A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Janssen Research & Development, LLC169 个研究点分布在 8 个国家目标入组 272 人2024年4月9日

干预措施TAR-200 Mitomycin C Gemcitabine

概览

阶段: 3 期
干预措施: TAR-200
疾病 / 适应症: 未指定
发起方: Janssen Research & Development, LLC
入组人数: 272
试验地点: 169
主要终点: Disease-free Survival (DFS)
状态: 进行中（未招募）
最后更新: 19天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

注册库

clinicaltrials.gov

开始日期

2024年4月9日

结束日期

2031年4月14日

最后更新

19天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Janssen Research & Development, LLC

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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-
•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

研究组 & 干预措施

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.

干预措施: TAR-200

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.

干预措施: Mitomycin C

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.

干预措施: Gemcitabine

结局指标

主要结局

Disease-free Survival (DFS)

时间窗: 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.

次要结局

Time to Disease Worsening (TTDW)(Up to 6 years 7 months)
Recurrence-Free Survival (RFS)(Up to 6 years 7 months)
Time to Next Intervention (TTNI)(Up to 6 years 7 months)
Time to Progression (TTP)(Up to 6 years 7 months)
Overall Survival (OS)(Up to 6 years 7 months)
DFS Rate at 12 and 24 Months(At 12 and 24 months)
Number of Participants With Change from Baseline in Laboratory Abnormalities(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(Up to 5 years)
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores(Up to 5 years)
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores(Up to 5 years)
Recurrence-Free Survival (RFS)(Up to 6 years 7 months)
Time to Next Intervention (TTNI)(Up to 6 years 7 months)
Time to Disease Worsening (TTDW)(Up to 6 years 7 months)
Time to Progression (TTP)(Up to 6 years 7 months)
Overall Survival (OS)(Up to 6 years 7 months)
DFS Rate at 12 and 24 Months(At 12 and 24 months)
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 Change from Baseline in Laboratory Abnormalities(Up to 6 years 7 months)
Number of Participants With Change from Baseline in Vital Signs Abnormalities(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(Up to 5 years)
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores(Up to 5 years)
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores(Up to 5 years)