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).
Study Type
OBSERVATIONAL
Enrollment
150
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGArkansas Urology
Little Rock, Arkansas, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGColorado Clinical Research
Lakewood, Colorado, United States
RECRUITINGFlorida Urology Partners
Wimauma, Florida, United States
RECRUITINGAssociated Urological Specialists
Chicago Ridge, Illinois, United States
RECRUITINGIndiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITINGMichigan Institute of Urology
Troy, Michigan, United States
RECRUITINGSpecialty Clinical Research of St Louis
St Louis, Missouri, United States
RECRUITING...and 7 more locations
Disease-Free Survival (DFS)
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: Up to 24 months
Complete Response (CR) Rate
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: At 3, 6, 12, 18, and 24 months
Duration of Response (DOR)
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
Overall Survival (OS)
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
Cancer-Specific Survival (CSS)
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
Time to Next Treatment (TTNT)
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
Number of Participants with Radical Cystectomy (RC) /Bladder-Intact Survival
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
Time to RC /Bladder-Intact Survival
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
Number of Participants with Adverse Events (AEs)
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 for TAR-200
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
Time to TAR-200 discontinuation will be reported.
Time frame: Up to 24 months
Study Dropout Rate
Study dropout rate and reason for dropout from the study will be reported.
Time frame: Up to 24 months
Treatment Adherence: Impact of Follow-up Reminders
Number of participants who adhered to treatment after follow-up reminders will be reported.
Time frame: Up to 24 months
DFS After Re-Treatment with TAR-200
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
CR Rate After Re-treatment with TAR-200
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
DOR After Re-Treatment with TAR-200
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
OS After Re-Treatment with TAR-200
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
CSS After Re-Treatment with TAR-200
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
TTNT After Re-Treatment with TAR-200
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
Number of Participants with Radical cystectomy/ Bladder-Intact Survival After Re-Treatment with TAR-200
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
Time to RC /Bladder-Intact Survival After Re-Treatment with TAR-200
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
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