A phase I/Ib study of concurrent intravenous (IV) and intrathecal (IT) nivolumab (Nivo) for melanoma patients (pts) with leptomeningeal disease (LMD)

Abstract

Background: Although advances in treatment with immune checkpoint inhibitors (CPI) have greatly improved the survival for pts with metastatic melanoma (MM), many still progress and ultimately die from this disease. Metastases to the Central Nervous System (CNS) are one of the most common and devastating complications of MM, occurring in up to 60% of pts and those with LMD have the worst prognosis (overall survival only weeks) and limited treatment options. Our program has demonstrated that IT administration of interleukin-2 (IL2) induces durable disease control and prolonged survival in pts with LMD, with 1, 2, 5- year survival rates of 36%, 26%, and 13% respectively. Given the favorable clinical activity and safety compared to systemic IL2 and supported by pre-clinical data, we hypothesize that IT administration of nivo is safe and will induce CNS immune responses in pts with LMD.