Non-Muscle Invasive Bladder Neoplasms
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Currently participating in an interventional bladder cancer clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTNT After Re-Treatment with TAR-200 | 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. |
| Number of Participants with Radical cystectomy/ Bladder-Intact Survival After Re-Treatment with TAR-200 | 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 to RC /Bladder-Intact Survival After Re-Treatment with TAR-200 | 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. |
| Complete Response (CR) Rate | 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. |
| Duration of Response (DOR) | 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. |
| Overall Survival (OS) | 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. |
| Cancer-Specific Survival (CSS) | 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 to Next Treatment (TTNT) | 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. |
| Number of Participants with Radical Cystectomy (RC) /Bladder-Intact Survival | 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 to RC /Bladder-Intact Survival | 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. |
| Number of Participants with Adverse Events (AEs) | 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. |
| Treatment Patterns for TAR-200 | 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 to TAR-200 Discontinuation | Up to 24 months | Time to TAR-200 discontinuation will be reported. |
| Study Dropout Rate | Up to 24 months | Study dropout rate and reason for dropout from the study will be reported. |
| Treatment Adherence: Impact of Follow-up Reminders | Up to 24 months | Number of participants who adhered to treatment after follow-up reminders will be reported. |
| DFS After Re-Treatment with TAR-200 | 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. |
| CR Rate After Re-treatment with TAR-200 | 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. |
| DOR After Re-Treatment with TAR-200 | 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. |
| CSS After Re-Treatment with TAR-200 | 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. |
| OS After Re-Treatment with TAR-200 | 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. |
Countries
United States
Contacts
CONTACTStudy Contact
CONTACTEliza M. Raymundo, MD, DMCC, FPUA, FPCS
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed