NCT02243371已完成2 期
A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins5 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2015年1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
- 93
- 试验地点
- 5
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age ≥18 years.
- •Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients with mixed histology will be excluded.
- •Have metastatic disease.
- •Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer.
- •Patients with the presence of at least one measurable lesion.
- •Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- •ECOG performance status 0 or
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •known history or evidence of brain metastases.
- •Had surgery within the last 28 days
- •Have received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal vaccinations within 28 days of study treatment.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207
- •Systemic steroids within the last 14 days
- •Use more than 3 g/day of acetaminophen.
- •Patients on immunosuppressive agents.
- •Patients receiving growth factors within the last 14 days
- •Known allergy to both penicillin and sulfa.
- •Severe hypersensitivity reaction to any monoclonal antibody.
- •Have artificial joints or implants that cannot be easily removed
- •Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.
- •Have significant and/or malignant pleural effusion
- •Infection with HIV or hepatitis B or C at screening
- •Significant heart disease
- •Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
- •Unable to avoid intimate contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen.
- •Are pregnant or breastfeeding.
- •Have rapidly progressing disease
研究组 & 干预措施
Arm A: CY/ GVAX/ CRS-207/ nivolumab
Experimental
干预措施: CY (Drug)
Arm B: CY/ GVAX/ CRS-207
Experimental
干预措施: CRS-207 (Biological)
Arm A: CY/ GVAX/ CRS-207/ nivolumab
Experimental
干预措施: CRS-207 (Biological)
Arm A: CY/ GVAX/ CRS-207/ nivolumab
Experimental
干预措施: nivolumab (Drug)
Arm A: CY/ GVAX/ CRS-207/ nivolumab
Experimental
干预措施: GVAX (Biological)
Arm B: CY/ GVAX/ CRS-207
Experimental
干预措施: GVAX (Biological)
Arm B: CY/ GVAX/ CRS-207
Experimental
干预措施: CY (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 2 years and 7 months
OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
次要结局
- Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
- Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity(2 years and 7 months)
- Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
- Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
- Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients(2 years and 7 months)
- Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration(120 days)
研究者
研究点 (5)
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