Back to resultsA Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1)
Primary Purpose
Urinary Bladder Neoplasms
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAR-200
Cetrelimab
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of persistent or recurrent (carcinoma in situ [CIS] or Tumour in situ [Tis]), with or without papillary disease (T1, high-grade Ta) within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant (example, less than (<) 20 percent (%) variant histologic subtype). However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
- All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS acceptable) and documented in the electronic case report form (eCRF) at screening cystoscopy
- Participants must be ineligible for or have elected not to undergo radical cystectomy
- BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion Criteria:
- Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV
- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/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
- Participants with an active, known or suspected autoimmune disease. Participants with autoimmune disorders not requiring systemic treatment (example, skin conditions such as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll
- Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
- Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor
Sites / Locations
- Urological Associates of Southern Arizona, P.C.Recruiting
- University of Southern CaliforniaRecruiting
- The Urology Center of Colorado
- Foothills Urology - Golden OffRecruiting
- DuPage Medical GroupRecruiting
- Michigan Institute of UrologyRecruiting
- NYU Langone HealthRecruiting
- SUNY Upstate Medical UniversityRecruiting
- Associated Medical ProfessionalsRecruiting
- Levine Cancer InstituteRecruiting
- The Urology GroupRecruiting
- Urologic Consultants of Southeastern PennsylvaniaRecruiting
- Thomas Jefferson University
- Urology Associates, PCRecruiting
- Vanderbilt University Medical CenterRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Urology San Antonio ResearchRecruiting
- Spokane Urology
- Flinders Medical Centre
- Eastern Health Research
- Macquarie University HospitalRecruiting
- Algemeen Ziekenhuis Sint-JanRecruiting
- AZ St.-Jan Brugge-Oostende AVRecruiting
- Hopital ErasmeRecruiting
- Universitair Ziekenhuis GentRecruiting
- Algemeen Ziekenhuis DeltaRecruiting
- AZ NikolaasRecruiting
- Exdeo Clinical Research IncRecruiting
- William Osler Health SystemRecruiting
- Princess Margaret Hospital- UHNRecruiting
- McGill University Health CentreRecruiting
- Universite de SherbrookeRecruiting
- Polyclinique Bordeaux Nord AcquitaineRecruiting
- CHU GrenobleRecruiting
- Clinique Sainte MargueriteRecruiting
- Polyclinique de Limoges - Francois ChenieuxRecruiting
- Hôpital Edouard HerriotRecruiting
- Institut Paoli-CalmettesRecruiting
- CHU NîmesRecruiting
- Hôpital Universitaire Pitié-SalpêtrièreRecruiting
- Hopital Saint-LouisRecruiting
- Hopital Europeen Georges-PompidouRecruiting
- Groupe Hospitalier Diaconesses Croix Saint SimonRecruiting
- Hopital Bichat Claude BernardRecruiting
- Hopital PontchaillouRecruiting
- CHP Saint GregoireRecruiting
- Institut de Cancerologie Strasbourg Europe (ICANS)Recruiting
- Hopital FochRecruiting
- Hopital RangueilRecruiting
- Urologicum DuisburgRecruiting
- Klinikum Herne - UrologieRecruiting
- Urologische Partnerschaft Köln UPKRecruiting
- Matthias Schulze - GermanyRecruiting
- Urologie Neandertal Praxis MettmannRecruiting
- Universitätsklinikum MünsterRecruiting
- Schön Klinik Nürnberg FürthRecruiting
- Studienpraxis Urologie Nürtingen - GermanyRecruiting
- Urologische Praxis am Wasserturm - GermanyRecruiting
- Metropolitan General A.E.Recruiting
- Athens Medical CenterRecruiting
- Bioclinic - ThessalonikiRecruiting
- General Hospital of Thessaloniki G. GennimatasRecruiting
- Euromedica General ClinicRecruiting
- 'Papageorgiou' General Hospital of ThessalonikiRecruiting
- Azienda Ospedaliera Universitaria CareggiRecruiting
- Ospedale San MartinoRecruiting
- Ospedale San RaffaeleRecruiting
- Azienda Ospedaliero Universitaria PisanaRecruiting
- Azienda Ospedaliera Sant AndreaRecruiting
- Istituto Nazionale Tumori Regina ElenaRecruiting
- Azienda Ospedaliera Universitaria Città della Salute e della Scienza di TorinoRecruiting
- Ospedale di Circolo e Fondazione MacchiRecruiting
- Ospedale San BortoloRecruiting
- Aso Co.,Ltd Iizuka Hospital
- St.Marianna University HospitalRecruiting
- Nara Medical University HospitalRecruiting
- Kimitsu Chuo HospitalRecruiting
- Nagasaki University HospitalRecruiting
- JOHAS Osaka Rosai HospitalRecruiting
- Toranomon HospitalRecruiting
- Toyama University HospitalRecruiting
- Fujita Health University HospitalRecruiting
- University of Tsukuba HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Inje University Haeundae Paik HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- Keimyung University Dongsan HospitalRecruiting
- National Cancer CenterRecruiting
- Chonnam National University HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance HospitalRecruiting
- Gangnam Severance HospitalRecruiting
- The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
