Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia

Sponsor
Institute of Oncology Ljubljana
Study ID
NCT07422779
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.
  • Nivolumab — DRUG
    Nivolumab is a PD-1 immune checkpoint inhibitor administered as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice, either as monotherapy or in combination with ipilimumab.
  • Ipilimumab — DRUG
    Ipilimumab is a CTLA-4 immune checkpoint inhibitor administered in combination with nivolumab as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice.

Study Details

The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.

Key Dates

Start date
Mar 1, 2022
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: PD-1 inhibitor therapy
    Participants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice.
  • Other: Combination PD-1 and CTLA-4 inhibitor therapy
    Participants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice.

Primary Outcome Measure

Objective Response Rate (ORR) According to irRECIST [ Time Frame: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks) ]

Central Contacts

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