Spots Global Cancer Trial Database for Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
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Trial Identification
Brief Title: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
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 ID: NCT04498117
Study Description
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.
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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Saint 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, Framingham, 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
Montefiore Medical Center PRIME, Bronx, 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
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 Village, 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, Cordoba, Argentina
Clínica Universitaria Privada Reina Fabiola, Córdoba, Cordoba, Argentina
Sanatorio de la Mujer, Rosario, , Argentina
Sanatorio Parque S.A, Salta, , Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica, San Juan, , Argentina
Clinicas Viedma S.A., Viedma, , Argentina
ZNA Middelheim, Antwerpen, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Clinique CHC MontLégia, Liège, , Belgium
Centro de Pesquisas Clinica Reichow, Blumenau, , Brazil
Oncosite - Centro de Pesquisa Clinica e Oncologia, Guimaraes, , Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus, Porto Alegre, , Brazil
Fundação Doutor Amaral Carvalho, San Paolo, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, , Brazil
Clínica São Germano - Oncologia, Sao 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), Montréal, Quebec, Canada
McGill University Health Centre/Glen Site/ Royal Victoria Hospital, Montréal, 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 Kralove, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Prague, , Czechia
Fakultni nemocnice Bulovka, Praha, , Czechia
Fakultni nemocnice v Motole, Praha, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha, , 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
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, , Italy
Università Campus Bio-Medico di Roma, Rome, , Italy
National Cancer Center, Goyang, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Soeul, , Korea, Republic of
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 Potosi, , Mexico
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
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Sunil Gupta, MD, FRCPC
Affiliation: CanariaBio Inc.
Role: STUDY_DIRECTOR
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