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:

• You are 18 years of age or older (male or female)
• You are willing to sign a consent form agreeing to take part
• Your doctors expect you to live for more than 6 months
• You have been newly diagnosed with advanced (Stage IV) melanoma that started in the skin, on the hands or feet (acral), or from an unknown location, confirmed by a tissue biopsy
• Your melanoma has spread to between 1 and 5 spots outside the brain, seen on CT and PET-CT scans, and cannot be removed by surgery
• You may also have the original melanoma site and/or up to 4 nearby skin spread spots, as long as the total number of spots does not exceed 5
• If you had surgery to relieve urgent symptoms (such as a bowel blockage), you may still qualify as long as no more than one spot was removed and 5 or fewer spots remain
• At least one of your cancer spots can be measured on scans using standard measurement guidelines
• There is no sign of melanoma spread to the brain (checked by MRI, or CT scan if MRI is not suitable for you)
• All of your cancer spots can be treated with a precise, high-dose form of targeted radiation therapy (SBRT) at the required dose level
• Your specialist doctor has decided you are well enough to receive immunotherapy treatment
• Your general health and ability to carry out daily activities meets a standard score of 0–2 (meaning you are fully active to capable of basic self-care) (confirm with trial site)
• If you could become pregnant, you must have a negative blood pregnancy test within 7 days of being assigned to a treatment group

Who may not be able to join:

• Your melanoma started in the eye or on the mucous membranes (such as inside the mouth or nose)
• You have serious or unstable health conditions that could affect your safety or ability to participate
• You need radiotherapy urgently and immediately for a serious complication (such as pressure on the spinal cord or rapidly worsening symptoms)
• You have previously had radiotherapy for Stage IV (advanced/spread) melanoma
• Not all of your cancer spots can be safely treated with the targeted radiation therapy (SBRT), as decided by your radiation specialist
• You have previously had drug treatment (such as chemotherapy or immunotherapy) for melanoma, unless it was given as a preventative treatment at an earlier, less advanced stage
• You have any reason why you cannot safely receive the planned immunotherapy drugs
• You have melanoma that has spread to the liver AND you have moderate or severe liver problems
• You have a history of another cancer, unless you have been cancer-free for at least 1 year, have been fully treated, and have a low chance of it coming back
• You are currently pregnant or breastfeeding

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