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 have been diagnosed with melanoma that has spread to other parts of the body or cannot be surgically removed, confirmed by a tissue biopsy.
• You have a specific gene change in your tumor called a "BRAF V600 mutation," confirmed by an approved lab test.
• Your melanoma has either been stable for 3 or more months on certain targeted therapy drugs (dabrafenib/trametinib or encorafenib/binimetinib), OR these types of drugs have stopped working for you.
• You may have previously received immunotherapy or certain cell-based treatments, though these are not required; aside from radiation, no other prior treatments are allowed.
• You are 18 years of age or older.
• You are generally healthy enough to carry out light activity and care for yourself (your doctor will assess this using a standard scale).
• Your blood counts, liver, and kidney function are within acceptable ranges based on recent lab tests.
• If you have HIV, you are on effective treatment and your virus levels are undetectable within the last 6 months.
• If you have a history of hepatitis B, your virus levels are undetectable while on appropriate treatment.
• If you have a history of hepatitis C, you have been successfully treated and cured, or are currently on treatment with undetectable virus levels.
• If you have had brain metastases (cancer spread to the brain), they have already been treated and follow-up scans at least 4 weeks later show no sign of growth.
• If you have or have had another type of cancer, it is not expected to interfere with this trial's treatments or results.
• If you have a history of heart problems or have received treatments that can affect the heart, your heart function meets a minimum acceptable level (confirm with trial site).
• Your cancer can be measured on imaging scans using standard criteria.
• If you are able to become pregnant, or are a man whose partner could become pregnant, you agree to use non-hormonal or barrier birth control (or abstinence) throughout the trial and for 4 months after finishing treatment.
• You are able to understand and willing to sign a consent form agreeing to participate.

Who may not be able to join:

• You have ongoing and unresolvable low potassium or low magnesium levels in your blood (though a repeat test showing normal levels may still allow eligibility).
• You have a heart condition called long QT syndrome, or your heart's electrical activity (measured by an ECG) is above a certain threshold (confirm with trial site).
• You are still experiencing side effects from a previous cancer treatment that have not returned to a mild or baseline level, with some exceptions such as hair loss, mild tiredness, skin colour changes, or hormone-related conditions being managed with stable medication.
• You are currently taking part in another experimental treatment study that could affect this trial's results.
• You have cancer that has spread to the brain that has not yet been treated.
• You have had a serious allergic reaction to drugs similar to those used in this trial (nilotinib, dabrafenib, encorafenib, binimetinib, or trametinib).
• You are currently taking certain medications that strongly affect how the body processes some of the trial drugs (known as strong CYP3A inhibitors or inducers — confirm with trial site, as this list changes regularly).
• You are currently taking certain other medications that interfere with dabrafenib or trametinib specifically (known as strong CYP2C8 inhibitors — confirm with trial site).
• You regularly take proton pump inhibitors (a common type of heartburn/acid medication) alongside one of the trial drugs (nilotinib); certain other antacids may be acceptable as alternatives.
• You are taking any drugs or substances known to affect heart rhythm in a way that could interact with nilotinib (confirm with trial site).
• You have another serious illness that is not currently under control.
• You have a mental health condition or personal circumstances that would make it difficult to follow the trial's requirements.
• You are currently pregnant or breastfeeding.

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