Safety Comparison of Two Dosing Regimens for Nivolumab Plus Ipilimumab in Advanced Melanoma

Source: The ASCO Post, April 2019

In the phase IIIb/IV CheckMate 511 study reported by Lebbé et al in the Journal of Clinical Oncology, a regimen of nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg (NIVO3+IPI1) was found to significantly reduce the incidence of treatment-related grade 3 to 5 adverse events compared with nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg (NIVO1+IPI3) in patients with advanced melanoma. The NIVO1+IPI3 regimen is approved for the first-line treatment of advanced melanoma in several countries, including the United States.

Study Details

In the trial, 360 patients with previously untreated unresectable stage III or IV melanoma were randomly assigned between April 2016 and March 2017 to receive NIVO3+IPI1 (n =180) or NIVO1+IPI3 (n = 180) every 3 weeks for 4 doses. After 6 weeks, all patients received nivolumab at 480 mg once every 4 weeks until disease progression or unacceptable toxicity.

The primary endpoint was the incidence of treatment-related grade 3 to 5 adverse events. Secondary endpoints included descriptive analyses of objective response rate, progression-free survival, and overall survival. The study was not designed to formally demonstrate noninferiority of NIVO3+IPI1 vs NIVO1+IPI3 for efficacy endpoints.