Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and
efficacy of four administrations of oregovomab 2 mg IV 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 ovarian cancer who have
undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort
1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already
completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).
For Cohort 1 - Primary Surgery, 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy
with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, 230
subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or
chemotherapy and placebo).
Major Inclusion Criteria:
1. Adults 18 years old or older.
2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal
origin FIGO Stage III or IV disease.
3. 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.).
4. 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).
5. Preoperative serum CA- 125 levels ≥ 50 U/mL.
6. Adequate bone marrow function:
1. Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
2. Platelets greater than or equal to100,000/µL
3. 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).
7. Adequate liver function:
1. Bilirubin < 1.5 times upper limit normal (ULN)
2. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
3. Albumin >3.5 g/dL
8. Adequate renal function:
a. Creatinine less than or equal to1.5 times ULN
9. ECOG Performance Status of 0 or 1.
Major Exclusion Criteria:
1. BRCA1 or BRCA2 germline gene mutation test result with:
1. Positive, ambiguous or inconclusive result available within 28 days prior to
starting study treatment, or
2. Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
3. Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor
front-line maintenance therapy.
2. Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.
3. Female subjects who are lactating and breastfeeding, or have a positive serum
pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for
Cohort 1 or C4D1 for Cohort 2).
4. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus
(SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing
spondylitis requiring active disease modifying treatment.
5. Known allergy to murine proteins or hypersensitivity to any of the excipients of the
oregovomab, paclitaxel, or carboplatin.
6. Chronically treated with immunosuppressive drugs such as cyclosporine,
adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
7. Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or
equivalent, with the exception of inhalers or those on a pre-planned steroid taper.
(Note: Premedication with corticosteroids per institutional standard of care is
allowed.)
8. Recognized acquired, hereditary, or congenital immunodeficiency disease, including
cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
9. Anticipated treatment with any other anti-cancer medications, including bevacizumab,
poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s)
during the study.
