Table 1.

Summary of ipilimumab phase II trials included in the survival analyses

Study	Na	Design	Population	Ipilimumab Treatment	End points
CA184-008 [10]	155	Single-arm, open-label, multicenter study	Heavily pretreated, progressed on prior therapy	10 mg/kg every 3 weeks × 4 doses (induction); maintenance every 12 weeks from week 24 for eligible patients	Primary: best overall response rate Secondary: median OS; 1-year survival rate
CA184-022 [11]	217	Randomized, double-blind, parallel-group, multicenter, dose-ranging study	Progressed on or were intolerant of prior therapy	0.3, 3, or 10 mg/kg every 3 weeks × 4 doses (induction); maintenance every 12 weeks from week 24 for eligible patientsb	Primary: best overall response rate Secondary: median OS; 1-year survival rate
CA184-007 [12]	115	Randomized, open-label (for ipilimumab), multicenter study	Treatment-naïve and previously treated	10 mg/kg every 3 weeks × 4 doses (induction), plus oral budesonide or placebo	Primary: rate of grade ≥2 diarrhea Secondary: best overall response rate; median OS; 1-year survival rate

^aNumber of patients treated for study CA184-008 and number of patients randomized for studies CA184-007 and CA184-022.

^bAfter disease progression, eligible patients in the 0.3 and 3 mg/kg dose groups could cross over to study CA184-025 to be reinduced with ipilimumab at 10 mg/kg. On-treatment patients without disease progression could receive ipilimumab maintenance therapy at their assigned dose.