NCT02351739已完成2 期
Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Number of Participants With Overall Response
研究概览
简要总结
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer
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
- •Men and women ≥ 18 years of age
- •Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer
- •Metastatic bladder cancer with disease progression on or after platinum-based chemotherapy
- •Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters
- •Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma
- •Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion that measures ≥ 10 mm [≥ 15 mm for lymph nodes]
- •ECOG performance status of 0 or 1
排除标准
- •Prior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years of which will not limit survival to < 2 years.
- •Known central nervous system metastases and/or carcinomatous meningitis
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function
- •Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
研究组 & 干预措施
Pembrolizumab
Other
Arm 1: pembrolizumab monotherapy
干预措施: pembrolizumab (Drug)
ACP-196 in combination with pembrolizumab
Other
Arm 2: ACP-196 in combination with pembrolizumab
干预措施: ACP-196 in combination with pembrolizumab (Drug)
结局指标
主要结局
Number of Participants With Overall Response
时间窗: Every 12 weeks for up to 2 years.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
未报告次要终点
研究者
研究点 (6)
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