NCT03161379已完成2 期
A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年2月2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
- 31
- 试验地点
- 2
- 主要终点
- CD8+ T Cell Density in Tumor Tissue
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with 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
盲法说明
Open Label
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
- •Have histologically proven pancreatic cancer that is borderline resectable
- •No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
- •Age >18 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Woman of child bearing potential must have a negative pregnancy test.
- •Must use an acceptable form of birth control while on study.
- •Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Had major surgery within the last 28 days
- •Had an investigational drug or device within the past 28 days
- •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
- •Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
- •Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
- •Other cancer diagnosis requiring treatment within two years
- •History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
- •Patients receiving growth factors within the last 14 days.
- •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
- •Pregnant or breastfeeding.
- •Have known history of infection with HIV, hepatitis B, or hepatitis C.
- •Unwilling or unable to follow the study schedule for any reason.
- •Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
- •Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%
研究组 & 干预措施
CY, Nivolumab, GVAX, and SBRT
Experimental
CY, Nivolumab, GVAX, and SBRT
干预措施: Cyclophosphamide (Drug)
CY, Nivolumab, GVAX, and SBRT
Experimental
CY, Nivolumab, GVAX, and SBRT
干预措施: Nivolumab (Drug)
CY, Nivolumab, GVAX, and SBRT
Experimental
CY, Nivolumab, GVAX, and SBRT
干预措施: GVAX Pancreas Vaccine (Drug)
CY, Nivolumab, GVAX, and SBRT
Experimental
CY, Nivolumab, GVAX, and SBRT
干预措施: Stereotactic Body Radiation (SBRT) (Radiation)
结局指标
主要结局
CD8+ T Cell Density in Tumor Tissue
时间窗: evaluated at time of surgery, approximately 2 months from first dose of study drug
Mean CD8+ T cell density \[log(cells per mm\^2)\], found in resected surgical tissue by Immunohistochemistry (IHC).
次要结局
- Pathologic Complete Response (pCR) Rate at Surgical Resection(Assessed at time of surgical resection, approximately 2 months after first dose of study drug)
研究者
研究点 (2)
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