Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 200
• From 27 Aug 2026 to the primary completion date, 30 Nov 2027
• No sites listed in no country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov