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:

• People who have been diagnosed with metastatic melanoma (skin cancer that has spread) that has also spread to the brain, confirmed by scans and tissue testing
• People whose brain metastases require regular steroid medication (above certain doses) to manage symptoms
• People who have at least one tumour that can be measured on a scan, according to standard medical guidelines
• People who have brain tumour activity that doctors can assess and monitor
• People aged 18 or older
• People with a general health and activity level rated 0–2 on a standard medical scale (confirm with trial site)
• People who are able to have an MRI scan using a contrast dye called gadolinium
• People whose blood counts and organ function (such as liver and kidneys) meet the required levels
• People who have little to no lasting side effects from previous cancer treatments (rated below level 1 on a standard scale)
• Women who could become pregnant must have a negative pregnancy test before starting and must use an accepted form of contraception from the screening period until 6 months after treatment ends (accepted methods include the pill, IUD/coil, hormonal injections, implants, vaginal rings, or skin patches)
• Men with a female partner who could become pregnant must use an accepted form of contraception from screening until 6 months after treatment ends (accepted methods include those listed above for the female partner, plus documented vasectomy, confirmed sterility, or double barrier methods)
• People who have read or heard information about the study and have signed a consent form agreeing to participate
• People who are willing and able to attend follow-up appointments and manage potential side effects
• For one specific treatment group (Arm E only): people whose tumour cells carry a specific genetic change called a BRAF mutation

Who may not be able to join:

• People who have had, or currently have, another type of cancer, unless they have been cancer-free for at least 3 years
• People whose melanoma originated in the eye (ocular melanoma)
• People who are experiencing neurological symptoms from brain metastases (such as headaches, confusion, or weakness) that persist even while taking steroids — unless those symptoms are related to a previous brain surgery
• People with a known allergy or sensitivity to any of the medicines used in this trial
• People with an active or ongoing HIV or hepatitis infection
• People with any other health condition that could affect their safety or ability to follow the trial requirements
• People who have previously received certain types of immunotherapy drugs (anti-PD-1, PD-L1, PD-L2, or CTLA-4 treatments) for metastatic melanoma
• People who received those same immunotherapy drugs as a preventative (adjuvant) treatment less than 6 months before joining the trial
• People currently receiving other experimental treatments or additional anti-cancer therapies at the same time
• People who are pregnant or breastfeeding
• For one specific treatment group (Arm E only): people who have previously been treated with BRAF or MEK inhibitor drugs

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