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

NCT07407166 | Recruiting DMC

• 2 other identifiers: ERID-KSOPKR-0021/2021ERIDEK-0031/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Melanoma; Melanoma

Keywords

Immunotherapy; First-Line Treatment

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) to First-Line Immunotherapy

  Proportion of patients with metastatic melanoma achieving complete response (CR) or partial response (PR) during first-line immunotherapy, assessed by imaging (CT or PET/CT)

  Up to 28 weeks after start of immunotherapy

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  Up to 3 years

• Time to Disease Progression

  Up to 3 years

• Safety of First-Line Immunotherapy

  Up to 3 years

• Predictive and Prognostic Biomarkers in Blood, Stool and Body Fluids

  Baseline and weeks 4, 12, and 28

Study Arms (1)

First-Line Immunotherapy

OTHER

Patients receiving standard-of-care first-line immunotherapy for metastatic melanoma.

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

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.

First-Line Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Tanja Mesti, MD

CONTACT

015879287; tmesti@onko-i.si

Klavdija Korošec

CONTACT

kkorosec@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: May 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

SL (1)