AzTrials
AzTrials

Bladder CancerPhase 3SunRISe-3NCT05714202

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

A Phase 3 study testing TAR-200, Cetrelimab and BCG Vesiculture in people with Bladder Cancer, run by Janssen Research & Development, LLC at 240 sites in 21 countries.

Active, not recruiting

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

Official record
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Trial summary

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
TAR-200, Cetrelimab and BCG Vesiculture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,135 participants
Where
240 sitesin 21 countries
Study dates
23 Mar 2023to 18 Sep 2029
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 initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
  • BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
  • All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
  • All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization
  • Participants must be willing to undergo all study procedures

Who cannot join

  • Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)
  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
  • Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. 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 (mL)
  • Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Trial locations and contacts

240 sites in 21 countries.

240 sites in 21 countries

United States51 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • The Emory Clinic Department of Urology

    Atlanta, Georgia, 30322

  • Urology Austin

    Austin, Texas, 78745

  • Centers for Advanced Urology LLC d b a MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Cooper Health System MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • Urology of Indiana

    Carmel, Indiana, 46032

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • Vidant Urology - Greenville

    Greenville, North Carolina, 27834

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

  • Urological Research Network

    Hialeah, Florida, 33016

  • Houston Metro Urology

    Houston, Texas, 77027

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • First Urology

    Jeffersonville, Indiana, 47130

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • Duly Health and Care

    Lisle, Illinois, 60532

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • VA Long Beach Health Care System

    Long Beach, California, 90822

  • Genesis Research, LLC - West Coast Urology

    Los Alamitos, California, 90720

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • AMR Kansas City Oncology

    Merriam, Kansas, 66204

  • University Of Minnesota

    Minneapolis, Minnesota, 55455

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • VA NY Harbor Healthcare System

    New York, New York, 10010

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

  • The Urology Center, PC

    Omaha, Nebraska, 68114

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • Blessing Hospital

    Quincy, Illinois, 62301

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95630

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • George E. Wahlen VAMC

    Salt Lake City, Utah, 84148

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Genesis Research

    San Diego, California, 92123

  • Providence Saint Johns Cancer Institute

    Santa Monica, California, 90404

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Spokane Urology

    Spokane, Washington, 99202

  • Associated Medical Professionals of Ny

    Syracuse, New York, 13210

  • SUNY Upstate Med Univ

    Syracuse, New York, 13210

  • Urology Of Virginia, Pllc

    Virginia Beach, Virginia, 23462

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

China22 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Hospital

    Beijing, 100730

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, 101100

  • The First Bethune Hospital of Jilin University

    Changchun, 130499

  • Hunan Province Cancer Hospital

    Changsha, 410013

  • West China Hospital Sichuan University

    Chengdu, 610044

  • Chongqing University Cancer Hospital

    Chongqing, 400000

  • People's Hospital of Deyang City

    Deyang, 618000

  • Sun Yat Sen University Cancer Center

    Guangzhou, 430030

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310000

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010

  • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

    Shanghai, 200025

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200400

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300211

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

France16 sites

  • Polyclinique Bordeaux Nord Acquitaine

    Bordeaux, 33000

  • CHU Gabriel-Montpied

    Clermont-Ferrand, 63003

  • CHU Grenoble

    Grenoble, 38043

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000

  • Hôpital Edouard Herriot

    Lyon, 69437

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • CHU Nimes

    Nîmes, 30029

  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

    Orléans, 45067

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, 75013

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75960

  • Clinical La Croix Du Sud - Ramsay Santé

    Quint-Fonsegrives, 31130

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200

  • CHU Rangueil

    Toulouse, 31059

Other trials in France

Germany15 sites

  • Urologische Partnerschaft Koln UPK

    Cologne, 50968

  • Urologicum Duisburg

    Duisburg, 47169

  • Universitatsklinikum Erlangen

    Erlangen, 91054

  • Universitatsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Matthias Schulze - Germany

    Markkleeberg, 04416

  • Urologie Neandertal Praxis Mettmann

    Mettmann, 40822

  • Klinikum rechts der Isar an der Technischen Universitat Munchen

    München, 81675

  • Universitatsklinikum Munster

    Münster, 48149

  • Klinikum Nurnberg Nord

    Nuremberg, 90419

  • Medizinisches Versorgungszentrum - Urologie

    Nuremberg, 90491

  • Studienpraxis Urologie Nurtingen

    Nürtingen, 72622

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

  • Universitat Tubingen

    Tübingen, 72076

Other trials in Germany

Brazil14 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • NAIC Nair Antunes Instituto do Cancer

