Table 1.
Patient demographics and clinical characteristics in the full analysis set of the CREATIVE study and the nivolumab arm in the CheckMate 037 (6), 066 (7) and 067 (18) studies
| Characteristics | CREATIVE | CheckMate 037 | CheckMate 066 | CheckMate 067 |
|---|---|---|---|---|
| All | n = 124 | n = 272 | n = 210 | n = 316 |
| Age, years | ||||
| Median [range] | 65.9 [35–88] | 59 [23–88] | 64.0 [18–86] | 58.7 [25–90] |
| Sex | ||||
| Male | 72 (58.1) | 176 (65) | 121 (57.6) | 202 (63.9) |
| Female | 52 (41.9) | 96 (36) | 89 (42.4) | 114 (36.1) |
| Performance status | ||||
| 0 | 79 (63.7) | 162 (60) | 148 (70.5) | 238 (75.3) |
| 1 | 35 (28.2) | 110 (40) | 60 (28.6) | 77 (24.4) |
| 2 | 10 (8.1) | 1 (0.5) | 1 (0.3) | |
| Metastasis stage | ||||
| M0, M1a, M1b | 46 (37.1) | 69 (25) | 82 (39.0) | 132 (41.8) |
| M1c | 77 (62.1) | 203 (75) | 128 (61.0) | 184 (58.2) |
| Others | 1 (0.8) | |||
| Stage | ||||
| III | 12 (9.7) | 11 (4) | NA | NA |
| IV | 110 (88.7) | 261 (96) | NA | NA |
| Others | 2 (1.6) | NA | NA | |
| LDH, IU/L | ||||
| Lowa | 92 (74.2) | 132 (48.5) | 120 (57.1) | 196 (62.0) |
| Higha | 30 (24.2) | 140 (51.5) | 79 (37.6) | 112 (35.4) |
| Not reported | 2 (1.6) | 11 (5.2) | 8 (2.5) | |
| Brain metastasis | ||||
| Absent | 110 (88.7) | 217 (80) | 203 (96.7) | 308 (97.5) |
| Present | 14 (11.3) | 55 (20)c | 8 (3.8)c | 8 (2.5)c |
| BRAF status | ||||
| Wild type | 93 (75.0) | 212 (78) | 202 (96.2) | 216 (68.4) |
| Mutant | 20 (16.1) | 60 (22) | 0 (0.0) | 100 (31.6) |
| Not investigated | 11 (8.9) | 8 (3.8) | ||
| Treatment line | ||||
| First line | 77 (62.1) | 210 (100) | 316 (100) | |
| Second line | 47 (37.9) | 262 (100) | ||
Data are presented as n (%), unless otherwise indicated. NA, not available; LDH, lactate dehydrogenase.
aLow LDH is <400 IU/L, based on the CREATIVE study and less than equal to upper limit of normal (ULN) in global phase III studies (CheckMate 037, 066 and 067 studies), respectively.
bHigh LDH is ≥400 IU/L, based on the CREATIVE study and greater than ULN in global phase III studies.
cHistory of brain metastases without active diseases in CheckMate 037, 066 and 067 studies.