An open-label, two-stage, single-arm, multi-center study of tebentafusp in HLA-A*0201 positive previously untreated (1L) mUM (TARGET-tebe). HLAA*0201 positive patients with 1L mUM and detectable ctDNA at baseline to evaluate reduction in ctDNA by 12 weeks (W12), and induction of CD8+ T cells intratumorally.

Who can Participate

Inclusion: -HLA-A*0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review. -No prior systemic therapy in the metastatic or advanced setting including chemotherapy, or targeted therapy. Exclusion: -Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass -History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biologic drugs or monoclonal antibodies -Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1 More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.

Study ID

More information available at ClinicalTrials.gov: NCT06070012