Table 1.
Baseline characteristics of patients enrolled prior to and after trial amendment.
| Baseline Characteristics | Patients Enrolled Prior to Trial Amendment n = 6 |
Patients Enrolled after Trial Amendment n = 10 |
|---|---|---|
| Sex (n (%)) | ||
| Male | 4 (66.7) | 4 (40.0) |
| Female | 2 (33.3) | 6 (60.0) |
| Age (median (range)) | 70 (44–77) | 58 (30–84) |
| ECOG PS (n (%)) | ||
| 0 | 5 (83.3) | 4 (40.0) |
| 1 | 1 (16.7) | 5 (50.0) |
| 2 | 0 | 1 (10.0) |
| Melanoma subtype (n (%)) | ||
| Superficial spreading | 2 (33.3) | 5 (50.0) |
| Nodular | 0 | 4 (40.0) |
| Lentigo maligna | 1 (16.7) | 0 |
| Spitzoid | 1 (16.7) | 0 |
| Cutaneous NOS | 1 (16.7) | 0 |
| Unknown primary lesion | 1 (16.7) | 1 (10.0) |
| AJCC stage (n (%)) | ||
| IIIC | 0 | 1 (10.0) |
| IV-M1b | 0 | 1 (10.0) |
| IV-M1c | 6 (100.0) | 5 (50.0) |
| IV-M1d | 0 | 3 (30.0) |
| Number of affected organs | ||
| Median (range) | 5 (2–7) | 5 (1–8) |
| Lactate dehydrogenase (n (%)) | ||
| Increased | 2 (33.3) | 4 (40.0) |
| Normal | 4 (66.7) | 6 (60.0) |
| NRAS mutation subtype (n (%)) | ||
| Q61R | 3 (50.0) | 6 (60.0) |
| Q61K | 3 (50.0) | 3 (30.0) |
| Q61L | 0 | 1 (10.0) |
| Prior lines of therapy | ||
| Median (range) | 2.5 (2–4) | 2.5 (1–5) |
| 1 (n (%)) | 0 | 3 (30.0) |
| 2 (n (%)) | 3 (50.0) | 5 (50.0) |
| 3 (n (%)) | 2 (33.3) | 0 |
| >3 (n (%)) | 1 (16.7) | 2 (20.0) |
| Prior PD-1 ICI (n (%)) | 6 (100.0) | 9 (90.0) |
| Prior CTLA-4 ICI (n (%)) | 5 (83.3) | 6 (60.0) |
| Prior PD-1 ICI/CTLA-4 ICI combination (n (%)) | 1 (16.7) | 3 (30.0) |
| NRASQ61R/K/L mutant ctDNA (n (%)) | ||
| Present | 2 (33.3) | 4 (40.0) |
| Absent | 4 (66.7) | 6 (60.0) |
| Total metabolic tumor volume mL (median (range)) |
123 (3–4392) | 44 (0–614) * |
* Only 9 patients underwent baseline whole-body 18F-FDG-PET/CT imaging. Abbreviations: AJCC: American Joint Committee on Cancer; ctDNA: circulating tumor DNA; CTLA-4 ICI: cytotoxic T-lymphocyte-associated antigen 4 immune checkpoint inhibitor; ECOG PS: Eastern Cooperative Oncology Group Performance Status; NOS: not otherwise specified; PD-1 ICI: programmed cell death 1 immune checkpoint inhibitor.