | Rozzano Istituto Clinico Humanitas |
RECRUITING
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| Italy | Torino PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino |
RECRUITING
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| Japan | Hyogo Hyogo Prefectural Amagasaki General Medical Center |
RECRUITING
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| Japan | Niigata Niigata Cancer Center Hospital |
RECRUITING
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| Japan | Okayama National Hospital Organization Okayama Medical Center |
RECRUITING
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| Japan | Sakura Toho University Sakura Medical Center |
RECRUITING
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| Japan | Tokyo Toranomon Hospital |
RECRUITING
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| Japan | Yokohama Yokohama City University Medical Center |
RECRUITING
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| South Korea | Chungcheongbuk Do Chungbuk National University Hospital |
RECRUITING
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| South Korea | Daegu Keimyung University Dongsan Hospital |
RECRUITING
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| South Korea | Gyeonggi-do National Cancer Center |
RECRUITING
|
| South Korea | Jeollanam-do Chonnam National University Hwasun Hospital |
RECRUITING
|
| South Korea | Seoul Seoul National University Hospital |
RECRUITING
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| South Korea | Seoul Samsung Medical Center |
RECRUITING
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| South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
RECRUITING
|
| South Korea | Yangsan-si Pusan National University Yangsan Hospital |
RECRUITING
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| Poland | Przemysl Wojewodzki Szpital im Sw Ojca Pio w Przemyslu |
RECRUITING
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| Poland | Torun MICS Centrum Medyczne Torun |
RECRUITING
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| Poland | Wieliszew Mazowiecki Szpital Onkologiczny |
RECRUITING
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| Poland | Wroclaw Dolnoslaskie Centrum Onkologii |
RECRUITING
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| Romania | Brasov Centrul Medical Unirea SRL |
RECRUITING
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| Romania | Bucuresti Ponderas Academic Hospital |
RECRUITING
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| Romania | Cluj-Napoca Institutul Oncologic Ion Chiricuta |
RECRUITING
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| Romania | Cluj-Napoca Regina Maria |
RECRUITING
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| Romania | Timisoara Spitalul Clinic Judetean de Urgenta Pius Brinzeu |
RECRUITING
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| Spain | Madrid Hosp. Univ. 12 de Octubre |
RECRUITING
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| Spain | Málaga Hosp Virgen de La Victoria |
RECRUITING
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| Spain | Sabadell Hosp.Univ.Parc Tauli |
RECRUITING
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| United Kingdom | London St Bartholomews Hospital |
RECRUITING
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| United Kingdom | Salford Salford Royal Hospital |
RECRUITING
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| United Kingdom | Southampton Southampton University Hospital |
RECRUITING
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| United Kingdom | Stevenage Lister Hospital |
RECRUITING
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| United States | Los Angeles USC Norris Comprehensive Cancer Center |
RECRUITING
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| United States | San Francisco University of California San Francisco |
RECRUITING
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| United States | Chicago Northwestern University |
RECRUITING
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| United States | Charleston Ralph H. Johnson Veterans Affairs Medical Center |
RECRUITING
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| United States | Nashville Vanderbilt University Medical Center |
RECRUITING
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| United States | Dallas University of Texas Southwestern Medical Center |
RECRUITING
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| Argentina | Mar del Plata Hospital Privado de la Comunidad |
COMPLETED
|
| Belgium | Bruxelles Cliniques Universitaires Saint Luc |
RECRUITING
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| Brazil | Campinas Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP |
RECRUITING
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| Brazil | Curitiba Liga Paranaense de Combate ao Cancer |
RECRUITING
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| Brazil | Salvador Hospital da Bahia |
RECRUITING
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| Brazil | São Paulo Sociedade Beneficente de Senhoras Hospital Sirio Libanes |
RECRUITING
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| France | Lille Hopital Claude Huriez |
RECRUITING
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| France | Marseille Institut Paoli Calmettes |
RECRUITING
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| France | Rennes Chu Rennes Hopital Pontchaillou |
RECRUITING
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| Italy | Macerata Ospedale Provinciale di Macerata |
RECRUITING
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| Italy | Milano San Raffaele Hospital |
RECRUITING
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| Italy | Milano Istituto Dei Tumori Di Milano |
RECRUITING
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| Italy | Roma Universita Campus Bio-Medico di Roma |
RECRUITING
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| Japan | Chiba Funabashi Munitiple Medical Center |
RECRUITING
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| Japan | Hakodate Hakodate Goryoukaku Hospital |
RECRUITING
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| Poland | Bialystok Uniwersytecki Szpital Kliniczny w Bialymstoku |
RECRUITING
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| Poland | Bydgoszcz IN VIVO Sp. z o.o |
RECRUITING
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| Poland | Krakow Szpital Uniwersytecki w Krakowie |
RECRUITING
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| Poland | Lublin Uniwersytecki Szpital Kliniczny nr 4 |
RECRUITING
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| Poland | Tarnow Szpital Wojewodzki im Sw Lukasza SP ZOZ |
RECRUITING
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| Spain | Badalona Hosp. Univ. Germans Trias I Pujol |
RECRUITING
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| Spain | Barcelona Fund. Puigvert |
RECRUITING
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| Spain | Madrid Hosp. Gral. Univ. Gregorio Maranon |
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| Spain | Santander Hosp. Univ. Marques de Valdecilla |
RECRUITING
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| Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
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| Spain | Valencia Hosp. Clinico Univ. de Valencia |
RECRUITING
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Geo Locations
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39.46975, -0.37739
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