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Precision radiation meets new drugs in fight against brain metastases from melanoma

NCT ID NCT07691255

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study looks at how a highly targeted form of radiation called stereotactic radiosurgery (CyberKnife) works alongside newer treatments like immunotherapy and targeted therapy for people with melanoma that has spread to the brain. Researchers will observe 50 patients over time to see how long the treated brain tumors stay under control and how the timing of treatments affects outcomes. The goal is to help doctors design better treatment plans for this challenging condition.

What this could mean

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

Active substance
stereotactic radiosurgery (CyberKnife)
What this could lead to
If successful, this could help doctors choose the best timing and combination of radiation and newer drugs to better control melanoma that has spread to the brain.
What could go wrong
This is an observational study with only 50 patients, so results may not apply to everyone. It does not test a new treatment directly, and outcomes depend on many factors.

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 50 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

Patients receiving stereotactic radiotherapy for melanoma brain metastases as first local approach. Target therapy and immunotherapy in combination or not will be permitted. Given the descriptive nature of the study, no formal sample size calculation was performed. The planned sample size was predefined according to historical data from the RT Division and reflects the expected number of eligible patients treated at our institution over the planned three-year study period. Based on these data, we anticipate enrolling approximately 50 patients.

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: * Age \> 18 * Written informed consent for treatment and research purposes * Melanoma Brain Metastases (MBM) diagnosed with brain MRI/CT * MBM treatable with stereotactic radiotherapy * Systemic therapy (immunotherapy, target therapy, or both) is allowed, as concurrent or non-concurrent treatment with stereotactic radiotherapy Exclusion Criteria: * Leptomeningeal neoplastic infiltration * Previous whole-brain radiotherapy or surgical removal of brain metastases * Patients with histological diagnosis of non-cutaneous melanoma (e.g. uveal melanoma)

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Conditions

The condition(s) this trial relates to.

brain cancer melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma (skin cancer)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • European Institute of Oncology, Milan

    Milan, Mi, 20141, Italy

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