GOG-3035/OncoQuest QPT-ORE-005/FLORA-5

Official 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

Study Purpose

To see how safe and effective four doses of the experimental drug oregovomab is given at the same time as specific cycles of the chemotherapy regimen paclitaxel and carboplatin.

Diagnosis

Patients with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.

Eligibility

Newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

BRCA negative.

Completed debulking surgery (both primary and interval allowed).

ECOG 0-1. No mucinous or low-grade adeno allowed.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

Adjuvant chemo (3 or 6 cycles depending on primary or interval debulking) + Oregovomab/Placebo