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Brief Title: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title: A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study ID: NCT03038100
Brief Summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
St. Joseph'S Hospital & Medical Center, Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HAL, Scottsdale, Arizona, United States
Arizona Oncology - HOPE Wilmot, Tucson, Arizona, United States
Moores Cancer Center at UC San Diego Health, La Jolla, California, United States
LAC + USC Medical Center, Los Angeles, California, United States
UCLA - School of Medicine, Los Angeles, California, United States
Kaiser Permanente - Oakland, Oakland, California, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange, Orange, California, United States
UC Irvine Medical Center, Orange, California, United States
Stanford University, Palo Alto, California, United States
Kaiser Permanente - Sacramento, Roseville, California, United States
Southern California Kaiser Permanente, San Diego, California, United States
California Pacific Medical Center Research Institute, San Francisco, California, United States
K. Permanente - San Fransisco, San Francisco, California, United States
University of California San Francisco Cancer Center, San Francisco, California, United States
Kaiser Permanente - Santa Clara, Santa Clara, California, United States
Olive View/Ucla Medical Center, Sylmar, California, United States
Kaiser Permanente - Walnut Creek, Walnut Creek, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Danbury Hospital, Danbury, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO), Norwich, Connecticut, United States
Sylvester Comprehensive Cent., Miami, Florida, United States
Miami Cancer Institute of Baptist Health, Inc., Miami, Florida, United States
Women's Cancer Associates, Saint Petersburg, Florida, United States
Sarasota Memorial Health Care System; Cancer Research Program, Sarasota, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northeast Georgia Medical Center; Oncology Research Dept-5C, Gainesville, Georgia, United States
Women's Cancer Center, Honolulu, Hawaii, United States
Rush University Medical Center, Chicago, Illinois, United States
Univ of Chicago, Chicago, Illinois, United States
Sudarshan K. Sharma, MD, Ltd., Hinsdale, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
St.Vincent Health System; Gynecologic Oncology, Indianapolis, Indiana, United States
University of Iowa Hospital & Clinic; Division of Hematology/Oncology, Iowa City, Iowa, United States
University of Kentucky; Gynecologic Oncology, Lexington, Kansas, United States
St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood, Edgewood, Kentucky, United States
Woman's Hospital, Baton Rouge, Louisiana, United States
Maine Medical Partners Women's Health; Gyn-Oncology, Scarborough, Maine, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Weinberg CA Inst Franklin Sq, Baltimore, Maryland, United States
Frederick Health Hospital, Frederick, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Baystate Medical Center, Springfield, Massachusetts, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Sanford Health Bemidji, Bemidji, Minnesota, United States
University of Minnesota, Minneapolis, Minnesota, United States
Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Minnesota Oncology Hematology Woodbury, Woodbury, Minnesota, United States
St. Dominic-Jackson Memorial Hospital, Jackson, Mississippi, United States
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology, Saint Louis, Missouri, United States
Billings Clinic; Cancer Center, Billings, Montana, United States
Community Cancer Care, Missoula, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Women's Cancer Center, Las Vegas, Nevada, United States
Center of Hope, Reno, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
MSK @Basking Ridge, Basking Ridge, New Jersey, United States
Cooper Health System; MD Anderson Cancer Center, Camden, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center; MSK Monmouth, Middletown, New Jersey, United States
Jersey Shore Med Ctr; OB/GYN, Neptune, New Jersey, United States
Holy Name Hospital, Teaneck, New Jersey, United States
Southwest Gynecologic Oncology Associates, Inc., Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Womens Cancer Care Association, Albany, New York, United States
New York Presbyterian Queens, Flushing, New York, United States
Northwell Health; Monter Cancer Center, Lake Success, New York, United States
New York Univ Medical Center; Obstetrics & Gynecolog, New York, New York, United States
Mount Sinai Downtown Chelsea Centre, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan-Kettering CC, Rockville Centre, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterain Medical Center, Charlotte, North Carolina, United States
Duke Medical Center, Durham, North Carolina, United States
Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Sanford Health Bismarck, Bismarck, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
University of Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Univ Hospitals of Cleveland, Cleveland, Ohio, United States
Fairview Hospital; Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
Columbus NCORP, Columbus, Ohio, United States
Ohio State University, Arthur James Cancer Hospital, Columbus, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute, Springfield, Oregon, United States
Northwest Cancer Specialists, P.C., Tigard, Oregon, United States
University of Pennsylvania Health System; Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Magee-Woman's Hospital, Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins, Willow Grove, Pennsylvania, United States
WellSpan Gynecologic Oncology, York, Pennsylvania, United States
Women & Infants Hospital, Providence, Rhode Island, United States
Bon Secours - St. Francis Hospital, Greenville, South Carolina, United States
Monument Health Rapid City Hospital, Inc., Rapid City, South Dakota, United States
Sanford Health System, Sioux Falls, South Dakota, United States
Dell Seton Medical Center at UT-Seton Infusion Center; Research Department, Austin, Texas, United States
Texas Oncology Cancer Center, Austin, Texas, United States
Texas Oncology, Bedford, Texas, United States
UT Southwestern Medical Center at Dallas; Department of Pathology, Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth, Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
Rocky Mountain Cancer Centers, LLP, Irving, Texas, United States
Texas Oncology San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology, P.A., The Woodlands, Texas, United States
Texas Oncology- Northeast Texas, Tyler, Texas, United States
Dixie Medical Center, Saint George, Utah, United States
Huntsman Cancer Institute; Oncology, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Henrico Doctors' Hospital - Forest, Richmond, Virginia, United States
Shenandoah Oncology Associates, Winchester, Virginia, United States
University of Washington Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
DN Greenwald Center, Mukwonago, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
The Royal North Shore Hospital; Northern Sydney Cancer Centre, St Leonards, New South Wales, Australia