    Bauru, 17033-495

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    Campinas, 13083-888

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Hospital Regional do Cancer Hospital de Esperanca

    Presidente Prudente, 19013-050

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Hospital Ana Nery Santa Cruz do Sul

    Santa Cruz do Sul, 96835-090

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-870

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 1321 001

Other trials in Brazil

Japan14 sites

  • Fuji City General Hospital

    Fuji-shi, 417-8567

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522

  • Kimitsu Chuo Hospital

    Kisarazu-shi, 292-8535

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Nagano Municipal Hospital

    Nagano, 381-8551

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • JRC Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Saiseikai Narashino Hospital

    Narashino-shi, 275-8580

  • Ehime University Hospital

    Toon-shi, 791-0295

  • Toyama University Hospital

    Toyama, 930 0194

  • Yamaguchi University Hospital

    Ube, 755-8505

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Spain13 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Punta de Europa

    Algeciras, 11207

  • Fund. Puigvert

    Barcelona, 08025

  • Hosp. Puerta Del Mar

    Cadiz, 11009

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004

  • Hosp. Univ. de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

  • Clinica Univ. de Navarra

    Madrid, 28027

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

South Korea12 sites

  • Pusan National University Hospital

    Busan, 49241

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • National Cancer Center

    Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Belgium9 sites

  • ZNA Middelheim

    Antwerp, 2020

  • AZ Sint-Jan

    Bruges, 8000

  • AZ Sint-Lucas

    Bruges, 8310

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • Centre Hospitalier de l'Ardenne

    Libramont-Chevigny, 6800

  • AZ Delta

    Roeselare, 8800

  • Vitaz

    Sint-Niklaas, 9100

  • GZA Ziekenhuizen- Campus St Augustinus

    Wilrijk, 2610

Other trials in Belgium

Italy9 sites

  • Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021

  • Ospedale Cardinal Massaia

    Asti, 14100

  • Ospedale San Giuseppe Moscati di Avellino

    Avellino, 83100

  • Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale

    Castelfranco Veneto, 31033

  • Ospedale San Raffaele di Milano

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80138

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00128

Other trials in Italy

Poland9 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15 276

  • IN VIVO Sp. z o.o

    Bydgoszcz, 85 048

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

    Lublin, 20 708

  • Centrum Medyczne

    Piotrkow Trybunalski, 97 300

  • Clinical Research Center sp z o o MEDIC R s k

    Poznan, 61 731

  • Wojewodzki Szpital Specjalistyczny im Janusza Korczaka

    Słupsk, 76-200

  • Provita Poliklinika

    Warsaw, 02-647

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 556

Other trials in Poland

United Kingdom9 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • St Bartholomews Hospital

    London, EC1A 7BE

  • The Royal Marsden NHS Trust

    London, SW3 6JJ

  • Charing Cross Hospital

    London, W6 8RF

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Scunthorpe General Hospital

    Scunthorpe, DN15 7BH

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF

  • Lister Hospital

    Stevenage, SG1 4AB

  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

Argentina7 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    Buenos Aires, C1417

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602CBM

  • Instituto Medico Rio Cuarto

    Río Cuarto, 5800

Other trials in Argentina

Czechia7 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Krajská nemocnice Liberec a.s.

    Liberec, 460 01

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Thomayerova nemocnice, Onkologicka klinika

    Prague, 140 59

  • Fakultni nemocnice v Motole

    Prague, 15006

Other trials in Czechia

Canada6 sites

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • St Josephs Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • CHUM - Centre hospitalier universitaire de Montreal

    Montreal, Quebec, H2X 3E4

  • CHU de Quebec Universite Laval Hopital de l Enfant Jesus

    Québec, Quebec, G1J1Z4

  • Unite de Recherche Clinique du CISSS des Laurentides

    Saint Jerome Quebec, Quebec, J7Z 2V4

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

India6 sites

  • Health Care Global Enterprises pvt Ltd

    Bangalore, 560027

  • Post Graduate Institute of Medical Education And Research PGIMER

    Chandigarh, 160012

  • Artemis Hospital

    Gurugram, 122001

  • Netaji Subhas chandra Bose Cancer Research Institute

    Kolkata, 700094

  • Tata Memorial Hospital

    Mumbai, 400012

  • CIMET s Inamdar Multispeciality Hospital

    Pune, 411040

Other trials in India

Taiwan6 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Kung Memorial Hospital

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33382

Other trials in Taiwan

Mexico5 sites

  • Eme Red Hospitalaria

    Mérida, 97000

  • Consultorio Medico dentro del Hospital Angeles Acoxpa

    Mexico City, 14308

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Avix Investigacion Clinica S C

