Non-Muscle Invasive Bladder Neoplasms
Conditions
Interventions
Experimental: Group A: TAR-200
Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.
Drug: TAR-200
Participants will rec
Sponsors
Kitani Sumiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)] - Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded - Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC) - Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
Exclusion criteria
Exclusion criteria: - Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+) - Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded - A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL) - Indwelling catheters are not permitted; however, intermittent catheterization is acceptable - Previous treatment with TAR-200
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Disease-free Survival (DFS) DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [high grade (HG) Ta, any T1 or carcinoma in situ (CIS)], progression, or death due to any cause, whichever occurs first. [Time Frame: Up to 6 years 7 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. 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] 3. 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] 4. 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] 5. 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] 6. 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] 7. 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] 8. 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] 9. 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 urina | — |
Countries
Argentina, Belgium, Brazil, China, France, Germany, Italy, Japan, Korea Republic Of, Poland, Romania, Spain, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed