Study on Tebentafusp and Radioembolization for Treating Metastatic Uveal Melanoma

Inclusion Criteria

• Have uveal melanoma that has spread mainly to the liver, confirmed by medical tests.
• Blood tests showing bilirubin levels less than 2 mg/dl, and liver enzymes (AST and ALT) less than 5 times the normal limit.
• A test called a mapping angiogram shows that radioembolization can be safely performed.
• Have a specific genetic marker called HLA A*02:01.
• Be 18 years or older.
• Be able to understand and sign a consent form.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have measurable or non-measurable disease according to specific medical criteria.

Exclusion Criteria

• Have any tumor larger than 8 cm.
• Blood tests showing bilirubin levels higher than 1.5 times the normal limit, except for certain conditions like Gilbert's syndrome.
• Certain abnormal blood test results, such as low blood cell counts or high liver enzymes.
• Angiogram shows issues that prevent safe radioembolization.
• History of severe allergic reactions to similar treatments.
• Significant heart problems, such as heart failure or uncontrolled high blood pressure.
• Untreated or symptomatic brain metastases.
• Active infections requiring antibiotics.
• History of HIV, active hepatitis B or C infections.
• Other active cancers, unless they were treated and have not returned for at least 2 years.
• Medical conditions that could interfere with the study.
• Recent use of steroids or other immune-suppressing drugs, with some exceptions.
• History of lung diseases like interstitial lung disease or pneumonitis.
• Active autoimmune diseases requiring treatment, with some exceptions.
• Recent major surgery or radiation therapy.
• Recent use of certain growth factors or vaccines.
• Pregnant or breastfeeding women, or those not using effective birth control.
• Men not using effective birth control methods.
• Previous liver-directed treatments like radioembolization.
• Impaired decision-making capacity.