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)

June 4, 2026 updated by: Janssen Research & Development, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Benemerita Associacao Portuguesa de Beneficencia
  • 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
        • Hopital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-free Survival (DFS)
Time Frame: Up to 6 years 7 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Up to 6 years 7 months
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)
Time Frame: Up to 6 years 7 months
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)
Time Frame: Up to 6 years 7 months
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)
Time Frame: Up to 6 years 7 months
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
Time Frame: 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)
Time Frame: Up to 6 years 7 months
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
Time Frame: Up to 6 years 7 months
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
Time Frame: Up to 6 years 7 months
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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)
Time Frame: Up to 6 years 7 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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