Table 1.
Clinical characteristics.
| All Patients | Cohort A | Cohort B | ||
|---|---|---|---|---|
| N (%) | N (%) | N (%) | ||
| Patients | 20 | 10 (50) | 10 (50) | |
| Age at consent, y | Median (range) | 60 (28–86) | 65 (28–86) | 51 (37–76) |
| Sex | Male | 12 (60) | 4 (40) | 8 (80) |
| Female | 8 (40) | 6 (60) | 2 (20) | |
| Race | White | 18 (90) | 8 (80) | 10 (100) |
| Asian | 2 (10) | 2 (20) | 0 (0) | |
| ECOG at Screening | 0 | 9 (45) | 4 (40) | 5 (50) |
| 1 | 11 (55) | 6 (60) | 5 (50) | |
| Stage at Enrollment | IV | 18 (90) | 9 (90) | 9 (90) |
| IVA | 2 (10) | 1 (10) | 1 (10) | |
| M Stage at Enrollment | M1a | 3 (15) | 2 (20) | 1 (10) |
| M1b | 1 (5) | 1 (10) | 0 (0) | |
| M1c | 13 (65) | 6 (60) | 7 (70) | |
| M1d | 3 (15) | 1 (10) | 2 (20) | |
| LDH at Enrollment | Median (range) | 265 (143–856) | 284 (148–856) | 234 (143–582) |
| Not elevated | 11 (55) | 3 (30) | 8 (80) | |
| Elevated | 9 (45) | 7 (70) | 2 (20) | |
| Prior treatment | ||||
| Anti-CTI_A4 | 5 (25) | 3 (30) | 2 (20) | |
| Anti-PD-1 | 13 (65) | 4 (40) | 9 (90) | |
| Combined anti-CTLA-4 and anti-PD-1 | 2 (10) | 0 (0) | 2 (20) | |
| BRAF/MEK Inhibitor | 1 (5) | 0 (0) | 1 (10) | |
| Radiotherapy | 10 (50) | 5 (50) | 5 (50) | |
| Doses of Nivo + Ipi | 1 | 1 (5) | 0 (0) | 1 (10) |
| 2 | 3 (15) | 3 (30) | 0 (0) | |
| 3 | 3 (15) | 0 (0) | 3 (30) | |
| 4 | 13 (65) | 7 (70) | 6 (60) | |
| Baseline tumor volume | ||||
| Baseline RECIST target sum outside irradiated volume (mm) | Median (range) | 33.0 (10.0–134.0) | 43.5 (10.0–134.0) | 32.8 (10.0–105.0) |
| N = | 20 | 10 | 10 | |
| Baseline RECIST target sum inside irradiated volume (mm) | Median (range) | 41.8 (14.0–116.0) | 43.0 (14.0–116.0) | 39.4 (25.0–63.9) |
| N = | 17 | 9 | 8 | |