A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 367
- 试验地点
- 154
- 主要终点
- Recurrence Free Survival (RFS)
研究概览
简要总结
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
详细描述
Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance after TURBT (Arm B).
Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.
Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. CT Urogram/MRU every 12 months.
Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A.
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
- •Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
- •Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
- •Solitary LG Ta >3 cm tumor
- •Multifocal LG Ta tumors
- •Primary and solitary HG Ta ≤3 cm tumor
- •LG T1 tumor
- •All visible disease removed by TURBT within 90 days of study randomization
- •Acceptable baseline organ function
排除标准
- •High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)
- •Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
- •Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
- •Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
- •Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)
研究组 & 干预措施
Cretostimogene after TURBT
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
干预措施: n-dodecyl-B-D-maltoside (Other)
Cretostimogene after TURBT
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
干预措施: Cretostimogene Grenadenorepvec (Drug)
Observation after TURBT
Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter surveillance.
Participants who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.
结局指标
主要结局
Recurrence Free Survival (RFS)
时间窗: 29 months
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT
次要结局
- Recurrence Free Survival (RFS) at 6 months, 12 months and 24 months(27 months (RFS at 6 months), 33 months (RFS at 12 months) and 45 months (RFS at 24 months))
- Incidence of Adverse Events(34 months)