Canadian cohort expanded access program of nivolumab plus ipilimumab in advanced melanoma
Background Combination nivolumab and ipilimumab is approved for the first-line treatment of patients with advanced melanoma in several jurisdictions (United States, European Union, and Canada). CheckMate 218 is a North American expanded access program (EAP) of nivolumab plus ipilimumab in patients with advanced melanoma. We report safety and survival outcomes of the Canadian cohort in this EAP.
Methods Eligible patients were aged ≥18 years with unresectable stage III or stage IV melanoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no prior anti–PD-1 or anti–CTLA-4 therapy. Patients were treated with nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase) and then continued with nivolumab 3 mg/kg every 2 weeks (maintenance phase) until progression, unacceptable toxicity, or a maximum of 48 weeks, whichever occurred first. Safety and overall survival (OS) data were collected.
Results A total of 194 patients were enrolled; 174 were treated, and 51% continued on nivolumab maintenance. The median follow-up time was 12.9 months. All-grade and grade 3–4 treatment-related adverse events were reported in 98% and 60% of patients, respectively, and led to treatment discontinuation in 40% and 28% of patients, respectively. Two treatment-related deaths were reported. Twelve- and 18-month OS rates were 80% (95% confidence interval [CI]: 73 to 86) and 76% (95% CI: 67 to 82), respectively.
Conclusion In this Canadian population, nivolumab plus ipilimumab demonstrated a safety profile and survival outcomes consistent with phase 2 and 3 clinical trial data.Trial registration: NCT02186249