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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 (SunRISe-3)

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAR-200
Cetrelimab
BCG Vesiculture
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas UrologyRecruiting
  • Genesis Research, LLC - West Coast UrologyRecruiting
  • Genesis ResearchRecruiting
  • Providence Medical FoundationRecruiting
  • Colorado Clinical ResearchRecruiting
  • Urological Research NetworkRecruiting
  • Blessing HospitalRecruiting
  • Urology of IndianaRecruiting
  • First UrologyRecruiting
  • AMR Kansas City OncologyRecruiting
  • Wichita Urology GroupRecruiting
  • Chesapeake Urology Research AssociatesRecruiting
  • The Urology Center, PCRecruiting
  • Associated Medical Professionals of NyRecruiting
  • SUNY Upstate Med UnivRecruiting
  • Vidant Urology - GreenvilleRecruiting
  • Centers for Advanced Urology, LLC; d/b/a MidLantic UrologyRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Urology AssociatesRecruiting
  • Houston Metro UrologyRecruiting
  • Urology San Antonio ResearchRecruiting
  • George E. Wahlen VAMCRecruiting
  • Urology Of Virginia, PllcRecruiting
  • Spokane UrologyRecruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Sociedade Beneficente de Senhoras - Hospital Sírio LibanêsRecruiting
  • Centro Urologico Profesor BengioRecruiting
  • Hospital Privado - Centro Medico de CordobaRecruiting
  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion ClinicaRecruiting
  • Hospital Privado de la ComunidadRecruiting
  • Instituto Médico Río CuartoRecruiting
  • Austin HealthRecruiting
  • Macquarie University HospitalRecruiting
  • Hollywood Private HospitalRecruiting
  • Mater Hospital BrisbaneRecruiting
  • ZNA MiddelheimRecruiting
  • AZ Sint-JanRecruiting
  • AZ Maria MiddelaresRecruiting
  • UZ GentRecruiting
  • Centre Hospitalier de l'ArdenneRecruiting
  • AZ DeltaRecruiting
  • VitazRecruiting
  • GZA Ziekenhuizen- Campus St AugustinusRecruiting
  • Fundacao Pio XIIRecruiting
  • NAIC - Nair Antunes Instituto do CâncerRecruiting
  • Universidade Estadual De CampinasRecruiting
  • Liga Paranaense de Combate ao CancerRecruiting
  • Hospital Regional do Câncer - Hospital de EsperançaRecruiting
  • Hospital Ana Nery Santa Cruz do SulRecruiting
  • Real e Benemérita Associação Portuguesa de BeneficênciaRecruiting
  • Fundacao Antonio Prudente - A.C. Camargo Cancer CenterRecruiting
  • Nova Scotia Health AuthorityRecruiting
  • St Josephs Healthcare HamiltonRecruiting
  • Princess Margaret Cancer Centre University Health NetworkRecruiting
  • CHUM - Centre hospitalier universitaire de MontrealRecruiting
  • CHU de Quebec-Universite Laval-Hopital de l'Enfant-JesusRecruiting
  • Peking University First HospitalRecruiting
  • Beijing Luhe Hospital, Capital Medical UniversityRecruiting
  • The First Bethune Hospital of Jilin UniversityRecruiting
  • West China Hospital Sichuan UniversityRecruiting
  • Chongqing University Cancer HospitalRecruiting
  • People's Hospital of Deyang CityRecruiting
  • Sun Yat-Sen University Cancer CenterRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • The First Affiliated Hospital of Ningbo UniversityRecruiting
  • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of MedicineRecruiting
  • Huadong Hospital Affiliated to Fudan UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • The Second Hospital of Tianjin Medical UniversityRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & TechnologyRecruiting
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong UniversityRecruiting
  • Yantai Yuhuangding HospitalRecruiting
  • Fakultni nemocnice u sv. Anny v BrneRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Krajská nemocnice Liberec a.s.Recruiting
  • Fakultní nemocnice OlomoucRecruiting
  • Fakultni nemocnice v MotoleRecruiting
  • Thomayerova nemocnice, Onkologicka klinikaRecruiting
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • Polyclinique Bordeaux Nord AcquitaineRecruiting
  • CHU Gabriel-MontpiedRecruiting
  • CHU GrenobleRecruiting
  • Polyclinique de Limoges - Francois ChenieuxRecruiting
  • Hôpital Edouard HerriotRecruiting
  • CHU de Nantes hotel-DieuRecruiting
  • CHU NîmesRecruiting
  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La SourceRecruiting
  • Groupe Hospitalier Diaconesses Croix Saint SimonRecruiting
  • Hopital Europeen Georges-PompidouRecruiting
  • APHP - Hopital Bichat - Claude BernardRecruiting
  • Clinical La Croix Du Sud - Ramsay SantéRecruiting
  • Chu Rennes - Hopital PontchaillouRecruiting
  • CHU RangueilRecruiting
  • Urologicum DuisburgRecruiting
  • Universitätsklinikum ErlangenRecruiting
  • Universitatsklinikum EssenRecruiting
  • Universitaetsklinikum FrankfurtRecruiting
  • Urologische Partnerschaft Köln UPKRecruiting
  • Urologie Neandertal Praxis MettmannRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Klinikum Nürnberg Nord - HautklinikRecruiting
  • Medizinisches Versorgungszentrum - UrologieRecruiting
  • Studienpraxis Urologie NürtingenRecruiting
  • Caritas-Krankenhaus St. JosefRecruiting
  • Universität TübingenRecruiting
  • Health Care Global Enterprises pvt LtdRecruiting
  • Artemis HospitalRecruiting
  • Netaji Subhas chandra Bose Cancer Research InstituteRecruiting
  • CIMET's Inamdar Multispeciality HospitalRecruiting
  • Generale Regionale F. MiulliRecruiting
  • Ospedale Cardinal MassaiaRecruiting
  • Ospedale San Giuseppe Moscati di AvellinoRecruiting
  • Ospedale San Giacomo Apostolo, Guardia pediatrica territorialeRecruiting
  • Ospedale San Raffaele di MilanoRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • Fondazione G. Pascale - Istituto Nazionale Tumori IRCCSRecruiting
  • Ospedale S. Maria Delle CrociRecruiting
  • Istituto Nazionale Tumori Regina ElenaRecruiting
  • Fuji City General HospitalRecruiting
  • Kimitsu Chuo HospitalRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Nagano Municipal HospitalRecruiting
  • JRC Nagasaki Genbaku HospitalRecruiting
  • Saiseikai Narashino HospitalRecruiting
  • Toyama University HospitalRecruiting
  • Yamaguchi University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Pusan National University HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • National Cancer CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
  • IN VIVO Sp. z o.oRecruiting
  • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZRecruiting
  • Centrum MedyczneRecruiting
  • Clinical Research Center sp. z o.o MEDIC-R s.k.Recruiting
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,Recruiting
  • Provita PoliklinikaRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Recruiting
  • Hosp. Univ. A CoruñaRecruiting
  • Hosp. Punta de EuropaRecruiting
  • Fundacion PuigvertRecruiting
  • Hosp. Gral. Univ. De CastellonRecruiting
  • Hosp. Puerta Del MarRecruiting
  • Hosp. Univ. de BellvitgeRecruiting
  • Hosp. Univ. Lucus AugustiRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. La PazRecruiting
  • Hosp. Virgen de La VictoriaRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Hosp. Clinico Univ. de ValenciaRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Chang Kung Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Linkou Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Treatment Group A: TAR-200 + Cetrelimab

Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture

Treatment Group C: TAR-200 Alone

Arm Description

Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.

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).

Participants will receive intravesical TAR-200 alone once Q3W.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Overall Survival (OS)
OS is defined as the time from randomization to death, due to any cause.
Cancer Specific Survival (CSS)
CSS is defined as the time from randomization to the date of death due to bladder cancer.
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.
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.
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.
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.
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).
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).

Full Information

First Posted
January 27, 2023
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05714202
Brief Title
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
Acronym
SunRISe-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
May 9, 2030 (Anticipated)
Study Completion Date
May 23, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 C) versus intravesical BCG (Group B).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A: TAR-200 + Cetrelimab
Arm Type
Experimental
Arm Description
Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Arm Title
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Treatment Group C: TAR-200 Alone
Arm Type
Experimental
Arm Description
Participants will receive intravesical TAR-200 alone once Q3W.
Intervention Type
Drug
Intervention Name(s)
TAR-200
Other Intervention Name(s)
JNJ-17000139
Intervention Description
TAR-200 will be administered intravesically.
Intervention Type
Biological
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Cetrelimab will be administered.
Intervention Type
Biological
Intervention Name(s)
BCG Vesiculture
Intervention Description
BCG will be administered intravesically.
Primary Outcome Measure Information:
Title
Event-free Survival (EFS)
Description
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.
Time Frame
Up to 5 years 2 months
Secondary Outcome Measure Information:
Title
Overall Complete Response (CR) Rate
Description
Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.
Time Frame
Up to 5 years 2 months
Title
Duration of CR
Description
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.
Time Frame
Up to 5 years 2 months
Title
Recurrence-Free Survival (RFS)
Description
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.
Time Frame
Up to 5 years 2 months
Title
Time to Progression (TTP)
Description
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.
Time Frame
Up to 5 years 2 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death, due to any cause.
Time Frame
Up to 5 years 2 months
Title
Cancer Specific Survival (CSS)
Description
CSS is defined as the time from randomization to the date of death due to bladder cancer.
Time Frame
Up to 5 years 2 months
Title
Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
Description
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.
Time Frame
Up to 5 years 2 months
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to 5 years 2 months
Title
Number of Participants with Change from Baseline in Laboratory Abnormalities
Description
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.
Time Frame
Up to 5 years 2 months
Title
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Description
Number of participants with change from baseline in vital signs (blood pressure [systolic and diastolic], heart rate, temperature, and weight) abnormalities will be reported.
Time Frame
Up to 5 years 2 months
Title
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
Description
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).
Time Frame
Up to 5 years 2 months
Title
Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores
Description
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).
Time Frame
Up to 5 years 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Research, LLC - West Coast Urology
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Urological Research Network
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Blessing Hospital
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Individual Site Status
Recruiting
Facility Name
AMR Kansas City Oncology
City
Merriam
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Individual Site Status
Recruiting
Facility Name
Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Individual Site Status
Recruiting
Facility Name
The Urology Center, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Medical Professionals of Ny
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Upstate Med Univ
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
Vidant Urology - Greenville
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Centers for Advanced Urology, LLC; d/b/a MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
George E. Wahlen VAMC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology Of Virginia, Pllc
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Name
Spokane Urology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
Buenos Aires
ZIP/Postal Code
C1417
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Urologico Profesor Bengio
City
Cordoba
ZIP/Postal Code
X5000KPH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Privado - Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Privado de la Comunidad
City
Mar del Plata
ZIP/Postal Code
B7602CBM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Médico Río Cuarto
City
Rio Cuarto
ZIP/Postal Code
5800
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Macquarie University Hospital
City
Macquarie University
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hollywood Private Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mater Hospital Brisbane
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Ardenne
City
Libramont-Chevigny
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vitaz
