Table 1.
Patient Demographics and Baseline Disease Characteristics.
| Ipi10 + HDI (N = 18 ) |
Ipi10 (N = 22) |
Ipi3 + HDI (N = 19) |
Ipi3 (N = 22) |
|
|---|---|---|---|---|
| Age (median & range) | 60 (20–74) | 57 (27–83) | 65 (29–77) | 57 (26–73) |
| Gender | ||||
| Female | 10 (56%) | 8 (36%) | 6 (32%) | 9 (41%) |
| Male | 8 (44%) | 14 (64%) | 13 (68%) | 13 (59%) |
| Performance (ECOG) | ||||
| 0 | 9 (50%) | 11 (50%) | 8 (42%) | 15 (68%) |
| 1 | 9 (50%) | 11 (50%) | 11 (58%) | 7 (332%) |
| Primary | ||||
| Cutaneous | 16 (89%) | 16 (73%) | 14 (74%) | 17 (77%) |
| Unknown | 2 (11%) | 6 (27%) | 5 (26%) | 5 (23%) |
| Ulceration of primary | ||||
| Yes | 6 (33%) | 9 (41%) | 8 (42%) | 3 (14%) |
| No | 8 (44%) | 3 (14%) | 5 (26%) | 14 (64%) |
| Unknown | 4 (22%) | 10 (46%) | 6 (32%) | 5 (23%) |
| BRAF Status | ||||
| Mutant (E/K) | 5 (28%) | 11 (50%) | 5 (26%) | 8 (36%) |
| Wild type | 13 (72%) | 7 (32%) | 13 (68%) | 14 (64%) |
| Unknown | 0 | 4 (18.1%) | 1 (5%) | 0 |
| AJCC Stage | ||||
| III (N3)/M1a | 3 (17%) | 5 (23%) | 5 (26.3%) | 5 (22.7%) |
| M1b | 6 (33%) | 6 (27%) | 6 (31.6%) | 6 (27.3%) |
| M1c | 9 (50%) | 11 (50%) | 8 (42%) | 11 (50%) |
| Prior Treatment | 7 (39%) | 10 (45%) | 7 (37%) | 8 (36%) |
| Adjuvant IFN / peg-IFN | 5 (28%) | 4 (18%) | 4 (21%) | 7 (32%) |
| BRAF inhibitor | 0 | 3 (14%) | 2 (111%) | 0 |
| Interleukin-2 | 2 (11%) | 2 (9%) | 1 (5%) | 1 (5%) |
| PD1/PDL1 inhibitor | 0 | 1 (5%) | 0 | 0 |
*
A total of 88 patients were enrolled, but 7 who never started study treatment or found ineligible were excluded.
Arm A (ipilimumab 10 mg/kg [ipi10] + high-dose interferon-α [HDI])
Arm B (ipilimumab 10 mg/kg alone)
Arm C (ipilimumab 3 mg/kg [ipi3] + high-dose interferon-α)
Arm D (ipilimumab 3 mg/kg alone)
IFN: Interferon; peg-IFN: Pegylated-interferon