Therapeutic Drug Monitoring of Kinase Inhibitors and Study of Circulating Tumor DNA in Patients With Mutated BRAF Metastatic Cutaneous Melanoma and Treated With Anti-BRAF and Anti-MEK Kinase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 7
- 主要终点
- Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma
研究概览
简要总结
BRAF V600-mutant metastatic melanoma are commonly treated using a combination of anti-BRAF and anti-MEK tyrosine kinase inhibitors (TKIs). The OPTIMEL trial aims to study the interest of therapeutic drug monitoring (TDM) of TKIs and circulating tumor DNA (ctDNA) detected in plasma of patients with metastatic melanoma for disease monitoring. 35 patients with metastatic melanoma and treated with dabrafenib and trametinib will be enrolled in this trial. Blood samples will be collected for the determination of TKIs concentration and ctDNA detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Men and women 18 years of age and older
- •Histologic proven advanced skin melanoma (Stage IV or stage IIIc inoperable) with BRAF V600 mutation
- •Patient who will treated with combined kinase inhibitors (dabrafenib + trametinib).
- •Patient able to stand a blood collection of 20 mL
- •Ability to provide an informed written consent form
- •Patient must be affiliated to a social security system
- •Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.
排除标准
- •Patient with mucosal melanoma
- •Patient with non-metastatic skin melanoma (All stages except stage IV and stage III C inoperable)
- •Patient with another synchronous cancer, or within 3 years
- •Patient with a contraindication to blood collection of 20 mL
- •Patient deprived of liberty or under supervision
- •Patient unable to receive kinase inhibitor therapy
- •Patient treated with another combined kinase inhibitors than dabrafenib and trametinib
- •Pregnant or breastfeeding women
- •Patient (man or woman) of childbearing age who does not agree to use of contraceptive methods validated during the study
结局指标
主要结局
Link between the presence of circulating tumor DNA and plasma concentrations of kinase inhibitors n patient with advanced BRAF(V600) mutated melanoma
时间窗: 1 day
ctDNA in patient with advanced BRAF(V600) mutated melanoma is estimated by the ratio of the Ct of the sample to the control. Plasma concentrations of anti-BRAF and anti-MEK tyrosine kinase inhibitors are expressed in μg / mL
次要结局
未报告次要终点