Phase II Single-Arm Multi-Center Study of Adjuvant Ipilimumab in Combination with Nivolumab in Subjects with High-Risk Ocular Melanoma

Description

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT03528408 Opens a new window