A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
NCT06919965
Carcinoma, Female Urogenital Diseases
Sun City, Arizona, United States
View Trial DetailsNCT Number: NCT07309445
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).
Interested in participating?
Request Info18 year and older
All sexes
Observational
University of Alabama at Birmingham, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 24 months
DFS is defined as the time from first TAR-200 initiation date to the time of the first recurrence of NMIBC (Ta, any T1 or carcinoma in-situ [CIS)], 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), or death due NMIBC, whichever occurs first.
Time frame: At 3, 6, 12, 18, and 24 months
CR rate is defined as the percentage of participants achieving a CR at any time after the initial TAR-200 treatment. CR is defined as the total absence of NMIBC (both CIS and papillary) per investigator assessment.
Time frame: Up to 24 months
DOR is defined as the interval between the noted date of first complete response of any kind to TAR-200 and the date on which recurrence of NMIBC (Ta, any T1 or CIS), progressive disease or death due to NMIBC occurs, whichever occurs first.
Time frame: Up to 24 months
OS is defined as the interval between the date of the first TAR-200 administration and date of death due to any cause.
Time frame: Up to 24 months
CSS is defined as the interval between the date of the first TAR-200 insertion and date of death due to bladder cancer or if cause of death is unknown.
Time frame: Up to 24 months
TTNT is defined as the time difference from the first TAR-200 insertion date to the start date of next bladder cancer treatment.
Time frame: Up to 24 months
Radical cystectomy or bladder-intact survival is defined as the time from first TAR-200 insertion date to the date of the first evidence of radical cystectomy.
Time frame: Up to 24 months
Radical cystectomy or bladder-intact survival is defined as the time from first TAR-200 insertion date to the date of the first evidence of radical cystectomy.
Time frame: Up to 24 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. AE related to TAR-200 treatment and/or TAR-200 procedure (that is, insertion and removal of TAR-200 or its urinary placement catheter [UPC]) will be reported.
Time frame: Up to 24 months
Treatment patterns, including frequency, adherence, sequencing, and reasons for initiation, interruption, and discontinuation of treatment, and subsequent line of treatment (including re-treatment with TAR-200) will be reported.
Time frame: Up to 24 months
Time to TAR-200 discontinuation will be reported.
Time frame: Up to 24 months
Study dropout rate and reason for dropout from the study will be reported.
Time frame: Up to 24 months
Number of participants who adhered to treatment after follow-up reminders will be reported.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow Transurethral Resection of bladder tumor (TURBT) for papillary disease or cold cup biopsy for CIS only recurrence. DFS is defined as the time from first TAR-200 initiation date to the time of the first recurrence of NMIBC (Ta, any T1 or CIS), progression (to MIBC [T greater than or equal to {>=} 2] or to lymph node [N+] or to distant disease [M+], whichever occurs first), or death due to NMIBC, whichever occurs first.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for carcinoma in-situ (CIS) only recurrence. CR rate is defined as the percentage of participants achieving a CR at any time after the TAR-200 re-treatment. CR is defined as the total absence of NMIBC (both carcinoma in-situ [CIS] and papillary) per investigator assessment.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. DOR is defined as the interval between the noted date of first complete response of any kind to TAR-200 and the date on which recurrence of NMIBC (Ta, any T1 or CIS), progressive disease or death due to NMIBC occurs, whichever occurs first.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. OS is defined as the interval between the date of the first TAR-200 re-administration and date of death due to any cause.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. CSS is defined as the interval between the date of the TAR-200 re-insertion and date of death due to bladder cancer or if cause of death is unknown.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. TTNT is defined as the time difference from TAR-200 re-insertion date to the start date of next bladder cancer treatment.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. Radical cystectomy or bladder-intact survival is defined as the time from TAR-200 re-insertion date to the date of the first evidence of radical cystectomy.
Time frame: Up to 24 months
Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. Radical cystectomy or bladder-intact survival is defined as the time from TAR-200 re-insertion date to the date of the first evidence of radical cystectomy.
Contact information is provided by the study sponsor or research team.
Eliza M. Raymundo, MD, DMCC, FPUA, FPCS
CONTACT
Study Contact
CONTACT
Janssen Research & Development, LLC
Industry
A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US
Acronym: Nova-sTAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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