RecruitingPhase 1Phase 2NCT06163820

Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases

Bevacizumab and Immune chEckpoint Inhibitors Plus Hypofractionated Stereotactic radioTherapy for the Treatment of sympTomatic mElanoma bRain Metastases.

Sponsor

Melanoma and Skin Cancer Trials Limited

Enrollment

46 participants

Start Date

May 31, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma Brain Metastases

Summary

Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination approach for melanoma that has spread to the brain: bevacizumab (a drug that cuts off tumor blood supply), immune checkpoint inhibitors (ICIs), and stereotactic radiosurgery (precisely targeted radiation). The goal is to control brain tumors and reduce dangerous brain swelling. **You may be eligible if...** - You are 18 or older with melanoma that has spread to the brain (brain metastases) - Your brain tumors are causing symptoms (symptomatic) - You have not received prior whole-brain radiation - Your general health allows treatment (ECOG 0–2) **You may NOT be eligible if...** - You have uncontrolled systemic disease or active bleeding - You have conditions that make bevacizumab unsafe (recent surgery, uncontrolled high blood pressure, blood-clotting disorders) - You have had prior radiation to the same brain areas - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBevacizumab

Bevacizumab is a humanised monoclonal antibody with molecular weight 167kD that inhibits all isoforms of the vascular endothelial growth factor (VEGF) and is produced from a Chinese hamster ovary mammalian system. It has high specificity for isoform-A and has a half-life of \~21 days.

DRUGIpilimumab

Ipilimumab is an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Ipilimumab is a recombinant human immunoglobulin monoclonal antibody that binds CTLA4 and blocks the interaction between CD80/86 and CTLA4.

DRUGNivolumab

Nivolumab ia an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Nivolumab is a fully human monoclonal IgG4 antibody targeting PD-1 which demonstrates activity across a range of tumours.

RADIATIONHypofractionated stereotactic radiotherapy

Hypofractionated stereotactic radiotherapy (hSRT) will be delivered to previously untreated brain metastases in eligible participants. hSRT will be delivered to all symptomatic brain metastases, all brain metastases \>1 cm and all brain metastases located in eloquent areas of the brain. hSRT will be commenced after the first cycle of nivolumab plus ipilimumab and completed before the second cycle of nivolumab plus ipilimumab. hSRT should be commenced within 1 week from the planning MRI.

Locations(1)

Alfred Health

Melbourne, Victoria, Australia

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NCT06163820