A New Dosing Regimen for Nivolumab Plus Ipilimumab in Advanced Melanoma

Source: Cancer Network, March 2019

Among advanced melanoma patients in the CheckMate 511 phase IIIb/IV trial, raising the nivolumab dose to 3 mg/kg and lowering the ipilimumab dose to 1 mg/kg leads to a better safety profile without compromising efficacy. The trial results, recently published in the Journal of Clinical Oncology, may offer patients with advanced melanoma a safer dosing regimen of nivolumab and ipilimumab.

“This study is an important step towards optimizing combination immunotherapy with ipilimumab plus nivolumab,” Shailender Bhatia, MD, a medical oncologist at Seattle Cancer Care Alliance, told Cancer Network. He was not involved in the CheckMate 511 trial. “Using a lower dose of ipilimumab at 1 mg/kg appears to lower the risk of severe toxicity, while retaining the efficacy of the combination.”

The CheckMate 511 trial included 360 adult patients with treatment-naïve, unresectable stage III or IV melanoma. Patients were randomly assigned treatment with either the standard approved dosing of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or the alternative dosing of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg once every 3 weeks for four doses. The primary trial endpoint was the comparison of the incidence of treatment-related grade 3 to 5 adverse events (AEs) between groups.

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