Table 1.

Patient demographics

Protocol 1: ipi + gp100 (N = 56)Protocol 2: ipi + IL-2 (N = 36)Protocol 3: ipi (DE) ± gp100 (N = 85)
Gender
 Female19 (34)14 (39)29 (34)
 Male37 (66)22 (61)56 (66)
Age, y
 21–304 (7)3 (8)6 (7)
 31–405 (9)4 (11)18 (21)
 41–5017 (30)16 (44)23 (27)
 51–6017 (30)11 (31)22 (26)
 61–7013 (23)2 (6)16 (19)
ECOG
 044 (79)27 (75)54 (64)
 112 (21)9 (25)29 (34)
 20 (0)0 (0)2 (2)
M1 stage
 M1a11 (20)10 (28)13 (15)
 M1b12 (21)8 (22)21 (25)
 M1c33 (59)18 (50)51 (60)
Prior therapy
 Surgery56 (100)36 (100)85 (100)
 Chemotherapy21 (38)8 (22)47 (55)
 Radiotherapy15 (27)7 (19)25 (29)
 Immunotherapy41 (73)23 (64)72 (85)
 Hormonal2 (4)0 (0)2 (2)
Prior systemic therapya
 Any 1 or more43 (76)24 (66)80 (94)
 Any 2 or more20 (36)8 (22)39 (46)
 Any 3 or more2 (4)0 (0)2 (2)

NOTE: All values are expressed as n (%).

Abbreviations: DE, intrapatient dose-escalation of ipilimumab; ECOG, Eastern Cooperative Oncology Group performance score; gp100, gp100:209-217(210M) and gp100:280-288(288V) peptides; ipi, ipilimumab.

  • aSystemic therapy includes chemotherapy, immunotherapy, and/or hormonal therapy.