A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 302
- 主要终点
- To compare DFS between study arms
研究概览
简要总结
This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
详细描述
Participants will be randomized 1:1 to NDV-1 (sustained-release gemcitabine-docetaxel) after TURBT (Arm A) vs surveillance after TURBT (Arm B).
Participants in Arm A will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through Month 12, 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.
Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with NDV-1 (sustained-release gemcitabine-docetaxel) 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
- •Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR NMIBC.
- •Participants must have ≥ 1 IBCG risk factors: multiple tumors, early recurrence (Within 1 year), frequent recurrences (> 1 per year), tumor size (> 3 cm), failure of prior intravesical therapy.
- •Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method).
- •Patients with LG T1 may be eligible after repeat-TURBT (within 4 weeks of first TURBT) if the repeat pathology shows non-invasive (Ta or less) or no disease. Original and repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen. TURBT to occur within 4 months of screening. All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.
排除标准
- •Histologically confirmed diagnosis of HR NMIBC (including CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.
- •Has had urothelial carcinoma outside of the urinary bladder, (including prostatic urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study.
- •Participant has tumor(s) involving the prostatic urethra (ductal or stromal).
- •N+ and/or M+ per CT/MR urography.
研究组 & 干预措施
Arm A: NDV-01 (sustained-release gemcitabine-docetaxel)
Intervention with NDV-01 (sustained-release gemcitabine-docetaxel)
干预措施: NDV-01 (sustained-release gemcitabine-docetaxel) (Drug)
Arm B: surveillance
Surveillance with Cystoscopy, Urine Cytology, Biopsy (if indicated)
结局指标
主要结局
To compare DFS between study arms
时间窗: From date of randomization to at least 2 years of follow-up assessing for DFS events.
Time from randomization to either time of the first recurrence or progression, or death due to any cause, whichever occurs first. It is hypothesized that sustained local delivery of GEM and DOCE (via NDV-01) in participants with IR-NMIBC will result in longer DFS than achieved with observation after TURBT. Under the exponential distribution assumption for DFS, this translates into testing the statistical hypothesis that the hazard ratio is significantly less than 1.0. Primary endpoint will be tested using a one-sided 2.5% level of significance. This study will randomize 302 participants in a 1:1 randomization ratio. The primary efficacy analysis for DFS will be performed when approximately 133 DFS events have been observed. Assuming a 25% recurrence rate (hazard rate 0.14384) in the 2-year DFS in the treated arm, vs. a 40% recurrence rate (hazard rate 0.2554) in the control arm (i.e., a hazard ratio of 0.563 under the exponential distribution assumption for DFS, 53 vs. 80 events.
次要结局
未报告次要终点