NCT06390111撤回4 期
A Phase 4, Multi-center, Open Label Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment
研究概览
简要总结
In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation.
- •Diagnosed, as documented, with:
- •Low risk of disease progression as assessed at the discretion of the investigator
- •Previous Bacillus Calmette Guerin (BCG) therapy (BCG exposed) with no maximum limit to the amount of BCG administered
排除标准
- •Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive include but are not limited to:
- •Presence of lymphovascular invasion and / or micropapillary disease as shown in the histology of the biopsy sample
- •Subjects with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor
- •Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec
- •Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec
- •Clinically significant and unexplained elevated liver or renal function tests
- •History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded
研究组 & 干预措施
Nadofaragene Firadenovec
Experimental
Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments.
干预措施: nadofaragene firadenovec (Drug)
结局指标
主要结局
Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment
时间窗: at month 3
次要结局
- Maintenance of CR at months 12 after nadofaragene firadenovec retreatment(at 12 months after nadofaragene firadenovec retreatment)
- Durability of CR at months 9 after nadofaragene firadenovec retreatment(at 9 months after nadofaragene firadenovec retreatment)
- Durability of CR at months 12 after nadofaragene firadenovec retreatment(at 12 months after nadofaragene firadenovec retreatment)
- Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment(Up to12 months after nadofaragene firadenovec retreatment)
- Maintenance of CR at months 9 after nadofaragene firadenovec retreatment(at 9 months after nadofaragene firadenovec retreatment)
- Maintenance of CR at months 6 after nadofaragene firadenovec retreatment(at 6 months after nadofaragene firadenovec retreatment)
- Time to cystectomy(Up to 12 months after nadofaragene firadenovec retreatment)
- Pathological staging at cystectomy(Up to 12 months after nadofaragene firadenovec retreatment)
- Durability of CR at months 6 after nadofaragene firadenovec retreatment(at 6 months after nadofaragene firadenovec retreatment)
- Incidence of cystectomy(Up to 12 months after nadofaragene firadenovec retreatment)
研究者
研究点 (1)
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