Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.
研究概览
简要总结
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
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
- •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
排除标准
- •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.
研究组 & 干预措施
Pembrolizumab with stereotactic radiation therapy and surgical resection
干预措施: Stereotactic Radiation Therapy (Radiation)
Pembrolizumab with stereotactic radiation therapy and surgical resection
干预措施: Pembrolizumab (Drug)
Pembrolizumab with stereotactic radiation therapy and surgical resection
干预措施: Surgical Resection (Procedure)
结局指标
主要结局
Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.
时间窗: 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.
Overall survival
时间窗: 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.
次要结局
- Immune action(At baseline, prior to stereotactic radiation therapy, and prior to surgery.)
- Progression free survival(From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.)
研究者
Chirag G. Patil
Associate Professor of Neurosurgery Program Director, Neurosurgery Residency Training
Cedars-Sinai Medical Center