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 have been diagnosed with metastatic uveal melanoma (a type of eye cancer that has spread) confirmed by tissue testing, and whose blood test shows a specific genetic marker called HLA-A*0201.
• People whose uveal melanoma has spread to the liver in a way that surgeons consider removable or potentially removable, as assessed by scans reviewed by a specialist medical team.
• People who have not previously received any systemic treatment (such as chemotherapy, immunotherapy, or targeted therapy) for their advanced or metastatic disease.
• People who have not previously had any liver-directed treatments such as chemotherapy, radiotherapy, radiofrequency ablation, or embolization to the liver.
• People who received treatment before or after surgery for early-stage (localised) disease may still be considered eligible (confirm with trial site).
• People aged 18 or older at the time of signing the consent form.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard medical fitness scale (ECOG score of 0 or 1).
• People whose blood and organ function tests meet the required levels, including healthy enough red blood cells, white blood cells, platelets, liver function, kidney function, and certain mineral levels — without needing a blood transfusion to reach those levels.

Who may not be able to join:

• People whose cancer has spread to areas of the body outside the liver.
• People who currently have, or have had in the past 5 years, another type of cancer — with exceptions for certain minor skin cancers or superficial bladder cancers that have been treated locally.
• People who have had a severe allergic reaction (such as anaphylaxis) to a biological drug or monoclonal antibody in the past.
• People with significant or poorly controlled heart conditions, including moderate-to-severe heart failure, uncontrolled high blood pressure, serious heart rhythm problems, a specific abnormal result on a heart trace (ECG) test, an inherited heart rhythm condition, or a heart attack or unstable chest pain within the past 6 months.
• People with a history of adrenal gland insufficiency (a condition where the adrenal glands do not produce enough hormones).
• People with a history of interstitial lung disease (scarring or inflammation of the lungs).
• People who have had lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with a history of colitis or inflammatory bowel disease.
• People who currently have an active infection that requires antibiotic treatment taken by mouth or injection, unless that antibiotic course was completed at least one week before the first study treatment dose.
• People with a known history of HIV infection.
• People with an active hepatitis B or hepatitis C infection, assessed according to local hospital procedures.
• People who have previously been treated with the drug tebentafusp.
• People currently taking steroid tablets or injections, or any other medication that suppresses the immune system — though steroid drops, eye drops, joint injections, or inhalers are generally acceptable.
• People who have had major surgery within 2 weeks before the first dose of the study drug.
• People who have used certain medications that stimulate blood cell production (such as G-CSF or GM-CSF) within the 2 weeks before starting the study drug.
• People who are known to be allergic to tebentafusp or any of its ingredients, which include certain acids, salts, sugars, and stabilising agents listed in the trial details (confirm with trial site for the full ingredient list).
• People whose personal circumstances would make it unlikely they could complete the trial or attend required follow-up visits.
• People who are pregnant, likely to become pregnant, or currently breastfeeding.
• Women who are capable of becoming pregnant and are sexually active with a male partner who has not been surgically sterilised, unless highly effective contraception is used throughout treatment and for one week after the final dose.
• Male participants who are not surgically sterilised must use double-barrier contraception from enrolment through to one week after the last dose of study drug.

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