Phase II/III clinical trials for patients with EOC by DC vaccines pulsed with whole tumor cell antigens
| Study phase and design | Patient number | DC vaccine treatment | Control arm | Primary endpoints | Secondary endpoints | Trial ID/Ref. |
| Multicenter, double-blind, randomized, placebo-controlled, phase III | 678 | Stage I: Placebo+carboplatin and gemcitabine or carboplatin and paclitaxel Stage II: Placebo+bevacizumab or PARPi | OS | PFS, ORR, DOR, TEAEs | NCT03905902/21 | |
| SOV02 : randomized, open-label, parallel-group, multicenter phase II | 64 | DC pulsed with tumor cell lysate (DCVAC/OvCa) | Carboplatin and gemcitabine | Median OS: 35.5 vs 22.3 months (HR=0.38 p=0.0032) | Median PFS: 11.3 vs 9.5 months | 21 |
| Single-arm, open-label, multicenter, phase II | 30 | DC pulsed with tumor cell lysate (DCVAC/OvCa) | No | PFS | OS, ORR, DOR, AEs, | NCT03657966 |
| Single-arm, open-label, phase II | 36 | DC pulsed with tumor cell lysate or WT1 and MUC1 peptide | No | ORR | TAEs | NCT00703105 |
| Open label, randomized, parallel assignment, phase II | 23 | DC pulsed with tumor cell lysate | No | Cellular immunity | TAEs, ORR | NCT00799110 |
| Multicenter, double-blind, randomized, placebo-controlled, phase II | 99 | DC pulsed with tumor cell lysate (AVOVA-1) | MC+GM-CSF | OS | PFS | NCT02033616 |
| Single-arm, open-label, phase I/IIa | 18 | Alpha-DC1 vaccine | No | AEs>grade 3, Immunologic responses, | ORR, OS, PFS | NCT03735589 |
| Open label, randomized, parallel assignment, phase II | 25 | DC vaccine | No | AEs>grade 3, Immunologic response | NCT02432378 |
AEs, Incidence of adverse events; DC, dendritic cell; DOR, duration of response; EOC, epithelial ovarian cancer; GM-CSF, granulocyte-macrophage colony-stimulating factor; MC, monocytes cell; MUC1, Mucin 1; ORR, objective response rate; OS, Overall survival; PARP, Poly ADP-ribose Polymerase; PFS, progression-free survival; Ref, Reference; TAEs, toxicities of adverse events; TEAEs, treatment emergent adverse events; WT1, Wilms' tumor protein 1.