Phase I and II Study of NovoTTF-200A and Pembrolizumab in Newly Diagnosed Melanoma Brain Metastasis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants with Dose Limiting Toxicity
研究概览
简要总结
This research study involves studying a device as a possible treatment for metastatic melanoma in the brain. The purpose of this study is to obtain information on the safety and effectiveness of the study device, NovoTTF-200A, in melanoma participants with brain metastases when it is combined with Pembrolizumab.
The name of the study device involved in this study is:
-- NovoTTF-200A
The name of the drug used in this study is:
-- Pembrolizumab
详细描述
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
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The name of the study device involved in this study is: NovoTTF-200A
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The name of the drug used in this study is: Pembrolizumab
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Eligible participants will be in this research study for up to 2 years, or until progressive disease or unacceptable toxicity as is reflected in the protocol.
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This is a Phase I/II clinical trial.
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A Phase I clinical trial tests the safety and toxicity of adding an investigational device NovoTTF-200A to standard-of-care drug Pembrolizumab to use for further studies.
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A Phase II clinical trial tests how well the combination works for your brain disease. "Investigational" means that the device is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved NovoTTF-200A for your brain metastasis from melanoma.
A metastatic brain tumor is usually found when a cancer patient begins to experience neurological symptoms and a brain scan (CT or MRI) is ordered. However, some participants are symptom-free and are only diagnosed with brain metastases with MRI or CT scans for another reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PHASE 1: NovoTTF-200A + PEMBROLIZUMAB
The Phase I portion of the study will have a 3 + 3 design and consist of one cohort treated
- NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle.
- Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle
干预措施: NovoTTF-200A (Device)
PHASE 1: NovoTTF-200A + PEMBROLIZUMAB
The Phase I portion of the study will have a 3 + 3 design and consist of one cohort treated
- NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle.
- Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle
干预措施: Pembrolizumab (Drug)
PHASE 2: NovoTTF-200A + PEMBROLIZUMAB
- NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle.
- Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle
干预措施: NovoTTF-200A (Device)
PHASE 2: NovoTTF-200A + PEMBROLIZUMAB
- NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle.
- Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicity
时间窗: 21 Days
Dose limited toxicity is considered grade 3 or higher treatment-related adverse events.
次要结局
- Quality of Life Assessment(Baseline, 63 Days, 129 Days, 189 Days, 30 days after last study treatment)
- 12-month Overall Survival Rate(1 Year after last study treatment)
- 6-month progression-free survival (PFS) rate(6 months after last study treatment)
- Overall Response Rate(defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 100 months)