Table 1.

Summary of Ipilimumab Studies Included in Pooled OS Analyses

Study Identification No.	Reference	Trial Identifier	Phase	No. of Patients	Study Population	Ipilimumab Dose	Retreatment or Maintenance	Primary End Point
MDX010-20	Hodi et al6	NCT00094653	III	540	Previously treated	3 mg/kg ± gp100	Retreatment	OS
CA184-024	Robert et al7	NCT00324155	III	250	Treatment naive	10 mg/kg + dacarbazine	Maintenance	OS
CA184-022	Wolchok et al14	NCT00289640	II	217	Previously treated	0.3, 3, or 10 mg/kg	Maintenance	Best overall response rate
CA184-008	O'Day et al13	NCT00289627	II	155	Previously treated	10 mg/kg	Maintenance	Best overall response rate
CA184-007	Weber et al12	NCT00135408	II	115	Treatment naive or previously treated	10 mg/kg ± budesonide	Maintenance	Rate of ≥ grade 2 diarrhea
CA184-004	Hamid et al11	NCT00261365	II	82	Treatment naive or previously treated	3 or 10 mg/kg	Maintenance	Biomarkers of response and/or toxicity
CA184-042	Margolin et al15	NCT00623766	II	72	Melanoma with brain metastases	10 mg/kg	Maintenance	Disease control rate
NCI04C0083	Prieto et al8	NCT00077532	I/II	88	Previously treated	3, 5, or 9 mg/kg ± gp100	Not included	Objective response
NCI02C0106	Prieto et al8	NCT00032045	I/II	56	Previously treated	3 mg/kg + gp100 3 → 1 mg/kg + gp100	Not included	Objective response, safety
NCI03C0109	Prieto et al8	NCT00058279	I/II	36	Previously treated	0.1, 0.3, 1, 2, or 3 mg/kg + IL-2	Not included	Maximum-tolerated dose, objective response, pharmacokinetics, safety
CA184-338	Margolin et al17		Observational	160	Treatment naive	3 mg/kg	No	OS
CA184-332	Patt et al16		Observational	90	Treatment naive	3 mg/kg	No	OS
CA184-045	Hamid et al18	NCT00495066	US expanded access program	2,985	Previously treated	3 or 10 mg/kg	Maintenance only for patients treated at 10 mg/kg	NA

Abbreviations: IL-2, interleukin-2; NA, not applicable; OS, overall survival.