Phase III Trial Comparing Adjuvant Weekly Intravenous Tebentafusp to Observation in Adults with High-risk HLA-A*0201 Positive Uveal Melanoma After Primary Treatment

What this Trial Is About

Researchers are studying patients with high-risk primary uveal melanoma to evaluate whether treatment with tebentafusp can reduce the risk of disease recurrence after initial tumor treatment. This study compares the effects of tebentafusp versus observation alone in adults who have undergone surgery or radiotherapy but have no metastatic disease. Tebentafusp has previously shown improved survival in patients with metastatic uveal melanoma, and this trial explores its benefit in the adjuvant setting. Participants in this trial are randomly assigned to receive either weekly intravenous tebentafusp or observation without intervention. Tebentafusp dosing starts at 20 mcg in the first week, increases to 30 mcg in the second week, then 68 mcg in the third week and continues at 68 mcg weekly for up to six months, totaling a maximum of 26 infusions. The study focuses on adults who are positive for HLA-A*0201 and have completed primary tumor treatment within the prior 12 weeks. During the trial, participants are monitored over approximately 8.1 years to assess recurrence-free survival, overall survival, adverse events, and health-related quality of life. Baseline imaging is required to confirm no recurrence before randomization. Researchers will conduct regular evaluations to track tumor status and collect safety and quality of life data. The trial extends long-term to capture meaningful outcomes related to disease recurrence and survival.

Adjuvant Tebentafusp in High Risk Ocular Melanoma