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:

• People who are 18 years of age or older at the time of signing the consent form
• People who are generally well enough to carry out normal daily activities with little to no limitation (a measure doctors use called ECOG performance status 0 or 1)
• People who have been confirmed through a tissue or cell sample to have uveal melanoma (a type of eye cancer) that has spread to the liver
• People who test positive for a specific genetic marker called HLA-A*02:01
• People who have at least one measurable area of cancer in the liver, detectable on a CT scan using standard measurement guidelines
• People who the treating medical team considers suitable for both of the treatments used in this trial
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting treatment
• Women who could become pregnant must agree to use an adequate form of contraception during the study and for 150 days after the last dose (abstinence is accepted if that is their usual practice)
• Men who could father a child must agree to use an adequate form of contraception from the first dose until 150 days after the last dose (abstinence is accepted if that is their usual practice)
• People with a small amount of cancer outside the liver may still be considered, if that cancer can be treated with targeted radiation therapy or surgery before the trial treatment begins (confirm with trial site)
• People who are able to read, understand, and sign a consent form before any study procedures begin

Who may not be able to join:

• People with a life expectancy of less than 6 months
• People where more than half of the liver has been replaced by tumour, as measured by MRI
• People who have cancer that has spread significantly to areas outside the liver, beyond what could be treated with targeted radiation or surgery beforehand
• People with a history of heart failure, unstable chest pain, a recent heart attack, significant irregular heartbeat, or severe heart valve disease that would make general anaesthesia unsafe
• People with significant lung disease, such as severe COPD, that would make general anaesthesia unsafe
• People who are unable to have a general anaesthetic for any reason
• People with reduced kidney function, based on specific blood test results (confirm with trial site for exact values)
• People with reduced liver function based on specific blood test results, a history of liver cirrhosis of a certain severity, or signs of high pressure in the liver's blood vessels
• People with low levels of haemoglobin, platelets, or neutrophils (types of blood cells), based on specific blood test thresholds (confirm with trial site for exact values)
• People who have received a live vaccine within four weeks before the last study treatment
• People with a history of severe reactions to melphalan, heparin, or iodine contrast dye — though those with a contrast dye reaction history may still be considered if pre-medications are used or if an MRI is substituted (confirm with trial site)
• People with known HIV, AIDS, hepatitis B, or hepatitis C
• People with an active autoimmune disease or a history of autoimmune disease that required ongoing treatment affecting the immune system — though type 1 diabetes, atopic dermatitis, and an underactive thyroid are exceptions
• People currently taking corticosteroids at doses above 10 mg of prednisone per day, or other immune-suppressing medications, within 14 days before starting the study drug (inhaled or topical steroids and certain replacement doses are permitted)
• People receiving any other cancer treatment, immune-suppressing medications, or other experimental drugs at the same time as this trial
• People who have another cancer that is currently growing or requiring active treatment
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period and for 150 days after the last dose
• People who have any other condition, treatment history, or abnormal test result that the treating doctor believes would affect the study results or would not be in the person's best interest
• People who have previously been treated with either of the two treatments used in this trial (PHP or tebentafusp)

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