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
A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
2 other identifiers
interventional
272
14 countries
123
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
Longer than P75 for phase_3
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedStudy Start
First participant enrolled
April 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 14, 2031
April 13, 2026
April 1, 2026
6.6 years
January 9, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free Survival (DFS)
DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[high grade (HG) Ta, any T1 or carcinoma in situ (CIS)\], progression, or death due to any cause, whichever occurs first.
Up to 6 years 7 months
Secondary Outcomes (12)
Recurrence-Free Survival (RFS)
Up to 6 years 7 months
Time to Next Intervention (TTNI)
Up to 6 years 7 months
Time to Disease Worsening (TTDW)
Up to 6 years 7 months
Time to Progression (TTP)
Up to 6 years 7 months
Overall Survival (OS)
Up to 6 years 7 months
- +7 more secondary outcomes
Study Arms (2)
Group A: TAR-200
EXPERIMENTALParticipants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.
Group B: Mitomycin C (MMC) or Gemcitabine
ACTIVE COMPARATORParticipants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.
Interventions
Participants will receive TAR-200 intravesically.
Participants will receive MMC intravesically.
Participants will receive gemcitabine intravesically.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (123)
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Genesis Research LLC 1
Los Alamitos, California, 90720, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
University of California San Francisco
San Francisco, California, 94158 2549, United States
Genesis Research LLC
Torrance, California, 90503, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Florida Urology Partners
Riverview, Florida, 33578, United States
Northwestern University
Chicago, Illinois, 60611, United States
UroPartners
Chicago Ridge, Illinois, 60415, United States
Urology of Indiana
Carmel, Indiana, 46032, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
Comprehensive Urology
Royal Oak, Michigan, 48073, United States
Specialty Clinical Research of St Louis
St Louis, Missouri, 63141, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Central Ohio Urology Group
Gahanna, Ohio, 43230, United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Low Country Urology Clinics
North Charleston, South Carolina, 29406, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Urology Austin
Austin, Texas, 78759, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Spokane Urology
Spokane, Washington, 99202, United States
Clinica Santa Isabel
Buenos Aires, C1406, Argentina
Investigaciones Clinico Moleculares (ICM)
CABA, C1425, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Hospital Privado de la Comunidad
Mar del Plata, B7602, Argentina
AZ Sint-Jan
Bruges, 8000, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Algemeen ziekenhuis Maria Middelares
Ghent, 9000, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
NAIC Nair Antunes Instituto do Cancer
Bauru, 17030-495, Brazil
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
Campinas, 13083-872, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital da Bahia
Salvador, 41810-011, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308 901, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, 01323 900, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Peking University First Hospital
Beijing, 100034, China
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, 610041, China
Chongqing Cancer Hospital
Chongqing, 400033, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Shengjing Hospital Of China Medical University
Shenyang, 110055, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
The Second Hospital Of Tianjin Medical University
Tianjin, 300211, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325015, China
Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
Wuhan, 430032, China
Xi an Jiaotong University Hospital
Xi'an, 710063, China
Hopital Claude Huriez
Lille, 59000, France
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000, France
Institut Paoli Calmettes
Marseille, 13009, France
APHP - Hopital Bichat - Claude Bernard
Paris, 75018, France
Clinique de la Croix du Sud
Quint-Fonsegrives, 31130, France
Chu Rennes Hopital Pontchaillou
Rennes, 35000, France
Hopital Foch
Suresnes, 92150, France
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Halle Saale
Halle, 06120, Germany
Klinikum Leverkusen gGmbH
Leverkusen, 51375, Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, 23538, Germany
Urologie Neandertal Praxis Mettmann
Mettmann, 40822, Germany
Klinikum der Universitaet Muenchen
München, 81377, Germany
Ospedale San Donato
Arezzo, 52100, Italy
Ospedale Provinciale di Macerata
Macerata, 62100, Italy
San Raffaele Hospital
Milan, 20132, Italy
Istituto Dei Tumori Di Milano
Milan, 20133, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Universita Campus Bio-Medico di Roma
Roma, 00128, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Funabashi Municipal Medical Center
Funabashi Shi, 273 8588, Japan
Hakodate Goryoukaku Hospital
Hakodate, 040 8611, Japan
Hyogo Prefectural Amagasaki General Medical Center
Hyōgo, 660-8550, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
IN VIVO Sp. z o.o
Bydgoszcz, 85 048, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 30 688, Poland
Uniwersytecki Szpital Kliniczny nr 4
Lublin, 20 090, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37 700, Poland
Szpital Wojewodzki im Sw Lukasza SP ZOZ
Tarnów, 33 100, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, 05-135, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, 53 413, Poland
Centrul Medical Unirea SRL
Brasov, 500091, Romania
Ponderas Academic Hospital
Bucharest, 014142, Romania
Institutul Oncologic Ion Chiricuta
Cluj-Napoca, 400015, Romania
Regina Maria
Cluj-Napoca, 400117, Romania
Spitalul Clinic Judetean de Urgenta Pius Brinzeu
Timișoara, 300723, Romania
Chungbuk National University Hospital
Chungcheongbuk Do, 28644, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Fund. Puigvert
Barcelona, 08025, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Hosp.Univ.Parc Tauli
Sabadell, 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Southampton University Hospital
Southampton, SO16 6YD, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 18, 2024
Study Start
April 9, 2024
Primary Completion (Estimated)
November 27, 2030
Study Completion (Estimated)
April 14, 2031
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.