NCT07436390Completed
IFN-Gamma Expression as a Predictor of Response to Immune Checkpoint Inhibitors in First-Line Metastatic Melanoma
IFN-Gamma Expression in Tumor Tissue and Blood as a Predictor of Response to Immune Checkpoint Inhibitors in the First-Line Treatment of Metastatic Melanoma
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
This study evaluates whether interferon-gamma (IFN-γ) expression in tumor tissue and peripheral blood can serve as a predictive biomarker of response to immune checkpoint inhibitors in the first-line treatment of metastatic melanoma. Although immune checkpoint inhibitors have substantially improved outcomes in metastatic melanoma, not all patients respond to therapy. Reliable biomarkers that could help identify patients most likely to benefit from treatment are still lacking. This study investigates the association between IFN-γ expression levels and objective treatment response. In addition, the study explores whether characteristics of the gut microbiome are associated with immunotherapy outcomes. The results may contribute to improved patient stratification and personalized treatment approaches in metastatic melanoma.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 132 (actual)
- First submitted
- 5 Feb 2026
- Start date
- 31 Mar 2024
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Melanoma
- NCT number
- NCT07436390
What you commit to
- Study type: Interventional
- Participants enrolled: 132
- From 31 Mar 2024 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic therapy for melanoma
Other illness
- Contraindications for immunotherapy (known immune deficiency, active immunosuppressive treatment, or active autoimmune disease requiring treatment)
- Other malignant diseases (except cured basal cell carcinoma, squamous cell carcinoma, and other cured solid tumors without recurrence more than three years after treatment)
Other
- Performance status WHO 3-4 (ECOG criteria)
Who the study is looking for
- Age over 18 years
- Cytologically or histologically verified malignant melanoma
- Stage IIID unresectable/IV according to AJCC classification (8th edition, 2018)
- Performance status WHO 0-2 (ECOG criteria)
- First-line systemic immunotherapy treatment (nivolumab, ipilimumab/nivolumab combination, pembrolizumab)
- CT triple scan/PET CT performed within 4 weeks prior to the first administration
- Signed informed consent for participation in the clinical study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.