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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   May 14, 2025

Want to learn how to participate in this trial?

17000139BLC3004

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    123 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)]
* Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
* Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2


Exclusion Criteria:

* Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
* Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
* A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
* Previous treatment with TAR-200


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

More...

DETAILS

LOCATIONS

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

34.74648, -92.28959

33.80307, -118.07256

33.78779, -117.85311

33.83585, -118.34063

39.70471, -105.08137

27.86614, -82.32648

41.70142, -87.77922

39.97837, -86.11804

38.27757, -85.73718

37.69224, -97.33754

42.48948, -83.14465

38.62727, -90.19789

43.04812, -76.14742

39.12713, -84.51435

40.01923, -82.87934

40.00761, -75.23407

33.68906, -78.88669

32.85462, -79.97481

36.16589, -86.78444

30.26715, -97.74306

32.78306, -96.80667

29.76328, -95.36327

47.65966, -117.42908

-34.61315, -58.37723

-34.61315, -58.37723

-31.4135, -64.18105

-20.55722, -48.56778

-22.31472, -49.06056

-30.03306, -51.23

-23.5475, -46.63611

-23.5475, -46.63611

39.9075, 116.39723

30.5970699, 104.05106

29.6433899, 106.45187

41.7822799, 123.42179

39.14222, 117.17667

39.14222, 117.17667

27.99942, 120.66682

30.58333, 114.26667

34.2075699, 108.94631

51.48159, 11.97948

50.93333, 6.95

51.0303, 6.98432

53.86893, 10.68729

51.2504, 6.97536

43.46276, 11.88068

44.41344, 12.20121

41.89193, 12.51133

45.38193, 9.1559

45.07049, 7.68682

34.7300449, 135.4133985

37.88637, 139.00589

34.65, 133.93333

35.71667, 140.23333

35.6895, 139.69171

35.43333, 139.65

36.6266068, 127.4570629

35.87028, 128.59111

37.58944, 126.76917

35.056264, 127.0025403

37.566, 126.9784

37.566, 126.9784

35.3251513, 129.0068369

53.01375, 18.59814

51.1, 17.03333

40.4165, -3.70256

36.72016, -4.42034

41.54329, 2.10942

51.50853, -0.12574

53.48771, -2.29042

50.90395, -1.40428

51.90224, -0.20256

34.05223, -118.24368

37.77493, -122.41942

41.85003, -87.65005

32.77657, -79.93092

36.16589, -86.78444

32.78306, -96.80667

-38.00228, -57.55754

-22.90556, -47.06083

-25.42778, -49.27306

-12.97111, -38.51083

-23.5475, -46.63611

43.29789, 13.45293

45.46427, 9.18951

45.46427, 9.18951

41.89193, 12.51133

41.77583, 140.73667

53.13333, 23.16433

50.06143, 19.93658

51.25, 22.56667

41.45004, 2.24741

41.38879, 2.15899

40.4165, -3.70256

43.46472, -3.80444

37.38283, -5.97317

39.46975, -0.37739

-31.4135, -64.18105

51.20892, 3.22424

50.85045, 4.34878

50.965, 5.50082

51.05, 3.71667

50.94653, 3.12269

23.1323999, 113.288

50.63297, 3.05858

45.83153, 1.25781

43.29551, 5.38958

48.85341, 2.3488

43.5852, 1.5272

48.11198, -1.67429

48.87143, 2.22929

48.13743, 11.57549

35.70129, 139.98648

37.566, 126.9784

53.1235, 18.00762

49.78498, 22.76728

50.01381, 20.98698

52.4513, 20.96827

45.64861, 25.60613

44.42802, 26.09665

46.76667, 23.6

46.76667, 23.6

45.75372, 21.22571

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5

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