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

JRCT ID: jRCT2011240009

Registered date:23/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-Muscle Invasive Bladder Neoplasms
• Date of first enrollment: 15/07/2024
• Target sample size: 250
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,China,Japan,Czechia,Japan,France,Japan,Germany,Japan,Italy,Japan,Korea Republic Of,Japan,United Kingdom Of Great Britain,Japan,Mexico,Japan,Poland,Japan,Romania,Japan,Spain,Japan,United States Of America,Japan
• Study type: Interventional

Intervention(s)

"Group A: TAR-200 (JNJ-17000139)
Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.

Group B:Mitomycin C (MMC) or Gemcitabine
Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase."

Outcome(s)

Primary Outcome

"Disease-free Survival (DFS)
Up to 6 years 7 months
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."

Secondary Outcome

" - Recurrence-Free Survival (RFS):Up to 6 years 7 months
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 to Next Intervention (TTNI):Up to 6 years 7 months
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 to Disease Worsening (TTDW):Up to 6 years 7 months
TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).
- Time to Progression (TTP):Up to 6 years 7 months
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 [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.
- Overall Survival (OS):Up to 6 years 7 months
OS is defined as the time from randomization to death, due to any cause.
- DFS Rate at 12 and 24 Months:At 12 and 24 months
DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.
- Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE):Up to 6 years 7 months
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.
- Number of Participants With Change from Baseline in Laboratory Abnormalities:Up to 6 years 7 months
Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported.
- Number of Participants With Change from Baseline in Vital Signs Abnormalities:Up to 6 years 7 months
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.
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores:Up to 5 years
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).
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores:Up to 5 years
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).
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores:Up to 5 years
Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported."

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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"

Exclude 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"

Related Information

• Primary Sponsor: Fujikawa Ei
• Secondary ID(s): NCT06211764