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NCT04498117

PHASE3

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

Sponsor: CanariaBio Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

615

Start Date

2020-08-25

Completion Date

2028-08-26

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Carcinoma, Ovarian Epithelial Ovarian Neoplasms Ovarian Cancer Ovarian Serous Adenocarcinoma Fallopian Tube Neoplasms Fallopian Tube Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Peritoneal Cancer Peritoneal Carcinoma Peritoneal Neoplasms

Interventions

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

DRUG

Paclitaxel

175 mg/m\^2, every 3 weeks

DRUG

Carboplatin

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

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)

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.

Locations (148)

Honor Health

Phoenix, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

John Muir Health Clinical Research Center

Concord, California, United States

Kaiser Permanente Southern California

Irvine, California, United States

Moores UC San Diego Cancer Center

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Epic Care

Pleasant Hill, California, United States

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

Contra Costa Oncology

Walnut Creek, California, United States

John Muir Health Gynecologic Cancer Services

Walnut Creek, California, United States

University of Colorado Health

Aurora, Colorado, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Smilow Cancer Hospital

New Haven, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

AdventHealth Orlando

Orlando, Florida, United States

Women's Cancer Florida/Women's Cancer Associates

St. Petersburg, Florida, United States

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

Savannah, Georgia, United States

The Queens Medical Center

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children/University of Hawaii

Honolulu, Hawaii, United States

Parkview Research Center

Fort Wayne, Indiana, United States

Women's Cancer Care/Mary Bird Perkins Cancer Center

Covington, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

MetroWest Medical Center

Farmington, Massachusetts, United States

Lowell General Hospital

Lowell, Massachusetts, United States

Tufts Medical Center Cancer Center in Stoneham

Stoneham, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Sparrow Hospital

Lansing, Michigan, United States

Minnesota Oncology Hematology - Mercy Hospital

Coon Rapids, Minnesota, United States

Minnesota Oncology Hematology

Edina, Minnesota, United States

University of Minnesota Health - Maple Grove Clinic

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Park Nicollet Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

Minnesota Oncology Hematology

Saint Paul, Minnesota, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The Valley Hospital (Valley Health)

Paramus, New Jersey, United States

Womens Cancer Care Associates

Albany, New York, United States

Mount Sinai - PRIME

Lake Success, New York, United States

Mount Sinai The Blavatnik Family Chelsea Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Montefiore Medical Center PRIME

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, United States

SCC at UH Geauga Medical Center

Chardon, Ohio, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Grandview Medical Center/Kettering Medical Center

Kettering, Ohio, United States

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, United States

UH Minoff Health Center - Seidman

Orange, Ohio, United States

SCC at St. John's Medical Center

Westlake, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialist and Research Institution, LLC

Tulsa, Oklahoma, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

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

Portland, Oregon, United States

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center at UPMC Passavant

Pittsburgh, Pennsylvania, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Sanford Research/USD-Sioux Falls

Sioux Falls, South Dakota, United States

Texas Oncology, P.A. - Austin

Austin, Texas, United States

Texas Oncology, P.A.

Dallas, Texas, United States

Texas Oncology, P.A. - Fort Worth

Fort Worth, Texas, United States

Memorial Herman Hospital

Houston, Texas, United States

Texas Oncology San Antonio Medical Center

San Antonio, Texas, United States

University of Virginia Health Systems

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates - Hampton

Norfolk, Virginia, United States

VCU Massey Cancer Center

Richmond, Virginia, United States

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, United States

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

MultiCare Regional Cancer Center-Gig Harbor Medical Park

Gig Harbor, Washington, United States

MultiCare Institute for Research and Innovation

Puyallup, Washington, United States

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

CEMAIC - Centro Medico Privado

Córdoba, Córdoba Province, Argentina

Clínica Universitaria Privada Reina Fabiola

Córdoba, Córdoba Province, Argentina

Sanatorio de la Mujer

Rosario, Rosario, Argentina

Sanatorio Parque S.A

Salta, Salta Province, Argentina

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

San Juan, Argentina

Clinicas Viedma S.A.

Viedma, 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, Canada

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

Laval, Quebec, Canada

CHUM Centre de Recherche (affiliated with University of Montreal)

Montreal, Quebec, Canada

McGill University Health Centre/Glen Site/ Royal Victoria Hospital

Montreal, Quebec, Canada

CHUS - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Centro de Investigación Clínica Bradford Hill

Santiago, Chile

Sociedad de Investigaciones Medicas Limitada

Temuco, Chile

Fakultni nemocnice Hradec Kralove

Hradec Králové, 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, 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, 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, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (148)