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Identification of the optimal combination dosing schedule of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma (OpACIN-neo): A multicentre, phase 2, randomised, controlled trial

The Lancet Oncology Jun 07, 2019

Rozeman EA, et al. - Because high toxicity with the standard ipilimumab plus nivolumab dosing schedule in patients with macroscopic stage III melanoma prevents its wider clinical use, researchers looked for a less toxic but equally efficacious dosing schedule of ipilimumab plus nivolumab in the OpACIN-neo trial, a multicenter, open-label, phase 2, randomized, controlled trial. They tested 3 dosing schedules: two cycles of ipilimumab 3 mg/kg plus nivolumab 1 mg/kg once every 3 weeks intravenously; two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg once every 3 weeks intravenously; and two cycles of ipilimumab 3 mg/kg once every 3 weeks directly followed by two cycles of nivolumab 3 mg/kg once every 2 weeks intravenously. According to findings, two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg is a tolerable neoadjuvant dosing schedule. In a high proportion of patients, this dosing schedule induced a pathological response. In addition, its possible suitability for broader clinical use was also suggested.

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