Phase 2 Melanoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older (male or female)
• You have agreed in writing to take part in the study after being fully informed about it
• You have been diagnosed with advanced melanoma (skin, nail area, or mucous membrane type, or of unknown origin) that cannot be surgically removed, and you have at least one brain tumour spot that is between 5mm and 40mm in size, detectable on a scan
• Your doctors have confirmed whether or not your melanoma has a specific gene change called a BRAF mutation, before you join the study
• Your doctors believe the brain tumours could be treated with a targeted form of radiotherapy (stereotactic radiotherapy) rather than whole-brain radiotherapy, and your situation is not so urgent that you need immediate treatment
• Your brain tumours have not yet been treated with radiotherapy or drug treatment (previous surgery to fully remove a brain tumour is allowed in some cases)
• Any previous drug treatment for melanoma was only given before or after surgery for disease outside the brain, and your brain tumours were confirmed absent at that time, with the brain tumours now appearing at least 6 months after stopping that earlier treatment
• You have no current symptoms from your brain tumours and do not need steroids, painkillers, or other treatments for brain-related symptoms (anti-seizure medicines are allowed; recently resolved symptoms may also be acceptable — confirm with trial site)
• You are reasonably active and able to carry out daily activities to an acceptable level (confirm with trial site)
• Your life expectancy is more than 30 days
• You are able to have an MRI scan with a contrast dye called gadolinium
• Your blood, liver, and kidney function results are within acceptable ranges as measured by standard blood tests (confirm specific values with trial site)
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 7 days of starting treatment and agree to use effective contraception from 14 days before starting treatment until 23 weeks after the last dose

Who may not be able to join:

• Your brain tumours have changed significantly between scans, meaning targeted radiotherapy is no longer suitable for you
• Any single brain tumour is larger than 40mm
• There is evidence that the cancer has spread to the lining of the brain or spinal cord (leptomeningeal disease)
• You have or have had melanoma of the eye (ocular melanoma)
• You currently have neurological symptoms caused by your brain tumours
• You have previously had any radiotherapy to the brain
• You have previously received drug treatment for melanoma, unless it was given in a pre- or post-surgery setting and finished at least 6 months ago
• You have an active autoimmune disease (some milder autoimmune conditions such as vitiligo, Type 1 diabetes, thyroid conditions on hormone replacement, or mild psoriasis may still be acceptable — confirm with trial site)
• You are currently taking steroid medicines, or have taken them within the last 7 days, above a low non-immune-suppressing dose (some exceptions apply — confirm with trial site)
• You have an active infection that is being treated
• You have a history of a lung condition called interstitial lung disease
• You have another active cancer requiring treatment, or have had another cancer within the last 3 years
• You have serious or unstable health conditions that could affect your safety or ability to take part
• You are pregnant or breastfeeding
• You have received a live vaccine within 30 days of starting the trial, or plan to during the trial
• You have had a known allergic reaction to the study treatments

Important: Always verify eligibility with the trial site directly before applying.