- Pusan National University Yangsan HospitalRecruiting
- NKI-AVL, AmsterdamRecruiting
- Catharina ZiekenhuisRecruiting
- Canisius-Wilhelmina ZiekenhuisRecruiting
- The Julius Center - Utrecht Science Park - StratenumRecruiting
- Hospital Garcia de OrtaRecruiting
- Chbv - Hosp. Infante D. PedroRecruiting
- Hosp. Sra. Da Oliveira - GuimaraesRecruiting
- Centro Hospitalar de Lisboa CentralRecruiting
- Fundação ChampalimaudRecruiting
- Hospital Beatriz Angelo
- Instituto Portugues de Oncologia do Porto Francisco GentilRecruiting
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Recruiting
- Centro Hospitalar de Trás os Montes e Alto-DouroRecruiting
- Hertzen Oncology Research Institute
- City Clinical Hospital #1
- Avicenna Medical Center
- A. Tsyb Medical Radiological Research Center
- BHI of Omsk region Clinical Oncology Dispensary
- Ultrasound Clinic 4D
- Saratov State Medical University
- Multifunctional clinical medical center 'Medical city'
- Bashkir State Medical University
- Hosp. Univ. A CoruñaRecruiting
- Hosp. Puerta Del MarRecruiting
- Hosp. Univ. Virgen de Las NievesRecruiting
- Hosp. de Jerez de La FronteraRecruiting
- Hosp. Univ. Ramon Y CajalRecruiting
- Hosp. Univ. 12 de OctubreRecruiting
- Hosp. Univ. La PazRecruiting
- Hosp. Univ. Hm MonteprincipeRecruiting
- Hosp. Virgen de La VictoriaRecruiting
- Corporacio Sanitari Parc TauliRecruiting
- Instituto Valenciano de OncologiaRecruiting
- Chernihivskyi oblasnyi onkolohichnyi dyspanser
- Asklepion LLC
- Sumy Regional Clinical Oncology Centre
- NHS Greater Glasgow and ClydeRecruiting
- Leeds Teaching Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: TAR-200 and Cetrelimab
Cohort 2: TAR-200
Cohort 3: Cetrelimab
Cohort 4: TAR-200 (Participants with Papillary Disease only)
Arm Description
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Outcomes
Primary Outcome Measures
Cohort 1, 2, and 3: Overall Complete Response (CR) Rate
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Cohort 4: Disease-free Survival (DFS)
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Secondary Outcome Measures
Cohort 1, 2, and 3: Duration of Response (DOR)
DOR is defined from the date of first CR achieved to the date of first evidence of recurrence or progression or death (whichever is earlier) for participants who achieve a CR.
Overall Survival (OS)
OS, defined as the time from the date of first dose of study treatment to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive.
Cohort 1, 2, and 4: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.
Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies
Serum concentration of anti-cetrelimab antibodies will be assessed using a validated immunoassay for anti-drug antibody (ADA) analysis.
Number of Participants with Anti-cetrelimab Antibodies
Number of participants with anti-cetrelimab antibodies will be reported.
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with 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).
Number of Participants with Adverse Events (AEs) by Severity Grades
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity grades 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.
Full Information
NCT ID
NCT04640623
First Posted
November 20, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04640623
Brief Title
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Acronym
SunRISe-1
Official Title
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
November 20, 2026 (Anticipated)
Study Completion Date
July 2, 2027 (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 evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: TAR-200 and Cetrelimab
Arm Type
Experimental
Arm Description
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).
Arm Title
Cohort 2: TAR-200
Arm Type
Experimental
Arm Description
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Arm Title
Cohort 3: Cetrelimab
Arm Type
Experimental
Arm Description
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
Arm Title
Cohort 4: TAR-200 (Participants with Papillary Disease only)
Arm Type
Experimental
Arm Description
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Intervention Type
Drug
Intervention Name(s)
TAR-200
Other Intervention Name(s)
JNJ-17000139, Gemcitabine-Releasing Intravesical System
Intervention Description
TAR-200 will be administered transuretherally.
Intervention Type
Biological
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Cetrelimab will be administered.
Primary Outcome Measure Information:
Title
Cohort 1, 2, and 3: Overall Complete Response (CR) Rate
Description
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Time Frame
Up to 5 years
Title
Cohort 4: Disease-free Survival (DFS)
Description
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Cohort 1, 2, and 3: Duration of Response (DOR)
Description
DOR is defined from the date of first CR achieved to the date of first evidence of recurrence or progression or death (whichever is earlier) for participants who achieve a CR.
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
OS, defined as the time from the date of first dose of study treatment to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive.
