A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Zusammenfassung

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Eignung

Studiendesign

Endpunkte

1. Primärer Endpunkt

   Disease Free Survival (DFS)

   DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.

   Zeitrahmen From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)

2. Sekundärer Endpunkt

   Time to next Treatment (TTNT)

   TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.

   Zeitrahmen From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)

3. Sekundärer Endpunkt

   High Grade Recurrence-free Survival (HG RFS)

   HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first

   Zeitrahmen From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)

4. Sekundärer Endpunkt

   Progression Free Survival (PFS)

   PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.

   Zeitrahmen From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)

5. Sekundärer Endpunkt

   Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment

   Number of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported.

   Zeitrahmen From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)

6. Sekundärer Endpunkt

   Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)

   An AE is any untoward medical occurrence in a participant participating in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product, that does not necessarily have a causal relationship with the treatment. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening and Grade 5: Death. Number of participants with adverse events (including physical examination, vital signs and laboratory abnormalities) will be reported.

   Zeitrahmen From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)

7. Sekundärer Endpunkt

   Overall Survival (OS)

   OS is defined as the time from randomization to the date of death from any cause.

   Zeitrahmen From randomization to the date of death (approximately 4 years and 2 months)

8. Sekundärer Endpunkt

   European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores

   EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 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). Higher scores indicated greater severity.

   Zeitrahmen Baseline, Weeks 6, 12, 24, 36, and 48

9. Sekundärer Endpunkt

   European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores

   EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

   Zeitrahmen Baseline, Weeks 6, 12, 24, 36, and 48

10. Sekundärer Endpunkt

    Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores

    EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the HRQoL of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 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). Higher scores indicated greater severity.

    Zeitrahmen Weeks 6, 12, 24, 36, and 48

11. Sekundärer Endpunkt

    Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores

    EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

    Zeitrahmen Weeks 6, 12, 24, 36, and 48

Daten

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