A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Overall Survival (OS) Rate at 1 Year
研究概览
简要总结
This is a phase II study assessing the activity of bevacizumab combined with atezolizumab in metastatic urothelial carcinoma patients who are ineligible for cisplatin-based therapy.
详细描述
This is a multi-center trial.
INVESTIGATIONAL TREATMENT:
Eligible patients will be receive atezolizumab 1200 mg IV flat dose plus bevacizumab 15 mg/kg IV every 21 days
21 days equals 1 cycle of therapy and patients will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity for up to 24 months.
To demonstrate adequate organ function, all screening labs must be obtained within 14 days prior to Cycle 1 Day 1 (C1D1) of treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-Label
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A - Atezolizumab + Bevacizumab
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
干预措施: Atezolizumab (Drug)
Arm A - Atezolizumab + Bevacizumab
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Overall Survival (OS) Rate at 1 Year
时间窗: 1 years
Determine the percentage of overall survival at 1 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.
次要结局
- Objective Response Rate (ORR)(Up to a maximum of 14 months)
- Duration of Response (DOR)(Up to a maximum of 14 months)
- Progression-Free Survival (PFS)(Time of treatment start until the criteria for disease progression or death, up to a maximum of 36 months.)
- Number of Participants With Adverse Events(Adverse events were recorded from time of registration until 30 days after discontinuation of study drug(s), up to maximum of 12 months)
研究者
Arjun Balar, MD
Sponsor-Investigator
Hoosier Cancer Research Network