IFN-Gamma Expression as a Predictor of Response to Immune Checkpoint Inhibitors in First-Line Metastatic Melanoma

Sponsor
Institute of Oncology Ljubljana
Study ID
NCT07436390
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    PD-1 inhibitor used as first-line immunotherapy in patients with metastatic malignant melanoma.
  • Nivolumab — DRUG
    PD-1 inhibitor used as first-line immunotherapy in patients with metastatic malignant melanoma.
  • Ipilimumab/Nivolumab — DRUG
    Combination immunotherapy with PD-1 inhibitor (nivolumab) and CTLA-4 inhibitor (ipilimumab) used as first-line treatment in metastatic malignant melanoma.

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Mar 31, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
132 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Immune Checkpoint Inhibitor Therapy
    Patients with metastatic malignant melanoma will be treated in the first line with immune checkpoint inhibitors: PD-1 inhibitors (pembrolizumab, nivolumab) or combination PD-1 and CTLA-4 inhibitors (ipilimumab/nivolumab).

Primary Outcome Measure

Objective Response Rate (ORR) Assessed by Immune-Related RECIST (irRECIST) [ Time Frame: Up to 28 weeks after treatment initiation ]

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