Early Phase 1 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 must be 18 years old or older when you sign the consent form
• You must have been diagnosed with melanoma (confirmed by a tissue sample), from any location on the body or of unknown origin
• Your melanoma must have a specific gene change called a BRAFV600 mutation, and must be at an advanced stage (Stage III B/C/D or Stage IV)
• You must be well enough to carry out basic daily activities (your doctor will assess this using a standard scale)
• Your blood test results must show acceptable levels of red blood cells, platelets, liver function, and kidney function
• If you could become pregnant, you must have a negative pregnancy test and agree to use highly effective non-hormonal contraception during the trial
• If you are male, you must agree to use highly effective contraception during the trial
• You may have previously received certain immunotherapy treatments (anti-PD-1/PD-L1 or CTLA-4 inhibitors)
• People living with HIV may be eligible if they are on effective treatment and their virus levels are undetectable
• People with a history of hepatitis C may be eligible if they have been successfully treated and cured, or have undetectable virus levels if currently being treated

Who may not be able to join:

• You are not eligible if your melanoma got worse while you were actively taking BRAF or MEK inhibitor drugs (though progressing after stopping those drugs may be permitted)
• You cannot join if you previously had to stop taking the specific study drugs (encorafenib and/or binimetinib) due to serious side effects
• You cannot join if you have had major surgery or radiation treatment within the last 14 days, or have not yet recovered from those procedures
• You cannot join if you are unwilling to avoid grapefruit, pomegranates, star fruit, Seville oranges, or their juices during the study
• You cannot join if you have brain tumours that are unstable, causing symptoms, require steroid treatment, or have been treated with radiation within the last 28 days (confirm with trial site)
• You cannot join if you have certain serious heart problems, including severe heart failure, uncontrolled irregular heart rhythms, or an abnormal heart electrical reading above a certain level
• You cannot join if you have a known history of a blood clot in the eye (retinal vein occlusion)
• You cannot join if you are currently taking, or have recently taken within the past week, any medications, herbal supplements, or foods that are not permitted in this trial (confirm with trial site for the full list)
• You cannot join if you are pregnant or currently breastfeeding

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