Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Immunotherapy
  Standard-of-care first-line immunotherapy for metastatic melanoma, including immune checkpoint inhibitors (anti-PD-1 with or without anti-CTLA-4), administered according to institutional practice.

Первичные конечные точки

• Overall Response Rate (ORR) to First-Line Immunotherapy [Срок оценки: Up to 28 weeks after start of immunotherapy]

Вторичные конечные точки (4)

• Progression-Free Survival (PFS) [Срок оценки: Up to 3 years]
• Time to Disease Progression [Срок оценки: Up to 3 years]
• Safety of First-Line Immunotherapy [Срок оценки: Up to 3 years]
• Predictive and Prognostic Biomarkers in Blood, Stool and Body Fluids [Срок оценки: Baseline and weeks 4, 12, and 28]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Metastatic (diffuse) melanoma
• Planned first-line immunotherapy treatment
• Signed informed consent for participation in the study

Критерии исключения

• Age < 18 years
• Inability to provide informed consent
• Any condition preventing participation or sample collection according to investigator judgment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Словения · 1 центр

• Institute of Oncology Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07407166 · ERID-KSOPKR-0021/2021 · ERIDEK-0031/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