Melanoma Brain Metastases Treated with Stereotactic Radiosurgery and Systemic Therapy
Official title: Impact of Stereotactic Radiosurgery With Cyberknife In Patients With Brain Melanoma Metastases In The Era Of New Drugs
Run by European Institute of Oncology · NCT07691255 · Data updated 2026-11-12
This study looks at how stereotactic radiosurgery for melanoma brain metastases works when patients are also receiving immunotherapy or targeted therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | immunotherapy, Radiation |
| Locations | 2 sites (Milan, Italy and 1 other locations) |
| Status | Recruiting |
| Started | August 25, 2026 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2030 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07691255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with melanoma brain metastases suitable for stereotactic radiotherapy, who may or may not be receiving systemic therapy.
✕Probably not a fit
Patients whose brain metastases do not respond to radiation or who cannot tolerate systemic therapy may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will observe adults with melanoma that has spread to the brain who are treated with stereotactic radiosurgery (SRS) at the European Institute of Oncology between 2026 and 2028. The goal is to see how the timing and sequencing of SRS with systemic therapies influence outcomes and to collect real-world data to guide future treatment decisions. It is an observational study without a specified intervention beyond standard SRS and concurrent or non-concurrent systemic therapy. Eligible participants are adults with brain-d metastatic melanoma treatable by SRS, able to provide informed consent, and without prior whole-brain radiotherapy or non-cutaneous melanoma. Data will be collected from medical records to analyze local control, survival, and safety.
Why it matters
Potential benefit: If successful, the study could clarify how best to combine SRS with systemic therapies to improve outcomes for patients with melanoma brain metastases.
How similar studies have gone: Previous analyses suggest SRS provides good local control for limited brain metastases, but this study seeks to expand understanding in the context of modern systemic therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
European Institute of Oncology, Milan
Milan, Italy, Italy Recruiting -
European Institute of Oncology, Milan
Milan, Mi, Italy Recruiting
Study contacts
- Principal investigator: Samantha Dicuonzo, MD — European Institute of Oncology
- Study coordinator: Samantha Dicuonzo, MD
- Email: samantha.dicuonzo@ieo.it
- Phone: +39 0257489037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.