Study of Tebentafusp-Tebn Combined With Liver-Directed Therapies for Metastatic Uveal Melanoma in HLA-A*0201 Positive Patients

What this Trial Is About

Researchers are evaluating the safety and clinical efficacy of tebentafusp-tebn combined with liver-directed therapies in patients with metastatic uveal melanoma who are HLA-A*0201 positive. This multicenter, open-label phase III trial focuses on two groups those with low to moderate liver disease burden and those with more extensive liver involvement. The study aims to assess progression-free survival and other response measures while monitoring safety. The study has two main parts. Part 1 involves tebentafusp-tebn combined with hepatic immunoembolization IE plus GM-CSF in patients with smaller liver tumors, starting with a 4-week induction of tebentafusp-tebn alone followed by combination treatment cycles. Part 1B expands to a randomized phase II comparing combination therapy to tebentafusp-tebn alone. Part 2 focuses on patients with larger liver tumors, using sequential transarterial chemoembolization TACE with BCNU followed by weekly tebentafusp-tebn treatment. Additional TACE treatments may be given after induction as needed. Participants undergo imaging, blood sampling, and optional tumor biopsies at baseline and during treatment to assess tumor response and immune markers. Safety is closely monitored during and after treatment cycles. Treatments continue until disease progression or clinical benefit ends, with long-term follow-up planned. The primary outcomes include safety, progression-free survival, and liver-specific disease control, with secondary measures including overall response and survival.

Tebentafusp-tebn With LDT in Metastatic UM