COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 11
- 主要终点
- high-grade recurrence-free survival
研究概览
简要总结
The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care of the participating treating urologists
- •One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed
- •°Any amount of maintenance BCG is allowed
- •In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment
- •An intravesical agent can include BCG or any other NMIBC treatment
- •Up to 15 months from the last instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by urinary cytology, imaging, or cystoscopy) within 12 months of last exposure to an intravesical agent.
- •In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care"
排除标准
- •Opting for treatment with radical cystectomy
- •Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC
- •Prior exposure to nadofaragene firadenovec
研究组 & 干预措施
Nadofaragene firadenovec
The patient will receive nadofaragene firadenovec.
干预措施: Nadofaragene Firadenovec (Drug)
Best usual care
For patients randomized to receive best usual care, the combination of intravesical GemDoce is the current standard of care at MSK for most patients with BCG failure.
干预措施: Docetaxel (Drug)
Best usual care
For patients randomized to receive best usual care, the combination of intravesical GemDoce is the current standard of care at MSK for most patients with BCG failure.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
high-grade recurrence-free survival
时间窗: up to 24 months
The time from the initiation of treatment to the detection of recurrence of high-grade bladder cancer (biopsy-proven intravesical recurrence or distant metastasis). Biopsy proven high grade intravesical recurrence will be based on the MSK pathology review of the bladder tissue samples.
次要结局
- Progression-free survival(up to 24 months)