EUCTR2004-003910-41-DE进行中（未招募）不适用
Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects with Unresectable Metastatic Cutaneous Melanoma - 852A-IV-NA-LI-04-MC-M
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Most important inclusion criteria:
- •Subjects have:
- •-histological evidence of melanoma
- •-advanced melanoma not responding to a first line of chemotherapy
- •-Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •-a life expectancy of greater than or equal to 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Most important exclusion criteria:
- •Subjects are excluded who have:
- •- had prior immunotherapy for stage IV melanoma (including but not limited to: Interferons, IL-2, TNF alpha and melanoma vaccines) within 6 weeks of the first dose of 852A
- •- stage IV disease which has previously progressed during treatment with interferon alone or combined interferon and monochemotherapy
- •-brain metastases with the exception of brain metastases completely excised or
- •successfully controlled with stereotactic radiosurgery
研究者
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