Ovarian cancer hope: new antibody combo aims to delay disease worsening

NCT ID NCT04498117

Disease control Sponsor: CanariaBio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding an experimental antibody called oregovomab to standard chemotherapy (paclitaxel and carboplatin) helps people with newly diagnosed advanced ovarian cancer live longer without their cancer getting worse. About 615 participants who had surgery to remove as much cancer as possible will receive either the antibody or a placebo alongside chemo. The study is active but no longer recruiting, and results are expected to show if the combination is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: oregovomab (an experimental antibody) plus standard chemotherapy (paclitaxel and carboplatin)
What this could lead to: If it works, this could give people with advanced ovarian cancer more time before their disease gets worse, without needing lifelong medication.
What could go wrong: This is an early-stage Phase 3 trial, so results are not yet known. The added antibody may not improve outcomes over chemo alone, and could cause extra side effects like infusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

615 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ovarian Epithelial fallopian tube adenocarcinoma fallopian tube cancer fallopian tube carcinoma fallopian tube neoplasm fallopian tube serous adenocarcinoma ovarian cancer ovarian carcinoma ovarian epithelial tumor ovarian neoplasm ovarian serous adenocarcinoma peritoneal carcinoma peritoneal neoplasm peritoneum cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, ovarian epithelial Fallopian tube adenocarcinoma Fallopian tube neoplasms Fallopian tube serous adenocarcinoma Ovarian cancer Ovarian neoplasms Ovarian serous adenocarcinoma Peritoneal cancer Peritoneal carcinoma Peritoneal neoplasms

Contacts and locations

Locations

AdventHealth Orlando

Orlando, Florida, 32804, United States
All India Institute of Medical Services

Delhi, India
Asan Medical Center

Seoul, South Korea
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Monza, Italy
Bacs-Kiskun Megyei Oktatokorhaz

Kecskemét, Hungary
CEMAIC - Centro Medico Privado

Córdoba, Córdoba Province, 2941, Argentina
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, Brazil
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

San Juan, Argentina
CHUM Centre de Recherche (affiliated with University of Montreal)

Montreal, Quebec, H2X 3E4, Canada
CHUS - Hôpital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada
Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24106, United States
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus

Porto Alegre, Brazil
Centro Potosino de Investigación Medica S.C.

San Luis Potosí City, Mexico
Centro de Investigación Clínica Bradford Hill

Santiago, Chile
Centro de Pesquisas Clinica Reichow

Blumenau, Brazil
City of Health Hospital at Laval (Cité de la Santé de Laval)

Laval, Quebec, H7M 3L9, Canada
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States
Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States
Clinical Medical Research S.C.

Orizaba, Veracruz, Mexico
Clinicas Viedma S.A.

Viedma, R8500, Argentina
Clinique CHC MontLégia

Liège, Belgium
Cliniques Universitaires Saint-Luc

Brussels, Belgium
Clínica São Germano - Oncologia

São Paulo, Brazil
Clínica Universitaria Privada Reina Fabiola

Córdoba, Córdoba Province, Argentina
Contra Costa Oncology

Walnut Creek, California, 94598, United States
Debreceni Egyetem

Debrecen, Hungary
Deenanath Mangeshkar Hospital

Pune, India
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary
Duke University

Durham, North Carolina, 27710, United States
Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States
Epic Care

Pleasant Hill, California, 94523, United States
Fakultni nemocnice Bulovka

Prague, Czechia
Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia
Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia
Fakultni nemocnice v Motole

Prague, Czechia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Rome, 00168, Italy
Fortis Hospital

Noida, India
Fortis Hospital Ltd

Bangalore, India
Fortis Hospital Ltd

Bengaluru, India
Fundação Doutor Amaral Carvalho

São Paulo, Brazil
Grandview Medical Center/Kettering Medical Center

Kettering, Ohio, 45429, United States
Honor Health

Phoenix, Arizona, 85016, United States
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
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Instituto Valenciano de Oncologia IVO

Valencia, Spain
Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)

La Paz, 23040, Mexico
John Muir Health Clinical Research Center

Concord, California, 94520, United States
John Muir Health Gynecologic Cancer Services

Walnut Creek, California, 94598, United States
Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
Kaiser Permanente Riverside Medical Center

Riverside, California, 95505, United States
Kaiser Permanente Southern California

Irvine, California, 92120, United States
Kapiolani Medical Center for Women and Children/University of Hawaii

Honolulu, Hawaii, 96826, United States
Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan
Korea University Guro Hospital

Seoul, South Korea
Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States
Lewis Cancer & Research Pavilion at St. Joseph's Candler

Savannah, Georgia, 31405, United States
Lowell General Hospital

Lowell, Massachusetts, 01854, United States
Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States
Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary
Max Super Specialty Hospital

Mohali, India
McGill University Health Centre/Glen Site/ Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada
Memorial Herman Hospital

