Purpose

Study 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1- Surgery Active
Six (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
  • Biological: Oregovomab
    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
    Other names:
    • MAb-B43.13
  • Drug: Paclitaxel
    175 mg/m^2, every 3 weeks
    Other names:
    • Taxol
  • Drug: Carboplatin
    AUC 6 IV Day 1 x 6 cycles (every 21 days)
    Other names:
    • Paraplatin
Placebo Comparator
Cohort 1 - Primary Surgery Control
Six (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
  • Drug: Paclitaxel
    175 mg/m^2, every 3 weeks
    Other names:
    • Taxol
  • Drug: Carboplatin
    AUC 6 IV Day 1 x 6 cycles (every 21 days)
    Other names:
    • Paraplatin
  • Biological: Placebo
    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
Experimental
Cohort 2 - NACT + Interval Surgery Active
In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
  • Biological: Oregovomab
    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
    Other names:
    • MAb-B43.13
  • Drug: Paclitaxel
    175 mg/m^2, every 3 weeks
    Other names:
    • Taxol
  • Drug: Carboplatin
    AUC 6 IV Day 1 x 6 cycles (every 21 days)
    Other names:
    • Paraplatin
Placebo Comparator
Cohort 2 - NACT + Interval Surgery Control
In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
  • Drug: Paclitaxel
    175 mg/m^2, every 3 weeks
    Other names:
    • Taxol
  • Drug: Carboplatin
    AUC 6 IV Day 1 x 6 cycles (every 21 days)
    Other names:
    • Paraplatin
  • Biological: Placebo
    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes

Recruiting Locations

Montefiore Medical Center PRIME
Bronx, New York 10467
Contact:
Nicole Nevandusky, MD

More Details

Status
Recruiting
Sponsor
OncoQuest Pharmaceuticals Inc.

Study Contact

VP Product Development
780-448-1400
ClinicalTrialDisclosures@oncoquestinc.com

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.