| Trial ID # | NCT02107937; SOVO1 |
| Phase | II |
| Drug Class | Immunotherapy: Vaccine/TAA |
| Drug Name | DCVAC/OvCa |
| Alternate Drug Names | ovarian tumor antigen-activated autologous dendritic cell vaccine |
| Drugs in Trial | DCVAC/OvCa |
| Eligible Participant | Newly diagnosed stage III ovarian cancer with optimal debulking (< 1 cm residual disease) |
| Patients Enrolled | 99 |
| Therapy Setting | First-line, Maintenance |
| Study Design | Open-Label, Randomized |
| Endpoints | PFS, evaluated per RECIST |
| Efficacy | DCVAC concomitant with Chemo (n=31) vs DCVAC sequential after chemo (n=29) vs chemo alone (n=30): PFS: 20.3 vs NR vs 21.4 months, HR: 0.98 (0.48-2.00), HR: 0.39 (0.16-0.96, p=0.034) |
| Clinically Significant Adverse Events | DCVAC concomitant with Chemo (n=31) vs DCVAC sequential after chemo (n=29) vs chemo alone (n=30): |
| Conclusion | DCVAC/OvCa sequential to chemo is associated with a statistically significant improvement in PFS in patients undergoing first-line treatment |
| Reference | Rob L et al. Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. J Immunother Cancer (2022) 10(1):e003190 |