Study on Tebentafusp for Preventing Recurrence in High-Risk Eye Melanoma

Inclusion Criteria

• Have been treated for primary uveal melanoma (not including iris melanoma) with surgery or radiotherapy.
• Treatment must have been completed within the last 11 weeks.
• Classified as high-risk based on specific clinical or genetic criteria.
• Be in good general health with an ECOG performance status of 0 or 1.
• Be 18 years or older.
• Have a specific genetic marker called HLA-A*02:01.
• No signs of cancer recurrence based on recent imaging tests.
• Have normal organ function.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
• Women who are breastfeeding must agree to stop nursing before starting the study and for 6 months after.
• Must provide written informed consent to participate.

Exclusion Criteria

• Have significant heart problems or uncontrolled heart disease.
• Have a prolonged QT interval on an ECG or a history of long QT syndrome.
• Have had a heart attack or unstable chest pain in the last 6 months.
• Have an active infection requiring antibiotics.
• Have severe or uncontrolled systemic diseases or active infections like hepatitis B, hepatitis C, or HIV.
• Have a history of another cancer unless it was treated over 3 years ago and is not expected to return.
• Have active autoimmune diseases requiring treatment, except for certain stable conditions like vitiligo or well-controlled asthma.
• Have any condition that might make it difficult to follow the study protocol.
• Have known allergies to imaging tracers or contrast media used in MRI or CT scans.