A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

Recurrence-Free Survival (RFS)

RFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), or death due to any cause, whichever occurs first.

Time frame: Up to 6 years 7 months

Time to Next Intervention (TTNI)

TTNI will be measured as the time from randomization to the time of next intervention (localized or systemic) for the treatment of bladder cancer.

Time frame: Up to 6 years 7 months

Time to Disease Worsening (TTDW)

TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).

Time frame: Up to 6 years 7 months

Time to Progression (TTP)

TTP will be measured as the time from randomization to the time of first documented evidence of disease progression (that is, progression to muscle-invasive bladder cancer \[MIBC\] \[T greater than or equal to {\>=} 2\], lymph node disease \[N+\], or distant disease \[M+\]), or death due to disease progression, whichever occurs first.

Time frame: Up to 6 years 7 months

Overall Survival (OS)

OS is defined as the time from randomization to death, due to any cause.

Time frame: Up to 6 years 7 months

DFS Rate at 12 and 24 Months

DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.

Time frame: At 12 and 24 months

Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)

Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.

Time frame: Up to 6 years 7 months

Number of Participants With Change from Baseline in Laboratory Abnormalities

Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported.

Time frame: Up to 6 years 7 months

Number of Participants With Change from Baseline in Vital Signs Abnormalities

Number of participants with change from baseline in vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.

Time frame: Up to 6 years 7 months

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores

EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).

Time frame: Up to 5 years

Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much).

Time frame: Up to 5 years

Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores

Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported.

Time frame: Up to 5 years