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
4 other identifiers
interventional
615
14 countries
148
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Longer than P75 for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 26, 2028
April 1, 2026
March 1, 2026
6.3 years
July 28, 2020
March 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Overall Survival
Date of randomization up until date of death from any cause, up to approximately 11 years
Safety and Tolerability
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
Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years
Other Outcomes (2)
Efficacy by times to subsequent therapies and time to next progression
Date of randomization, until date of subsequent therapy or death, or up to approximately 6 years
Potential Biomarkers
Date of randomization, until date of discontinuation, or up to approximately 6 years
Study Arms (4)
Cohort 1- Surgery Active
EXPERIMENTALSix (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).
Cohort 1 - Primary Surgery Control
PLACEBO COMPARATORSix (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).
Cohort 2 - NACT + Interval Surgery Active
EXPERIMENTALIn 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).
Cohort 2 - NACT + Interval Surgery Control
PLACEBO COMPARATORIn 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).
Interventions
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
175 mg/m\^2, every 3 weeks
AUC 6 IV Day 1 x 6 cycles (every 21 days)
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
Eligibility Criteria
You may qualify if:
- 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 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.
- 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
- 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.
- Suitable venous access for the study-required procedures
- 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.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 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
- +6 more criteria
You may not qualify if:
- BRCA1 or BRCA2 germline gene mutation test result with:
- 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
- Known BRCA1 and BRCA2 somatic mutations, if testing is performed
- 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.
- Subjects with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine features 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).
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- 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.
- 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.
- Clinically significant active infection(s) at the time of screening.
- Any of the following conditions (on-study testing is not required unless it is required by a specific participating country):
- Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CanariaBio Inc.lead
- Gynecologic Oncology Groupcollaborator
- Iqvia Pty Ltdcollaborator
Study Sites (148)
Honor Health
Phoenix, Arizona, 85016, United States
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
John Muir Health Clinical Research Center
Concord, California, 94520, United States
Kaiser Permanente Southern California
Irvine, California, 92120, United States
Moores UC San Diego Cancer Center
La Jolla, California, 92093, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Epic Care
Pleasant Hill, California, 94523, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, 95505, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Contra Costa Oncology
Walnut Creek, California, 94598, United States
John Muir Health Gynecologic Cancer Services
Walnut Creek, California, 94598, United States
University of Colorado Health
Aurora, Colorado, 80045, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Smilow Cancer Hospital
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
Women's Cancer Florida/Women's Cancer Associates
St. Petersburg, Florida, 33701, United States
Lewis Cancer & Research Pavilion at St. Joseph's Candler
Savannah, Georgia, 31405, United States
The Queens Medical Center
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children/University of Hawaii
Honolulu, Hawaii, 96826, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Women's Cancer Care/Mary Bird Perkins Cancer Center
Covington, Louisiana, 70433, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
MetroWest Medical Center
Farmington, Massachusetts, 01702, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Tufts Medical Center Cancer Center in Stoneham
Stoneham, Massachusetts, 02180, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Sparrow Hospital
Lansing, Michigan, 48219, United States
Minnesota Oncology Hematology - Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology
Edina, Minnesota, 55435, United States
University of Minnesota Health - Maple Grove Clinic
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426, United States
Minnesota Oncology Hematology
Saint Paul, Minnesota, 55102, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
The Valley Hospital (Valley Health)
Paramus, New Jersey, 07450, United States
Womens Cancer Care Associates
Albany, New York, 12208, United States
Mount Sinai - PRIME
Lake Success, New York, 10019, United States
Mount Sinai The Blavatnik Family Chelsea Medical Center
New York, New York, 10011, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Montefiore Medical Center PRIME
The Bronx, New York, 10461, United States
Duke University
Durham, North Carolina, 27710, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
SCC at UH Geauga Medical Center
Chardon, Ohio, 44024, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43026, United States
Grandview Medical Center/Kettering Medical Center
Kettering, Ohio, 45429, United States
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
UH Minoff Health Center - Seidman
Orange, Ohio, 44122, United States
SCC at St. John's Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialist and Research Institution, LLC
Tulsa, Oklahoma, 74146, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists, P.C.-Portland-Rose Quarter
Portland, Oregon, 97227, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
UPMC Hillman Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, 15237-9643, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Sanford Research/USD-Sioux Falls
Sioux Falls, South Dakota, 57104, United States
Texas Oncology, P.A. - Austin
Austin, Texas, 78731, United States
Texas Oncology, P.A.
