Enrollment, demographics, and clinical features
Seviprotimut-L | Placebo | |
N | 230 | 117 |
Age: median (range) | 58 (18, 80) | 56 (26, 80) |
Sex: % female | 42 | 44 |
Race: % white | 99 | 100 |
Prior melanoma therapy (%) | ||
Any | 5.2 | 4.3 |
Radiotherapy | 4.3 | 4.3 |
Tumor location (%) | ||
Extremities | 35 | 37 |
Head and neck | 26 | 21 |
Trunk | 37 | 41 |
Other | 2.6 | 0.9 |
Ethnicity: % Hispanic or Latino | 3 | 3.4 |
ECOG performance status 0 (%) | 86 | 86 |
Completed lymphadenectomy (%) | 64 | 64 |
Median Breslow depth (mm) | 2.8 | 3 |
T staging (%) | ||
T0 or TX | 4.8 | 5.1 |
T1–T2a | 29 | 27 |
T2b–T4a | 48 | 55 |
T4b | 18 | 17 |
N staging (%) | ||
N0 | 32 | 32 |
N1a | 36 | 30 |
N1b–N2b | 19 | 23 |
N2c/N3 | 13 | 15 |
Summary AJCC stage (V.7, %) | ||
IIB/IIC | 32 | 32 |
IIIA | 30 | 29 |
IIIB/IIIC | 38 | 39 |
BRAF mutant* (%) | 35 | 33 |
*BRAF mutation status known for 93%, 96%, and 94% of patients receiving vaccine, placebo, or total. Values shown above are percentages of all.