Metastatic Melanoma
Conditions
Keywords
Immunotherapy, Mestastatic melanoma
Brief summary
Cutaneous melanoma is an aggressive malignancy with a rising global incidence; its prognosis has been radically transformed by immune checkpoint inhibitors (ICIs), a class of immunotherapeutic agents targeting immune regulatory pathways such as programmed cell death protein 1 (PD-1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and lymphocyte activation gene 3 (LAG-3). Currently approved first-line treatment strategies-including anti-PD-1 monotherapy and the combinations of nivolumab plus ipilimumab and nivolumab plus relatlimab-have demonstrated significant survival benefits, although combination regimens are associated with a considerably more burdensome toxicity profile compared with monotherapy. Despite these major therapeutic advances, the optimal treatment choice for each individual patient remains uncertain, primarily due to the lack of validated predictive biomarkers in the metastatic setting. This unmet clinical need represents the central rationale of the present study, which aims to bridge this gap through the systematic collection and integrated analysis of clinical, pathological, and molecular data from approximately 200 patients treated with first-line immunotherapy at the European Institute of Oncology.
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of metastatic or locally advanced unresectable melanoma * Patients treated with first-line immunotherapy as monotherapy (e.g., pembrolizumab or nivolumab) or in combination (e.g., ipilimumab - nivolumab or nivolumab - relatlimab) * Patients treated at IEO (Milan) from 01/01/2022 to 30/11/2027 * Age ≥18 years
Exclusion criteria
* Patients who received targeted therapy as first-line treatment for metastatic melanoma * Patients with a diagnosis of resectable stage III melanoma or operated stage IV with no evidence of disease (NED)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival Rate | through study completion, an average of 1 year | The progression-free survival (PFS) rate will be evaluated to identify clinical and/or biological predictive markers of efficacy of first-line immune checkpoint inhibitor (ICI) therapy in patients with metastatic melanoma treated at the European Institute of Oncology (IEO), receiving either ICI monotherapy (pembrolizumab or nivolumab) or ICI combination therapy (nivolumab plus ipilimumab or nivolumab plus relatlimab). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Overall Survival | through study completion, an average of 1 year | Real-world Overall Survival |
Contacts
CONTACTGabriele Antonarelli, MD
STUDY_DIRECTORChristian Blank, MD
Istituto Europeo di Oncologia
Outcome results
None listed