NCT00651703已完成2 期
Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.
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
- •Histological confirmed Stage III or IV malignant melanoma
- •HLA-A*0201 haplotype
- •Expected survival of at least 9 months
- •Willing and able to comply with all trial requirements (e.g. diaries, CTs)
- •Given written informed consent
- •Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception
排除标准
- •Any contraindication to any study related test or assessment
- •Current or planned use of contraindicated concomitant medication
- •Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
- •Infection with HIV, HBV or HCV
- •Pregnancy or lactation or females planning to become pregnant during the study
- •Abuse of alcohol or other drugs
- •Use of investigational drug within 30 days before enrolment
- •Previous participation in a clinical trial with a Qb-based Cytos vaccine.
研究组 & 干预措施
1
Experimental
干预措施: CYT004-MelQbG10 + Montanide (Biological)
2
Experimental
干预措施: CYT004-MelQbG10 + Montanide + Imiquimod (Biological)
3
Experimental
干预措施: CYT004-MelQbG10 + Imiquimod (Biological)
4
Experimental
干预措施: CYT004-MelQbG10 intra nodal injection (Biological)
研究者
研究点 (2)
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