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) (SunRISe-3)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Biological: Cetrelimab; Drug: TAR-200; Biological: BCG Vesiculture

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.

• Study Type: Interventional
• Enrollment (Actual): 1135
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1199
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina, C1417
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • Córdoba, Argentina, X5016KEH
    • Hospital Privado Centro Médico de Córdoba
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Córdoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • Mar del Plata, Argentina, B7602CBM
    • Hospital Privado de La Comunidad
  • Río Cuarto, Argentina, 5800
    • Instituto Medico Río Cuarto
• Australia
  • Heidelberg, Australia, 3084
    • Austin Health
  • Macquarie University, Australia, 2109
    • Macquarie University Hospital
  • Nedlands, Australia, 6009
    • Hollywood Private Hospital
  • South Brisbane, Australia, 4101
    • Mater Hospital Brisbane
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Bruges, Belgium, 8000
    • AZ Sint-Jan
  • Bruges, Belgium, 8310
    • AZ Sint-Lucas
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Ghent, Belgium, 9000
    • UZ Gent
  • Libramont-Chevigny, Belgium, 6800
    • Centre Hospitalier de l'Ardenne
  • Roeselare, Belgium, 8800
    • AZ DELTA
  • Sint-Niklaas, Belgium, 9100
    • VITAZ
  • Wilrijk, Belgium, 2610
    • GZA Ziekenhuizen- Campus St Augustinus
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII
  • Bauru, Brazil, 17033-495
    • NAIC Nair Antunes Instituto do Cancer
  • Campinas, Brazil, 13083-888
    • Universidade Estadual de Campinas
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra o Câncer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Presidente Prudente, Brazil, 19013-050
    • Hospital Regional do Cancer - Hospital de Esperança
  • Salvador, Brazil, 41253 190
    • Hospital Sao Rafael
  • Santa Cruz do Sul, Brazil, 96835-090
    • Hospital Ana Nery Santa Cruz do Sul
  • Santo André, Brazil, 09060-870
    • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • São Paulo, Brazil, 01508-010
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01246 000
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 05652 900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 1321 001
    • Real e Benemérita Associação Portuguesa de Beneficência
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St Josephs Healthcare Hamilton
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Centre University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • CHUM - Centre hospitalier universitaire de Montreal
    • Québec, Quebec, Canada, G1J1Z4
      • CHU de Quebec Universite Laval Hopital de l Enfant Jesus
    • Saint Jerome Quebec, Quebec, Canada, J7Z 2V4
      • Unité de Recherche Clinique du CISSS des Laurentides
• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 101100
    • Beijing Luhe Hospital, Capital Medical University
  • Changchun, China, 130499
    • The First Bethune Hospital of Jilin University
  • Changsha, China, 410013
    • Hunan Province Cancer Hospital
  • Chengdu, China, 610044
    • West China Hospital Sichuan University
  • Chongqing, China, 400000
    • Chongqing University Cancer Hospital
  • Deyang, China, 618000
    • People's Hospital of Deyang City
  • Guangzhou, China, 430030
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310000
    • Zhejiang Provincial People's Hospital
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Ningbo, China, 315010
    • The first affiliated Hospital of Ningbo University
  • Shanghai, China, 200025
    • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
  • Shanghai, China, 200400
    • Huadong Hospital Affiliated to Fudan University
  • Shenyang, China, 110004
    • Shengjing Hospital of China Medical University
  • Tianjin, China, 300211
    • The Second Hospital of Tianjin Medical University
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430030
    • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Yantai, China, 264000
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Czechia
  • Brno, Czechia, 65691
    • Fakultni Nemocnice u sv. Anny v Brne
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Liberec, Czechia, 460 01
    • Krajska nemocnice Liberec a.s.
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 15006
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 140 59
    • Thomayerova nemocnice, Onkologicka klinika
• France
  • Bordeaux, France, 33000
    • Polyclinique Bordeaux Nord Acquitaine
  • Clermont-Ferrand, France, 63003
    • CHU Gabriel-Montpied
  • Grenoble, France, 38043
    • CHU Grenoble
  • Limoges, France, 87000
    • Polyclinique de Limoges - Francois Chenieux
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Nantes, France, 44093
    • CHU de Nantes Hotel Dieu
  • Nîmes, France, 30029
    • CHU Nîmes
  • Orléans, France, 45067
    • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
  • Paris, France, 75013
    • Hôpital Universitaire Pitié-Salpêtrière
  • Paris, France, 75018
    • APHP - Hopital Bichat - Claude Bernard
  • Paris, France, 75960
