About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
Must provide informed consent as described in the protocol
Disqualifiers
Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
Previously received TAR-200 intravesically as part of a clinical trial(s)
Previously received greater than (>) 2 doses/cycles of TAR-200 in the real-world setting
Trial population
Participants aged 18 years or above with confirmed diagnosis of NMIBC (based on transurethral resection of bladder tumor \[TURBT\] or cold cup biopsy), who initiated the first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1 and willing to provide informed consent will be enrolled into the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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