Table 1.
Patient Characteristics
| Total study subjects | 32 | ||
| Age, median (Range), years | 63 | 26–95 | |
| Sex | Male | 17 | 53% |
| Female | 15 | 47% | |
| ECOG PS pretreatment (median ECOG 1, range 0–2) | 0 | 14 | 44% |
| 1 | 15 | 47% | |
| 2 | 3 | 9% | |
| Mutational status | BRAF | 6 | 19% |
| NRAS | 11 | 34% | |
| Non-BRAF or NRAS | 15 | 47% | |
| Pretreatment median LDH (range) | 169 | 112–2090 | |
| Patients with elevated LDH (%) | 11 | 23% | |
| Pretreatment median ALC | 1.13 | ||
| Prior lines of therapy, n (%) | 0 | 21 | 66% |
| 1 | 5 | 16% | |
| 2 | 3 | 9% | |
| ≥3 | 3 | 9% | |
| Median prior lines of therapy | 0 | ||
| Prior radiation | 18 | 56% | |
| Number of metastatic sites | 1 | 6 | 19% |
| M1b | 5 | 16% | |
| M1c | 1 | 3% | |
| 2 | 8 | 25% | |
| ≥3 | 18 | 56% | |
| Brain | 13 | 41% | |
| Median doses ipilimumab, n (range) | 4 | (1–4) | |
| Total doses of ipilimumab | 105 | ||
| Doses of GM-CSF* | 1302/1470 | 88.6% |
LDH = lactate dehydrogenase in units/L
ALC = absolute lymphocyte count (Kcells/μL)
*
14 doses possible per dose of ipilimumab or 56 for treatment course