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)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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
Sites / Locations
- St. Joseph'S Hospital & Medical Center
- Arizona Oncology Associates, PC - HAL
- Arizona Oncology - HOPE Wilmot
- Moores Cancer Center at UC San Diego Health
- LAC + USC Medical Center
- UCLA - School of Medicine
- Kaiser Permanente - Oakland
- The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
- UC Irvine Medical Center
- Stanford University
- Kaiser Permanente - Sacramento
- Southern California Kaiser Permanente
- California Pacific Medical Center Research Institute
- K. Permanente - San Fransisco
- University of California San Francisco Cancer Center
- Kaiser Permanente - Santa Clara
- Olive View/Ucla Medical Center
- Kaiser Permanente - Walnut Creek
- University of Colorado Hospital - Anschutz Cancer Pavilion
- Danbury Hospital
- Eastern Connecticut Hematology and Oncology Associates; (ECHO)
- Sylvester Comprehensive Cent.
- Miami Cancer Institute of Baptist Health, Inc.
- Women's Cancer Associates
- Sarasota Memorial Health Care System; Cancer Research Program
- Northside Hospital
- Northeast Georgia Medical Center; Oncology Research Dept-5C
- Women's Cancer Center
- Rush University Medical Center
- Univ of Chicago
- Sudarshan K. Sharma, MD, Ltd.
- Parkview Research Center
- St.Vincent Health System; Gynecologic Oncology
- University of Iowa Hospital & Clinic; Division of Hematology/Oncology
- University of Kentucky; Gynecologic Oncology
- St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood
- Woman's Hospital
- Maine Medical Partners Women's Health; Gyn-Oncology
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Weinberg CA Inst Franklin Sq
- Frederick Health Hospital
- Massachusetts General Hospital
- Baystate Medical Center
- St. Joseph Mercy Hospital
- Karmanos Cancer Institute
- Munson Medical Center
- Sanford Health Bemidji
- University of Minnesota
- Metro-Minnesota Community Oncology Research Consortium
- Minnesota Oncology Hematology Woodbury
- St. Dominic-Jackson Memorial Hospital
- Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
- Billings Clinic; Cancer Center
- Community Cancer Care
- Nebraska Methodist Hospital
- University of Nebraska Medical Center
- Women's Cancer Center
- Center of Hope
- Dartmouth Hitchcock Medical Center
- MSK @Basking Ridge
- Cooper Health System; MD Anderson Cancer Center
- John Theurer Cancer Center at Hackensack University Medical Center
- Memorial Sloan Kettering Cancer Center; MSK Monmouth
- Jersey Shore Med Ctr; OB/GYN
- Holy Name Hospital
- Southwest Gynecologic Oncology Associates, Inc.
- University of New Mexico Cancer Center
- Womens Cancer Care Association
- New York Presbyterian Queens
- Northwell Health; Monter Cancer Center
- New York Univ Medical Center; Obstetrics & Gynecolog
- Mount Sinai Downtown Chelsea Centre
- Icahn School of Medicine at Mount Sinai
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan-Kettering CC
- Levine Cancer Institute
- Novant Health Presbyterain Medical Center
- Duke Medical Center
- Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
- Wake Forest Baptist Medical Center
- Sanford Health Bismarck
- Sanford Roger Maris Cancer Center
- University of Cincinnati
- Cleveland Clinic
- Univ Hospitals of Cleveland
- Fairview Hospital; Cleveland Clinic Cancer Center
- Columbus NCORP
- Ohio State University, Arthur James Cancer Hospital
- Kettering Medical Center
- University of Oklahoma; Stephenson Oklahoma Canc Ctr
- Oklahoma Cancer Specialists and Research Institute
- Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
- Northwest Cancer Specialists, P.C.
- University of Pennsylvania Health System; Cancer Center
- Thomas Jefferson University
- Temple University Hospital
- Magee-Woman's Hospital
- Western Pennsylvania Hospital
- Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
- WellSpan Gynecologic Oncology
- Women & Infants Hospital
- Bon Secours - St. Francis Hospital
- Monument Health Rapid City Hospital, Inc.
- Sanford Health System
- Dell Seton Medical Center at UT-Seton Infusion Center; Research Department
- Texas Oncology Cancer Center
- Texas Oncology
- UT Southwestern Medical Center at Dallas; Department of Pathology
- Texas Oncology, P.A. - Fort Worth
- The University of Texas MD Anderson Cancer Center
- Houston Methodist Hospital
- Rocky Mountain Cancer Centers, LLP
- Texas Oncology San Antonio Medical Center
- Texas Oncology, P.A.
