Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma

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)
OS: NR vs 43.2 months, HR: 0.35 (0.16-0.74, p=0.0043)

Clinically Significant Adverse Events

CarboPt+Pac+Ore vs CarboPt+Pac:
Serious AE: none
Grade 3-4 AE: any (4.3 vs 10.4%)

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
https://www.ncbi.nlm.nih.gov/pubmed/31916979