Table 1.
Patient demographics and baseline characteristics
| Nivolumab plus ipilimumab (N = 754) | |
|---|---|
| Age | |
| Median, years (range) | 58 (17–87) |
| ≥65 years, n (%) | 219 (29) |
| ≥75 years, n (%) | 59 (8) |
| Sex, n (%) | |
| Male | 478 (63) |
| Female | 276 (37) |
| Region, n (%) | |
| USA | 580 (77) |
| Canada | 174 (23) |
| ECOG PS, n (%) | |
| 0 | 520 (69) |
| 1 | 234 (31) |
| Subtype of melanoma, n (%) | |
| Cutaneous | 590 (78) |
| Mucosal | 47 (6) |
| Uveal | 38 (5) |
| Acral | 8 (1) |
| Other | 69 (9) |
| BRAF mutation status, n (%) | |
| Mutant | 329 (44) |
| Wild-type | 321 (43) |
| Not reported | 104 (14) |
| Disease stage at EAP entry, n (%) | |
| III | 97 (13) |
| IV | 643 (85) |
| Unknown | 14 (2) |
| M stage at EAP entry, n (%) | |
| M0, M1A, M1B | 321 (43) |
| M1C | 392 (52) |
| Unknown | 41 (5) |
| Brain metastases at initial diagnosis, n (%) | |
| Yes | 19 (3) |
| No | 602 (80) |
| Unknown | 132 (18) |
| Not reported | 1 (<1) |
| Baseline LDH, n (%) | |
| ≤ULN | 493 (65) |
| >ULN | 239 (32) |
| >2 × ULN | 72 (10) |
| Not performed or reported | 22 (3) |
| Number of prior therapies, n (%) | |
| 0 | 532 (71) |
| 1 | 109 (14) |
| 2 | 73 (10) |
| ≥3 | 40 (5) |
| Time from prior therapy to first dose date, n (%)a | |
| <6 months | 145 (19) |
| ≥6 months | 75 (10) |
| Not reported | 534 (71) |
EAP, expanded access program; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; ULN, upper limit of normal.
a
Percentages based on patients who received prior therapies.