A Pilot Trial of HU14.18-IL2 (EMD273063) in Subjects With Completely Resectable Recurrent Stage III or Stage IV Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Recurrence Free Survival (RFS)
研究概览
简要总结
Evaluate the antitumor activity of hu14.18-IL2 in the minimal residual disease setting. Evaluate the time to recurrence and overall survival of patients treated with hu14.18-IL2.
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
- 15 Years 至 —（Child, 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
A
Hu14.18-IL2 -->Resection-->Hu14.18-IL2
干预措施: hu14.18-IL2 (Drug)
B
Resection -->Hu14.18-IL2-->Hu14.18-IL2
干预措施: hu14.18-IL2 (Drug)
结局指标
主要结局
Recurrence Free Survival (RFS)
时间窗: up to 24 months
RFS was defined as the number of days from the day of evaluation following course 2 of immunocytokine treatment to the day the subject experienced an event of recurrence or death, whichever occurred first. Participants who did not experience an event of recurrence or death at the time of analysis were censored at the date of the last evaluation for recurrence.
Overall Survival (OS)
时间窗: up to 24 months
OS was defined as the number of days from randomization to the date of the participant's death. Participants who did not experience an event of death at the time of analysis were censored at the date of the last follow-up.
Ganglioside Expressed by Tumor Cells (GD2)
时间窗: up to 1 week
Histological analysis of anti-tumor activity is a primary endpoint. This is measured after surgical resection via staining to indicate GD2 expression. The GD2 results were summarized in terms of positive (GD2 expression high or low/moderate) and negative (GD2 expression undetectable).
次要结局
- Anti-Idiotypic Antibodies(up to 12 weeks)
- Anti-Fc-IL2 Antibodies(up to 12 weeks)
- C-Reactive Protein (CRP)(up to 29 days)
- Lymphocyte Count(up to 29 days)
- In Vitro Soluble Interleukin-2 (IL2) Receptor Alpha Levels(up to 12 weeks)