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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Ovarian Cancer; Peritoneal Carcinoma; Peritoneal Cancer; Fallopian Tube Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Ovarian Serous Adenocarcinoma
• Intervention / Treatment: Biological: Oregovomab; Drug: Paclitaxel; Drug: Carboplatin; Biological: Placebo; Drug: Carboplatin

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, approximately 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy and placebo).

• Study Type: Interventional
• Enrollment (Actual): 615
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • San Juan, Argentina
    • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
  • Viedma, Argentina, R8500
    • Clinicas Viedma S.A.
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, 2941
      • CEMAIC - Centro Medico Privado
    • Córdoba, Córdoba Province, Argentina
      • Clínica Universitaria Privada Reina Fabiola
  • Rosario
    • Rosario, Rosario, Argentina, 2000
      • Sanatorio de la Mujer
  • Salta Province
    • Salta, Salta Province, Argentina, 4400
      • Sanatorio Parque S.A
• Belgium
  • Antwerp, Belgium
    • ZNA Middelheim
  • Brussels, Belgium
    • Cliniques universitaires Saint-Luc
  • Liège, Belgium
    • Clinique CHC MontLégia
• Brazil
  • Blumenau, Brazil
    • Centro de Pesquisas Clinica Reichow
  • Guimarães, Brazil
    • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • Porto Alegre, Brazil
    • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
  • Santo André, Brazil
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • São Paulo, Brazil
    • Clínica São Germano - Oncologia
  • São Paulo, Brazil
    • Fundação Doutor Amaral Carvalho
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • City of Health Hospital at Laval (Cité de la Santé de Laval)
    • Montreal, Quebec, Canada, H2X 3E4
      • CHUM Centre de Recherche (affiliated with University of Montreal)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre/Glen Site/ Royal Victoria Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS - Hôpital Fleurimont
• Chile
  • Santiago, Chile
    • Centro de Investigacion Clinica Bradford Hill
  • Temuco, Chile
    • Sociedad de Investigaciones Medicas Limitada
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Prague, Czechia
    • Fakultni nemocnice v Motole
  • Prague, Czechia
    • Vseobecna fakultni nemocnice v Praze
  • Prague, Czechia
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia
    • Fakultni Nemocnice Bulovka
• Hungary
  • Budapest, Hungary
    • Magyar Honvédség Egészségügyi Központ
  • Budapest, Hungary
    • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
  • Debrecen, Hungary
    • Debreceni Egyetem
  • Kecskemét, Hungary
    • Bacs-Kiskun Megyei Oktatokorhaz
  • Zalaegerszeg, Hungary
    • Zala Megyei Szent Rafael Korhaz
• India
  • Bangalore, India
    • Fortis Hospital Ltd
  • Bengaluru, India
    • Fortis Hospital Ltd
  • Delhi, India
    • All India Institute of Medical Services
  • Mohali, India
    • Max Super Specialty Hospital
  • Mumbai, India
    • Sushrut Hospital
  • Noida, India
    • Fortis Hospital
  • Pune, India
    • Deenanath Mangeshkar Hospital
  • Pune, India
    • Ruby Hall Clinic
• Italy
  • Monza, Italy
    • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
  • Rome, Italy
    • Università Campus Bio-Medico di Roma
  • Rome
    • Rome, Rome, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Mexico
  • La Paz, Mexico, 23040
    • Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)
  • Monterrey, Mexico
    • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Querétaro, Mexico
    • SMIQ S. de R.L. de C.V.
  • San Luis Potosí City, Mexico
    • Centro Potosino de Investigacion Medica S.C.
  • Veracruz
    • Orizaba, Veracruz, Mexico
      • Clinical Medical Research S.C.
• South Korea
  • Goyang, South Korea
    • National Cancer Center
  • Seongnam, South Korea
    • Seoul National University Bundang Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Korea University Guro Hospital
  • Seoul, South Korea
    • Samsung Medical Center
  • Seoul, South Korea
    • Seoul National University Hospital
  • Seoul, South Korea
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Soeul, South Korea
    • Severance Hospital Yonsei University Health System
• Spain
  • Barcelona, Spain
    • Hospital De La Santa Creu I Sant Pau
  • L'Hospitalet de Llobregat, Spain
    • ICO l'Hospitalet-Hospital Duran i Reynals
  • Valencia, Spain
    • Instituto Valenciano de Oncologia IVO
  • Catalonia
    • Barcelona, Catalonia, Spain
      • Hospital Clinic De Barcelona
    • Barcelona, Catalonia, Spain
      • Hospital Universitari Vall d'Hebrón
• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 70457
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei
    • Taipei County, Taipei, Taiwan
      • Taipei Veterans General Hospital
  • Taiwan
    • Taipei, Taiwan, Taiwan
      • National Taiwan University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Honor Health
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Cancer Center
  • California
    • Concord, California, United States, 94520
      • John Muir Health Clinical Research Center
    • Irvine, California, United States, 92120
      • Kaiser Permanente Southern California
    • La Jolla, California, United States, 92093
      • Moores UC San Diego Cancer Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Pleasant Hill, California, United States, 94523
      • Epic Care
    • Riverside, California, United States, 95505
      • Kaiser Permanente Riverside Medical Center
    • Sacramento, California, United States, 95817
      • University of California, Davis Comprehensive Cancer Center
    • Walnut Creek, California, United States, 94598
      • Contra Costa Oncology
    • Walnut Creek, California, United States, 94598
      • John Muir Health Gynecologic Cancer Services
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando
    • St. Petersburg, Florida, United States, 33701
      • Women's Cancer Florida/Women's Cancer Associates
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer & Research Pavilion at St. Joseph's Candler
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queens Medical Center
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children/University of Hawaii
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Women's Cancer Care/Mary Bird Perkins Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
    • Farmington, Massachusetts, United States, 01702
      • MetroWest Medical Center
    • Lowell, Massachusetts, United States, 01854
      • Lowell General Hospital
    • Stoneham, Massachusetts, United States, 02180
      • Tufts Medical Center Cancer Center in Stoneham
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • St. Joseph Mercy Hospital
    • Lansing, Michigan, United States, 48219
      • Sparrow Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology - Mercy Hospital
    • Edina, Minnesota, United States, 55435
      • Minnesota Oncology Hematology
    • Maple Grove, Minnesota, United States, 55369
      • University of Minnesota Health - Maple Grove Clinic
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Frauenshuh Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota Community Oncology Research Consortium
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Oncology Hematology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Portsmouth Regional Hospital
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
    • Paramus, New Jersey, United States, 07450
      • The Valley Hospital (Valley Health)
  • New York
    • Albany, New York, United States, 12208
      • Womens Cancer Care Associates
    • Lake Success, New York, United States, 10019
      • Mount Sinai - PRIME
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10011
      • Mount Sinai The Blavatnik Family Chelsea Medical Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center PRIME
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Raleigh, North Carolina, United States, 27607
      • Duke Women's Cancer Care Raleigh
  • Ohio
    • Chardon, Ohio, United States, 44024
      • SCC at UH Geauga Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fairview Hospital
    • Columbus, Ohio, United States, 43026
      • Ohio State University Wexner Medical Center
    • Kettering, Ohio, United States, 45429
      • Grandview Medical Center/Kettering Medical Center
    • Mayfield Heights, Ohio, United States, 44124
      • Cleveland Clinic Hillcrest Hospital
    • Orange, Ohio, United States, 44122
      • UH Minoff Health Center - Seidman
    • Westlake, Ohio, United States, 44145
      • SCC at St. John's Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialist and Research Institution, LLC
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Institute and Research Center
    • Portland, Oregon, United States, 97227
      • Northwest Cancer Specialists, P.C.-Portland-Rose Quarter
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15237-9643
      • UPMC Hillman Cancer Center at UPMC Passavant
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital of Rhode Island
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Research/USD-Sioux Falls
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology, P.A. - Austin
    • Dallas, Texas, United States, 75231
      • Texas Oncology, P.A.
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology, P.A. - Fort Worth
    • Houston, Texas, United States, 77030
      • Memorial Herman Hospital
    • San Antonio, Texas, United States, 78240
      • Texas Oncology San Antonio Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health Systems
    • Fairfax, Virginia, United States, 21055
      • Virginia Cancer Specialists
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates - Hampton
    • Richmond, Virginia, United States, 23298
      • VCU Massey Cancer Center
    • Roanoke, Virginia, United States, 24106
      • Carilion Clinic Gynecological Oncology
  • Washington
    • Auburn, Washington, United States, 98001
      • MultiCare Regional Cancer Center - Auburn
    • Gig Harbor, Washington, United States, 98335
      • MultiCare Regional Cancer Center-Gig Harbor Medical Park
    • Puyallup, Washington, United States, 98372
      • MultiCare Institute for Research and Innovation
    • Tacoma, Washington, United States, 98405
      • MultiCare Regional Cancer Center - Tacoma
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 less than 1 cm in diameter, or R0, microscopic or no evidence of tumor). Assessment of debulking surgery will be determined at the time of the surgical procedure, not by post-surgical imaging.

   1. For Cohort 1, subject will undergo primary debulking surgery. Subject must receive initial dose of paclitaxel 175 mg/m^2 given intravenously and carboplatin AUC 6 IV every 3 weeks for 6 cycles. Carboplatin total dose given as 5 consecutive daily pulse doses, for subjects who experiences significant grade 3 or higher emesis. Subsequent dose modifications will be instituted per protocol. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery
   2. For Cohort 2, subject will undergo interval debulking surgery (IDS). Prior to IDS, subjects must have receive 3 cycles of paclitaxel and carboplatin as neoadjuvant treatment. After IDS, subjects must receive paclitaxel 175 mg/m^2 IV and carboplatin AUC 5-6 IV every 3 weeks, starting cycle 4. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after IDS.
5. Suitable venous access for the study-required procedures
6. Preoperative serum CA-125 levels ≥ 50 U/mL for Cohort 1, serum CA-125 levels ≥ 50 U/mL prior to first neoadjuvant chemotherapy for Cohort 2.

7. Adequate bone marrow function:

   1. Absolute neutrophil count (ANC) ≥ 1,500/µL
   2. Platelets ≥ 100,000/µL
8. Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).

9. 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

10. Adequate renal function:

    a. Creatinine ≤ 1.5 times ULN

11. ECOG Performance Status of 0 or 1.
12. For women of childbearing potential, must be willing to avoid pregnancy by using highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment as defined per protocol. Belgium and South Korea only: Use of a highly effective method of contraception from 28 days before first dose.
13. Signed informed consent and authorization permitting release of personal health information.
14. Willingness and ability to complete patient quality of life questionnaires.

Exclusion Criteria:

1. BRCA1 or BRCA2 germline gene mutation test result with:

   1. Pathogenic, ambiguous or inconclusive result available within 28 days prior to starting study treatment (subjects with BRCA1 or BRCA 2 variants of uncertain significance can enroll onto the study as long as there is no intent to administer PARP inhibitors for front-line maintenance therapy), or
   2. Known BRCA1 and BRCA2 somatic mutations, if testing is performed
2. Known Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy. Subjects with somatic HRD are eligible as long as there is no intent to administer PARP inhibitor front-line maintenance therapy.
3. Subjects with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine features and low-grade adenocarcinoma.
4. 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).
5. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
6. 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.
7. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
8. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
9. 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.)
10. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
11. Clinically significant active infection(s) at the time of screening.

