| Trial ID # | NCT01309230 |
| Phase | II |
| Drug Class | Immunotherapy: Vaccine/TGFbeta |
| Drug Name | Gemogenovatucel-T |
| Alternate Drug Names | Vigil, bi-shRNA-furin/GMCSF-expressing autologous tumor cell vaccine, bi-shRNA-furin and granulocyte macrophage colony stimulating factor augmented autologous tumor cell vaccine, FANG vaccine |
| Drugs in Trial | Gemogenovatucel-T |
| Eligible Participant | Stage III/IV disease with no evidence of active disease after first-line therapy |
| Patients Enrolled | 42 |
| Therapy Setting | Maintenance |
| Study Design | Open-Label, Randomized |
| Endpoints | RFS, evaluated per RECIST |
| Efficacy | FANG maint vs Placebo: RFS (from time of procurement): mean/median: 27.5/20.1 (n=31) vs 16.0/12.6 months (n=11), HR: 0.43 (0.19-0.96, p=0.039) |
| Clinically Significant Adverse Events | Serious AE: none |
| Conclusion | FANG vaccine shows encouraging anti-tumor activity and increased RFS with remarkable safety |
| Reference | Oh J et al. Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer. Gynecol Oncol (2016) 143(3):504-510 |