    • Groupe Hospitalier Diaconesses Croix Saint Simon
  • Quint-Fonsegrives, France, 31130
    • Clinical La Croix Du Sud - Ramsay Santé
  • Rennes, France, 35000
    • Chu Rennes Hopital Pontchaillou
  • Strasbourg, France, 67200
    • Institut de Cancerologie Strasbourg Europe ICANS
  • Toulouse, France, 31059
    • CHU Rangueil
• Germany
  • Cologne, Germany, 50968
    • Urologische Partnerschaft Koln UPK
  • Duisburg, Germany, 47169
    • Urologicum Duisburg
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Frankfurt am Main, Germany, 60590
    • Universitaetsklinikum Frankfurt
  • Freiburg im Breisgau, Germany, 79106
    • Universitaetsklinikum Freiburg
  • Markkleeberg, Germany, 04416
    • Matthias Schulze - Germany
  • Mettmann, Germany, 40822
    • Urologie Neandertal Praxis Mettmann
  • München, Germany, 81675
    • Klinikum rechts der Isar an der Technischen Universitat Munchen
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Nuremberg, Germany, 90419
    • Klinikum Nürnberg Nord
  • Nuremberg, Germany, 90491
    • Medizinisches Versorgungszentrum - Urologie
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie Nurtingen
  • Regensburg, Germany, 93053
    • Caritas-Krankenhaus St. Josef
  • Tübingen, Germany, 72076
    • Universität Tübingen
• India
  • Bangalore, India, 560027
    • Health Care Global Enterprises pvt Ltd
  • Chandigarh, India, 160012
    • Post Graduate Institute of Medical Education And Research PGIMER
  • Gurugram, India, 122001
    • Artemis hospital
  • Kolkata, India, 700094
    • Netaji Subhas chandra Bose Cancer Research Institute
  • Mumbai, India, 400012
    • Tata Memorial Hospital
  • Pune, India, 411040
    • CIMET s Inamdar Multispeciality Hospital
• Italy
  • Acquaviva delle Fonti, Italy, 70021
    • Generale Regionale F. Miulli
  • Asti, Italy, 14100
    • Ospedale Cardinal Massaia
  • Avellino, Italy, 83100
    • Ospedale San Giuseppe Moscati di Avellino
  • Castelfranco Veneto, Italy, 31033
    • Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia
  • Milan, Italy, 20132
    • Ospedale San Raffaele di Milano
  • Naples, Italy, 80138
    • Fondazione G Pascale Istituto Nazionale Tumori IRCCS
  • Ravenna, Italy, 48121
    • Ospedale S. Maria Delle Croci
  • Rome, Italy, 00128
    • Istituto Nazionale Tumori Regina Elena
• Japan
  • Fuji-shi, Japan, 417-8567
    • Fuji City General Hospital
  • Kanazawa, Japan, 920 8641
    • Kanazawa University Hospital
  • Kashihara-shi, Japan, 634-8522
    • Nara Medical University Hospital
  • Kisarazu-shi, Japan, 292-8535
    • Kimitsu Chuo Hospital
  • Kobe, Japan, 650 0047
    • Kobe City Medical Center General Hospital
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Nagano, Japan, 381-8551
    • Nagano Municipal Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagasaki, Japan, 852-8511
    • JRC Nagasaki Genbaku Hospital
  • Narashino-shi, Japan, 275-8580
    • Saiseikai Narashino Hospital
  • Toon-shi, Japan, 791-0295
    • Ehime University Hospital
  • Toyama, Japan, 930 0194
    • Toyama University Hospital
  • Ube, Japan, 755-8505
    • Yamaguchi University Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
• Mexico
  • Mexico City, Mexico, 14308
    • Consultorio Medico dentro del Hospital Angeles Acoxpa
  • Monterrey, Mexico, 64460
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Monterrey, Mexico, 64710
    • Avix Investigacion Clinica S C
  • Mérida, Mexico, 97000
    • EME RED Hospitalaria
  • San Luis Potosí City, Mexico, 78260
    • Oncológico Potosino
• Netherlands
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Gasthuis
  • Nijmegen, Netherlands, 6524 KD
    • Canisius-Wilhelmina Ziekenhuis
  • Nijmegen, Netherlands, 6525 GA
    • Radboud Umcn
• Poland
  • Bialystok, Poland, 15 276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Bydgoszcz, Poland, 85 048
    • IN VIVO Sp. z o.o
  • Lublin, Poland, 20 708
    • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
  • Piotrkow Trybunalski, Poland, 97 300
    • Centrum Medyczne
  • Poznan, Poland, 61 731
    • Clinical Research Center sp z o o MEDIC R s k
  • Słupsk, Poland, 76-200
    • Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Warsaw, Poland, 02-647
    • Provita Poliklinika
  • Wroclaw, Poland, 50 556
    • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
• Portugal
  • Coimbra, Portugal, 3000-075
    • Ipo Coimbra
  • Lisbon, Portugal, 1769 001
    • Uls Santa Maria - Hosp. Santa Maria
  • Vila Nova de Gaia, Portugal, 4434 502
    • Uls Gaia Espinho
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok 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, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Algeciras, Spain, 11207
    • Hosp. Punta de Europa
  • Barcelona, Spain, 08025
    • Fund. Puigvert
  • Cadiz, Spain, 11009
    • Hosp. Puerta Del Mar
  • Castellon, Spain, 12004
    • Hosp. Gral. Univ. de Castellon
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hosp. Univ. de Bellvitge
  • Lugo, Spain, 27003
    • Hosp. Univ. Lucus Augusti
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28027
    • Clinica Univ. de Navarra
  • Málaga, Spain, 29010
    • Hosp Virgen de La Victoria
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Chang Kung Memorial Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 33382
