复发性胶质母细胞瘤患者抗 PD-1 免疫疗法和立体定向放射疗法的试验
复发性胶质母细胞瘤患者抗 PD-1 免疫疗法和立体定向放射治疗的 Ib/II 期试验
The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Clinical Trial Recruitment Navigator
- 电话号码：310-423-5842
- 邮箱：GroupCancerTrialInformation@cshs.org
学习地点
-
-
California
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Los Angeles、California、美国、90048
- 招聘中
- Cedars-Sinai Medical Center
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副研究员：
- Behrooz Hakimian, MD
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副研究员：
- Amin Mirhadi, MD
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副研究员：
- Jethro Hu, MD
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副研究员：
- Jeremy Rudnick, MD
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副研究员：
- Keith Black, MD
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副研究员：
- Ray Chu, MD
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副研究员：
- John Yu, MD
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副研究员：
- Adam Mamelak, MD
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首席研究员：
- Stephen Shiao, MD, PhD
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接触：
- Clinical Trial Recruitment Navigator
- 电话号码：310-423-5842
- 邮箱：GroupCancerTrialInformation@cshs.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 years or older
- Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme
- GBM recurrence or progression with planned standard of care surgical resection and repeat radiation
- Tumor size less than 6 cm
- ECOG performance status of 0-1
- Adequate laboratory values
Exclusion Criteria:
- Contraindication to additional radiation
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
- Severe hypersensitivity to pembrolizumab
Complete inclusion/exclusion criteria are detailed in the protocol.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pembrolizumab 联合立体定向放射治疗和手术切除
|
Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7 Standard of care surgical resection of tumor on Day 10-28 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.
大体时间：From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
|
Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0. |
From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
|
|
Overall survival
大体时间：From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years.
|
From start of study treatment until death, loss to follow-up, or withdrawal of consent. Subjects who are lost to survival follow-up will not be replaced, and public records may be accessed to assess Overall Survival. |
From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression free survival
大体时间：From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
|
From start of study treatment until confirmation of disease progression (per iRANO Criteria), intolerable toxicities, withdrawal of consent, or up to 2 years or 18 cycles of pembrolizumab, whichever comes first. |
From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
|
|
Immune action
大体时间：At baseline, prior to stereotactic radiation therapy, and prior to surgery.
|
To assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment. Blood draws for research purposes performed after obtaining consent but prior to neoadjuvant pembrolizumab administration, and at the time of initiation of SRT and at the time of surgery |
At baseline, prior to stereotactic radiation therapy, and prior to surgery.
|
合作者和调查者
调查人员
- 首席研究员：Chirag G Patil, MD, MS、Cedars-Sinai Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IIT2019-13-Patil-NeoPD1SRS
- R21CA256421 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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