NCT04149574终止3 期
A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG
Bristol-Myers Squibb63 个研究点 分布在 14 个国家目标入组 13 人开始时间: 2020年1月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 63
- 主要终点
- Part 2: Event Free Survival
研究概览
简要总结
A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive
- •Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
- •Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
排除标准
- •Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
- •UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
- •UC and/or CIS in the prostatic urethra within 12 months of enrollment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
Experimental
干预措施: nivolumab (Drug)
Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
Experimental
干预措施: Bacillus Calmette-Guérin (BCG) (Biological)
Arm B: placebo +BCG
Placebo Comparator
干预措施: Placebo (Other)
Arm B: placebo +BCG
Placebo Comparator
干预措施: Bacillus Calmette-Guérin (BCG) (Biological)
结局指标
主要结局
Part 2: Event Free Survival
时间窗: Approximately 44 Months and 1 Week
The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC)
次要结局
- Part 2: Worsening-Free Survival(Approximately 44 months and 1 week)
- Part 2: Overall Survival(Approximately 44 months and 1 week)
- Part 2: Complete Response Rate at 13 Weeks(13 Weeks)
- Part 2: Duration of Response(Approximately 44 months and 1 week)
- All-causality Adverse Events Leading to Discontinuation(24.6 months)
- All-causality Adverse Events(24.6 months)
- Drug-related Adverse Events(24.6 months)
研究者
研究点 (63)
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