Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma (PREMIO)

August 28, 2026 updated by: European Institute of Oncology

Identifying Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma: the PREMIO Study

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 Overview

Status

Not yet recruiting

Conditions

Metastatic Melanoma

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Gabriele Antonarelli, MD
Phone Number: +39 02 57489265
Email: gabriele.antonarelli@ieo.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study will include patients who received an immune checkpoint inhibitors agent for their metastatic melanoma from 01/01/2022 until 30/11/2027 at IEO, Milan.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival Rate Time Frame: 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).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world Overall Survival Time Frame: through study completion, an average of 1 year	Real-world Overall Survival	through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

Study Director: Christian Blank, MD, Istituto Europeo di Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 27, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)