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 (IMagyn050)

February 15, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1301

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • The Royal North Shore Hospital; Northern Sydney Cancer Centre
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital; Cabrini Foundation
      • North Melbourne, Victoria, Australia, 3051
        • Peter MacCallum Cancer Center
  • Austria
      • Graz, Austria, 8020
        • Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  • Belgium
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • AZ Maria Middelares
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Oncologia
    • SP
      • Sao Paulo, SP, Brazil, 01317-001
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing City, China, 100032
        • Peking Union Medical College Hospital
      • Chengdu City, China, 610066
        • West China Second University Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Guangzhou City, China, 510663
        • Sun Yet-sen University Cancer Center
      • Hangzhou, China, 310006
        • Women's Hospital School of Medicine Zhejiang University
      • Harbin, China, 150081
        • Harbin medical university cancer hospital
      • Nanjing, China, 210009
        • Zhongda Hospital Affiliated to Southeast University
      • Nanjing City, China, 210029
        • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
      • Nanning, China, 530021
        • Guangxi Cancer Hospital of Guangxi Medical University
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
      • Tianjin City, China, 300052
        • Tianjin Central Hospital of Gynecology Obstetrics.
      • Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Ostrava-Poruba, Czechia, 70852
        • University Hospital Ostrava; Fakultní nemocnice
      • Prague, Czechia, 120 00
        • Gynekologicko-porodnicka klinika
      • Praha 5, Czechia, 15006
        • Onkologicka klinika UK 2.LF a FN v Motole
  • Denmark
      • København Ø, Denmark, 2100
        • Rigshospitalet; Onkologisk Klinik
  • Finland
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
      • Tampere, Finland, 33520
        • Tampereen Yliopistollinen Sairaala
      • Turku, Finland, 20521
        • Turku Uni Central Hospital; Gynaecology Dept
  • France
      • Avignon, France, 84918
        • Clinique Sainte Catherine; Hopital De Semaine
      • Le Mans, France, 72000
        • Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
      • Lyon, France, 69373
        • Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
      • Nantes, France, 44202
        • l'Hôpital privé du Confluent SAS
      • Paris, France, 75571
        • Hopital Des Diaconesses; Oncologie
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • St Cloud, France, 92210
        • Centre Rene Huguenin; CONSULT SPECIALISEES
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 13353
        • Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
      • Dresden, Germany, 01307
        • Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe
      • Essen, Germany, 45136
        • Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg; Frauenklinik
      • Greifswald, Germany, 17475
        • Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)
      • Konstanz, Germany, 78464
        • Klinikum Konstanz, Frauenklinik
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
      • Muenchen, Germany, 81377
        • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
      • Rostock, Germany, 18059
        • Klinikum Südstadt
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
      • Wiesbaden, Germany, 65199
        • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
  • Greece
      • Athens, Greece, 115 28
        • Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
      • Ioannina, Greece, 455 00
        • Uni Hospital of Ioannina; Oncology Dept.
      • Kifisia, Greece, 145 64
        • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
      • Patras, Greece, 265 04
        • University Hospital of Patras Medical Oncology
      • Thessaloniki, Greece, 546 45
        • EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare
  • Israel
      • Hadera, Israel, 3810101
        • Hillel Yaffe MC; Gynaecology
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center; Oncology Dept
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center; Obstetrics and Gynecology
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center; Obstetrics and Gynecology
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center; Oncology Inst.
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Napoli, Campania, Italy, 80131
        • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
      • Faenza, Emilia-Romagna, Italy, 48018
        • Ospedale Degli Infermi - Faenza; Oncologia Medica
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • Arcispedale Santa Maria Nuova; Oncologia
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Policlinico A. Gemelli e C.I.C.; Area Salute della Donna
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • A.O.Spedali Civili; Ostetricia e Ginecologia
      • Milano, Lombardia, Italy, 20162
        • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
      • Milano, Lombardia, Italy, 20132
        • IRCCS S. Raffaele; Ginecologia Oncologica
      • Milano, Lombardia, Italy, 20133
        • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
      • Monza, Lombardia, Italy, 20052
        • A.O. San Gerardo; Ginecologia
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica
      • Torino, Piemonte, Italy, 10128
        • Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino; Oncologia Medica
    • Umbria
      • Perugia, Umbria, Italy, 06123
        • Ospedale Silvestrini; Oncologia ed Ematologia
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Ehime, Japan, 791-0295
        • Ehime University Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Japan, 830-0011
        • Kurume University Hospital
      • Fukuoka, Japan, 811-1395
        • Nho Kyushu Cancer Center
      • Hiroshima, Japan, 737-0023
        • Kure Medical Center
      • Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Hyogo, Japan, 673-0021
        • Hyogo Cancer Center
      • Iwate, Japan, 028-3695
        • Iwate Medical University Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Mie, Japan, 514-8507
        • Mie University Hospital
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Tokyo, Japan, 105-8471
        • The Jikei University Hospital
      • Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
  • Norway
      • Oslo, Norway, 0310
        • Oslo Universitetssykehus HF; Radiumhospitalet
      • Trondheim, Norway, 7006
        • St. Olavs Hospital
  • Poland
      • Krakow, Poland, 31-115
        • Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej
      • Pozna?, Poland, 60-569
        • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej
      • Szczecin, Poland, 70-111
        • Icu Spsk - 2
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
      • Moscow, Russian Federation, 105229
        • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
      • Saint-Petersburg, Russian Federation, 197022
        • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
    • Moskovskaja Oblast
      • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
        • Moscow City Oncology Hospital #62
  • Spain
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal; Servicio de Oncología
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe; Servicio de Oncologia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet; Servicio Oncologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Hospital Universitario Son Espases
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon; Servicio de Oncologia
  • Sweden
      • Linköping, Sweden, 58185
        • Uni Hospital Linkoeping; Dept. of Oncology
      • Stockholm, Sweden, 171 76
        • Karolinska Hospital; Oncology - Radiumhemmet
  • Turkey
      • Adana, Turkey, 01230
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Ankara, Turkey, 06100