    • Linkou Chang Gung Memorial Hospital
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Trust
  • London, United Kingdom, EC1A 7BE
    • St Bartholomews Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Scunthorpe, United Kingdom, DN15 7BH
    • Scunthorpe General Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Stevenage, United Kingdom, SG1 4AB
    • Lister Hospital
  • Truro, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Long Beach, California, United States, 90822
      • VA Long Beach Health Care System
    • Los Alamitos, California, United States, 90720
      • Genesis Research, LLC - West Coast Urology
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Sacramento, California, United States, 95630
      • UC Davis Comprehensive Cancer Center
    • San Diego, California, United States, 92123
      • Genesis Research
    • Santa Monica, California, United States, 90404
      • Providence Saint Johns Cancer Institute
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Florida
    • Hialeah, Florida, United States, 33016
      • Urological Research Network
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic Department of Urology
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Lisle, Illinois, United States, 60532
      • Duly Health and Care
    • Quincy, Illinois, United States, 62301
      • Blessing Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Urology of Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology
  • Kansas
    • Merriam, Kansas, United States, 66204
      • AMR Kansas City Oncology
    • Wichita, Kansas, United States, 67226
      • Wichita Urology Group
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital & Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • The Urology Center, PC
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System MD Anderson Cancer Center at Cooper
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
    • New York, New York, United States, 10010
      • VA NY Harbor Healthcare System
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of NY
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Med Univ
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Vidant Urology - Greenville
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • 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
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Hospital
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • Austin, Texas, United States, 78745
      • Urology Austin
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
    • Salt Lake City, Utah, United States, 84148
      • George E. Wahlen VAMC
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology Of Virginia, Pllc
  • Washington
    • Spokane, Washington, United States, 99202
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group A: TAR-200 + Cetrelimab; Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.	Biological: Cetrelimab; Cetrelimab will be administered.; Other Names: JNJ-63723283; Drug: TAR-200; TAR-200 will be administered intravesically.; Other Names: JNJ-17000139
Experimental: Treatment Group C: TAR-200 Alone; Participants will receive intravesical TAR-200 alone once Q3W.	Drug: TAR-200; TAR-200 will be administered intravesically.; Other Names: JNJ-17000139
Active Comparator: Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture; Participants 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).	Biological: BCG Vesiculture; BCG will be administered intravesically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years 2 months
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.	Up to 5 years 2 months
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.	Up to 5 years 2 months
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.	Up to 5 years 2 months
Overall Survival (OS)	OS is defined as the time from randomization to death, due to any cause.	Up to 5 years 2 months
Cancer Specific Survival (CSS)	CSS is defined as the time from randomization to the date of death due to bladder cancer.	Up to 5 years 2 months
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.	Up to 5 years 2 months
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.	Up to 5 years 2 months
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.	Up to 5 years 2 months
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.	Up to 5 years 2 months
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).	Up to 5 years 2 months
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).	Up to 5 years 2 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): March 23, 2023
• Primary Completion (Estimated): September 18, 2029
• Study Completion (Estimated): September 18, 2029

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 6, 2023

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; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CR109223; 2020-004506-64 (EudraCT Number); 17000139BLC3002 (Other Identifier: Janssen Research & Development, LLC); 2023-507187-39-00 (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 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

Drug and device information, study documents

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