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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

615

Participants

Timeline

Start Date

August 25, 2020

Primary Completion Date

March 26, 2026

Study Completion Date

August 26, 2028

Conditions
Carcinoma, Ovarian EpithelialOvarian NeoplasmsOvarian CancerOvarian Serous AdenocarcinomaFallopian Tube NeoplasmsFallopian Tube AdenocarcinomaFallopian Tube Serous AdenocarcinomaPeritoneal CancerPeritoneal CarcinomaPeritoneal 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)

Trial Locations (148)

2000

Sanatorio de la Mujer, Rosario

2941

CEMAIC - Centro Medico Privado, Córdoba

4400

Sanatorio Parque S.A, Salta

10011

Mount Sinai The Blavatnik Family Chelsea Medical Center, New York

10019

Mount Sinai - PRIME, Lake Success

10029

Icahn School of Medicine at Mount Sinai, New York

10461

Montefiore Medical Center PRIME, The Bronx

11794

Stony Brook University Hospital, Stony Brook

12208

Womens Cancer Care Associates, Albany

15213

Magee Women's Hospital of UPMC, Pittsburgh

21055

Virginia Cancer Specialists, Fairfax

22903

University of Virginia Health Systems, Charlottesville

23040

Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech), La Paz

23298

VCU Massey Cancer Center, Richmond

23502

Virginia Oncology Associates - Hampton, Norfolk

24106

Carilion Clinic Gynecological Oncology, Roanoke

27607

Duke Women's Cancer Care Raleigh, Raleigh

27710

Duke University, Durham

31405

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

32804

AdventHealth Orlando, Orlando

33701

Women's Cancer Florida/Women's Cancer Associates, St. Petersburg

43026

Ohio State University Wexner Medical Center, Columbus

44024

SCC at UH Geauga Medical Center, Chardon

44106

University Hospitals of Cleveland, Cleveland

44111

Cleveland Clinic Fairview Hospital, Cleveland

44122

UH Minoff Health Center - Seidman, Orange

44124

Cleveland Clinic Hillcrest Hospital, Mayfield Heights

44145

SCC at St. John's Medical Center, Westlake

44195

Cleveland Clinic, Cleveland

45429

Grandview Medical Center/Kettering Medical Center, Kettering

46845

Parkview Research Center, Fort Wayne

48106

St. Joseph Mercy Hospital, Ann Arbor

48219

Sparrow Hospital, Lansing

53792

University of Wisconsin, Madison

55102

Minnesota Oncology Hematology, Saint Paul

55369

University of Minnesota Health - Maple Grove Clinic, Maple Grove

55404

Minnesota Oncology Hematology, Minneapolis

55416

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park

55426

Park Nicollet Frauenshuh Cancer Center, Saint Louis Park

55433

Minnesota Oncology Hematology - Mercy Hospital, Coon Rapids

55435

Minnesota Oncology Hematology, Edina

57104

Sanford Research/USD-Sioux Falls, Sioux Falls

68114

Nebraska Methodist Hospital, Omaha

70433

Women's Cancer Care/Mary Bird Perkins Cancer Center, Covington

70457

National Cheng Kung University Hospital, Tainan City

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialist and Research Institution, LLC, Tulsa

75231

Texas Oncology, P.A., Dallas

76104

Texas Oncology, P.A. - Fort Worth, Fort Worth

77030

Memorial Herman Hospital, Houston

78240

Texas Oncology San Antonio Medical Center, San Antonio

78731

Texas Oncology, P.A. - Austin, Austin

80045

University of Colorado Health, Aurora

85016

Honor Health, Phoenix

85724

The University of Arizona Cancer Center, Tucson

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

92093

Moores UC San Diego Cancer Center, La Jolla

92120

Kaiser Permanente Southern California, Irvine

94520

John Muir Health Clinical Research Center, Concord

94523

Epic Care, Pleasant Hill

94598

Contra Costa Oncology, Walnut Creek

John Muir Health Gynecologic Cancer Services, Walnut Creek

95505

Kaiser Permanente Riverside Medical Center, Riverside

95817

University of California, Davis Comprehensive Cancer Center, Sacramento

96813

The Queens Medical Center, Honolulu

96826

Kapiolani Medical Center for Women and Children/University of Hawaii, Honolulu

97227

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

97401

Willamette Valley Cancer Institute and Research Center, Eugene

98001

MultiCare Regional Cancer Center - Auburn, Auburn

98335

MultiCare Regional Cancer Center-Gig Harbor Medical Park, Gig Harbor

98372

MultiCare Institute for Research and Innovation, Puyallup

98405

MultiCare Regional Cancer Center - Tacoma, Tacoma

06030

University of Connecticut Health Center, Farmington

06510

Smilow Cancer Hospital, New Haven

Yale University School of Medicine, New Haven

02111

Tufts Medical Center, Boston

01805

Lahey Hospital and Medical Center, Burlington

01702

MetroWest Medical Center, Framingham

01854

Lowell General Hospital, Lowell

02180

Tufts Medical Center Cancer Center in Stoneham, Stoneham

01605

UMass Memorial Medical Center, Worcester

03801

Portsmouth Regional Hospital, Portsmouth

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

07450

The Valley Hospital (Valley Health), Paramus

15237-9643

UPMC Hillman Cancer Center at UPMC Passavant, Pittsburgh

02905

Women & Infants Hospital of Rhode Island, Providence

Unknown

Clínica Universitaria Privada Reina Fabiola, Córdoba

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

ZNA Middelheim, Antwerp

Cliniques Universitaires Saint-Luc, Brussels

Clinique CHC MontLégia, Liège

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

Centro de Investigación Clínica Bradford Hill, Santiago

Sociedad de Investigaciones Medicas Limitada, Temuco

Fakultni nemocnice Bulovka, Prague

Fakultni nemocnice Kralovske Vinohrady, Prague

Fakultni nemocnice v Motole, Prague

Vseobecna fakultni nemocnice v Praze, Prague

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

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

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

Università Campus Bio-Medico di Roma, Rome

Clinical Medical Research S.C., Orizaba

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

SMIQ S. de R.L. de C.V., Querétaro

Centro Potosino de Investigación Medica S.C., San Luis Potosí City

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

Hospital Clinic de Barcelona, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

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

Taipei Veterans General Hospital, Taipei County

Taichung Veterans General Hospital, Taichung

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

National Taiwan University Hospital, Taipei

R8500

Clinicas Viedma S.A., Viedma

B3H 2Y9

Queen Elizabeth II Health Sciences Centre, Halifax

H7M 3L9

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

H2X 3E4

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

H4A 3J1

McGill University Health Centre/Glen Site/ Royal Victoria Hospital, Montreal

J1H 5N4

CHUS - Hôpital Fleurimont, Sherbrooke

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Gynecologic Oncology Group

NETWORK

collaborator

Iqvia Pty Ltd

INDUSTRY

lead

CanariaBio Inc.

INDUSTRY

NCT04498117 - Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery | Biotech Hunter | Biotech Hunter