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Uveal melanoma is a rare cancer that starts in the eye. In some people, the cancer spreads to other parts of the body. When this happens, it is called metastatic uveal melanoma. New treatments are needed for people with this disease. This study is testing a drug tebentafusp and how well it works in people with metastatic uveal melanoma that have tested positive for a protein called HLA-A*0201. If you join the study, you will first complete screening tests. Screening may take up to 35 days. During screening, the study team will review your medical history and check your health. You may have blood and urine tests, a physical exam, and imaging scans. You will also have a heart test. Some people may also have a biopsy so the study team can collect a small tumor sample. If you are able to join the study, you will get the study drug once every 7 days. The drug will be given through a small tube placed in a vein, called an IV. Each treatment cycle lasts 7 days (one week). You will visit the study clinic about once a week during treatment. At these visits, the study team will check your health and ask about any side effects. Blood samples will be collected to measure your health and measure the tumor DNA in your blood. You may also have imaging scans to see how the cancer is responding to treatment. Some visits may include stool samples and short questions about your diet. The length of each visit may change based on the tests done that day. If treatment ends, you will return for an end-of–treatment visit. You will also return for a safety follow-up visit about 30 days later. The study team may reach out to you and review your medical records to check your health after treatment. You may stay on the study as long as the treatment is helping you, and your doctor believes it is safe. Your participation may end sooner if your cancer worsens, if side effects become too severe, or if you choose to leave the study. You will not be paid for being in this study. The study sponsor will pay for tests and procedures done only for the research. You and your insurance will need to pay for routine medical care.

Who can Participate

You may be able to join this study if you are an adult with metastatic uveal melanoma and have tested positive for the HLA-A*0201 genetic marker. You must not have received prior drug treatment for metastatic disease. You may not be able to join if you received radiation therapy within 2 weeks before starting the study drug, unless the radiation was given to relieve symptoms. You may also not be able to join if you have had severe allergic reactions (e.g., anaphylaxis) to certain drugs or monoclonal antibody treatments. People with untreated or symptomatic cancer that has spread to the brain or central nervous system may also not be able to join. Your doctor or study team member will review these requirements with you. You can click on the NCT number link below to learn more on ClinicalTrials.gov.

Study ID

More information available at ClinicalTrials.gov: NCT06070012