Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays
研究概览
简要总结
The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.
详细描述
Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation.
The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.
- Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;
- Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;
- Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;
- Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically confirmed stage III or stage IV melanoma
- •Tumor expression of Melan-A +/- Tyrosinase
- •Human leukocyte antigen-A2 (HLA-A2) positive
排除标准
- •Clinically significant heart disease
- •Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
- •History of immunodeficiency disease or autoimmune disease
- •Coagulation or bleeding disorders
结局指标
主要结局
Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays
时间窗: Change from baseline in CD8 T-cells reactivity at day 375
Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
时间窗: Change from baseline to day 375
次要结局
- In patients with measurable disease, tumor response will be assessed radiologically(Change from baseline in tumor response at day 375)
研究者
Prof Olivier Michielin, M.D., Ph.D.
Professor
Centre Hospitalier Universitaire Vaudois