Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Epacadostat
研究概览
简要总结
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207.
The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.
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
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: Epacadostat (Drug)
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: Pembrolizumab (Drug)
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: CRS-207 (Biological)
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: Cyclophosphamide (Drug)
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: GVAX Pancreas Vaccine (Biological)
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: Epacadostat (Drug)
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: Pembrolizumab (Drug)
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: CRS-207 (Biological)
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: Cyclophosphamide (Drug)
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
干预措施: Epacadostat (Drug)
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
干预措施: GVAX Pancreas Vaccine (Biological)
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
干预措施: Epacadostat (Drug)
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
干预措施: Pembrolizumab (Drug)
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
干预措施: CRS-207 (Biological)
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
干预措施: Pembrolizumab (Drug)
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
干预措施: CRS-207 (Biological)
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
干预措施: Epacadostat (Drug)
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
干预措施: Pembrolizumab (Drug)
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
干预措施: CRS-207 (Biological)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Epacadostat
时间窗: 9 weeks
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
6 Month Survival
时间窗: 6 months
Number of subjects who are alive 6 months or longer after the date of first treatment.
次要结局
- Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation(15 months)