First-line immunotherapy for metastatic melanoma in Slovenia with biomarker identification

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center study at the Institute of Oncology Ljubljana will enroll adults with metastatic melanoma who are starting first-line immunotherapy. Participants will undergo baseline and scheduled imaging (CT or PET/CT at baseline, week 4, week 12, and week 28) to measure response, and primary clinical outcomes include overall response rate, progression-free survival, and safety. Peripheral blood, stool, and available pleural or peritoneal effusion samples will be collected at predefined time points and analyzed for molecular tumor markers. Biomarker data will be correlated with imaging and clinical outcomes to identify prognostic and predictive markers that could support more personalized treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Tanja Mesti, MD
• Email: tmesti@onko-i.si
• Phone: 015879287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.