        • Ankara University Medical Faculty; Medikal Onkoloji
      • Ankara, Turkey, 06490
        • Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü
      • Istanbul, Turkey, 34093
        • Istanbul Uni Istanbul Medical Faculty
      • Istanbul, Turkey, 34010
        • Koc University Medical Faculty; Department of Gynecology & Obstetrics
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital & Medical Center
      • Scottsdale, Arizona, United States, 85258
        • Arizona Oncology Associates, PC - HAL
      • Tucson, Arizona, United States, 85710
        • Arizona Oncology - HOPE Wilmot
    • California
      • La Jolla, California, United States, 92093
        • Moores Cancer Center at UC San Diego Health
      • Los Angeles, California, United States, 90033
        • LAC + USC Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA - School of Medicine
      • Oakland, California, United States, 94611
        • Kaiser Permanente - Oakland
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • Orange, California, United States, 92868
        • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
      • Palo Alto, California, United States, 94305
        • Stanford University
      • Roseville, California, United States, 95661
        • Kaiser Permanente - Sacramento
      • San Diego, California, United States, 92108
        • Southern California Kaiser Permanente
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center Research Institute
      • San Francisco, California, United States, 94115
        • K. Permanente - San Fransisco
      • San Francisco, California, United States, 94158
        • University of California San Francisco Cancer Center
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente - Santa Clara
      • Sylmar, California, United States, 91342
        • Olive View/Ucla Medical Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente - Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates; (ECHO)
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cent.
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute of Baptist Health, Inc.
      • Saint Petersburg, Florida, United States, 33701
        • Women's Cancer Associates
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System; Cancer Research Program
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center; Oncology Research Dept-5C
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Women's Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • Univ of Chicago
      • Hinsdale, Illinois, United States, 60521
        • Sudarshan K. Sharma, MD, Ltd.
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
      • Indianapolis, Indiana, United States, 46260
        • St.Vincent Health System; Gynecologic Oncology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital & Clinic; Division of Hematology/Oncology
    • Kansas
      • Lexington, Kansas, United States, 40536
        • University of Kentucky; Gynecologic Oncology
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70817
        • Woman's Hospital
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Partners Women's Health; Gyn-Oncology
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21237
        • Weinberg CA Inst Franklin Sq
      • Frederick, Maryland, United States, 21701
        • Frederick Health Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Health Bemidji
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro-Minnesota Community Oncology Research Consortium
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology Woodbury
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • St. Dominic-Jackson Memorial Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic; Cancer Center
      • Missoula, Montana, United States, 59804
        • Community Cancer Care
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68198-0600
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Women's Cancer Center
      • Reno, Nevada, United States, 89511
        • Center of Hope
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • MSK @Basking Ridge
      • Camden, New Jersey, United States, 08103
        • Cooper Health System; MD Anderson Cancer Center
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Cancer Center; MSK Monmouth
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Med Ctr; OB/GYN
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87106
        • Southwest Gynecologic Oncology Associates, Inc.
    • New York
      • Albany, New York, United States, 12208
        • Womens Cancer Care Association
      • Flushing, New York, United States, 11355
        • New York Presbyterian Queens
      • Lake Success, New York, United States, 11042
        • Northwell Health; Monter Cancer Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 11101
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • New York Univ Medical Center; Obstetrics & Gynecolog
      • New York, New York, United States, 10029-6574
        • Mount Sinai Downtown Chelsea Centre
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan-Kettering CC
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterain Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
    • North Dakota
      • Bismarck, North Dakota, United States, 58506
        • Sanford Health Bismarck
      • Fargo, North Dakota, United States, 58102
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45203-0542
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital; Cleveland Clinic Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Univ Hospitals of Cleveland
      • Columbus, Ohio, United States, 43210
        • Ohio State University, Arthur James Cancer Hospital
      • Columbus, Ohio, United States, 43125
        • Columbus NCORP
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma; Stephenson Oklahoma Canc Ctr
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
      • Tigard, Oregon, United States, 97223
        • Northwest Cancer Specialists, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System; Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Woman's Hospital
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
      • York, Pennsylvania, United States, 17403
        • Wellspan Gynecologic Oncology
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours - St. Francis Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Rapid City Hospital, Inc.
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Health System
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology Cancer Center
      • Austin, Texas, United States, 78701
        • Dell Seton Medical Center at UT-Seton Infusion Center; Research Department
      • Bedford, Texas, United States, 76022
        • Texas Oncology
      • Dallas, Texas, United States, 75390-9016
        • UT Southwestern Medical Center at Dallas; Department of Pathology
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A. - Fort Worth
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030-4009
        • The University of Texas MD Anderson Cancer Center
      • Irving, Texas, United States, 75063
        • Rocky Mountain Cancer Centers, LLP
      • San Antonio, Texas, United States, 78240
        • Texas Oncology San Antonio Medical Center
      • The Woodlands, Texas, United States, 77060
        • Texas Oncology, P.A.
      • Tyler, Texas, United States, 75702
        • Texas Oncology- Northeast Texas
    • Utah
      • Saint George, Utah, United States, 84790
        • Dixie Medical Center
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute; Oncology
    • Virginia
      • Charlottesville, Virginia, United States, 22906
        • University of Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23229
        • Henrico Doctors' Hospital - Forest
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Seattle Cancer Care Alliance
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Mukwonago, Wisconsin, United States, 53149
        • DN Greenwald Center
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy greater than (>) 12 weeks
  • For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)

