Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- rate of objective response
研究概览
简要总结
This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease
详细描述
The aim of the study is to evaluate the activity and efficacy of anti PD-1 antibodies in adolescent, childhood and young adult with early and advanced melanomas through a multicenter transnational European retrospective analysis Clinical outcomes will be retrospectively retrieved beginning from the primary diagnosis of melanoma. Clinical outcomes will be retrospectively evaluated starting from the time of start of treatment for up to a the most recent follow-up. Data collected will include demographic information, disease history, baseline conditions, clinical outcomes of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex aged ≥ 12 years;
- •Histologically confirmed melanoma;
- •Anti PD-1 Immunotherapy (Ipilimumab plus Nivolumab);
- •Previous and subsequent treatments will be collected;
- •Clinical and follow-up data available
排除标准
- •No immunotherapy received;
- •No melanoma;
- •Age > 30 yrs
结局指标
主要结局
rate of objective response
时间窗: 12 months
efficay of anti PD-1 antibodies in adolescent, childhood and young through Tumor assessment revision adult with early and advanced melanomas
次要结局
- adverse event incidence(12 months)
研究者
Mario Mandalà
Associate Professor
Azienda Ospedaliera di Perugia