Phase 12 Study of Tebentafusp Combined With IL-2 for Treating Metastatic Uveal Melanoma

What this Trial Is About

This research focuses on metastatic uveal melanoma mUM, a rare and aggressive eye cancer that often spreads to the liver and other organs. Patients with mUM generally have a poor outlook, with limited treatment options and no established standard care. Researchers aim to test whether adding interleukin-2 IL-2 to the existing therapy tebentafusp can improve tumor response and survival by overcoming resistance to tebentafusp. All participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. During the first cycle, IL-2 is given on days 1 to 3, 10, 17, and 24, with tebentafusp administered on days 4, 11, 18, and 25. From the second cycle onward, IL-2 is given on days 1, 8, 15, and 22, while tebentafusp is given on days 2, 9, 16, and 23. This single-arm Phase Ib study evaluates this combination therapys safety and effectiveness. Participants will be monitored through approximately one year of study completion, with researchers assessing safety, radiological progression-free survival, and overall survival. The study involves regular imaging and clinical evaluations to track tumor progression and participant health. This trial is sponsored by St Vincents Hospital, Sydney, and aims to offer new options for patients with this serious illness.

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression