Table 1.
Baseline demographics and clinical characteristics
|
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) |