Baseline characteristics
| Characteristics | Cohort 08 (n=12) | Cohort 09 (n=14) | Total (N=26) |
| Age, years, mean (range) | 55 (42–77) | 61 (26–83) | 59 (26–83) |
| Sex, n (%) | |||
| Male | 5 (41.7) | 8 (57.1) | 13 (50.0) |
| Female | 7 (58.3) | 6 (42.9) | 13 (50.0) |
| ECOG performance status, n (%) | |||
| 0 | 7 (58.3) | 4 (28.6) | 11 (42.3) |
| 1 | 5 (41.7) | 10 (71.4) | 15 (57.7) |
| Disease stage*, n (%) | |||
| IIIC | 5 (41.7) | 4 (28.6) | 9 (34.6) |
| IVM1a | 4 (33.3) | 7 (50.0) | 11 (42.3) |
| IVM1b | 2 (16.7) | 3 (21.4) | 5 (19.2) |
| IVM1c | 1 (8.3) | 0 (0.0) | 1 (3.8) |
| LDH, n (%) | |||
| ≤ULN | 10 (83.4) | 12 (85.7) | 22 (84.6) |
| >ULN | 2 (16.7) | 2 (14.3) | 4 (15.4) |
| Treatment line, n (%) | |||
| First | 7 (58.3) | 3 (21.4) | 10 (38.5) |
| Second or later† | 5 (41.7) | 11 (78.6) | 16 (61.5) |
| DTIC-based chemotherapy | 4 (33.3) | 7 (50) | 11 (42.3) |
| Platinum-based chemotherapy | 1 (8.3) | 1 (7.1) | 2 (7.7) |
| Immunotherapy | 0 | 1 (7.1) | 1 (3.8) |
| Targeted therapy | 0 | 2 (14.3) | 2 (7.7) |
| PD-1-based | 0 | 0 | 0 |
| Melanoma subtype, n (%) | |||
| Cutaneous (sun-exposed) | 4 (33.3) | 2 (14.3) | 6 (23.1) |
| Acral | 7 (58.3) | 11 (78.6) | 18 (69.2) |
| Mucosal | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Unknown | 1 (8.3) | 1 (7.1) | 2 (7.7) |
| Ulceration of primary melanoma, n (%) | |||
| Present | 7 (58.3) | 9 (64.3) | 16 (61.5) |
| Absent | 0 (0.0) | 2 (14.3) | 2 (7.7) |
| Unknown | 5 (41.7) | 3 (21.4) | 8 (30.8) |
| BRAF V600E status, n (%) | |||
| Mutation | 3 (25.0) | 3 (21.4) | 6 (23.1) |
| Wild-type | 9 (75.0) | 11 (78.6) | 20 (76.9) |
| Total tumor burden (mm±SD) | 66.7±28.3 | 100±56.2 | 84.6±47.8 |
M1a: metastases to the skin, soft tissue (including muscle), and/or non-regional lymph nodes; M1b, metastasis to the lung with or without metastasis of M1a; M1c, visceral metastases other than the central nervous system with or without metastasis of M1a or M1b.
*Disease stage based on TNM criteria according to the AJCC Seventh Edition.
†Patients who received multiple lines of prior treatment were counted only once by their first prior therapy received.
AJCC, American Joint Committee on Cancer; DTIC, dacarbazine; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; PD1, programmed cell death protein 1; TNM, tumor, node, metastasis; ULN, upper limit of normal.