A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 3
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX.
Funding Source - FDA Office of Orphan Product Development (OOPD)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ipilimumab + Vaccine (Arm A)
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
干预措施: Ipilimumab (Drug)
Ipilimumab + Vaccine (Arm A)
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
干预措施: Vaccine (Biological)
FOLFIRINOX (Arm B)
Administered every 14 days (one cycle)
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 4 years
Overall Survival is the time between the date of randomization on study and death.
次要结局
- Progression Free Survival (PFS)(Up to 4 years)
- Immune-related Objective Response Rate(Assessed until disease progression, up to 2 years)
- Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels(Baseline, Week 7, and Week 10 visits)
- Objective Response Rate(Assessed until disease progression, up to 2 years)
- Duration of Response(Up to 22 months)
- Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine(From the first dose of study drug through 70 days after last dose, up to 13 months)
- Immune-related Progression Free Survival (irPFS)(Up to 4 years)