Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma

Sponsor
European Institute of Oncology
Study ID
NCT07794501
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Aug 27, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Progression-Free Survival Rate [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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