| Trial ID # | NCT01616303 |
| Phase | II |
| Drug Class | Immunotherapy: Antibodies/MUC16 (CA125) |
| Drug Name | Oregovomab |
| Alternate Drug Names | OvaRex, Monoclonal Antibody B43.13, B43.13 |
| Drugs in Trial | Carboplatin, Oregovomab, Paclitaxel |
| Eligible Participant | Newly diagnosed stage III-IV ovarian, primary peritoneal or fallopian tube cancer with <1 cm residual disease after surgery |
| Patients Enrolled | 97 |
| Therapy Setting | First-line |
| Study Design | Open-Label, Randomized |
| Endpoints | PFS, OS, evaluated per RECIST |
| Efficacy | CarboPt+Pac+Ore (n=47) vs CarboPt+Pac (n=50) at 42 months median follow up: PFS: 41.8 vs 12.2 months, HR: 0.46 (0.28-0.77, p=0.0027) |
| Clinically Significant Adverse Events | CarboPt+Pac+Ore vs CarboPt+Pac: |
| Conclusion | Addition of oregovomab to carboplatin+paclitaxel significantly increases PFS and OS |
| Reference | Brewer M et al. Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study. Gynecol Oncol (2020) 156(3):523-529 |