Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.
• Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review
• Serum bilirubin \<2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN)
• Mapping angiogram procedure shows radioembolization is feasible and safe to perform
• Human leukocyte antigen-A\*02:01(HLA A⁕ 02:01) positive
• Patient age ≥ 18 years old
• Ability to provide and understand written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009).