NCT02648282已完成2 期
A Phase II Study of GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine in Combination With PD-1 Blockade Antibody (Pembrolizumab) and Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Locally Advanced Adenocarcinoma of the Pancreas
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Distant Metastasis Free Survival (DMFS)
研究概览
简要总结
This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.
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
- •Locally advanced pancreatic adenocarcinoma
- •Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment.
- •Age >18 years
- •No metastatic disease
- •ECOG Performance Status of 0 to 1
- •Adequate organ function as defined by study-specified laboratory tests
- •Patients must be able to have fiducials placed for SBRT
- •Must use acceptable form of birth control through the study
- •Signed informed consent form
- •Willing and able to comply with study procedures
排除标准
- •Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days
- •Patients who have had more than one line of chemotherapy
- •Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
- •Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
- •Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug
- •Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration
- •Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin.
- •Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
- •Patients with evidence of interstitial lung disease
- •Patients on home oxygen
- •Patients with oxygen saturation of <92% on room air by pulse oximetry
- •Pregnant or lactating
- •Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
研究组 & 干预措施
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT
Experimental
干预措施: Cyclophosphamide (Drug)
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT
Experimental
干预措施: GVAX Pancreatic Cancer Vaccine (Drug)
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT
Experimental
干预措施: Pembrolizumab (Drug)
Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT
Experimental
干预措施: SBRT (Radiation)
结局指标
主要结局
Distant Metastasis Free Survival (DMFS)
时间窗: 62 months
DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.
次要结局
- Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities(41 months)
研究者
研究点 (1)
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