A phase 1 study of nivolumab in combination with interferon-gamma for patients with advanced solid tumors.

ABSTRACT: This phase I, dose-escalation trial evaluates the safety of combining interferon-gamma (IFN-γ) and nivolumab in patients with metastatic solid tumors. Twenty-six patients are treated in four cohorts assessing increasing doses of IFN-γ with nivolumab to evaluate the primary endpoint of safety and determine the recommended phase two dose (RP2D). Most common adverse events are low grade and associated with IFN-γ. Three dose limiting toxicities are reported at the highest dose cohorts. We report only one patient with any immune related adverse event (irAE). No irAEs ≥ grade 3 are observed and no patients require corticosteroids. The maximum tolerated dose of IFN-γ is 75 mcg/m², however based on a composite of safety, clinical, and correlative factors the RP2D is 50 mcg/m²

SUBMITTER: Zibelman M 

PROVIDER: S-EPMC10374608 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature