Table 1.
Patient demographics and clinical characteristics
| Characteristic | NIVO3 (n = 10) |
NIVO1+IPI3 (n = 10) |
NIVO3+IPI1 (n = 20) |
|---|---|---|---|
| Age | |||
| Median, y (range) | 58.5 (42–73) | 57 (37–68) | 60 (27–73) |
| <65, n (%) | 6 (60) | 7 (70) | 17 (85) |
| ≥65 to <75, n (%) | 4 (40) | 3 (30) | 3 (15) |
| Sex, n (%) | |||
| Male | 5 (50) | 6 (60) | 14 (70) |
| Female | 5 (50) | 4 (40) | 6 (30) |
| Race, n (%) | |||
| White | 8 (80) | 10 (100) | 18 (90) |
| Black | 2 (20) | 0 | 0 |
| Asian | 0 | 0 | 1 (5) |
| Other/unknown | 0 | 0 | 1 (5) |
| KPS, n (%) | |||
| 90% | 7 (70) | 6 (60) | 11 (55) |
| 80% | 1 (10) | 1 (10) | 5 (25) |
| 70% | 2 (20) | 3 (30) | 4 (20) |
| Histopathologic diagnosis, n (%) | |||
| Glioblastoma | 9 (90) | 10 (100) | 20 (100) |
| Gliosarcoma | 1 (10) | 0 | 0 |
| MGMT promoter methylation status, n (%) | |||
| Methylated | 2 (20) | 2 (20) | 7 (35) |
| Unmethylated | 4 (40) | 6 (60) | 10 (50) |
| Not reported | 4 (40) | 2 (20) | 3 (15) |
| Steroid use, n (%) | |||
| Yes | 2 (20) | 4 (40) | 6 (30) |
| No | 8 (80) | 6 (60) | 14 (70) |
| Median time from initial diagnosis to recurrent diagnosis, mo (range) | 9.7 (3.7–48.9) | 8.4 (5.1–23.0) | 11.35 (4.9–32.9) |
| Patients with ≥1 measurable target lesion, n (%) | 9 (90) | 10 (100) | 20 (100) |
| Sum of reference diameters of target lesions, mm 2 (range) | 903 (120–1664) | 660 (273–1856) | 607 (143–3552) |
| Patients with ≥2 lesions, n (%)a | 4 (40) | 1 (10) | 5 (25) |
| Patients with evaluable PD-L1 expression, n (%)b | 10 (100) | 9 (90) | 18 (90) |
| PD-L1 expression levelsc | |||
| <1% | 3 (30) | 4 (44) | 5 (28) |
| ≥1% | 7 (70) | 5 (56) | 13 (72) |
| ≥10% | 4 (40) | 1 (11) | 5 (28) |
Abbreviations: MGMT, O6-methylguanine-DNA methyltransferase; NIVO3, nivolumab 3 mg/kg; NIVO1+IPI3, nivolumab 1 mg/kg + ipilimumab 3 mg/kg; NIVO3+IPI1, nivolumab 3 mg/kg + ipilimumab 1 mg/kg; ; PD-L1, programmed death ligand 1. aIncludes target and nontarget lesions. bPD-L1 analyses were performed using archival (at initial diagnosis) or fresh (at recurrence) tissue. cPercentages are based on the number of patients with evaluable PD-L1 expression.