GOG-3035 QPT-ORE-005 (Ovarian, Fallopian Tube or Peritoneal Carcinoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the investigational drug, oregovomab when given for advanced ovarian cancer.

Oregovomab is the study drug that is designed to attach to the CA-125 marker on a tumor and can activate your immune system to attack cancer cells.

What is the Condition Being Studied?

Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Who Can Participate in the Study?

Adult females with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:
-Be randomized (a fair 50/50 chance) to Group A or Group B:
---Group A will get the study drug (Oregovomab) and paclitaxel and carboplatin
---Group B will get a Placebo (harmless saltwater) and paclitaxel and carboplatin

-Both groups will get 6 doses of (paclitaxel and carboplatin) total with 4 total doses of oregovomab or placebo depending on your group assignment
-Both groups will return for a follow-up visit 30 days after your last chemotherapy visit

*Long term follow-up contact will be every 3 months for the first 2 years and then every 6 months indefinitely.

Study Details

Full Title
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00105747
NCT: NCT04498117
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698