AzTrials
AzTrials

Carcinoma, Ovarian EpithelialPhase 3FLORA-5NCT04498117

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

A Phase 3 study testing Oregovomab, Paclitaxel and Carboplatin in people with Carcinoma, Ovarian Epithelial and Ovarian Neoplasms, run by CanariaBio Inc. at 148 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Oregovomab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
615 participants
Where
148 sitesin 14 countries
Study dates
25 Aug 2020to 26 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Adequate renal function:
  • Creatinine ≤ 1.5 times ULN
  • ECOG Performance Status of 0 or 1.
  • 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.
  • Signed informed consent and authorization permitting release of personal health information.
  • Willingness and ability to complete patient quality of life questionnaires.

Who cannot join

  • 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).
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  • 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
  • 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
  • Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
  • Uncontrolled or life-threatening diseases compromising safety evaluation.
  • 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.
  • Contraindications to the use of pressor agents.
  • Undergone more than one surgical debulking or have not recovered from surgery.
  • Anticipated treatment with any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any investigational agent(s) during the study.
  • History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.
  • Any of the following cardiovascular conditions:
  • Acute myocardial infarction within 6 months before the first dose of study treatment.
  • Current history of New York Heart Association (NYHA) Class III or IV heart failure.
  • Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
  • Unable to read or understand or unable to sign the necessary written consent before starting treatment.
  • 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.
  • 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.

Trial locations and contacts

148 sites in 14 countries.

148 sites in 14 countries

United States81 sites

  • Womens Cancer Care Associates

    Albany, New York, 12208

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98001

  • University of Colorado Health

    Aurora, Colorado, 80045

  • Texas Oncology, P.A. - Austin

    Austin, Texas, 78731

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • SCC at UH Geauga Medical Center

    Chardon, Ohio, 44024

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22903

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43026

  • John Muir Health Clinical Research Center

    Concord, California, 94520

  • Minnesota Oncology Hematology - Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Women's Cancer Care/Mary Bird Perkins Cancer Center

    Covington, Louisiana, 70433

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • Duke University

    Durham, North Carolina, 27710

  • Minnesota Oncology Hematology

    Edina, Minnesota, 55435

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 21055

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • MetroWest Medical Center

    Farmington, Massachusetts, 01702

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • MultiCare Regional Cancer Center-Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • The Queens Medical Center

    Honolulu, Hawaii, 96813

  • Kapiolani Medical Center for Women and Children/University of Hawaii

    Honolulu, Hawaii, 96826

  • Memorial Herman Hospital

    Houston, Texas, 77030

  • Kaiser Permanente Southern California

    Irvine, California, 92120

  • Grandview Medical Center/Kettering Medical Center

    Kettering, Ohio, 45429

  • Moores UC San Diego Cancer Center

    La Jolla, California, 92093

  • Mount Sinai - PRIME

    Lake Success, New York, 10019

  • Sparrow Hospital

    Lansing, Michigan, 48219

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Minnesota Health - Maple Grove Clinic

    Maple Grove, Minnesota, 55369

  • Cleveland Clinic Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Smilow Cancer Hospital

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Mount Sinai The Blavatnik Family Chelsea Medical Center

    New York, New York, 10011

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Virginia Oncology Associates - Hampton

    Norfolk, Virginia, 23502

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • UH Minoff Health Center - Seidman

    Orange, Ohio, 44122

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • The Valley Hospital (Valley Health)

    Paramus, New Jersey, 07450

  • Honor Health

    Phoenix, Arizona, 85016

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • UPMC Hillman Cancer Center at UPMC Passavant

    Pittsburgh, Pennsylvania, 15237-9643

  • Epic Care

    Pleasant Hill, California, 94523

  • Northwest Cancer Specialists, P.C.-Portland-Rose Quarter

    Portland, Oregon, 97227

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • MultiCare Institute for Research and Innovation

    Puyallup, Washington, 98372

  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27607

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 95505

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24106

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota, 55102

  • Texas Oncology San Antonio Medical Center

    San Antonio, Texas, 78240

  • Lewis Cancer & Research Pavilion at St. Joseph's Candler

    Savannah, Georgia, 31405

  • Sanford Research/USD-Sioux Falls

    Sioux Falls, South Dakota, 57104

  • Women's Cancer Florida/Women's Cancer Associates

    St. Petersburg, Florida, 33701

  • Tufts Medical Center Cancer Center in Stoneham

    Stoneham, Massachusetts, 02180

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • MultiCare Regional Cancer Center - Tacoma

    Tacoma, Washington, 98405

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10461

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Oklahoma Cancer Specialist and Research Institution, LLC

    Tulsa, Oklahoma, 74146

  • Contra Costa Oncology

    Walnut Creek, California, 94598

  • John Muir Health Gynecologic Cancer Services

    Walnut Creek, California, 94598

  • SCC at St. John's Medical Center

    Westlake, Ohio, 44145

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

South Korea9 sites

  • National Cancer Center

    Goyang

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

  • Severance Hospital Yonsei University Health System

    Soeul

Other trials in South Korea

India8 sites

  • Fortis Hospital Ltd

    Bangalore

  • Fortis Hospital Ltd

    Bengaluru

  • All India Institute of Medical Services

    Delhi

  • Max Super Specialty Hospital

    Mohali

  • Sushrut Hospital

    Mumbai

  • Fortis Hospital

    Noida

  • Deenanath Mangeshkar Hospital

    Pune

  • Ruby Hall Clinic

    Pune

Other trials in India

Argentina6 sites

  • CEMAIC - Centro Medico Privado

    Córdoba, Córdoba Province, 2941

  • Clínica Universitaria Privada Reina Fabiola

    Córdoba, Córdoba Province

  • Sanatorio de la Mujer

    Rosario, Rosario, 2000

  • Sanatorio Parque S.A

    Salta, Salta Province, 4400

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    San Juan

  • Clinicas Viedma S.A.