Exclusion Criteria:

  • Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
  • Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
  • Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
  • Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
  • Have synchronous primary endometrial cancer
  • Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
  • Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
  • Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery. This may include but is not limited to laparotomy.
  • Have prior allogeneic bone marrow transplantation or solid organ transplant
  • Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
  • Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
  • Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
  • Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
  • Have known sensitivity to any component of bevacizumab
  • Have known sensitivity to any component of paclitaxel
  • Current treatment with anti-viral therapy for hepatitis B virus (HBV)
  • History of leptomeningeal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
Drug: Paclitaxel
Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
Drug: Atezolizumab
Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
Drug: Bevacizumab
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
Placebo Comparator: Placebo With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and placebo for additional 16 cycles.
Drug: Paclitaxel
Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
Drug: Bevacizumab
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
Drug: Atezolizumab Placebo
Placebo matching to atezolizumab on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population
Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
From randomization until disease progression or death from any cause (up to approximately 55 months)
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
From randomization until disease progression or death from any cause (up to approximately 55 months)
Overall Survival - ITT Population
Time Frame: From randomization up to death from any cause (up to approximately 59 months)
Overall Survival (OS) is defined as the time from randomization to death from any cause.
From randomization up to death from any cause (up to approximately 59 months)
Overall Survival - PD-L1-Positive Subpopulation
Time Frame: From randomization up to death from any cause (up to approximately 59 months)
Overall Survival (OS) is defined as the time from randomization to death from any cause.
From randomization up to death from any cause (up to approximately 59 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
From randomization until disease progression or death from any cause (up to approximately 55 months)
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population
Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
From randomization until disease progression or death from any cause (up to approximately 55 months)
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
Time Frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population
Time Frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Clinically-meaningful improvement defined as a >=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a >=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Percentage of participants with clinical improvement, defined as >= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
Percentage of participants with deterioration in patient-reported function and HRQoL, defined as >= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
Percentage of Participants With at Least One Adverse Event
Time Frame: From randomization up to approximately 59 months
Percentage of participants with at least one adverse event.
From randomization up to approximately 59 months
Maximum Serum Concentration (Cmax) of Atezolizumab
Time Frame: Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Minimum Serum Concentration (Cmin) of Atezolizumab
Time Frame: Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame: Baseline to approximately 55 months
Baseline to approximately 55 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

February 8, 2022

Study Completion (Actual)

August 12, 2022

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YO39523
  • 2016-003472-52 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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