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GZA Ziekenhuizen- Campus St Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
NAIC - Nair Antunes Instituto do Câncer
City
Bauru
ZIP/Postal Code
17033-495
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Universidade Estadual De Campinas
City
Campinas
ZIP/Postal Code
13083-888
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Regional do Câncer - Hospital de Esperança
City
Presidente Prudente
ZIP/Postal Code
19013-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Ana Nery Santa Cruz do Sul
City
Santa Cruz Do Sul
ZIP/Postal Code
96835-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
Sao Paulo
ZIP/Postal Code
1321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01508-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
St Josephs Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHUM - Centre hospitalier universitaire de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Quebec-Universite Laval-Hopital de l'Enfant-Jesus
City
Quebec
ZIP/Postal Code
G1J1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
101100
Country
China
Individual Site Status
Recruiting
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130499
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital Sichuan University
City
Chengdu
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Deyang City
City
Deyang City
ZIP/Postal Code
618000
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen University Cancer Center
City
GuangZhou
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Ningbo University
City
Ningbo
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200400
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xian
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Krajská nemocnice Liberec a.s.
City
Liberec
ZIP/Postal Code
460 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole
City
Prague
ZIP/Postal Code
15006
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Thomayerova nemocnice, Onkologicka klinika
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Polyclinique Bordeaux Nord Acquitaine
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Gabriel-Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
Polyclinique de Limoges - Francois Chenieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nîmes
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
PARIS cedex 20
ZIP/Postal Code
75960
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Europeen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
APHP - Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical La Croix Du Sud - Ramsay Santé
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47169
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Urologische Partnerschaft Köln UPK
City
Köln
ZIP/Postal Code
50968
Country
Germany
Individual Site Status
Recruiting
Facility Name
Urologie Neandertal Praxis Mettmann
City
Mettmann
ZIP/Postal Code
40822
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Nürnberg Nord - Hautklinik
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinisches Versorgungszentrum - Urologie
City
Nurnberg
ZIP/Postal Code
90491
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienpraxis Urologie Nürtingen
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Recruiting
Facility Name
Caritas-Krankenhaus St. Josef
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universität Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Health Care Global Enterprises pvt Ltd
City
Bangalore
ZIP/Postal Code
560027
Country
India
Individual Site Status
Recruiting
Facility Name
Artemis Hospital
City
Gurugram
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Netaji Subhas chandra Bose Cancer Research Institute
City
Kolkata
ZIP/Postal Code
700094
Country
India
Individual Site Status
Recruiting
Facility Name
CIMET's Inamdar Multispeciality Hospital
City
Pune
ZIP/Postal Code
411040
Country
India
Individual Site Status
Recruiting
Facility Name
Generale Regionale F. Miulli
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Cardinal Massaia
City
Asti
ZIP/Postal Code
14100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Giuseppe Moscati di Avellino
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale
City
Castelfranco Veneto
ZIP/Postal Code
31033
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele di Milano
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale S. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fuji City General Hospital
City
Fuji-shi
ZIP/Postal Code
417-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kimitsu Chuo Hospital
City
Kisarazu-shi
ZIP/Postal Code
292-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe City
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagano Municipal Hospital
City
Nagano-shi
ZIP/Postal Code
381-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
JRC Nagasaki Genbaku Hospital
City
Nagasaki-Shi
ZIP/Postal Code
852-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saiseikai Narashino Hospital
City
Narashino-shi
ZIP/Postal Code
275-8580
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama University Hospital
City
Toyama-shi
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaguchi University Hospital
City
Ube
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Name
IN VIVO Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
City
Lublin
ZIP/Postal Code
20-708
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne
City
Piotrkow Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center sp. z o.o MEDIC-R s.k.
City
Poznan
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Provita Poliklinika
City
Warszawa
ZIP/Postal Code
02-647
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Punta de Europa
City
Algeciras
ZIP/Postal Code
11207
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundacion Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Gral. Univ. De Castellon
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Puerta Del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Bellvitge
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Kung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33382
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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