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A quest to find biomarkers that match melanoma patients with the right immunotherapy

NCT ID NCT07794501

Knowledge-focused Sponsor: European Institute of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study looks at whether clinical, pathological, and molecular features can predict how well people with metastatic melanoma respond to first-line immunotherapy. Researchers will collect and analyze data from about 200 patients treated at the European Institute of Oncology with either a single immunotherapy drug or a combination. The goal is to find markers that help doctors choose the best treatment for each person, balancing effectiveness against side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Immune checkpoint inhibitors (pembrolizumab, nivolumab, ipilimumab, relatlimab) as first-line therapy
What this could lead to
If successful, this could help doctors choose the most effective and least toxic immunotherapy for each person with metastatic melanoma, improving outcomes and reducing side effects.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. The findings may not apply to patients outside this single center, and the search for reliable biomarkers may not succeed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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