- Texas Oncology- Northeast Texas
- Dixie Medical Center
- Huntsman Cancer Institute; Oncology
- University of Virginia
- Virginia Cancer Specialists, PC
- Virginia Oncology Associates
- Henrico Doctors' Hospital - Forest
- Shenandoah Oncology Associates
- University of Washington Seattle Cancer Care Alliance
- University of Wisconsin Hospital and Clinics
- DN Greenwald Center
- Aspirus Regional Cancer Center
- The Royal North Shore Hospital; Northern Sydney Cancer Centre
- Cabrini Hospital; Cabrini Foundation
- Peter MacCallum Cancer Center
- Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie
- Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
- Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
- Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
- AZ Maria Middelares
- UZ Gent
- UZ Leuven Gasthuisberg
- Sint Augustinus Wilrijk
- Instituto Nacional de Cancer - INCa; Oncologia
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
- Peking Union Medical College Hospital
- Beijing Cancer Hospital
- West China Second University Hospital
- Chongqing Cancer Hospital
- Sun Yet-sen University Cancer Center
- Women's hospital school of medicine Zhejiang University
- Harbin Medical University Cancer Hospital
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
- Zhongda Hospital Affiliated to Southeast University
- Guangxi Cancer Hospital of Guangxi Medical University
- Fudan University Shanghai Cancer Center
- Tianjin Central Hospital of Gynecology Obstetrics.
- Zhejiang Cancer Hospital
- Henan Cancer Hospital
- Fakultni nemocnice Olomouc; Onkologicka klinika
- University Hospital Ostrava; Fakultní nemocnice
- Gynekologicko-porodnicka klinika
- Onkologicka klinika UK 2.LF a FN v Motole
- Rigshospitalet; Onkologisk Klinik
- Kuopio University Hospital
- Tampereen yliopistollinen sairaala
- Turku Uni Central Hospital; Gynaecology Dept
- Clinique Sainte Catherine; Hopital De Semaine
- Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
- Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
- l'Hôpital privé du Confluent SAS
- Hopital Des Diaconesses; Oncologie
- Centre Hospitalier Lyon Sud
- Centre Rene Huguenin; CONSULT SPECIALISEES
- Institut Gustave Roussy
- Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
- Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe
- Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
- Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
- Universitätsklinikum Freiburg; Frauenklinik
- Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
- Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
- Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
- Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)
- Klinikum Konstanz, Frauenklinik
- Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
- Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
- Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
- Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
- Klinikum Südstadt
- Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
- HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
- Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
- Uni Hospital of Ioannina; Oncology Dept.
- Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
- University Hospital of Patras Medical Oncology
- EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare
- Hillel Yaffe MC; Gynaecology
- Shaare Zedek Medical Center; Oncology Dept
- Meir Medical Center; Obstetrics and Gynecology
- Chaim Sheba Medical Center; Obstetrics and Gynecology
- Kaplan Medical Center; Oncology Inst.
- Azienda Ospedaliera Universitaria Federico II
- ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
- Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
- Ospedale Degli Infermi - Faenza; Oncologia Medica
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
- Arcispedale Santa Maria Nuova; Oncologia
- Policlinico A. Gemelli e C.I.C.; Area Salute della Donna
- A.O.Spedali Civili; Ostetricia e Ginecologia
- IRCCS S. Raffaele; Ginecologia Oncologica
- Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
- Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
- Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
- A.O. San Gerardo; Ginecologia
- A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica
- Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia
- Ospedale Antonio Perrino; Oncologia Medica
- Ospedale Silvestrini; Oncologia ed Ematologia
- IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
- Nagoya University Hospital
- National Hospital Organization Shikoku Cancer Center
- Ehime University Hospital
- NHO Kyushu Cancer Center
- Kyushu University Hospital
- Kurume University Hospital
- Kure Medical Center
- National Hospital Organization Hokkaido Cancer Center
- Hyogo Cancer Center
- Iwate Medical University Hospital
- Kagoshima University Hospital
- Yokohama City University Hospital
- Kyoto University Hospital
- Mie University Hospital
- Tohoku University Hospital
- Niigata University Medical & Dental Hospital
- Osaka International Cancer Institute
- Shizuoka Cancer Center
- The Jikei University Hospital
- The University of Tokyo Hospital
- The Cancer Institute Hospital of JFCR
- Keio University Hospital
- National Cancer Center
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
- Oslo Universitetssykehus HF; Radiumhospitalet
- St. Olavs Hospital
- Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej
- Icu Spsk - 2
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
- Moscow City Oncology Hospital #62
- Clinical Oncology Dispensary of Ministry of Health of Tatarstan
- N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
- St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
- Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
- Hospital Universitario Son Espases
- Fundacion Hospital de Alcorcon; Servicio de Oncologia
- Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Centro Integral Oncologico Clara Campal; Servicio de Oncología
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
- Hospital Universitario la Fe; Servicio de Oncologia
- Hospital Universitario Miguel Servet; Servicio Oncologia
- Uni Hospital Linkoeping; Dept. of Oncology
- Karolinska Hospital; Oncology - Radiumhemmet
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
- Ankara University Medical Faculty; Medikal Onkoloji
- Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü
- Koc University Medical Faculty; Department of Gynecology & Obstetrics
- Istanbul Uni Istanbul Medical Faculty
- Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo 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.
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.