TABLE 1.
Trial | Peptide | Adjuvant | N | Gender, M | Age, <64y | IR+ (%) |
---|---|---|---|---|---|---|
Mel43a | 12MP;tetanus | IFA + GM-CSF | 58 | 37 | 47 | 20 (34%) |
IFA | 60 | 45 | 46 | 44 (73%) | ||
Mel44a | 12MP;tetanus | IFA+/− cyclophos | 82 | 53 | 57 | 58 (71%) |
12MP:6MHP | IFA+/− cyclophos | 85 | 59 | 64 | 18 (21%) | |
Mel48a,b | 12MP;tetanus | IFA | 42 | 30 | 35 | 20 (48%) |
Total | 327c | M 224 | <64y 249 | + (49%) | ||
F 103 | ≥64y 78 | − (51%) |
MHC major histocompatibility complex, 12MP 12 class I MHC-restricted melanoma peptides, IFA incomplete Freund's adjuvant, GM-CSF granulocyte-macrophage colony-stimulating factor, 6MHP 6 class II MHC-restricted melanoma helper peptides, IR Immune response
Ten vaccinations were administered for Mel43 and Mel44 and 6 for Mel48
Patients with nonmeasurable disease or equivocal findings may be enrolled in Mel48
One participant belonged to both trials 43 and 48