Clinical trial NCT03038100: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2017-01-31
Enrollment: 1301
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: From randomization until disease progression or death from any cause (up to approximately 55 months)
measure: PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
timeFrame: From randomization until disease progression or death from any cause (up to approximately 55 months)
measure: Overall Survival - ITT Population
timeFrame: From randomization up to death from any cause (up to approximately 59 months)
measure: Overall Survival - PD-L1-Positive Subpopulation
timeFrame: From randomization up to death from any cause (up to approximately 59 months)
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
timeFrame: From randomization until disease progression or death from any cause (up to approximately 55 months)
measure: 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
timeFrame: From randomization until disease progression or death from any cause (up to approximately 55 months)
measure: Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
timeFrame: 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.
measure: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
timeFrame: 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.
measure: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
timeFrame: 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.
measure: Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
timeFrame: 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.
measure: Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
timeFrame: 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.
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: From randomization up to approximately 59 months
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
timeFrame: Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
timeFrame: 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
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
timeFrame: Baseline to approximately 55 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph'S Hospital & Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology - HOPE Wilmot
state: Arizona
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego Health
state: California
city: Los Angeles
country: United States
facility: LAC + USC Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA - School of Medicine
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Orange
country: United States
facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Sacramento
state: California
city: San Diego
country: United States
facility: Southern California Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: San Francisco
country: United States
facility: K. Permanente - San Fransisco
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Cancer Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
state: California
city: Sylmar
country: United States
facility: Olive View/Ucla Medical Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)
state: Connecticut
city: Miami
country: United States
facility: Sylvester Comprehensive Cent.
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute of Baptist Health, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Women's Cancer Associates
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System; Cancer Research Program
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center; Oncology Research Dept-5C
state: Georgia
city: Honolulu
country: United States
facility: Women's Cancer Center
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Univ of Chicago
state: Illinois
city: Hinsdale
country: United States
facility: Sudarshan K. Sharma, MD, Ltd.
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: St.Vincent Health System; Gynecologic Oncology
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky; Gynecologic Oncology
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood
state: Kentucky
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Partners Women's Health; Gyn-Oncology
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Weinberg CA Inst Franklin Sq
state: Maryland
city: Frederick
country: United States
facility: Frederick Health Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Bemidji
country: United States
facility: Sanford Health Bemidji
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro-Minnesota Community Oncology Research Consortium
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology Woodbury
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic-Jackson Memorial Hospital
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
state: Missouri
city: Billings
country: United States
facility: Billings Clinic; Cancer Center
state: Montana
city: Missoula
country: United States
facility: Community Cancer Care
state: Montana
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Women's Cancer Center
state: Nevada
city: Reno
country: United States
facility: Center of Hope
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Basking Ridge
country: United States
facility: MSK @Basking Ridge
state: New Jersey
city: Camden
country: United States
facility: Cooper Health System; MD Anderson Cancer Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center; MSK Monmouth
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Med Ctr; OB/GYN
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest Gynecologic Oncology Associates, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albany
country: United States
facility: Womens Cancer Care Association
state: New York
city: Flushing
country: United States
facility: New York Presbyterian Queens
state: New York
city: Lake Success
country: United States
facility: Northwell Health; Monter Cancer Center
state: New York
city: New York
country: United States
facility: New York Univ Medical Center; Obstetrics & Gynecolog
state: New York
city: New York
country: United States
facility: Mount Sinai Downtown Chelsea Centre
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan-Kettering CC
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterain Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Health Bismarck
state: North Dakota
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: Univ Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital; Cleveland Clinic Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Columbus
country: United States
facility: Ohio State University, Arthur James Cancer Hospital
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Springfield
country: United States
facility: Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System; Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Woman's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
state: Pennsylvania
city: York
country: United States
facility: WellSpan Gynecologic Oncology
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Bon Secours - St. Francis Hospital
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital, Inc.
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Health System
state: South Dakota
city: Austin
country: United States
facility: Dell Seton Medical Center at UT-Seton Infusion Center; Research Department
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas; Department of Pathology
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A. - Fort Worth
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Irving
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Northeast Texas
state: Texas
city: Saint George
country: United States
facility: Dixie Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute; Oncology
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital - Forest
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: University of Washington Seattle Cancer Care Alliance
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Mukwonago
country: United States
facility: DN Greenwald Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Regional Cancer Center
state: Wisconsin
city: St Leonards
country: Australia
facility: The Royal North Shore Hospital; Northern Sydney Cancer Centre
state: New South Wales
city: Malvern
country: Australia
facility: Cabrini Hospital; Cabrini Foundation
state: Victoria
city: North Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
city: Graz
country: Austria
facility: Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
state: SP
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Chengdu City
country: China
facility: West China Second University Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Guangzhou City
country: China
facility: Sun Yet-sen University Cancer Center
city: Hangzhou
country: China
facility: Women's hospital school of medicine Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing
country: China
facility: Zhongda Hospital Affiliated to Southeast University
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin City
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics.
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava; Fakultní nemocnice
city: Prague
country: Czechia
facility: Gynekologicko-porodnicka klinika
city: Praha 5
country: Czechia
facility: Onkologicka klinika UK 2.LF a FN v Motole
city: København Ø
country: Denmark
facility: Rigshospitalet; Onkologisk Klinik
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Gynaecology Dept
city: Avignon
country: France
facility: Clinique Sainte Catherine; Hopital De Semaine
city: Le Mans
country: France
facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
city: Lyon
country: France
facility: Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
city: Nantes
country: France
facility: l'Hôpital privé du Confluent SAS
city: Paris
country: France
facility: Hopital Des Diaconesses; Oncologie
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: St Cloud
country: France
facility: Centre Rene Huguenin; CONSULT SPECIALISEES
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
city: Essen
country: Germany
facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg; Frauenklinik
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)
city: Konstanz
country: Germany
facility: Klinikum Konstanz, Frauenklinik
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
city: Muenchen
country: Germany
facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
city: Rostock
country: Germany
facility: Klinikum Südstadt
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
city: Wiesbaden
country: Germany
facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
city: Athens
country: Greece
facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
city: Ioannina
country: Greece
facility: Uni Hospital of Ioannina; Oncology Dept.
city: Kifisia
country: Greece
facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare
city: Hadera
country: Israel
facility: Hillel Yaffe MC; Gynaecology
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Oncology Dept
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Obstetrics and Gynecology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Obstetrics and Gynecology
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Oncology Inst.
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Napoli
country: Italy
facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
state: Campania
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
state: Emilia-Romagna
city: Faenza
country: Italy
facility: Ospedale Degli Infermi - Faenza; Oncologia Medica
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Oncologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico A. Gemelli e C.I.C.; Area Salute della Donna
state: Lazio
city: Brescia
country: Italy
facility: A.O.Spedali Civili; Ostetricia e Ginecologia
state: Lombardia
city: Milano
country: Italy
facility: IRCCS S. Raffaele; Ginecologia Oncologica
state: Lombardia
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Monza
country: Italy
facility: A.O. San Gerardo; Ginecologia
state: Lombardia
city: Torino
country: Italy
facility: A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica
state: Piemonte
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia
state: Piemonte
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino; Oncologia Medica
state: Puglia
city: Perugia
country: Italy
facility: Ospedale Silvestrini; Oncologia ed Ematologia
state: Umbria
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
state: Veneto
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Ehime
country: Japan
facility: Ehime University Hospital
city: Fukuoka
country: Japan
facility: NHO Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Hiroshima
country: Japan
facility: Kure Medical Center
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF; Radiumhospitalet
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Krakow
country: Poland
facility: Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej
city: Pozna?
country: Poland
facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej
city: Szczecin
country: Poland
facility: Icu Spsk - 2
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Moscow
country: Russian Federation
facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Linköping
country: Sweden
facility: Uni Hospital Linkoeping; Dept. of Oncology
city: Stockholm
country: Sweden
facility: Karolinska Hospital; Oncology - Radiumhemmet
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty; Medikal Onkoloji
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü
city: Istanbul
country: Turkey
facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics
city: Istanbul
country: Turkey
facility: Istanbul Uni Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, Myers T, Taskiran C, Robison K, Maenpaa J, Willmott L, Colombo N, Thomes-Pepin J, Liontos M, Gold MA, Garcia Y, Sharma SK, Darus CJ, Aghajanian C, Okamoto A, Wu X, Safin R, Wu F, Molinero L, Maiya V, Khor VK, Lin YG, Pignata S. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021 Jun 10;39(17):1842-1855. doi: 10.1200/JCO.21.00306. Epub 2021 Apr 23.
citation: Moore KN, Pignata S; IMagyn050 Steering Committee. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. 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. Int J Gynecol Cancer. 2019 Feb 4;29(2):430-433. doi: 10.1136/ijgc-2018-000071.