Table 1.
Patient Demographics and Baseline Characteristics
| Variable | Nivolumab + RT + TMZ n = 358 No. (%) |
Placebo + RT + TMZ n = 358 No. (%) |
|---|---|---|
| Age | ||
| Median (range), years | 60.0 (24-79) | 60.0 (18-81) |
| Age, years | ||
| <65 | 245 (68.4) | 237 (66.2) |
| ≥65 to <75 | 90 (25.1) | 104 (29.1) |
| ≥75 | 23 (6.4) | 17 (4.7) |
| Sex | ||
| Male | 205 (57.3) | 197 (55.0) |
| Female | 153 (42.7) | 161 (45.0) |
| Histopathologic diagnosis | ||
| Glioblastoma | 353 (98.6) | 353 (98.6) |
| Gliosarcoma | 4 (1.1) | 5 (1.4) |
| Not reported | 1 (<1) | 0 |
| RPA classa | ||
| III | 32 (8.9) | 23 (6.4) |
| IV | 287 (80.2) | 306 (85.5) |
| V | 38 (10.6) | 29 (8.1) |
| Not reported | 1 (<1) | 0 |
| Extent of surgeryb | ||
| Complete resection | 199 (55.6) | 200 (55.9) |
| Partial resection | 158 (44.1) | 158 (44.1) |
| Not reported | 1 (0.3) | 0 |
| Karnofsky performance status | ||
| 100 | 82 (22.9) | 89 (24.9) |
| 90 | 160 (44.7) | 162 (45.3) |
| 80 | 78 (21.8) | 78 (21.8) |
| 70 | 34 (9.5) | 28 (7.8) |
| 60 | 1 (<1) | 0 |
| Not reported | 3 (<1) | 1 (<1) |
| Time from initial diagnosis to randomization | ||
| Median (range), weeks | 5.29 (3.0-40.1c) | 5.36 (2.7-13.4) |
| MGMT promoter methylation status | ||
| Methylated | 353 (98.6) | 349 (97.5) |
| Indeterminate | 4 (1.1) | 7 (2.0) |
| Not reported | 1 (0.3) | 2 (0.6) |
| Patients with evaluable PD-L1 expression | ||
| PD-L1 expression level | 356 (99.4) | 356 (99.4) |
| <1% | 230 (64.6) | 238 (66.9) |
| ≥1% | 126 (35.4) | 118 (33.1) |
| Corticosteroid used | ||
| Yes | 112 (31.3) | 97 (27.1) |
| ≤3 mg/day | 89 (24.9) | 73 (20.4) |
| >3 mg/day | 23 (6.4) | 24 (6.7) |
| No | 246 (68.7) | 261 (72.9) |
Abbreviations: MGMT, O6-methylguanine DNA methyltransferase; NIVO + RT + TMZ, nivolumab + radiotherapy + temozolomide; PD-L1, programmed cell death-1 ligand 1; PBO + RT + TMZ, placebo + radiotherapy + temozolomide; RPA, recursive partitioning analysis.
aThe RPA classes were as follows: class III: age <50 years and Karnofsky performance status ≥90 (on a scale of 0-100, with higher scores indicating better function); class IV, <50 years and Karnofsky performance status <90 (or ≥50 years, Karnofsky performance status ≥70, complete or partial tumor resection, and ability to work); class V, ≥50 years, Karnofsky performance status ≥70, complete or partial tumor resection, and inability to work (or ≥50 years, Karnofsky performance status ≥70, and tumor-biopsy specimen only; or ≥50 years and Karnofsky performance status <70).8
bThis characteristic was used as a stratification factor.
cThe patient with 40.1 weeks from the initial diagnosis to the start of RT had two partial resections prior to randomization, with no RT or systemic cancer therapies in between.
dBased on average corticosteroid use 5 days prior to the start of dosing or randomization date for patients not treated.