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Non-Muscle Invasive Bladder NeoplasmsPhase 3SunRISe-5NCT06211764

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)

A Phase 3 study testing TAR-200, Mitomycin C and Gemcitabine in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 123 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Muscle Invasive Bladder Neoplasms
What is being tested?
TAR-200, Mitomycin C and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
123 sitesin 14 countries
Study dates
9 Apr 2024to 14 Apr 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

123 sites in 14 countries.

123 sites in 14 countries

United States29 sites

  • Urology Austin

    Austin, Texas, 78759

  • Centers for Advanced Urology LLC d b a MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Urology of Indiana

    Carmel, Indiana, 46032

  • Ralph H. Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401

  • Northwestern University

    Chicago, Illinois, 60611

  • UroPartners

    Chicago Ridge, Illinois, 60415

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • Houston Metro Urology

    Houston, Texas, 77027

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Genesis Research LLC 1

    Los Alamitos, California, 90720

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Low Country Urology Clinics

    North Charleston, South Carolina, 29406

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Florida Urology Partners

    Riverview, Florida, 33578

  • Comprehensive Urology

    Royal Oak, Michigan, 48073

  • University of California San Francisco

    San Francisco, California, 94158 2549

  • Spokane Urology

    Spokane, Washington, 99202

  • Specialty Clinical Research of St Louis

    St Louis, Missouri, 63141

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • Genesis Research LLC

    Torrance, California, 90503

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

China10 sites

  • Peking University First Hospital

    Beijing, 100034

  • West China School of Medicine/West China Hospital, Sichuan University

    Cheng Du Shi, 610041

  • Chongqing Cancer Hospital

    Chongqing, 400033

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300211

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325015

  • Tongji Medical College of Huazhong University Science Technology of Medicine Health Management

    Wuhan, 430032

  • Xi an Jiaotong University Hospital

    Xi'an, 710063

Other trials in China

Brazil9 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • NAIC Nair Antunes Instituto do Cancer

    Bauru, 17030-495

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    Campinas, 13083-872

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital da Bahia

    Salvador, 41810-011

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01323 900

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

Other trials in Brazil

Italy9 sites

  • Ospedale San Donato

    Arezzo, 52100

  • San Raffaele Hospital

    Milan, 20132

  • Istituto Dei Tumori Di Milano

    Milan, 20133

  • Ospedale Provinciale di Macerata

    Province of Macerata, 62100

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Universita Campus Bio-Medico di Roma

    Roma, 00128

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Poland9 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15 276

  • IN VIVO Sp. z o.o

    Bydgoszcz, 85 048

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30 688

  • Uniwersytecki Szpital Kliniczny nr 4

    Lublin, 20 090

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    Przemyśl, 37 700

  • Szpital Wojewodzki im Sw Lukasza SP ZOZ

    Tarnów, 33 100

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, 05-135

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53 413

Other trials in Poland

Spain9 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Fund. Puigvert

    Barcelona, 08025

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Hosp.Univ.Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

Japan8 sites

  • Funabashi Municipal Medical Center

    Funabashi Shi, 273 8588

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611

  • Hyogo Prefectural Amagasaki General Medical Center

    Hyōgo, 660-8550

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Toranomon Hospital

    Tokyo, 105-8470

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

South Korea8 sites

  • Chungbuk National University Hospital

    Chungcheongbuk Do, 28644

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • National Cancer Center

    Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

France7 sites

  • Hopital Claude Huriez

    Lille, 59000

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000

  • Institut Paoli Calmettes

    Marseille, 13009

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000

  • Hopital Foch

    Suresnes, 92150

Other trials in France

Germany6 sites

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum Halle Saale

    Halle, 06120

  • Klinikum Leverkusen gGmbH

    Leverkusen, 51375

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538

  • Urologie Neandertal Praxis Mettmann

    Mettmann, 40822

  • Klinikum der Universitaet Muenchen

    München, 81377

Other trials in Germany

Argentina5 sites

  • Clinica Santa Isabel

    Buenos Aires, C1406

  • Investigaciones Clinico Moleculares (ICM)

    CABA, C1425

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602

Other trials in Argentina

Belgium5 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Algemeen ziekenhuis Maria Middelares

    Ghent, 9000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

Romania5 sites

  • Centrul Medical Unirea SRL

    Brasov, 500091

  • Ponderas Academic Hospital

    Bucharest, 014142

  • Institutul Oncologic Ion Chiricuta

    Cluj-Napoca, 400015

  • Regina Maria

    Cluj-Napoca, 400117

  • Spitalul Clinic Judetean de Urgenta Pius Brinzeu

    Timișoara, 300723

Other trials in Romania

United Kingdom4 sites

  • St Bartholomews Hospital

    London, EC1A 7BE

  • Salford Royal Hospital

    Salford, M6 8HD

  • Southampton University Hospital

    Southampton, SO16 6YD

  • Lister Hospital

    Stevenage, SG1 4AB

Other trials in United Kingdom

About this study

Official title: 17000139BLC3004: 17000139BLC3004 [SunRISe-5] Ph III HR NMIBC BCG Exp/UR Pap (N=250)

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.

Being tested
TAR-200, Mitomycin C, Gemcitabine
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAR-200Drug

    Also called JNJ-17000139

    Participants will receive TAR-200 intravesically.

  • Mitomycin CDrug

    Participants will receive MMC intravesically.

  • GemcitabineDrug

    Participants will receive gemcitabine intravesically.

Study groups in NCT06211764
Study groupRoleWhat they receive
Group A: TAR-200ExperimentalParticipants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.
Receives: Drug: TAR-200
Group B: Mitomycin C (MMC) or GemcitabineActive comparatorParticipants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.
Receives: Drug: Mitomycin C; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 years 7 months

Secondary outcomes (12)

  1. 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.

    Measured: Up to 6 years 7 months

  2. 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.

    Measured: Up to 6 years 7 months

  3. Time to Disease Worsening (TTDW)

    TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).

    Measured: Up to 6 years 7 months

  4. 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.

    Measured: Up to 6 years 7 months

  5. Overall Survival (OS)

    OS is defined as the time from randomization to death, due to any cause.

    Measured: Up to 6 years 7 months

  6. DFS Rate at 12 and 24 Months

    DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.

    Measured: At 12 and 24 months

  7. 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.

    Measured: Up to 6 years 7 months

  8. 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.

    Measured: Up to 6 years 7 months

  9. 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.

    Measured: Up to 6 years 7 months

  10. 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).

    Measured: Up to 5 years

  11. 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).

    Measured: Up to 5 years

  12. 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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start9 Apr 2024
  3. Primary completion27 Nov 2030 (estimated)
  4. Study completion14 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211764
Sponsor's protocol ID
17000139BLC3004
Other IDs
17000139BLC3004, 2023-507685-10-00, 2023
Acronym
SunRISe-5
Status last verified
Nov 2026
First submitted
9 Jan 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAR-200, Mitomycin C and Gemcitabine in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 123 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, China, Brazil, Italy, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) (time frame: Up to 6 years 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06211764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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