NCT06211764进行中（未招募）3 期
17000139BLC3004: 17000139BLC3004 [SunRISe-5] Ph III HR NMIBC BCG Exp/UR Pap (N=250)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
- 试验地点
- 170
- 主要终点
- Disease-free Survival (DFS)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 B: Mitomycin C (MMC) or Gemcitabine
Active Comparator
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 (Drug)
Group B: Mitomycin C (MMC) or Gemcitabine
Active Comparator
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 (Drug)
Group A: TAR-200
Experimental
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 (Drug)
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)
研究者
研究点 (170)
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相关资讯
J&J's TAR-200 Shows Promising Results in BCG-Unresponsive Bladder Cancer Trial• New data from Johnson & Johnson's Phase IIb SunRISe-1 trial demonstrates high response rates for TAR-200 in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer, with 82.4% achieving complete response.
• The drug-device combination, which continuously delivers gemcitabine directly to the bladder over a week, showed durable efficacy with 52.9% of responders maintaining complete response at one year and a median duration of response of 25.8 months.
• J&J has filed a New Drug Application with the FDA for TAR-200 in January 2025, which is being reviewed through the Real-Time Oncology Review program, potentially offering a new treatment option for a disease with few therapeutic advances in over 40 years.last yearTAR-200 Shows Promise in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer• TAR-200, a novel gemcitabine delivery system, is being evaluated as a bladder-sparing treatment for high-risk NMIBC after BCG failure.
• The SunRISe-5 phase III trial compares TAR-200 to intravesical chemotherapy in patients with recurrent, papillary-only high-risk NMIBC.
• Early data from a phase II trial combining gemcitabine and BCG shows high complete response rates in BCG-exposed NMIBC, warranting further investigation.
• A phase III trial, GAIN, is planned to further assess the gemcitabine and BCG combination in BCG-exposed NMIBC patients, with the trial opening in May 2025.last year