A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
Objective
This Phase 3 study is designed to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking.
Study Arms
- Experimental: Cohort 1- Surgery Active
- Placebo Comparator: Cohort 1 - Primary Surgery Control
- Experimental: Cohort 2 - NACT + Interval Surgery Active
- Placebo Comparator: Cohort 2 - NACT + Interval Surgery Control
Eligibility
- Adults 18 years old or older.
- Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
- Histologic epithelial cell types: high-grade serous adenocarcinoma, high-grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
- Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
- Preoperative serum CA- 125 levels ≥ 50 U/mL.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
- Platelets greater than or equal to100,000/µL
- Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
- Adequate liver function:
- Bilirubin < 1.5 times upper limit normal (ULN)
- Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
- Albumin >3.5 g/dL
- Adequate renal function:
- Creatinine less than or equal to1.5 times ULN
- ECOG Performance Status of 0 or 1.
