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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06319820
Registration number
NCT06319820
Ethics application status
Date submitted
13/03/2024
Date registered
20/03/2024
Date last updated
22/06/2025
Titles & IDs
Public title
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
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Scientific title
A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
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Secondary ID [1]
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42756493BLC3004
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Secondary ID [2]
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42756493BLC3004
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Universal Trial Number (UTN)
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Trial acronym
MoonRISe-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Muscle Invasive 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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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - TAR-210
Treatment: Drugs - Gemcitabine
Treatment: Drugs - MMC
Experimental: Group A: TAR-210 - Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Active comparator: Group B: MMC or Gemcitabine - Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Other interventions: TAR-210
TAR-210 will be administered intravesically.
Treatment: Drugs: Gemcitabine
Gemcitabine will be administered intravesically.
Treatment: Drugs: MMC
MMC will be administered intravesically.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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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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Disease Free Survival (DFS)
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Assessment method [1]
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DFS is measured as the time from randomization to the date of the first documented recurrence of non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
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Timepoint [1]
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From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)
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Secondary outcome [1]
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Time to next Treatment (TTNT)
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Assessment method [1]
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TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.
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Timepoint [1]
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From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)
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Secondary outcome [2]
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High Grade Recurrence-free Survival (HG RFS)
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Assessment method [2]
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HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first
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Timepoint [2]
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From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
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Secondary outcome [3]
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Progression Free Survival (PFS)
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Assessment method [3]
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PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.
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Timepoint [3]
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From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
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Secondary outcome [4]
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Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment
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Assessment method [4]
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Rate of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported.
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Timepoint [4]
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From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)
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Secondary outcome [5]
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Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)
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Assessment method [5]
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An AE is any untoward medical occurrence in a participant participating in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product, that does not necessarily have a causal relationship with the treatment. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening and Grade 5: Death. Number of participants with adverse events (including physical examination, vital signs and laboratory abnormalities) will be reported.
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Timepoint [5]
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From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS is defined as the time from randomization to the date of death from any cause.
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Timepoint [6]
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From randomization to the date of death (approximately 4 years and 2 months)
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Secondary outcome [7]
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European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
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Assessment method [7]
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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). Higher scores indicated greater severity.
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Timepoint [7]
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Baseline, Weeks 6, 12, 24, 36, and 48
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Secondary outcome [8]
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European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
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Assessment method [8]
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EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with 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). Higher scores indicated greater severity.
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Timepoint [8]
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Baseline, Weeks 6, 12, 24, 36, and 48
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Secondary outcome [9]
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Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores
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Assessment method [9]
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EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the 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). Higher scores indicated greater severity.
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Timepoint [9]
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Weeks 6, 12, 24, 36, and 48
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Secondary outcome [10]
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Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores
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Assessment method [10]
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EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with 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). Higher scores indicated greater severity.
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Timepoint [10]
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Weeks 6, 12, 24, 36, and 48
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Eligibility
Key inclusion criteria
* Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year), iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
* Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
* Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
* Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
* Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Have an Eastern Cooperative Oncology Group performance status of 0 to 2
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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
* Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
* Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
* Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
* Current indwelling urinary catheters, however, intermittent catheterization is acceptable
* Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
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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
18/04/2024
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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
28/06/2028
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Actual
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Sample size
Target
540
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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 outside Australia
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Rozzano
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Italy
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Torino
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Amagasaki shi
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Japan
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Kawasaki Shi
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Japan
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Osaka
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Ota
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Saitama
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Japan
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Wakayama
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Japan
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Yokohama
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Japan
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Yokosuka
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Chungcheongbuk Do
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Jeollanam-do
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Seoul
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Poland
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Bialystok
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Bydgoszcz
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Lublin
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Przemysl
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Tarnow
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Torun
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Wieliszew
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Wroclaw
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A Coruna
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Alzira
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Spain
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Barcelona
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Cadiz
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Castellon
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Spain
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Jerez De La Frontera
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Spain
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Madrid
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Spain
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Malaga
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Oviedo
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Sabadell
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Sevilla
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Valencia
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Bristol
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
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Sutton
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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 main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
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Trial website
https://clinicaltrials.gov/study/NCT06319820
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
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Address
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Johnson & Johnson Enterprise Innovation Inc.
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Contact person for public queries
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Study Contact
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Phone
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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
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/NCT06319820
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