Table 3.
Summary of study treatment-related adverse eventsa (safety cohort [N = 46])
| Treatment-related adverse events (TRAE) | Arm A Cy-GVAX n = 17 | Arm B Cy-GVAX PD-1 n = 18 | Arm C Cy-GVAX PD-1 CD137 n = 11 |
|---|---|---|---|
| TRAE, #pts (any grade) | |||
| Abdominal pain | 0 (0%) | 0 (0%) | 3 (27.3%) |
| AST/ALT elevation | 0 (0%) | 0 (0%) | 1 (9.1%) |
| Chills/sweats | 4 (23.5%) | 2 (11.1%) | 2 (18.2%) |
| Dermatitisb | 3 (17.6%) | 3 (16.7%) | 6 (54.5%) |
| Diarrhea | 0 (0%) | 1 (5.6%) | 1 (9.1%) |
| Colitis | 0 (0%) | 1 (5.6%) | 0 (0%) |
| Dizziness/presyncope | 1 (5.9%) | 1 (5.6%) | 0 (0%) |
| Fatigue | 5 (29.4%) | 8 (44.4%) | 6 (54.5%) |
| Fever | 3 (17.6%) | 4 (22.2%) | 2 (18.2%) |
| Headache | 2 (11.8%) | 2 (11.1%) | 0 (0%) |
| Malaise | 1 (5.9%) | 5 (27.8%) | 1 (9.1%) |
| Myalgia/arthralgia | 1 (5.9%) | 6 (33.3%) | 2 (18.2%) |
| Nausea | 2 (11.8%) | 3 (16.7%) | 8 (72.7%) |
| Other | 0 (0%) | 0 (0%) | 2 (18.2%) |
| Swelling | 0 (0%) | 1 (5.6%) | 1 (9.1%) |
| Thyroid disorder | 0 (0%) | 0 (0%) | 4 (36.4%) |
| Vomiting | 2 (11.8%) | 2 (11.1%) | 2 (18.2%) |
| Grade ≥3 TRAEc | 0 (0%) | 1 (5.6%) | 1 (9.1%) |
| Serious TRAE (SAE)d | 0 (0%) | 1 (5.6%) | 0 (0%) |
| Trial therapy dose delay due to TRAE | 0 (0%) | 0 (0%) | 1 (9.1%) |
| Off trial due to TRAE | 0 (0%) | 0 (0%) | 0 (0%) |
aDoes not include vaccine site reactions (VSR). Common VSRs included erythema, swelling, tenderness, and itching at vaccine sites.
bIncludes hives, pruritus, rash.
cGrade 3+ TRAEs included grade 3 colitis (Arm B) and grade 3 rash (Arm C).
dSAE (treatment-related) was grade 3 colitis.