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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: NMIBC Participants: Routine Clinical Practice Setting

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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