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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Metastatic (diffuse) melanoma

Planned first-line immunotherapy treatment

Signed informed consent for participation in the study

Disqualifiers

Age < 18 years

Inability to provide informed consent

Any condition preventing participation or sample collection according to investigator judgment

Trial design

Treatments tested in this trial

  • Immunotherapy

Treatment groups

40 Participants
are divided into 1 treatment group