Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 19
- 主要终点
- Summary of Disease Progression in Study Participants, Intent-to-treat Population
研究概览
简要总结
Primary objective:
To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment.
Secondary objectives:
Safety: To describe the safety profile in both treatment groups.
Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
详细描述
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.
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
结局指标
主要结局
Summary of Disease Progression in Study Participants, Intent-to-treat Population
时间窗: Day 0 up to 35 weeks post 1st vaccination or treatment
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography \[CT\] scans or physical examination).
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
时间窗: Day 0 - up to 35 weeks post 1st vaccination or treatment
Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
次要结局
- Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population(Day 0 to 32 weeks post 1st vaccination or treatment)
- Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population(Day 0 to 32 weeks post 1st vaccination or treatment)
- Best Overall Objective Response in the Intent-to-treat Population(Day 0 to 32 weeks post 1st vaccination or treatment)
- Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term(Day 0 to 12 months post last vaccination)