Phase 2 Single Arm Study of Tebentafusp Combined with Yttrium-90 Radioembolization for Treating Metastatic Uveal Melanoma in the Liver

What this Trial Is About

Researchers are evaluating the effects of combining Tebentafusp with Yttrium-90 Y-90 radioembolization in patients who have metastatic uveal melanoma that has spread to the liver. This Phase 2 study aims to understand both the benefits and risks of this combined treatment approach. The study focuses on patients with liver metastases and includes detailed eligibility assessments based on medical history and tumor characteristics. Participants will first receive Y-90 Trans-Arterial Radioembolization TARE to target liver tumors, followed by a recovery period of 14 to 28 days. After recovery, Tebentafusp is administered intravenously once a week in 28-day treatment cycles. The first cycle includes a dose escalation schedule starting with 20 mcg on Day 1, increasing to 30 mcg on Day 8, and then 68 mcg on Day 15. Participants may continue Tebentafusp treatment for up to 24 months or 24 cycles. Total participation in the study lasts about three years. Throughout the study, participants will undergo regular monitoring for disease progression and treatment-related side effects. Researchers will evaluate progression-free survival and adverse events for up to 24 months, along with secondary measures like disease control rate, overall response, duration of response, and overall survival. Safety and response will be closely tracked with clinical assessments, imaging, and laboratory tests. Participants health status and treatment effects will be observed over the entire study period to gather comprehensive data on this combination therapy.

Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma