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/CA125
Drug Name Oregovomab
Alternate Drug Names OvaRex, Monoclonal Antibody B43.13, B43.13
Drugs in Trial Carboplatin, Oregovomab, Paclitaxel
Eligible Participant
Patients Enrolled

97

Therapy Setting

First-line

Study Design

Open-Label, Randomized

Endpoints

RFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac+Ore (n=47) vs CarboPt+Pac (n=50), at 26 months median follow-up:

RFS: NR vs 15.4 months; HR: 0.38 (0.21-0.69, p=0.0014)
OS: NR vs 38.3 months; HR: 0.18 (0.05-0.64, p=0.0080)

Clinically Significant Adverse Events

CarboPt+Pac+Ore vs CarboPt+Pac:
Grade 3-4 AE: 52.2 vs 57.1%
Oregovomab well tolerated with no significant toxicity beyond that seen with chemotherapy alone

Conclusion

Addition of oregovomab enhances the outcomes achievable with carboplatin+paclitaxel alone

Reference