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Fatal sepsis from colitis, severe skeletal myositis and myocarditis: 2 case reports In a cohort, observational, expanded-access program of 174 patients (aged 27–81 years) treated between October 2015 and December 2016, two patients [ages and sexes not stated] were described, who developed fatal sepsis from colitis or fatal severe skeletal myositis and myocarditis during treatment with ipilimumab and nivolumab for advanced melanoma. The patients, who had advanced melanoma, started receiving IV nivolumab 1 mg/kg over 60 minutes and IV ipilimumab 3 mg/kg over 90 minutes every 3 weeks for 4 doses during the induction phase. Then, they were scheduled to receive maintenance monotherapy with IV nivolumab 3 mg/kg over 60 minutes every 2 weeks. However, they both died due to treatment (ipilimumab and nivolumab)-related sepsis from grade IV colitis (n = 1) and severe skeletal myositis and myocarditis (n=1) [durations of treatments to reactions onsets not stated]. Hogg D, et al. Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma. Current Oncology 27: 204-214, No. 4, Aug 2020. Available 803504254 from: URL: http://doi.org/10.3747/co.27.5985

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Reactions 3 Oct 2020 No. 1824