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

NCT07407166 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07407166 on ClinicalTrials.gov