Table IV.

Major studies investigating combination of nivolumab [Opdivo®] plus ipilimumab [Yervoy®] (anti-PD-1 + anti-CTLA-4 immunotherapy) to treat melanoma

Enrollment period	Trial phase/Identifier	Patients	Randomization / Dosing regimen(s)	Primary endpoint / Results	Median follow-up	Grade 3-4 irAEs
2013-2014	Phase 2, CheckMate-069, NCT01927419	Untreated metastatic melanoma patients, n=142	Ipilimumab 3 mg/kg + nivolumab 1 mg/kg (combination group) once every 3 weeks for four doses, followed by nivolumab 3 mg/kg every 3 weeks for four doses or placebo every 2 weeks, n=95 Ipilimumab 3 mg/kg + placebo, followed by nivolumab 3 mg/kg every 3 weeks for four doses or placebo every 2 weeks, n=47	OR among patients with BRAF V600 wild type tumors: Ipilimumab + nivolumab (n=72): 61% Ipilimumab + placebo (n=37): 11%	11 mo.	Combination group: 54% Ipilimumab monotherapy: 24%
2013-2014	Phase 3, CheckMate-067, NCT01844505	Untreated, unresectable stage III or IV melanoma patients, n=945	Nivolumab alone, n=316 Nivolumab + ipilimumab, n=314 Ipilimumab alone, n=315	PFS Nivolumab + ipilimumab: 11.5 mo. Nivolumab alone: 6.9 mo. Ipilimumab alone: 2.9 mo.	12.2-12.5 mo.	Nivolumab alone: 16.3% Nivolumab + ipilimumab: 55% Ipilimumab alone: 27.3%