Phase 3 Melanoma Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older.
• People diagnosed with melanoma that cannot be surgically removed (stage III) or has spread to other parts of the body (stage IV), confirmed by a tissue or cell test.
• People whose melanoma did not respond to immunotherapy, or who were unable to tolerate immunotherapy.
• People whose melanoma has a specific gene change called an NRAS mutation.
• People who have at least one measurable tumour that doctors can track using standard imaging criteria.
• People who are reasonably active and able to carry out daily activities, rated 0 or 1 on a standard medical scale (ECOG performance status).
• People with a life expectancy of more than 3 months.
• People who have not had major surgery or a serious physical injury in the 4 weeks before starting the trial drug (routine tumour biopsy is not counted).
• People whose heart pumping function is at least 50%, confirmed by a heart scan done within 7 days before starting treatment.
• People whose recent blood test results (taken within 7 days before starting treatment) meet the trial's required levels (confirm specific values with the trial site).
• People who are able to understand the study information and sign a consent form voluntarily.
• People who are willing and able to complete all study visits and follow-up appointments.

Who may not be able to join:

• People who received chemotherapy, targeted therapy, or another trial drug within 4 weeks (or within 5 half-lives of that drug, whichever is longer) before starting this trial; or who received immunotherapy or biological therapy within 4 weeks before starting; or who received certain approved traditional Chinese anti-cancer medicines within 2 weeks before starting.
• People who still have unresolved side effects from previous cancer treatment.
• People currently taking other anti-cancer drugs.
• People who have brain metastases causing symptoms, untreated brain metastases, cancer spread to the membranes around the brain, or spinal cord compression — except for people with brain metastases that are not causing any symptoms.
• People who, within the past 6 months, have had a heart attack, severe chest pain, heart bypass surgery, serious heart failure, serious heart rhythm problems requiring medication, uncontrolled high blood pressure, stroke, mini-stroke, diabetic ketoacidosis, deep vein thrombosis, or a blood clot in the lungs.
• People with an abnormal heart electrical reading (QTc interval of 480 milliseconds or more) at screening, or a history of a condition called long QT syndrome.
• People with a history of or current eye (retinal) disease.
• People with a history of or current muscle or nerve disease associated with elevated levels of a muscle enzyme called CK.
• People with a history of or current scarring or inflammation of the lungs (interstitial lung disease or pneumonitis).
• People with serious infections or other medical conditions that are not under control.
• People who have had significant bleeding (grade 3 or higher on a standard medical scale) within the 4 weeks before starting the trial.
• People who are unable to swallow capsules, have persistent nausea and vomiting, have absorption problems, have had part of the small intestine removed, or have a bile drainage tube — any of which might prevent the study drug from being absorbed properly.
• People currently taking certain medications that strongly affect how the body processes drugs (specifically strong inducers or inhibitors of the liver enzyme CYP2C9) and who cannot stop taking them at least 1 week before starting the trial.
• People who have been diagnosed with another cancer within the past 5 years.
• People who test positive for HIV, syphilis, active hepatitis C, or active hepatitis B.
• People who have previously been treated with a type of drug called a MEK inhibitor.
• People with a known allergy or sensitivity to the trial drug or similar medicines.
• People who have had a bone marrow transplant or organ transplant from another person.
• Women who are pre-menopausal and have a positive pregnancy test.
• People with other serious medical or psychiatric conditions, or significant abnormal test results, that the trial doctors believe could increase risk or affect the study results.

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