Phase 3 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 advanced melanoma (Stage IIIC, IIID, or IV) that cannot be fully removed by surgery or has spread to other parts of the body, confirmed by a lab test on a tissue sample.
• Your doctor has assessed that you are generally well enough to carry out daily activities with little or no limitation, and your life expectancy is estimated to be more than 6 months.
• You have at least one tumor (or group of tumors) that a surgeon can remove to be used to create a personalised cell therapy called lifileucel.
• After the tumor removal, you still have at least one other measurable area of disease that doctors can track during the trial.
• Your organs (such as kidneys, liver, and heart) are working well enough to safely take part.
• If you or your partner could become pregnant, you must be willing to use a highly effective method of birth control during the trial.
• If you are over 70 years old, you may still be considered after your doctor discusses your case with the trial medical team.

Who may not be able to join:

• Your melanoma started in the eye (uveal or ocular melanoma).
• You have brain metastases (cancer that has spread to the brain) that are causing symptoms and have not been treated.
• You have already received more than one previous treatment course for your melanoma.
• You have previously received any treatment specifically for metastatic (spread) disease.
• If your tumor has a specific gene change called BRAF V600 mutation, and you have only received a type of immune therapy (called ICI) before surgery as a preventative treatment, you may not be eligible (confirm with trial site).
• You have an active serious illness — such as an ongoing infection, seizure disorder, blood clotting disorder, or significant heart, lung, or immune system condition — that your doctor believes could make participation risky.
• You have any condition that weakens your immune system, such as a severe immune deficiency (e.g., SCID) or AIDS.
• You have had another type of cancer diagnosed within the last 3 years, unless it did not need treatment or was fully treated more than 1 year ago and your doctor does not think it is likely to return.
• You have previously had a transplant of an organ or cells from another person.

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