Table 1.
Baseline clinical and demographic characteristics of patients from each of the four clinical trial cohorts.
| Nivolumab (CheckMate 238) | Nivolumab (CheckMate 915) | Ipilimumab | Ipilimumab plus nivolumab | |
|---|---|---|---|---|
| N | 157 | 190 | 408 | 195 |
| Age (years) | ||||
| Mean (SD) | 55.11 (14.00) | 56.39 (12.92) | 53.85 (13.35) | 56.39 (12.92) |
| Sex | ||||
| Female | 68 (43.3%) | 80 (42.1%) | 169 (41.4%) | 89 (45.6%) |
| Male | 89 (56.7%) | 110 (57.9%) | 239 (58.6%) | 106 (54.4%) |
| Race | ||||
| White | 153 (97.5%) | 189 (99.5%) | 391 (95.8%) | 191 (97.9%) |
| Asian | 4 (2.5%) | 1 (0.5%) | 16 (3.9%) | 0 (0.0%) |
| Disease stagea | ||||
| IIIB | 64 (40.8%) | 58 (30.5%) | 137 (33.6%) | 50 (20.6%) |
| IIIC | 60 (38.2%) | 97 (51.1%) | 190 (46.6%) | 111 (56.9%) |
| IIID | 0 (0.0%) | 8 (4.2%) | 0 (0.0%) | 8 (4.1%) |
| IV | 31 (19.7%) | 27 (14.2%) | 81 (19.9%) | 26 (13.3%) |
| BRAF mutation status | ||||
| Wild-type | 73 (46.5%) | 93 (48.9%) | 190 (46.6%) | 85 (43.6%) |
| Mutant | 66 (42.0%) | 53 (27.9%) | 174 (42.6%) | 66 (33.8%) |
| Not reported | 18 (11.5%) | 44 (23.2%) | 44 (10.8%) | 44 (22.6%) |
| Baseline ECOG | ||||
| 0 | 140 (89.2%) | 183 (96.3%) | 363 (89.0%) | 181 (92.8%) |
| 1 | 17 (10.8%) | 7 (3.7%) | 45 (11.0%) | 14 (7.2%) |
| Baseline LDH (U/L) | ||||
| Mean (SD) | 225.38 (97.52) | 208.69 (64.23) | 215.19 (88.36) | 223.15 (81.85) |
| PD-L1 status | ||||
| <5% | 94 (59.9%) | 147 (77.4%) | 253 (62.0%) | 142 (72.8%) |
| ≥5% | 56 (35.7%) | 43 (22.6%) | 143 (35.0%) | 53 (27.2%) |
| Not reported | 7 (4.5%) | 0 (0.0%) | 12 (2.9%) | 0 (0.0%) |
| Disease recurrence | ||||
| No | 99 (63.1%) | 129 (67.9%) | 190 (46.6%) | 121 (62.1%) |
| Yes | 58 (36.9%) | 61 (32.1%) | 218 (53.4%) | 74 (37.9%) |
| Severe toxicity | ||||
| No | 93 (59.2%) | 148 (77.9%) | 202 (49.5%) | 131 (67.2%) |
| Yes | 64 (40.8%) | 42 (22.1%) | 206 (50.5%) | 64 (32.8%) |
aPatients in CheckMate 238 were staged using the AJCC Staging Manual 7th Edition. Patients in CheckMate 915 were staged using the AJCC Staging Manual 8th Edition.