Dallas, Texas, 75231, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, 76104, United States
Memorial Herman Hospital
Houston, Texas, 77030, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240, United States
University of Virginia Health Systems
Charlottesville, Virginia, 22903, United States
Virginia Cancer Specialists
Fairfax, Virginia, 21055, United States
Virginia Oncology Associates - Hampton
Norfolk, Virginia, 23502, United States
VCU Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24106, United States
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, 98001, United States
MultiCare Regional Cancer Center-Gig Harbor Medical Park
Gig Harbor, Washington, 98335, United States
MultiCare Institute for Research and Innovation
Puyallup, Washington, 98372, United States
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
CEMAIC - Centro Medico Privado
Córdoba, Córdoba Province, 2941, Argentina
Clínica Universitaria Privada Reina Fabiola
Córdoba, Córdoba Province, Argentina
Sanatorio de la Mujer
Rosario, Rosario, 2000, Argentina
Sanatorio Parque S.A
Salta, Salta Province, 4400, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, Argentina
Clinicas Viedma S.A.
Viedma, R8500, Argentina
ZNA Middelheim
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Clinique CHC MontLégia
Liège, Belgium
Centro de Pesquisas Clinica Reichow
Blumenau, Brazil
Oncosite - Centro de Pesquisa Clinica e Oncologia
Guimarães, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
Porto Alegre, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, Brazil
Clínica São Germano - Oncologia
São Paulo, Brazil
Fundação Doutor Amaral Carvalho
São Paulo, Brazil
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
City of Health Hospital at Laval (Cité de la Santé de Laval)
Laval, Quebec, H7M 3L9, Canada
CHUM Centre de Recherche (affiliated with University of Montreal)
Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre/Glen Site/ Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Centro de Investigación Clínica Bradford Hill
Santiago, Chile
Sociedad de Investigaciones Medicas Limitada
Temuco, Chile
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Bulovka
Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
Debreceni Egyetem
Debrecen, Hungary
Bacs-Kiskun Megyei Oktatokorhaz
Kecskemét, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Hungary
Fortis Hospital Ltd
Bangalore, India
Fortis Hospital Ltd
Bengaluru, India
All India Institute of Medical Services
Delhi, India
Max Super Specialty Hospital
Mohali, India
Sushrut Hospital
Mumbai, India
Fortis Hospital
Noida, India
Deenanath Mangeshkar Hospital
Pune, India
Ruby Hall Clinic
Pune, India
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, 00168, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, Italy
Università Campus Bio-Medico di Roma
Rome, Italy
Clinical Medical Research S.C.
Orizaba, Veracruz, Mexico
Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)
La Paz, 23040, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Mexico
SMIQ S. de R.L. de C.V.
Querétaro, Mexico
Centro Potosino de Investigación Medica S.C.
San Luis Potosí City, Mexico
National Cancer Center
Goyang, South Korea
Seoul National University Bundang Hospital
Seongnam, 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
Seoul, South Korea
Severance Hospital Yonsei University Health System
Soeul, South Korea
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
ICO l'Hospitalet-Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Instituto Valenciano de Oncologia IVO
Valencia, Spain
Taipei Veterans General Hospital
Taipei County, Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, 70457, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sunil Gupta, MD, FRCPC
CanariaBio Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
August 4, 2020
Study Start
August 25, 2020
Primary Completion (Estimated)
December 26, 2026
Study Completion (Estimated)
August 26, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share