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

February 12, 2026 updated by: Institute of Oncology Ljubljana

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: First-Line Immunotherapy
Patients receiving standard-of-care first-line immunotherapy for metastatic melanoma.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) to First-Line Immunotherapy
Time Frame: Up to 28 weeks after start of 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 3 years
Time from initiation of first-line immunotherapy to disease progression or death from any cause.
Up to 3 years
Time to Disease Progression
Time Frame: Up to 3 years
Time from initiation of first-line immunotherapy to documented disease progression assessed by imaging.
Up to 3 years
Safety of First-Line Immunotherapy
Time Frame: Up to 3 years
Incidence of treatment-related adverse events during first-line immunotherapy.
Up to 3 years
Predictive and Prognostic Biomarkers in Blood, Stool and Body Fluids
Time Frame: Baseline and weeks 4, 12, and 28
Identification of molecular biomarkers in blood (10 mL), stool, and pleural/peritoneal effusions (if present) associated with response to immunotherapy and survival outcomes.
Baseline and weeks 4, 12, and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERID-KSOPKR-0021/2021
  • ERIDEK-0031/2021 (Other Identifier: Ethics Committee, Institute of Oncology Ljubljana)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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