Cabrini Hospital; Cabrini Foundation, Malvern, Victoria, Australia
Peter MacCallum Cancer Center, North Melbourne, Victoria, Australia
Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie, Graz, , Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie, Innsbruck, , Austria
Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie, Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie, Wien, , Austria
AZ Maria Middelares, Gent, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro, RJ, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Peking Union Medical College Hospital, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
West China Second University Hospital, Chengdu City, , China
Chongqing Cancer Hospital, Chongqing, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Women's hospital school of medicine Zhejiang University, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, , China
Zhongda Hospital Affiliated to Southeast University, Nanjing, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Tianjin Central Hospital of Gynecology Obstetrics., Tianjin City, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Henan Cancer Hospital, Zhengzhou, , China
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
University Hospital Ostrava; Fakultní nemocnice, Ostrava-Poruba, , Czechia
Gynekologicko-porodnicka klinika, Prague, , Czechia
Onkologicka klinika UK 2.LF a FN v Motole, Praha 5, , Czechia
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Kuopio University Hospital, Kuopio, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
Turku Uni Central Hospital; Gynaecology Dept, Turku, , Finland
Clinique Sainte Catherine; Hopital De Semaine, Avignon, , France
Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd, Le Mans, , France
Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes, Lyon, , France
l'Hôpital privé du Confluent SAS, Nantes, , France
Hopital Des Diaconesses; Oncologie, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Centre Rene Huguenin; CONSULT SPECIALISEES, St Cloud, , France
Institut Gustave Roussy, Villejuif, , France
Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie, Berlin, , Germany
Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe, Dresden, , Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde, Essen, , Germany
Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH, Essen, , Germany
Universitätsklinikum Freiburg; Frauenklinik, Freiburg, , Germany
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum, Greifswald, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie, Hamburg, , Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hannover, , Germany
Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg, , Germany
Klinikum Konstanz, Frauenklinik, Konstanz, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, , Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde, Mainz, , Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde, Muenchen, , Germany
Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde, München, , Germany
Klinikum Südstadt, Rostock, , Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik, Ulm, , Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie, Wiesbaden, , Germany
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine, Athens, , Greece
Uni Hospital of Ioannina; Oncology Dept., Ioannina, , Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept., Kifisia, , Greece
University Hospital of Patras Medical Oncology, Patras, , Greece
EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare, Thessaloniki, , Greece
Hillel Yaffe MC; Gynaecology, Hadera, , Israel
Shaare Zedek Medical Center; Oncology Dept, Jerusalem, , Israel
Meir Medical Center; Obstetrics and Gynecology, Kfar Saba, , Israel
Chaim Sheba Medical Center; Obstetrics and Gynecology, Ramat Gan, , Israel
Kaplan Medical Center; Oncology Inst., Rehovot, , Israel
Azienda Ospedaliera Universitaria Federico II, Napoli, Campania, Italy
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico, Napoli, Campania, Italy
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii, Bologna, Emilia-Romagna, Italy
Ospedale Degli Infermi - Faenza; Oncologia Medica, Faenza, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova; Oncologia, Reggio Emilia, Emilia-Romagna, Italy
Policlinico A. Gemelli e C.I.C.; Area Salute della Donna, Roma, Lazio, Italy
A.O.Spedali Civili; Ostetricia e Ginecologia, Brescia, Lombardia, Italy
IRCCS S. Raffaele; Ginecologia Oncologica, Milano, Lombardia, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
A.O. San Gerardo; Ginecologia, Monza, Lombardia, Italy
A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica, Torino, Piemonte, Italy
Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia, Torino, Piemonte, Italy
Ospedale Antonio Perrino; Oncologia Medica, Brindisi, Puglia, Italy
Ospedale Silvestrini; Oncologia ed Ematologia, Perugia, Umbria, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
Nagoya University Hospital, Aichi, , Japan
National Hospital Organization Shikoku Cancer Center, Ehime, , Japan
Ehime University Hospital, Ehime, , Japan
NHO Kyushu Cancer Center, Fukuoka, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Kurume University Hospital, Fukuoka, , Japan
Kure Medical Center, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
Hyogo Cancer Center, Hyogo, , Japan
Iwate Medical University Hospital, Iwate, , Japan
Kagoshima University Hospital, Kagoshima, , Japan
Yokohama City University Hospital, Kanagawa, , Japan
Kyoto University Hospital, Kyoto, , Japan
Mie University Hospital, Mie, , Japan
Tohoku University Hospital, Miyagi, , Japan
Niigata University Medical & Dental Hospital, Niigata, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
The Jikei University Hospital, Tokyo, , Japan
The University of Tokyo Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Keio University Hospital, Tokyo, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Oslo Universitetssykehus HF; Radiumhospitalet, Oslo, , Norway
St. Olavs Hospital, Trondheim, , Norway
Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej, Krakow, , Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej, Pozna?, , Poland
Icu Spsk - 2, Szczecin, , Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej, Warszawa, , Poland
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan, , Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept, Moscow, , Russian Federation
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares, Spain
Fundacion Hospital de Alcorcon; Servicio de Oncologia, Alcorcon, Madrid, Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal; Servicio de Oncología, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Uni Hospital Linkoeping; Dept. of Oncology, Linköping, , Sweden
Karolinska Hospital; Oncology - Radiumhemmet, Stockholm, , Sweden
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Ankara University Medical Faculty; Medikal Onkoloji, Ankara, , Turkey
Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü, Ankara, , Turkey
Koc University Medical Faculty; Department of Gynecology & Obstetrics, Istanbul, , Turkey
Istanbul Uni Istanbul Medical Faculty, Istanbul, , Turkey
Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology, Istanbul, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR