Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

  • STATUS
    Recruiting
  • End date
    Aug 26, 2027
  • participants needed
    602
  • sponsor
    OncoQuest Pharmaceuticals Inc.
Updated on 5 May 2021
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 Ovarian disorder, Peritoneal Neoplasm, Abdominal Neoplasm, Fallopian Tube Cancer, Ovarian Cancer, Neoplasm of unspecified nature of digestive system, Peritoneal Cancer, Ovarian Function, Primary Peritoneal Cavity Cancer, Fallopian Tube Serous Adenocarcinoma, Ovarian Serous Adenocarcinoma, Recurrent Ovarian Cancer, Abdominal Cancer, Peritoneal Carcinoma, Fallopian Tube Adenocarcinoma, Digestive System Neoplasms, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial, Carcinoma, Ovarian Epithelial
Treatment carboplatin, Placebo, Paclitaxel, Oregovomab
Clinical Study IdentifierNCT04498117
SponsorOncoQuest Pharmaceuticals Inc.
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Fallopian Tube Serous Adenocarcinoma or Ovarian Function or cancer ovarian or ovarian tumors or Abdominal Neoplasm or Carcinoma, Ovarian Epithelial or...?
Do you have any of these conditions: Ovarian Cancer or Primary Peritoneal Cavity Cancer or Digestive System Neoplasms or ovarian carcinomas or Ovarian disorder or Fallopian Tube Serous Ad...?
Do you have any of these conditions: Peritoneal Cancer or cancer of the ovary or Recurrent Ovarian Cancer or Abdominal Cancer or Digestive System Neoplasms or cancer ovarian or ovarian tu...?
Do you have any of these conditions: Ovarian disorder or Ovarian Function or cancer, ovarian or ovarian carcinomas or Primary Peritoneal Cavity Cancer or Peritoneal Cancer or Peritoneal N...?
Do you have any of these conditions: cancer ovarian or Ovarian Function or Carcinoma, Ovarian Epithelial or Fallopian Tube Serous Adenocarcinoma or cancer, ovarian or Ovarian Serous Adeno...?
Do you have any of these conditions: ovarian carcinomas or Abdominal Cancer or cancer ovarian or Abdominal Neoplasm or Ovarian Cancer or cancer of the ovary or Digestive System Neoplasms ...?
Do you have any of these conditions: ovarian tumors or Fallopian Tube Cancer or Fallopian Tube Serous Adenocarcinoma or Ovarian disorder or Fallopian Tube Adenocarcinoma or Peritoneal Neo...?
Do you have any of these conditions: Ovarian Function or Neoplasm of unspecified nature of digestive system or Ovarian disorder or Digestive System Neoplasms or Abdominal Cancer or Primar...?
Do you have any of these conditions: Ovarian disorder or Recurrent Ovarian Cancer or Neoplasm of unspecified nature of digestive system or cancer of the ovary or Fallopian Tube Serous Ade...?
Do you have any of these conditions: Peritoneal Cancer or cancer ovarian or Peritoneal Carcinoma or Digestive System Neoplasms or Recurrent Ovarian Cancer or ovarian carcinomas or Neoplas...?
Do you have any of these conditions: Carcinoma, Ovarian Epithelial or Recurrent Ovarian Cancer or cancer, ovarian or Peritoneal Carcinoma or Ovarian Cancer or Ovarian Serous Adenocarcinom...?
Do you have any of these conditions: Ovarian Cancer or Abdominal Neoplasm or Abdominal Cancer or ovarian tumors or Fallopian Tube Serous Adenocarcinoma or Digestive System Neoplasms or Pe...?
Do you have any of these conditions: Ovarian Cancer or cancer of the ovary or Primary Peritoneal Cavity Cancer or Ovarian Serous Adenocarcinoma or Peritoneal Neoplasm or Abdominal Cancer ...?
Do you have any of these conditions: Ovarian Function or Fallopian Tube Serous Adenocarcinoma or Ovarian disorder or Neoplasm of unspecified nature of digestive system or Ovarian Serous A...?
Do you have any of these conditions: Peritoneal Carcinoma or Fallopian Tube Adenocarcinoma or Peritoneal Cancer or Abdominal Cancer or ovarian carcinomas or Peritoneal Neoplasm or ovarian...?
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: ovarian carcinomas or cancer ovarian or Ovarian Serous Adenocarcinoma or Fallopian Tube Serous Adenocarcinoma or Digestive System Neoplasms or Fallopi...?
Do you have any of these conditions: Neoplasm of unspecified nature of digestive system or cancer of the ovary or Ovarian disorder or Carcinoma, Ovarian Epithelial or Peritoneal Neoplasm ...?
Do you have any of these conditions: Ovarian Function or Peritoneal Carcinoma or Ovarian disorder or Fallopian Tube Serous Adenocarcinoma or Ovarian Serous Adenocarcinoma or cancer, ovari...?
Do you have any of these conditions: Ovarian disorder or ovarian tumors or cancer, ovarian or Recurrent Ovarian Cancer or Fallopian Tube Adenocarcinoma or Fallopian Tube Serous Adenocarci...?
Do you have any of these conditions: Recurrent Ovarian Cancer or Carcinoma, Ovarian Epithelial or ovarian carcinomas or Ovarian disorder or Peritoneal Carcinoma or Fallopian Tube Serous A...?
Do you have any of these conditions: Peritoneal Neoplasm or ovarian tumors or Recurrent Ovarian Cancer or Primary Peritoneal Cavity Cancer or Abdominal Neoplasm or Neoplasm of unspecified...?
Do you have any of these conditions: cancer ovarian or Ovarian Cancer or Ovarian Serous Adenocarcinoma or Fallopian Tube Serous Adenocarcinoma or Fallopian Tube Adenocarcinoma or Peritone...?
Do you have any of these conditions: Recurrent Ovarian Cancer or Ovarian Function or Abdominal Neoplasm or Neoplasm of unspecified nature of digestive system or ovarian tumors or Abdomina...?
Do you have any of these conditions: Ovarian disorder or Neoplasm of unspecified nature of digestive system or Peritoneal Carcinoma or Peritoneal Neoplasm or Fallopian Tube Adenocarcinoma...?
Do you have any of these conditions: Abdominal Neoplasm or Neoplasm of unspecified nature of digestive system or ovarian tumors or Fallopian Tube Cancer or Fallopian Tube Serous Adenocarc...?
Do you have any of these conditions: Recurrent Ovarian Cancer or Peritoneal Carcinoma or Ovarian disorder or Ovarian Serous Adenocarcinoma or Fallopian Tube Serous Adenocarcinoma or Fallo...?
Do you have any of these conditions: Fallopian Tube Adenocarcinoma or Peritoneal Neoplasm or Fallopian Tube Serous Adenocarcinoma or Abdominal Neoplasm or Fallopian Tube Cancer or Periton...?
Are you female?
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/L
Platelets greater than or equal to100,000/L
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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