12. Any of the following conditions (on-study testing is not required unless it is required by a specific participating country):

    1. Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
    2. Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or
    3. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
13. Uncontrolled or life-threatening diseases compromising safety evaluation.
14. Diagnosed or treated for another malignancy within 5 years before the first dose, or previously diagnosed with another malignancy and have any evidence of residual disease including ductal carcinoma in situ of the breast. Subjects with non-melanoma skin cancer, other carcinoma in situ if have undergone complete resection or cervix carcinoma in situ are not excluded if they have undergone complete resection. Synchronous endometrial and prior diagnosis of endometrial cancer within 5 years is not excluded if all of the following conditions are met: Stage IA, superficial myometrial invasion, without lymphovascular invasion, and not poorly differentiated subtypes including papillary serous, clear cell lesions.
15. Contraindications to the use of pressor agents.
16. Undergone more than one surgical debulking or have not recovered from surgery.
17. Anticipated treatment with any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any investigational agent(s) during the study.
18. History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.

19. Any of the following cardiovascular conditions:

    1. Acute myocardial infarction within 6 months before the first dose of study treatment.
    2. Current history of New York Heart Association (NYHA) Class III or IV heart failure.
    3. Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
20. Unable to read or understand or unable to sign the necessary written consent before starting treatment.
21. May not receive any live, attenuated vaccine administered within 28 days (or 4 weeks) prior to enrollment, during the study, and for at least 90 days after the last dose of study treatment.
22. Subjects who receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any other investigational agent(s) with 3 cycles of paclitaxel and carboplatin neoadjuvant treatment prior to IDS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Drug: Carboplatin; AUC 5-6 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; Drug: Carboplatin; AUC 5-6 IV Day 1 x 6 cycles (every 21 days); Other Names: Paraplatin
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; Drug: Carboplatin; AUC 5-6 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; Drug: Carboplatin; AUC 5-6 IV Day 1 x 6 cycles (every 21 days); Other Names: Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Assessed Progression Free Survival	Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death	Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 6 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Date of randomization to the date of death	Date of randomization up until date of death from any cause, up to approximately 11 years
Safety and Tolerability	Incidence of adverse events (AEs) leading to discontinuation of treatment, frequency/severity of vital signs measurements, physical examination findings, and changes in clinical laboratory parameters	Date of randomization up until date of discontinuation of treatment, date of significant physical examination changes, date of significant clinical changes, up to approximately 6 years
Change in Quality of Life	Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O TOI); Three additional questions from the NFOSI-18 in each treatment group	Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy by times to subsequent therapies and time to next progression	Tumor response measurement by iRECIST; Time to First Subsequent Therapy (TFST), defined as tie form the date of randomization to first subsequent anti-cancer therapy or death; Time to Second Subsequent Therapy, defined as time from the date of randomization to second anti-cancer therapy start date or death; Progression Free Survival 2, defined from the date of randomization to the first documented progression on next-line therapy or death.	Date of randomization, until date of subsequent therapy or death, or up to approximately 6 years
Potential Biomarkers	Human Anti-Mouse Antibody (HAMA); HAMA interference-free CA-125; Neutrophil + Monocyte to Lymphocyte Ratio (NMLR); Phenotyping or immune subsets, including myeloid-derived suppressor cells (MDSC); Functional assessment of CD4+ and CD8+ T-cells with a focus on measuring the number and frequency of INF-y-producing CD8+ T-cells using flow cytometry	Date of randomization, until date of discontinuation, or up to approximately 6 years

Collaborators and Investigators

• Sponsor: CanariaBio Inc.
• Collaborators: Gynecologic Oncology Group; IQVIA Pty Ltd
• Investigators: Study Director: Sunil Gupta, MD, FRCPC, CanariaBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): August 26, 2028

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Peritoneal Diseases; Abdominal Neoplasms; Fallopian Tube Diseases; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Carboplatin; Paclitaxel; oregovomab
• Other Study ID Numbers: QPT-ORE-005; GOG-3035 (Other Identifier: Gynecologic Oncology Group); FLORA-5 (Other Identifier: CanariaBio Inc.); FLORA5 (Other Identifier: CanariaBio Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No