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 melanoma that cannot be surgically removed or has spread to other parts of the body, and whose tumour has a confirmed NF1 gene mutation (tested at an approved certified laboratory — variants of unknown significance do not qualify)
• People who have had NF1 gene sequencing results from a certified laboratory, either from a tumour tissue sample or a blood-based test
• People who have previously received certain immunotherapy treatments (specifically anti-PD-1/PD-L1 and either anti-CTLA-4 or anti-LAG3 antibody treatments), unless the treating doctor determined those treatments were not suitable due to health conditions or serious side effects
• People whose cancer is actively growing or spreading at the time of enrolment
• People aged 18 or older
• People whose cancer can be measured on scans according to standard criteria (called RECIST 1.1)
• People who are well enough to carry out basic daily activities, as assessed by a standard scale used by doctors (ECOG score of 0, 1, or 2)
• People whose blood counts, kidney, liver, and clotting function meet the minimum levels required by the trial (confirm with trial site for specific values)
• People whose heart is functioning adequately, including normal blood pressure, normal heart pumping function, and no significant abnormalities on a heart tracing test
• People with normal blood calcium and phosphate levels
• Women who cannot become pregnant (for example, due to surgical procedures or being post-menopausal for at least one year), or women who can become pregnant but agree to use highly effective contraception during the trial and for at least six months after the last dose
• Male participants, or their partners, who are surgically sterile or agree to use adequate contraception during treatment and for three months afterwards
• People who are able to understand the study and are willing to provide written consent to participate

Who may not be able to join:

• People who have previously been treated with MEK, ERK, or RAF inhibitor therapies
• People who have brain metastases causing symptoms, active brain lesions 6mm or larger, or who need steroid medication to manage brain lesions or disease affecting the lining of the brain
• People who have received any systemic cancer treatment within 28 days before starting the study drug
• People who are currently enrolled in another therapeutic clinical trial
• People who have received an experimental therapy within 4 weeks before the first dose, or within a period of less than 5 half-lives of that experimental drug, whichever is longer
• People who have a history of, or current signs of, certain eye conditions on examination that are considered risk factors for serious retinal problems (such as retinal vein occlusion or macular degeneration), including high eye pressure, high cholesterol, high triglycerides, or high blood sugar levels
• People with a history of glaucoma or other significant eye abnormalities found on examination, including anything that prevents a clear view of the retina or shows concerning findings on specialised eye imaging (mild and stable age-related conditions may be considered at the doctor's discretion)
• People who have had a serious heart-related event within the 6 months before starting the study, such as a heart attack, severe chest pain, heart failure, stroke, significant mini-stroke, blood clot in the lungs, unexplained fainting, or a condition affecting the heart's electrical rhythm
• People who are pregnant or breastfeeding
• People who have an active bacterial, fungal, or viral infection at the time of screening, including those currently taking antibiotics, antifungal, or antiviral medications
• People with underlying health conditions, abnormal test results, or alcohol or drug dependence that, in the treating doctor's judgement, could make treatment unsafe, make side effects harder to assess, or make it unlikely the person could complete the study
• People who have experienced serious medical or psychiatric conditions, including active or recent (within the past year) suicidal thoughts or behaviour, or other factors that in the treating doctor's judgement would make participation unsafe or affect the study results

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