    Viedma, R8500

Other trials in Argentina

Brazil6 sites

  • Centro de Pesquisas Clinica Reichow

    Blumenau

  • Oncosite - Centro de Pesquisa Clinica e Oncologia

    Guimarães

  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus

    Porto Alegre

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André

  • Clínica São Germano - Oncologia

    São Paulo

  • Fundação Doutor Amaral Carvalho

    São Paulo

Other trials in Brazil

Canada5 sites

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • City of Health Hospital at Laval (Cité de la Santé de Laval)

    Laval, Quebec, H7M 3L9

  • CHUM Centre de Recherche (affiliated with University of Montreal)

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre/Glen Site/ Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Czechia5 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Bulovka

    Prague

  • Fakultni nemocnice Kralovske Vinohrady

    Prague

  • Fakultni nemocnice v Motole

    Prague

  • Vseobecna fakultni nemocnice v Praze

    Prague

Other trials in Czechia

Hungary5 sites

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest

  • Debreceni Egyetem

    Debrecen

  • Bacs-Kiskun Megyei Oktatokorhaz

    Kecskemét

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg

Other trials in Hungary

Mexico5 sites

  • Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)

    La Paz, 23040

  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey

  • Clinical Medical Research S.C.

    Orizaba, Veracruz

  • SMIQ S. de R.L. de C.V.

    Querétaro

  • Centro Potosino de Investigación Medica S.C.

    San Luis Potosí City

Other trials in Mexico

Spain5 sites

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalonia

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • ICO l'Hospitalet-Hospital Duran i Reynals

    L'Hospitalet de Llobregat

  • Instituto Valenciano de Oncologia IVO

    Valencia

Other trials in Spain

Taiwan5 sites

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei

  • Taipei Veterans General Hospital

    Taipei County, Taipei

Other trials in Taiwan

Belgium3 sites

  • ZNA Middelheim

    Antwerp

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Clinique CHC MontLégia

    Liège

Other trials in Belgium

Italy3 sites

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Rome, 00168

  • Università Campus Bio-Medico di Roma

    Rome

Other trials in Italy

Chile2 sites

  • Centro de Investigación Clínica Bradford Hill

    Santiago

  • Sociedad de Investigaciones Medicas Limitada

    Temuco

Other trials in Chile

About this study

Official title: 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.

Read the 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).

Being tested
Oregovomab, Paclitaxel, Carboplatin, Placebo
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OregovomabBiological

    Also called MAb-B43.13

    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

  • PaclitaxelDrug

    Also called Taxol

    175 mg/m^2, every 3 weeks

  • CarboplatinDrug

    Also called Paraplatin

    AUC 6 IV Day 1 x 6 cycles (every 21 days)

  • PlaceboBiological

    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

  • CarboplatinDrug

    Also called Paraplatin

    AUC 5-6 IV Day 1 x 6 cycles (every 21 days)

Study groups in NCT04498117
Study groupRoleWhat they receive
Cohort 1- Surgery ActiveExperimentalSix (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).
Receives: Biological: Oregovomab; Drug: Paclitaxel; Drug: Carboplatin
Cohort 1 - Primary Surgery ControlPlacebo 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).
Receives: Drug: Paclitaxel; Drug: Carboplatin; Biological: Placebo
Cohort 2 - NACT + Interval Surgery ActiveExperimentalIn 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).
Receives: Biological: Oregovomab; Drug: Paclitaxel; Drug: Carboplatin
Cohort 2 - NACT + Interval Surgery ControlPlacebo 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).
Receives: Drug: Paclitaxel; Biological: Placebo; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Overall Survival

    Date of randomization to the date of death

    Measured: Date of randomization up until date of death from any cause, up to approximately 11 years

  2. 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

    Measured: 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

  3. Change in Quality of Life

    1. Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O TOI)
    2. Three additional questions from the NFOSI-18 in each treatment group

    Measured: Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start25 Aug 2020
  3. Primary completion26 Dec 2026 (estimated)
  4. Study completion26 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
615 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04498117
Sponsor's protocol ID
QPT-ORE-005
Other IDs
GOG-3035, FLORA-5, FLORA5
Acronym
FLORA-5
Status last verified
Mar 2026
First submitted
28 Jul 2020
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oregovomab, Paclitaxel and Carboplatin in people with Carcinoma, Ovarian Epithelial and Ovarian Neoplasms, run by CanariaBio Inc. at 148 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, South Korea, India, Argentina, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator Assessed Progression Free Survival (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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