Feasibility Study of Biomarker-driven Therapy Based on a Comprehensive Molecular Analysis of Tumor Tissue and Blood Collections in Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Feasibility (number of patients receiving the recommended therapy)
研究概览
简要总结
Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion.
The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of the patients treated according to recommendations or not. For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.
详细描述
Eligible patients have to have a histologically proven metastatic melanoma failing standard treatments. Other inclusion criteria included age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; life expectancy ≥ 24weeks; adequate renal, liver, and bone marrow functions. Previous therapy with intravenous chemotherapy, immunotherapy or major surgery at least 4 weeks before inclusion was allowed. Patients were excluded if they had a history of cardiac disease or metastatic brain or meningeal tumors. The study is approved by the institutional research ethics board.
Molecular analysis is performed at the Max Planck Institute for Molecular Genetics Berlin and a comprehensive report is made available with 4-8 weeks. The molecular tumor board interprets the data and transforms them into treatment recommendations by identifying and prioritizing predictive biomarkers. The recommendations rely on the definition of evidence levels attributed to every single aberration and the interdisciplinary discussion of the aberrations with regard to patient situation, availability of drugs, and clinical trials. The recommendations are transmitted to the physician in charge of the patient for the final decision to treat or not the patient accordingly.
The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of patients treated according to recommendations or not.
For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 proven metastatic melanoma failing standard treatments
- •age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •life expectancy ≥ 24 weeks
- •adequate renal, liver, and bone marrow functions
排除标准
- •history of cardiac disease or metastatic brain or meningeal tumors
研究组 & 干预措施
Molecular guided therapy
干预措施: Molecular guided therapy (Drug)
结局指标
主要结局
Feasibility (number of patients receiving the recommended therapy)
时间窗: Through study completion over 5 years
number of patients receiving the recommended therapy
Feasibility (actionable molecular alterations)
时间窗: Through study completion over 5 years
number of patients with actionable molecular alterations
Feasibility (number of patients with a treatment recommendation)
时间窗: Through study completion over 5 years
number of patients with a treatment recommendation
次要结局
- Overall survival(5 years)
- Response rate(1 year)
- Progression free survival at 6 months according to RECIST criteria(up to 6 months)
研究者
Ulrich Keilholz
Director Charité Comprehensive Cancer Center
Charite University, Berlin, Germany