Efficacy of Immunotherapy in the First Line of Treatment of Diffuse Melanoma in Slovenia and Recognition of Prognostic and Predictive Biomarkers From Primary Tumor, Faeces and Body Fluids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) to First-Line Immunotherapy
研究概览
简要总结
This study evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated at the Institute of Oncology Ljubljana in Slovenia. The main objectives are to assess treatment response rates, progression-free survival, and treatment safety, and to identify prognostic and predictive biomarkers associated with response to immunotherapy.
Biological samples including blood, stool, and body fluids (if available) will be collected at predefined time points and analyzed for molecular tumor markers. Imaging assessments (CT or PET/CT) will be performed before treatment initiation and during follow-up to evaluate response.
The study aims to improve identification of patient subgroups who benefit from immunotherapy and those who do not, supporting better personalized treatment strategies.
详细描述
Metastatic melanoma is a malignant skin cancer with significant morbidity and mortality. In recent years, immunotherapy has become a standard first-line treatment option for metastatic melanoma, but clinical benefit varies substantially among patients. Reliable prognostic and predictive biomarkers are needed to identify patients who are likely to respond to immunotherapy and those who may require alternative strategies.
This prospective study is conducted at the Institute of Oncology Ljubljana and evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated in Slovenia. The primary clinical outcomes include overall response rate, progression-free survival, and safety of treatment.
Patients will undergo routine imaging examinations (CT or PET/CT of the head, chest, and abdomen) prior to the start of immunotherapy and at follow-up time points (week 4, week 12, and week 28), and additionally as clinically indicated. Imaging results will be used to evaluate disease response to treatment.
In parallel, biological samples will be collected at the same time points, including peripheral blood (10 mL), stool samples, and samples of pleural or peritoneal effusions when present. Samples will be analyzed for molecular tumor markers to explore associations with clinical response and survival outcomes.
The study aims to identify biomarker-based subgroups of patients for whom immunotherapy is beneficial and those for whom it is not, contributing to improved individualized treatment approaches in metastatic melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Metastatic (diffuse) melanoma
- •Planned first-line immunotherapy treatment
- •Signed informed consent for participation in the study
排除标准
- •Age < 18 years
- •Inability to provide informed consent
- •Any condition preventing participation or sample collection according to investigator judgment
研究组 & 干预措施
First-Line Immunotherapy
Patients receiving standard-of-care first-line immunotherapy for metastatic melanoma.
干预措施: Immunotherapy (Drug)
结局指标
主要结局
Overall Response Rate (ORR) to First-Line Immunotherapy
时间窗: Up to 28 weeks after start of immunotherapy
Proportion of patients with metastatic melanoma achieving complete response (CR) or partial response (PR) during first-line immunotherapy, assessed by imaging (CT or PET/CT)
次要结局
- Progression-Free Survival (PFS)(Up to 3 years)
- Time to Disease Progression(Up to 3 years)
- Safety of First-Line Immunotherapy(Up to 3 years)
- Predictive and Prognostic Biomarkers in Blood, Stool and Body Fluids(Baseline and weeks 4, 12, and 28)