Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Ovarian Cancer
About this trial
This is an interventional treatment trial for Carcinoma, Ovarian Epithelial
Eligibility Criteria
Major 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:
a. Creatinine less than or equal to1.5 times ULN
- ECOG Performance Status of 0 or 1.
Major 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.
Sites / Locations
- Honor Health
- The University of Arizona Cancer Center
- John Muir Health Clinical Research Center
- Kaiser Permanente Southern California
- Moores UC San Diego Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- Epic Care
- Kaiser Permanente Riverside Medical Center
- University of California, Davis Comprehensive Cancer Center
- Contra Costa Oncology
- John Muir Health Gynecologic Cancer Services
- University of Colorado Health
- University of Connecticut Health Center
- Smilow Cancer Hospital
- Yale University School of Medicine
- AdventHealth Orlando
- Women's Cancer Florida/Women's Cancer Associates
- Lewis Cancer & Research Pavilion at St. Joseph's Candler
- The Queens Medical Center
- Kapiolani Medical Center for Women and Children/University of Hawaii
- Parkview Research Center
- Women's Cancer Care/Mary Bird Perkins Cancer Center
- Tufts Medical Center
- Lahey Hospital and Medical Center
- MetroWest Medical Center
- Lowell General Hospital
- Tufts Medical Center Cancer Center in Stoneham
- UMass Memorial Medical Center
- St. Joseph Mercy Hospital
- Sparrow Hospital
- Minnesota Oncology Hematology - Mercy Hospital
- Minnesota Oncology Hematology
- University of Minnesota Health - Maple Grove Clinic
- Minnesota Oncology Hematology
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Frauenshuh Cancer Center
- Minnesota Oncology Hematology
- Nebraska Methodist Hospital
- Portsmouth Regional Hospital
- Rutgers Cancer Institute of New Jersey
- The Valley Hospital (Valley Health)
- Womens Cancer Care Associates
- Montefiore Medical Center PRIME
- Mount Sinai - PRIME
- Mount Sinai The Blavatnik Family Chelsea Medical Center
- Icahn School of Medicine at Mount Sinai
- Stony Brook University Hospital
- Duke University
- Duke Women's Cancer Care Raleigh
- SCC at UH Geauga Medical Center
- University Hospitals of Cleveland
- Cleveland Clinic Fairview Hospital
- Cleveland Clinic
- Ohio State University Wexner Medical Center
- Grandview Medical Center/Kettering Medical Center
- Cleveland Clinic Hillcrest Hospital
- UH Minoff Health Center - Seidman
- SCC at St. John's Medical Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialist and Research Institution, LLC
- Willamette Valley Cancer Institute and Research Center
- Northwest Cancer Specialists, P.C.-Portland-Rose Quarter
- Magee Women's Hospital of UPMC
- Western Pennsylvania Hospital
- UPMC Hillman Cancer Center at UPMC Passavant
- Women & Infants Hospital of Rhode Island
- Sanford Research/USD-Sioux Falls
- Texas Oncology, P.A. - Austin
- Texas Oncology, P.A.
- Texas Oncology, P.A. - Fort Worth
- Memorial Herman Hospital
- Texas Oncology San Antonio Medical Center
- University of Virginia Health Systems
- Virginia Cancer Specialists
- Virginia Oncology Associates - Hampton
- VCU Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- MultiCare Regional Cancer Center - Auburn
- MultiCare Regional Cancer Center-Gig Harbor Medical Park
- MultiCare Institute for Research and Innovation
- MultiCare Regional Cancer Center - Tacoma
- University of Wisconsin
- CEMAIC - Centro Medico Privado
- Clínica Universitaria Privada Reina Fabiola
- Sanatorio de la Mujer
- Sanatorio Parque S.A
- CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
- Clinicas Viedma S.A.
- ZNA Middelheim
- Cliniques Universitaires Saint-Luc
- Clinique CHC MontLégia
- Centro de Pesquisas Clinica Reichow
- Oncosite - Centro de Pesquisa Clinica e Oncologia
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
- Fundação Doutor Amaral Carvalho
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
- Clínica São Germano - Oncologia
- Queen Elizabeth II Health Sciences Centre
- City of Health Hospital at Laval (Cité de la Santé de Laval)
- CHUM Centre de Recherche (affiliated with University of Montreal)
- McGill University Health Centre/Glen Site/ Royal Victoria Hospital
- Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal
- CHUS - Hôpital Fleurimont
- Centro de Investigación Clínica Bradford Hill
- Sociedad de Investigaciones Medicas Limitada
- Fakultni nemocnice Hradec Kralove
- Fakultni nemocnice Olomouc
- Fakultni nemocnice Kralovske Vinohrady
- Fakultni nemocnice Bulovka
- Fakultni nemocnice v Motole
- Vseobecna fakultni nemocnice v Praze
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
- Magyar Honvedseg Egeszsegugyi Kozpont
- Szent Margit Korhaz
- Debreceni Egyetem
- Bacs-Kiskun Megyei Oktatokorhaz
- Zala Megyei Szent Rafael Korhaz
- Fortis Hospital Ltd
- Fortis Hospital Ltd
- All India Institute of Medical Services
- Max Super Specialty Hospital
- Sushrut Hospital
- Fortis Hospital
- Deenanath Mangeshkar Hospital
- Ruby Hall Clinic
- Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Università Campus Bio-Medico di Roma
- National Cancer Center
- Seoul National University Bundang Hospital
- Asan Medical Center
- Korea Univ Anam Hsp
- Korea University Guro Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Severance Hospital Yonsei University Health System
- Clinical Medical Research S.C.
- Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)
- Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
- SMIQ S. de R.L. de C.V.
- Centro Potosino de Investigación Medica S.C.
- Hospital Clinic de Barcelona
- Hospital Universitari Vall d'Hebron
- Hospital de la Santa Creu i Sant Pau
- ICO l'Hospitalet-Hospital Duran i Reynals
- H.U. Fundacion Jimenez Diaz
- Hospital Universitario Virgen Macarena
- Instituto Valenciano de Oncologia IVO
- Taipei Veterans General Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Cohort 1- Surgery Active
Cohort 1 - Primary Surgery Control
Cohort 2 - NACT + Interval Surgery Active
Cohort 2 - NACT + Interval Surgery Control
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).
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).
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).
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).