Phase III (MDX010-20) | ||||
---|---|---|---|---|
Ipilimumab plus gp100 | Ipilimumab Alone | gp100 Alone | Total | |
(N = 403) | (N = 137) | (N = 136) | (N = 676) | |
Age (years), mean | 55.6 | 56.8 | 57.4 | 56.2 |
Gender, n (%) | ||||
Male | 247 (61) | 81 (59) | 73 (54) | 401 (59) |
Melanoma stage, n (%) | ||||
M0 | 5 (1.2) | 1 (0.7) | 4 (2.9) | 10 (1.5) |
M1a | 37 (9.2) | 14 (10.2) | 11 (8.1) | 62 (9.2) |
M1b | 76 (18.9) | 22 (16.1) | 23 (16.9) | 121 (17.9) |
M1c | 285 (70.7) | 100 (73.0) | 98 (72.1) | 483 (71.4) |
Prior treatment for advanced melanoma, n (%) | 403 (100.0) | 137 (100.0) | 136 (100.0) | 676 (100.0) |
ECOG PS, n (%) | ||||
0 | 233 (57.8) | 72 (52.6) | 70 (51.5) | 375 (55.5) |
1 | 165 (40.9) | 64 (46.7) | 61 (44.9) | 290 (42.9) |
2 or 3 | 5 (1.2) | 1 (0.7) | 4 (2.9) | 10 (1.4) |
Missing | 0 | 0 | 1 (0.7) | 1 (0.1) |
CNS metastases at baseline, n (%) | 46 (11.4) | 15 (10.9) | 21 (15.4) | 82 (12.1) |