Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Tolerability
研究概览
简要总结
The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.
详细描述
vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •malignant melanoma stage III/IV
- •fresh frozen tumor tissue available
- •informed consent given
- •Karnofsky >= 70%
排除标准
- •brain metastasis
- •parallel chemotherapy
- •systemic treatment with glucocorticoids
- •other malignancies
研究组 & 干预措施
mRNA Vacc
干预措施: mRNA coding for melanoma associated antigens (Biological)
mRNA Vacc
干预措施: GM-CSF (Drug)
结局指标
主要结局
Tolerability
时间窗: every 4 weeks
Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
次要结局
未报告次要终点
研究者
Thomas Eigentler
Study Coordinator
University Hospital Tuebingen