AIDS malignancy consortium (AMC) 095: A phase I study of ipilimumab (IPI) and nivolumab (NIVO) in advanced HIV-associated solid tumors (ST) with expansion cohorts in HIV-associated solid tumors and classical Hodgkin lymphoma (cHL).

Abstract

TPS44 Background: Immune checkpoint blockade (ICB) using agents that target the priming phase (i.e. CTLA-4) and effector phase (e.g. PD-1) of host immunity, used individually or in combination, has emerged as a therapeutic strategy for cancers. However, little is known about the safety, tolerability and efficacy of ICB in patients (pts) with HIV infection and cancer. Methods: AMC 095 (NCT02408861) is a multicenter, international phase I study of the PD-1 inhibitor, nivo alone or in combination with a CTLA-4 inhibitor, ipi, in 2 cohorts stratified by CD4 counts (Stratum 1: CD4 counts≥200/uL and Stratum 2: CD4 count 100-200/uL) with additional expansion cohorts at the recommended phase II dose in pts with ST and cHL. The primary study objective is to determine the safety and feasibility of nivo alone and the nivo+ipi combination. Secondary objectives are to evaluate the effects of single agent nivo, and ipi+ nivo, on HIV replication and immune function (HIV viral load in plasma using conventional assay, CD4+, and CD8+ cells), and to obtain preliminary information regarding response. The trial was initiated in 8/15, as of 9/30/17, the study is ongoing, and 14 pts have been enrolled. Updated information on the safety and responses will be presented. Clinical trial information: NCT02408861. Funded by the NCI Grant #UM1CA121947.[Table: see text]