Neoadjuvant Tebentafusp for Uveal Melanoma

This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A\*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.

NCT Number	NCT06414590
Lead Sponsor	Thomas Jefferson University Collaborators: Immunocore Ltd
Conditions	Locally Advanced Unresectable Uveal Melanoma
Enrollment	19 participants
Start Date	2025-09-05
Primary Completion	2027-08 (estimated)
Study Completion	2032-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-12