Clinical trial · Interventional
Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers
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
- 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 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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- First-Line Immunotherapy
- description
- Patients receiving standard-of-care first-line immunotherapy for metastatic melanoma.
- interventionNames
- Drug: Immunotherapy
Primary outcomes (1)
- measure
- Overall Response Rate (ORR) to First-Line Immunotherapy
- timeFrame
- Up to 28 weeks after start of immunotherapy
- description
- 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)
Secondary outcomes (4)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available