Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab/Nivolumab | Drug | Ipilimumab/Nivolumab Regimen | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Immune Checkpoint Inhibitor Therapy
- description
- 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).
- interventionNames
- Drug: Pembrolizumab
- Drug: Nivolumab
- Drug: Ipilimumab/Nivolumab
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) Assessed by Immune-Related RECIST (irRECIST)
- timeFrame
- Up to 28 weeks after treatment initiation
- description
- Objective response rate defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST), based on CT or PET/CT imaging assessment.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Previous systemic therapy for melanoma * Performance status WHO 3-4 (ECOG criteria) * 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)
References
Publications (0)
Data not yet available