Houston, Texas, 77030, United States
Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States
MetroWest Medical Center

Farmington, Massachusetts, 01702, United States
Minnesota Oncology Hematology

Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology

Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology - Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Montefiore Medical Center PRIME

The Bronx, New York, 10461, United States
Moores UC San Diego Cancer Center

La Jolla, California, 92093, 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
MultiCare Institute for Research and Innovation

Puyallup, Washington, 98372, United States
MultiCare Regional Cancer Center - Auburn

Auburn, Washington, 98001, United States
MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, 98405, United States
MultiCare Regional Cancer Center-Gig Harbor Medical Park

Gig Harbor, Washington, 98335, United States
National Cancer Center

Goyang, South Korea
National Cheng Kung University Hospital

Tainan, 70457, Taiwan
National Taiwan University Hospital

Taipei, Taiwan, Taiwan
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
Northwest Cancer Specialists, P.C.-Portland-Rose Quarter

Portland, Oregon, 97227, United States
Ohio State University Wexner Medical Center

Columbus, Ohio, 43026, United States
Oklahoma Cancer Specialist and Research Institution, LLC

Tulsa, Oklahoma, 74146, United States
Oncosite - Centro de Pesquisa Clinica e Oncologia

Guimarães, Brazil
Park Nicollet Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States
Parkview Research Center

Fort Wayne, Indiana, 46845, United States
Portsmouth Regional Hospital

Portsmouth, New Hampshire, 03801, United States
Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada
Ruby Hall Clinic

Pune, India
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
SCC at St. John's Medical Center

Westlake, Ohio, 44145, United States
SCC at UH Geauga Medical Center

Chardon, Ohio, 44024, United States
SMIQ S. de R.L. de C.V.

Querétaro, Mexico
Samsung Medical Center

Seoul, South Korea
Sanatorio Parque S.A

Salta, Salta Province, 4400, Argentina
Sanatorio de la Mujer

Rosario, Rosario, 2000, Argentina
Sanford Research/USD-Sioux Falls

Sioux Falls, South Dakota, 57104, United States
Seoul National University Bundang Hospital

Seongnam, South Korea
Seoul National University Hospital

Seoul, South Korea
Severance Hospital Yonsei University Health System

Soeul, South Korea
Severance Hospital, Yonsei University Health System

Seoul, South Korea
Smilow Cancer Hospital

New Haven, Connecticut, 06510, United States
Sociedad de Investigaciones Medicas Limitada

Temuco, Chile
Sparrow Hospital

Lansing, Michigan, 48219, United States
St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States
Stony Brook University Hospital

Stony Brook, New York, 11794, United States
Sushrut Hospital

Mumbai, India
Taichung Veterans General Hospital

Taichung, Taiwan
Taipei Veterans General Hospital

Taipei County, Taipei, Taiwan
Texas Oncology San Antonio Medical Center

San Antonio, Texas, 78240, United States
Texas Oncology, P.A.

Dallas, Texas, 75231, United States
Texas Oncology, P.A. - Austin

Austin, Texas, 78731, United States
Texas Oncology, P.A. - Fort Worth

Fort Worth, Texas, 76104, United States
The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea
The Queens Medical Center

Honolulu, Hawaii, 96813, United States
The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States
The Valley Hospital (Valley Health)

Paramus, New Jersey, 07450, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
Tufts Medical Center Cancer Center in Stoneham

Stoneham, Massachusetts, 02180, United States
UH Minoff Health Center - Seidman

Orange, Ohio, 44122, United States
UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States
UPMC Hillman Cancer Center at UPMC Passavant

Pittsburgh, Pennsylvania, 15237-9643, United States
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Mexico
University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States
University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Colorado Health

Aurora, Colorado, 80045, United States
University of Connecticut Health Center

Farmington, Connecticut, 06030, United States
University of Minnesota Health - Maple Grove Clinic

Maple Grove, Minnesota, 55369, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Virginia Health Systems

Charlottesville, Virginia, 22903, United States
University of Wisconsin

Madison, Wisconsin, 53792, United States
Università Campus Bio-Medico di Roma

Rome, Italy
VCU Massey Cancer Center

Richmond, Virginia, 23298, United States
Virginia Cancer Specialists

Fairfax, Virginia, 21055, United States
Virginia Oncology Associates - Hampton

Norfolk, Virginia, 23502, United States
Vseobecna fakultni nemocnice v Praze

Prague, Czechia
Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States
Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States
Women's Cancer Care/Mary Bird Perkins Cancer Center

Covington, Louisiana, 70433, United States
Women's Cancer Florida/Women's Cancer Associates

St. Petersburg, Florida, 33701, United States
Womens Cancer Care Associates

Albany, New York, 12208, United States
Yale University School of Medicine

New Haven, Connecticut, 06510, United States
ZNA Middelheim

Antwerp, Belgium
Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Hungary

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