    Monterrey, 64710

  • Oncologico Potosino

    San Luis Potosí City, 78260

Other trials in Mexico

Australia4 sites

  • Austin Health

    Heidelberg, 3084

  • Macquarie University Hospital

    Macquarie University, 2109

  • Hollywood Private Hospital

    Nedlands, 6009

  • Mater Hospital Brisbane

    South Brisbane, 4101

Other trials in Australia

Netherlands3 sites

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6524 KD

  • Radboud Umcn

    Nijmegen, 6525 GA

Other trials in Netherlands

Portugal3 sites

  • Ipo Coimbra

    Coimbra, 3000-075

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1769 001

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

About this study

Official title: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Read the detailed description

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

Conditions
Bladder Cancer
Being tested
TAR-200, Cetrelimab, BCG Vesiculture
Medical subject headings
Urinary 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

    TAR-200 will be administered intravesically.

  • CetrelimabBiological

    Also called JNJ-63723283

    Cetrelimab will be administered.

  • BCG VesicultureBiological

    BCG will be administered intravesically.

Study groups in NCT05714202
Study groupRoleWhat they receive
Treatment Group A: TAR-200 + CetrelimabExperimentalParticipants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Receives: Drug: TAR-200; Biological: Cetrelimab
Treatment Group B: Bacillus Calmette-Guerin (BCG) VesicultureActive comparatorParticipants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Receives: Biological: BCG Vesiculture
Treatment Group C: TAR-200 AloneExperimentalParticipants will receive intravesical TAR-200 alone once Q3W.
Receives: Drug: TAR-200

What is being measured

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

  1. Event-free Survival (EFS)

    EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.

    Measured: Up to 5 years 2 months

Secondary outcomes (12)

  1. Overall Complete Response (CR) Rate

    Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.

    Measured: Up to 5 years 2 months

  2. Duration of CR

    Duration of CR is defined from the time of first CR achieved to first evidence of recurrence, progression or death due to any cause (whichever occurs first) for participants who achieve a CR.

    Measured: Up to 5 years 2 months

  3. Recurrence-Free Survival (RFS)

    RFS is defined as the time from randomization to the time of the first recurrence of high-risk disease, or death due to any cause, whichever occurs first.

    Measured: Up to 5 years 2 months

  4. Time to Progression (TTP)

    TTP is defined as the time from randomization to the date of first documented evidence of disease progression or death due to disease progression, whichever occurs first.

    Measured: Up to 5 years 2 months

  5. Overall Survival (OS)

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

    Measured: Up to 5 years 2 months

  6. Cancer Specific Survival (CSS)

    CSS is defined as the time from randomization to the date of death due to bladder cancer.

    Measured: Up to 5 years 2 months

  7. Number of Participants with Adverse Events (AEs) by Grades 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 5 years 2 months

  8. Number of Participants with Adverse Events (AEs)

    Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

    Measured: Up to 5 years 2 months

  9. Number of Participants with Change from Baseline in Laboratory Abnormalities

    Number of participants with change from baseline in laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe, Grade 4- Life-threatening, and Grade 5- Death related to adverse event.

    Measured: Up to 5 years 2 months

  10. Number of Participants with Change from Baseline in Vital Signs Abnormalities

    Number of participants with change from baseline in vital signs (blood pressure [systolic and diastolic], heart rate, temperature, and weight) abnormalities will be reported.

    Measured: Up to 5 years 2 months

  11. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24

    EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the Health-related quality of life (HRQoL) of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the quality of life questionnaire (QLQ-C30) and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).

    Measured: Up to 5 years 2 months

  12. Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores

    EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).

    Measured: Up to 5 years 2 months

Timeline

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

  1. First posted6 Feb 2023
  2. Study start23 Mar 2023
  3. Primary completion18 Sep 2029 (estimated)
  4. Study completion18 Sep 2029 (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
1,135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05714202
Sponsor's protocol ID
CR109223
Other IDs
17000139BLC3002, 2020-004506-64, 2023-507187-39-00, 2023
Acronym
SunRISe-3
Status last verified
Sep 2026
First submitted
27 Jan 2023
Last updated
25 Sep 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 the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAR-200, Cetrelimab and BCG Vesiculture in people with Bladder Cancer, run by Janssen Research & Development, LLC at 240 sites in 21 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 6 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United States, China, France, Germany, Brazil and 16 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?

Event-free Survival (EFS) (time frame: Up to 5 years 2 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 NCT05714202.

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 25 Sep 2026.

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