Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma

N/ANot Yet RecruitingNCT07794501

European Institute of Oncology200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Metastatic Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Progression-Free Survival Rate

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).

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Real-world Overall Survival