Time Frame
Up to 5 years
Title
Cohort 1, 2, and 4: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
Description
Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.
Time Frame
Up to Week 21
Title
Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies
Description
Serum concentration of anti-cetrelimab antibodies will be assessed using a validated immunoassay for anti-drug antibody (ADA) analysis.
Time Frame
Predose, up to 3 years
Title
Number of Participants with Anti-cetrelimab Antibodies
Description
Number of participants with anti-cetrelimab antibodies will be reported.
Time Frame
Predose, up to 3 years
Title
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
Description
EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).
Time Frame
Baseline, up to 3 years and 4 months
Title
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Description
EORTC QLQ-NMIBC24 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
Baseline, up to 3 years and 4 months
Title
Number of Participants with Adverse Events (AEs) by Severity Grades
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity grades 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
Participants must be ineligible for or have elected not to undergo radical cystectomy
BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion Criteria:
Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/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
Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor
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
Urological Associates of Southern Arizona, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Individual Site Status
Completed
Facility Name
Foothills Urology - Golden Off
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Recruiting
Facility Name
DuPage Medical Group
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2375
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Medical Professionals
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Completed
Facility Name
Urology Associates, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
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
Spokane Urology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Completed
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Completed
Facility Name
Eastern Health Research
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Completed
Facility Name
Macquarie University Hospital
City
Sydney
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Sint-Jan
City
Assebroek
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ St.-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hopital Erasme
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Exdeo Clinical Research Inc
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Individual Site Status
Recruiting
Facility Name
William Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital- UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Universite de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5H3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Polyclinique Bordeaux Nord Acquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Sainte Marguerite
City
Hyeres
ZIP/Postal Code
83400
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 Cedex 03
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nîmes
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Universitaire Pitié-Salpêtrière
City
Paris Cedex 13
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
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
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75877
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pontchaillou
City
Rennes cedex 9
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
CHP Saint Gregoire
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de Cancerologie Strasbourg Europe (ICANS)
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Herne - Urologie
City
Herne
ZIP/Postal Code
44625
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
Matthias Schulze - Germany
City
Markkleeberg
ZIP/Postal Code
04416
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
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Schön Klinik Nürnberg Fürth
City
Nürnberg
ZIP/Postal Code
90491
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienpraxis Urologie Nürtingen - Germany
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Recruiting
Facility Name
Urologische Praxis am Wasserturm - Germany
City
Würselen
ZIP/Postal Code
52146
Country
Germany
Individual Site Status
Recruiting
Facility Name
Metropolitan General A.E.
City
Holargos
ZIP/Postal Code
155 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
Athens Medical Center
City
Maroussi
ZIP/Postal Code
151 25
Country
Greece
Individual Site Status
Recruiting
Facility Name
Bioclinic - Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 22
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Thessaloniki G. Gennimatas
City
Thessaloniki
ZIP/Postal Code
54635
Country
Greece
Individual Site Status
Recruiting
Facility Name
Euromedica General Clinic
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Individual Site Status
Recruiting
Facility Name
'Papageorgiou' General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
TK 56403
Country
Greece
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50135
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aso Co.,Ltd Iizuka Hospital
City
Iizuka
ZIP/Postal Code
820-8501
Country
Japan
Individual Site Status
Completed
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nara Medical University Hospital
City
Kashihara-shi
ZIP/Postal Code
634-8522
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
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
JOHAS Osaka Rosai Hospital
City
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
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
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Tsukuba-Shi
ZIP/Postal Code
305-8520
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
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-896
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
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
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
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
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
Pusan National University Yangsan Hospital
City
Yangsan-si
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
NKI-AVL, Amsterdam
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
The Julius Center - Utrecht Science Park - Stratenum
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Chbv - Hosp. Infante D. Pedro
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hosp. Sra. Da Oliveira - Guimaraes
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Lisboa Central
City
Lisboa
ZIP/Postal Code
1150-199
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Fundação Champalimaud
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Completed
Facility Name
Instituto Portugues de Oncologia do Porto Francisco Gentil
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
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
Centro Hospitalar de Trás os Montes e Alto-Douro
City
Vila Real
ZIP/Postal Code
5000508
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hertzen Oncology Research Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
City Clinical Hospital #1
City
Nizhny Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Avicenna Medical Center
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
A. Tsyb Medical Radiological Research Center
City
Obninsk
ZIP/Postal Code
249031
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Ultrasound Clinic 4D
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Multifunctional clinical medical center 'Medical city'
City
Tyumen
ZIP/Postal Code
625041
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Bashkir State Medical University
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Puerta Del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez De La Frontera
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
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. Univ. Hm Monteprincipe
City
Madrid
ZIP/Postal Code
28660
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
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Chernihivskyi oblasnyi onkolohichnyi dyspanser
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Asklepion LLC
City
Kiev
ZIP/Postal Code
08173
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Sumy Regional Clinical Oncology Centre
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Individual Site Status
Terminated
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
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 and 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, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
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