Phase II Trial of Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Overall Survival Rate at 12 Months (OS-12)
研究概览
简要总结
This research study is studying pembrolizumab and re-irradiation as possible treatments for glioblastoma.
The drugs involved in this study are:
- Pembrolizumab
- Radiation
- Bevacizumab, an FDA-approved drug for treating recurrent glioblastoma multiforme (GBM)
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
How the Study Interventions work:
Pembrolizumab: Pembrolizumab has been studied in lab experiments and in other types of cancer, and information from these studies suggests that it may be beneficial in this type of cancer. Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system.
The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this specific disease but it has been approved for other uses.
Radiation (Re-irradiation): Radiotherapy destroys cancer cells using radiation aimed at a cancer from a machine.
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
Pembrolizumab + Radiation (lead-in)
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.)
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Radiation (lead-in)
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.)
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Re-irradiation (Radiation)
Pembrolizumab + Bevacizumab + Radiation (lead-in)
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.)
- Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Bevacizumab + Radiation (lead-in)
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.)
- Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Bevacizumab (Drug)
Pembrolizumab + Bevacizumab + Radiation (lead-in)
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.)
- Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Re-irradiation (Radiation)
Pembrolizumab + Radiation
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Radiation
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Re-irradiation (Radiation)
Pembrolizumab + Bevacizumab + Radiation
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks
- Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Bevacizumab + Radiation
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks
- Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Bevacizumab (Drug)
Pembrolizumab + Bevacizumab + Radiation
- Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks
- Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks
- Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
干预措施: Re-irradiation (Radiation)
结局指标
主要结局
Overall Survival Rate at 12 Months (OS-12)
时间窗: 12 months
Overall Survival Rate at 6 Months (OS-6)
时间窗: 6 months
Objective Response Rate (ORR)
时间窗: 2 years
Per Response Assessment in Neuro-Oncology (RANO) Criteria: * Complete Response (CR): * Disappearance of all enhancing measurable \& non-measurable disease sustained for at least 4 weeks * No new lesions * Stable or improved non-enhancing (T2/FLAIR) lesions * No corticosteroids (or physiologic replacement doses only) * And stable or improved clinically * Partial Response (PR): * \>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; * No progression of non-measurable disease * No new lesions * Stable or improved non-enhancing (T2/FLAIR) lesions * Same or lower dose of corticosteroids compared with baseline scan * And stable or improved clinically Overall Response Rate (ORR) = Frequency of CR + PR within a population.
次要结局
- Safety & Tolerability: SAEs Experienced by Participants(2 years)
- Median Progression Free Survival (PFS)(2 years)
- Duration of Response(1 year)
- 6-month Progression Free Survival (PFS-6)(6 months)
- Median Overall Survival (OS)(Participants were followed for survival until death; survival was followed for a max of 4 years. Other Adverse Events (AEs) were collected from registration through 30 days after last dose (SAEs through 90 days); AEs were followed for a max of 2 years.)
研究者
David Reardon, MD
Principal Investigator
Dana-Farber Cancer Institute