Phase II clinical trial: Safety and efficacy study of tocilizumab (Toci) in combination with ipilimumab (Ipi) 3mg/kg plus nivolumab (Nivo) 1mg/kg in patients (pts) with metastatic melanoma (MM)

The combination of Ipi + Nivo is frequently used as first line therapy in pts with MM, however, high rate of grade 3/4 immune related adverse events (irAEs) and treatment discontinuation pose a challenge for both physicians and pts. Our prior retrospective translational studies suggested that targeting interlukin-6 (IL-6) -Th17 pathway could be an effective approach to alleviate irAEs without hindering antitumor immunity. This supported initiation of phase II open-label, single center study (NCT04940299) to assess the safety and efficacy of adding Toci (anti-IL-6 receptor) to Ipi + Nivo for treatment naïve, unresectable stage III/IV MM.