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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05714202
Registration number
NCT05714202
Ethics application status
Date submitted
27/01/2023
Date registered
6/02/2023
Titles & IDs
Public 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 (HR-NMIBC)
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Scientific 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
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Secondary ID [1]
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2020-004506-64
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Secondary ID [2]
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CR109223
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Universal Trial Number (UTN)
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Trial acronym
SunRISe-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAR-200
Treatment: Other - Cetrelimab
Treatment: Other - BCG Vesiculture
Experimental: Treatment Group A: TAR-200 + Cetrelimab - Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Active comparator: Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture - Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Experimental: Treatment Group C: TAR-200 Alone - Participants will receive intravesical TAR-200 alone once Q3W.
Treatment: Drugs: TAR-200
TAR-200 will be administered intravesically.
Treatment: Other: Cetrelimab
Cetrelimab will be administered.
Treatment: Other: BCG Vesiculture
BCG will be administered intravesically.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival (EFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 5 years 2 months
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Secondary outcome [1]
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Overall Complete Response (CR) Rate
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Assessment method [1]
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Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.
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Timepoint [1]
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Up to 5 years 2 months
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Secondary outcome [2]
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Duration of CR
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 5 years 2 months
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Secondary outcome [3]
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Recurrence-Free Survival (RFS)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 5 years 2 months
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Secondary outcome [4]
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Time to Progression (TTP)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 5 years 2 months
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is defined as the time from randomization to death, due to any cause.
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Timepoint [5]
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Up to 5 years 2 months
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Secondary outcome [6]
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Cancer Specific Survival (CSS)
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Assessment method [6]
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CSS is defined as the time from randomization to the date of death due to bladder cancer.
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Timepoint [6]
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Up to 5 years 2 months
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Secondary outcome [7]
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Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 5 years 2 months
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Secondary outcome [8]
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Number of Participants with Adverse Events (AEs)
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 5 years 2 months
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Secondary outcome [9]
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Number of Participants with Change from Baseline in Laboratory Abnormalities
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 5 years 2 months
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Secondary outcome [10]
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Number of Participants with Change from Baseline in Vital Signs Abnormalities
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Assessment method [10]
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Number of participants with change from baseline in vital signs (blood pressure \[systolic and diastolic\], heart rate, temperature, and weight) abnormalities will be reported.
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Timepoint [10]
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Up to 5 years 2 months
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Secondary outcome [11]
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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
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Assessment method [11]
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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).
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Timepoint [11]
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Up to 5 years 2 months
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Secondary outcome [12]
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Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores
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Assessment method [12]
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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).
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Timepoint [12]
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Up to 5 years 2 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
18/09/2029
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Actual
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Sample size
Target
1050
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Macquarie University Hospital - Macquarie University
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Hollywood Private Hospital - Nedlands
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Recruitment hospital [4]
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Mater Hospital Brisbane - South Brisbane
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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2109 - Macquarie University
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment outside Australia
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Freiburg
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Germany
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Köln
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Germany
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Markkleeberg
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Germany
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Mettmann
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Germany
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Muenster
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Germany
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München
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Germany
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Nuernberg
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Germany
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Nurnberg
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Germany
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Nürtingen
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Germany
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Regensburg
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Germany
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Tübingen
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Bangalore
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India
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India
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Gurugram
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India
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Kolkata
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India
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Mumbai
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India
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Pune
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Italy
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Acquaviva delle Fonti
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Italy
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Asti
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Italy
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Avellino
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Italy
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Castelfranco Veneto
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Italy
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Milano
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Italy
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Napoli
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Italy
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Ravenna
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Italy
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Rome
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Japan
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Kanazawa
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Japan
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Japan
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Kobe City
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Japan
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Japan
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Nagasaki-shi
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Japan
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Nagasaki-Shi
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Japan
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Japan
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Ube
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Japan
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Yokohama
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Korea, Republic of
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Busan
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Cheongju
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Daegu
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Seoul
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Mexico
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Ciudad de México
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Monterrey
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Mérida
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Mexico
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Hoofddorp
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Bialystok
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Bydgoszcz
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Lublin
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Piotrkow Trybunalski
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Poznan
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Slupsk
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Coimbra
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Portugal
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Lisboa
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Portugal
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Vila Nova de Gaia
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A Coruña
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Algeciras
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Barcelona
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Castellon
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Cádiz
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Spain
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L'Hospitalet de Llobregat
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Spain
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Lugo
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Santander
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Valencia
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Taichung
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Taipei
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Taoyuan
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Plymouth
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United Kingdom
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Scunthorpe
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United Kingdom
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Sheffield
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United Kingdom
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Stevenage
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT05714202
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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Contact person for public queries
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Study Contact
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Address
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Phone
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0
844-434-4210
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05714202