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).

A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States

Non-Muscle Invasive Bladder Neoplasms

Non-Muscle Invasive Bladder Cancer

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US

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.

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.

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.

OS is defined as the interval between the date of the first TAR-200 administration and date of death due to any cause.

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.

TTNT is defined as the time difference from the first TAR-200 insertion date to the start date of next bladder cancer treatment.

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.

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, 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 will be reported.

Study dropout rate and reason for dropout from the study will be reported.

Number of participants who adhered to treatment after follow-up reminders will be reported.

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.

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.

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.

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.

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.

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.

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.

Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study.

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).

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.

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.

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.

OS is defined as the interval between the date of the first TAR-200 administration and
date of death due to any cause.

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.

TTNT is defined as the time difference from the first TAR-200 insertion date to the start
date of next bladder cancer treatment.

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.

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, 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.

Number of participants who adhered to treatment after follow-up reminders will be
reported.

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.

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.

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.

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.

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.

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.

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.

Participants with confirmed diagnosis of NMIBC and who have initiated first dose of
TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study
visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200,
or until the participant dies, is lost to follow-up, or withdraws consent in the study.
No intervention will be administered as a part of this study.

A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States

Trials at a glance

Trials at a glance

A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States

Outcome measures

Primary outcome measures

Secondary outcome measures