| 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 |
Starting
January 1, 2025,
Clearity is joining
Ovarian Cancer
Research Alliance
(OCRA) and this website
will be redirected to
www.ocrahope.org
OCRA and Clearity are committed to serving the ovarian cancer community and providing the education, information, and support people need.