NCT00601861终止2 期
A Single Arm, Single-centre, Open-label, Exploratory Trial of Recombinant Interleukin-21 Administered Subcutaneously for 4 Weeks as Neo-adjuvant Treatment Prior to Sentinel Lymph Node/Complete Lymph Node Dissection Followed by 8 Weeks of Adjuvant Treatment in Subjects With Stage III Malignant Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Complete pathological response rate in the lymph nodes
研究概览
简要总结
The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma
详细描述
The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Stage III melanoma
- •ECOG performance status 0-1
排除标准
- •Signs of stage IV melanoma
- •Safety variables
研究组 & 干预措施
A
Experimental
干预措施: recombinant interleukin-21 (Drug)
结局指标
主要结局
Complete pathological response rate in the lymph nodes
时间窗: After 4 weeks of treatment
次要结局
- Safety(For the duration of the trial)
- Immunomodulatory effects(For the duration of the trial)
- Relapse free survival(For up to 4 years after the final visit or until progression of the disease in order to assess the relapse free survival (RFS))
研究者
研究点 (1)
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