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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Muscle Invasive Bladder Neoplasms
• Intervention / Treatment: Drug: TAR-200; Drug: Mitomycin C; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1406
    • Clinica Santa Isabel
  • CABA, Argentina, C1425
    • Investigaciones Clinico Moleculares (ICM)
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Córdoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • Mar del Plata, Argentina, B7602
    • Hospital Privado de La Comunidad
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint-Jan
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Ghent, Belgium, 9000
    • Algemeen Ziekenhuis Maria Middelares
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII
  • Bauru, Brazil, 17030-495
    • NAIC Nair Antunes Instituto do Cancer
  • Campinas, Brazil, 13083-872
    • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Porto Alegre, Brazil, 90020-090
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Salvador, Brazil, 41810-011
    • Hospital Da Bahia
  • São Paulo, Brazil, 01308 901
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01323 900
    • Real e Benemérita Associação Portuguesa de Beneficência
• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Cheng Du Shi, China, 610041
    • West China School of Medicine/West China Hospital, Sichuan University
  • Chongqing, China, 400033
    • Chongqing Cancer Hospital
  • Guangzhou, China, 510060
    • Sun Yat Sen University Cancer Center
  • Shenyang, China, 110055
    • Shengjing Hospital of China Medical University
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital
  • Tianjin, China, 300211
    • The Second Hospital of Tianjin Medical University
  • Wenzhou, China, 325015
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430032
    • Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
  • Xi'an, China, 710063
    • Xi an Jiaotong University Hospital
• France
  • Lille, France, 59000
    • Hôpital Claude Huriez
  • Limoges, France, 87000
    • Polyclinique de Limoges - Francois Chenieux
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Paris, France, 75018
    • APHP - Hopital Bichat - Claude Bernard
  • Quint-Fonsegrives, France, 31130
    • Clinique de la Croix du Sud
  • Rennes, France, 35000
    • Chu Rennes Hopital Pontchaillou
  • Suresnes, France, 92150
    • Hôpital Foch
• Germany
  • Cologne, Germany, 50937
    • Universitaetsklinikum Koeln
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle Saale
  • Leverkusen, Germany, 51375
    • Klinikum Leverkusen gGmbH
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • Mettmann, Germany, 40822
    • Urologie Neandertal Praxis Mettmann
  • München, Germany, 81377
    • Klinikum der Universitaet Muenchen
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato
  • Milan, Italy, 20132
    • San Raffaele Hospital
  • Milan, Italy, 20133
    • Istituto Dei Tumori Di Milano
  • Province of Macerata, Italy, 62100
    • Ospedale Provinciale di Macerata
  • Ravenna, Italy, 48121
    • Ospedale S. Maria Delle Croci
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena
  • Roma, Italy, 00128
    • Università Campus Bio-Medico di Roma
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
• Japan
  • Funabashi Shi, Japan, 273 8588
    • Funabashi Municipal Medical Center
  • Hakodate, Japan, 040 8611
    • Hakodate Goryoukaku Hospital
  • Hyōgo, Japan, 660-8550
    • Hyogo Prefectural Amagasaki General Medical Center
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Sakura, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
• Poland
  • Bialystok, Poland, 15 276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Bydgoszcz, Poland, 85 048
    • IN VIVO Sp. z o.o
  • Krakow, Poland, 30 688
    • Szpital Uniwersytecki w Krakowie
  • Lublin, Poland, 20 090
    • Uniwersytecki Szpital Kliniczny nr 4
  • Przemyśl, Poland, 37 700
    • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
  • Tarnów, Poland, 33 100
    • Szpital Wojewodzki im Sw Lukasza SP ZOZ
  • Torun, Poland, 87-100
    • MICS Centrum Medyczne Torun
  • Wieliszew, Poland, 05-135
    • Mazowiecki Szpital Onkologiczny
  • Wroclaw, Poland, 53 413
    • Dolnoslaskie Centrum Onkologii
• Romania
  • Brasov, Romania, 500091
    • Centrul Medical Unirea SRL
  • Bucharest, Romania, 014142
    • Ponderas Academic Hospital
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Ion Chiricuta
  • Cluj-Napoca, Romania, 400117
    • Regina Maria
  • Timișoara, Romania, 300723
    • Spitalul Clinic Judetean de Urgenta Pius Brinzeu
• South Korea
  • Chungcheongbuk Do, South Korea, 28644
    • Chungbuk National University Hospital
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Hospital
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital
• Spain
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08025
    • Fund. Puigvert
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28007
    • Hosp. Gral. Univ. Gregorio Maranon
  • Málaga, Spain, 29010
    • Hosp Virgen de La Victoria
  • Sabadell, Spain, 08208
    • Hosp.Univ.Parc Tauli
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • St Bartholomews Hospital
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
  • Stevenage, United Kingdom, SG1 4AB
    • Lister Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Los Alamitos, California, United States, 90720
      • Genesis Research LLC 1
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
    • San Francisco, California, United States, 94158 2549
      • University of California San Francisco
    • Torrance, California, United States, 90503
      • Genesis Research LLC
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Florida
    • Riverview, Florida, United States, 33578
      • Florida Urology Partners
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago Ridge, Illinois, United States, 60415
      • UroPartners
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Urology of Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Wichita Urology Group
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Comprehensive Urology
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Specialty Clinical Research of St Louis
  • New York
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Gahanna, Ohio, United States, 43230
      • Central Ohio Urology Group
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Centers for Advanced Urology LLC d b a MidLantic Urology
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson Veterans Affairs Medical Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
    • North Charleston, South Carolina, United States, 29406
      • Low Country Urology Clinics
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • Austin, Texas, United States, 78759
      • Urology Austin
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
  • Washington
    • Spokane, Washington, United States, 99202
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: TAR-200; Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.	Drug: TAR-200; Participants will receive TAR-200 intravesically.; Other Names: JNJ-17000139
Active Comparator: Group B: Mitomycin C (MMC) or Gemcitabine; Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.	Drug: Mitomycin C; Participants will receive MMC intravesically.; Drug: Gemcitabine; Participants will receive gemcitabine intravesically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-Free Survival (RFS)	RFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), or death due to any cause, whichever occurs first.	Up to 6 years 7 months
Time to Next Intervention (TTNI)	TTNI will be measured as the time from randomization to the time of next intervention (localized or systemic) for the treatment of bladder cancer.	Up to 6 years 7 months
Time to Disease Worsening (TTDW)	TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).	Up to 6 years 7 months
Overall Survival (OS)	OS is defined as the time from randomization to death, due to any cause.	Up to 6 years 7 months
DFS Rate at 12 and 24 Months	DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.	At 12 and 24 months
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)	Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.	Up to 6 years 7 months
Number of Participants With Change from Baseline in Laboratory Abnormalities	Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported.	Up to 6 years 7 months
Number of Participants With Change from Baseline in Vital Signs Abnormalities	Number of participants with change from baseline in vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.	Up to 6 years 7 months
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores	EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).	Up to 5 years
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores	EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much).	Up to 5 years
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores	Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported.	Up to 5 years
Time to Progression (TTP)	TTP will be measured as the time from randomization to the time of first documented evidence of disease progression (that is, progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node disease [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.	Up to 6 years 7 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): November 27, 2030
• Study Completion (Estimated): April 14, 2031

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Quinones; Azirines; Mitomycins; Indolequinones; Gemcitabine; Mitomycin
• Other Study ID Numbers: 17000139BLC3004 (Other Identifier: Janssen Research & Development, LLC); 2023-507685-10-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No