Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) According to irRECIST
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.
详细描述
This study evaluates the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and investigates the predictive value of PD-L1 expression in tumor tissue and blood. The aim is to assess the association between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to treatment with immune checkpoint inhibitors. In addition, the study evaluates the association between the occurrence of immune-related adverse events and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age ≥18 years
- •Cytologically or histologically confirmed metastatic malignant melanoma
- •Stage IIID unresectable or stage IV (AJCC 8th edition)
- •ECOG performance status 0-2
- •First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab/nivolumab)
- •CT/PET-CT performed within 4 weeks prior to treatment start
- •Signed informed consent
排除标准
- •Previous systemic therapy for melanoma
- •ECOG performance status 3-4
- •Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)
- •Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence >3 years)
研究组 & 干预措施
PD-1 inhibitor therapy
Participants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice.
干预措施: Pembrolizumab (Drug)
PD-1 inhibitor therapy
Participants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice.
干预措施: Nivolumab (Drug)
Combination PD-1 and CTLA-4 inhibitor therapy
Participants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice.
干预措施: Nivolumab (Drug)
Combination PD-1 and CTLA-4 inhibitor therapy
Participants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice.
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) According to irRECIST
时间窗: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)
Objective response will be assessed using CT or PET/CT imaging and evaluated according to irRECIST criteria. The outcome will be reported as the proportion (%) of participants achieving complete response (CR) or partial response (PR).
次要结局
- PD-L1 Expression in Tumor Tissue (Immunohistochemistry, H-score or % Positive Cells)(Baseline)