Phase II clinical trials for patients with EOC with DC vaccines pulsed tumor P/PA antigens
| Study phase and design | Patient number | DC vaccine method | Control arm | Primary endpoints | Secondary endpoints | Trial ID/Ref. |
| Open label, randomized, parallel assignment, phase IIb | 56 | DC pulsed with MUC1 (CVac) | Placebo | Median PFS: 13 vs 9 months (HR)=0.73, p=0.36) CR1 subgroup: median PFS 13 vs 18 months (HR=1.18; CI 0.52 to 2.71, p=0.69). CR2 subgroup: median PFS: >13 vs 5 months (HR=0.32, p=0.04) | CR2 subgroup: median OS: >42 vs 26 months (HR=0.17; CI 0.02 to 1.4, p=0.07). TEAEs>grade 3: 12.5% | NCT01068509/23 |
| Single-arm, open-label, phase II | 28 | DC pulsed with MUC1 (CVac) | No | CA125 response or stabilization: 15% | AEs>grade 3: 0 | 22 |
| Open label, parallel assignment, phase II | 21 | Arm a: P53 peptides, intravenous Arm b: DC pulsed P53 peptides, SC | No | Immunologic response: Arm a vs Arm b=69% vs 83% | Median PFS: 4.2 vs 8.7 months; Median OS: 40.8 vs 29.6 months: AEs>grade 3: 0, 0 for both | 25 |
| Single-arm, open-label, phase II | 56 | DC pulsed with MUC1, WT-1 peptides, intravenous | No | Immunologic response: 71%. Median OS：30.4 months | AEs>grade 3: 0 | 24 |
AEs, incidence of adverse events; CR1, first clinical remission; CR2, second clinical remission; DC, dendritic cell; EOC, epithelial ovarian cancer; MUC1, Mucin 1; OS, overall survival; PFS, progression-free survival; P/PA, peptide/protein; Ref, Reference; SC, subcutaneous; TEAEs, treatment emergent adverse events; WT1, Wilms' tumor protein 1.