Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)

  • STATUS
    Recruiting
  • End date
    Aug 26, 2027
  • participants needed
    602
  • sponsor
    OncoQuest Pharmaceuticals Inc.
Updated on 24 July 2022
paclitaxel
renal function
cancer
carcinoma
neutrophil count
carboplatin
blood transfusion
chemotherapy regimen
cancer chemotherapy
adenocarcinoma
ovarian cancer
fallopian tube
renal function tests
ovarian epithelial cancer
undifferentiated carcinoma
endometrioid adenocarcinoma
clear cell adenocarcinoma
carboplatin/paclitaxel
tumor debulking
ovarian epithelial carcinoma
serous cystadenocarcinoma
cancer of the ovary
oregovomab
epithelial ovarian cancer
debulking surgery
primary debulking surgery
interval debulking surgery

Summary

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.

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).

Details
Condition Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Ovarian Cancer, Ovarian Serous Adenocarcinoma, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Peritoneal Cancer, Peritoneal Carcinoma, Peritoneal Neoplasms
Treatment carboplatin, Placebo, Paclitaxel, Oregovomab
Clinical Study IdentifierNCT04498117
SponsorOncoQuest Pharmaceuticals Inc.
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

BRCA1 or BRCA2 germline gene mutation test result with
Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy
Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma
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)
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
Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin
Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G)
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.)
Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia
Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study
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