Phase II single-arm multicenter study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma.

Abstract

TPS9604 Background: Treatment of primary ocular melanoma is often very effective, with local recurrence rates of < 5%. However, distant recurrence is as high as 50% depending on features of the primary tumor. These data emphasize the need for effective adjuvant therapy for patients with locally treated ocular melanoma. Several adjuvant treatments have been developed for patients with high-risk cutaneous melanoma, including ipilimumab and nivolumab monotherapies and an ongoing trial is exploring the nivolumab/ipilimumab combination (CA209-915), but patients with high-risk ocular melanomas have been excluded from these trials. As yet there is no approved adjuvant treatment for high-risk ocular melanoma patients. Methods: We are conducting a Phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma. This study aims to generate efficacy and safety data for adjuvant this regimen in patients with locally treated high-risk ocular melanoma with 3-year risk of relapse > 50%. The primary endpoint is 3-year relapse-free survival rate. Secondary endpoints are median relapse-free survival, median overall survival, 3-year overall survival rate and safety. All patients will receive nivolumab 240mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab. The accrual goal is 50 patients across all participating institutions. Subjects treated in this study will be matched with controls selected from a contemporaneously collected OM registry, “contemporaneous control” in order to better assess efficacy. Control subjects will be from institutions not participating in this trial, will otherwise meet the trial eligibility criteria and will be further matched with trial participants for various demographic and risk factors to the extent possible. The study is enrolling in 6 comprehensive cancer centers in the US. Clinical trial information: NCT03528408.