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
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
2 other identifiers
interventional
1,301
21 countries
265
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started Mar 2017
265 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2022
CompletedResults Posted
Study results publicly available
February 17, 2023
CompletedFebruary 17, 2023
February 1, 2023
4.9 years
January 30, 2017
January 9, 2023
February 15, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
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 Outcomes (13)
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
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
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
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
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
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.
- +8 more secondary outcomes
Study Arms (2)
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
EXPERIMENTALParticipants 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.
Placebo With Paclitaxel, Carboplatin and Bevacizumab
PLACEBO COMPARATORParticipants 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.
Interventions
Paclitaxel 175 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of each 21-day cycle
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
Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
Placebo matching to atezolizumab on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- GOG Foundationcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (268)
St. Joseph'S Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Arizona Oncology Associates, PC - HAL
Scottsdale, Arizona, 85258, United States
Arizona Oncology - HOPE Wilmot
Tucson, Arizona, 85710, United States
Moores Cancer Center at UC San Diego Health
La Jolla, California, 92093, United States
LAC + USC Medical Center
Los Angeles, California, 90033, United States
UCLA - School of Medicine
Los Angeles, California, 90095, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California, 92868, United States
UC Irvine Medical Center
Orange, California, 92868, United States
Stanford University
Palo Alto, California, 94305, United States
Kaiser Permanente - Sacramento
Roseville, California, 95661, United States
Southern California Kaiser Permanente
San Diego, California, 92108, United States
California Pacific Medical Center Research Institute
San Francisco, California, 94115, United States
K. Permanente - San Fransisco
San Francisco, California, 94115, United States
University of California San Francisco Cancer Center
San Francisco, California, 94158, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051, United States
Olive View/Ucla Medical Center
Sylmar, California, 91342, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich, Connecticut, 06360, United States
Sylvester Comprehensive Cent.
Miami, Florida, 33136, United States
Miami Cancer Institute of Baptist Health, Inc.
Miami, Florida, 33176, United States
Sarasota Memorial Health Care System; Cancer Research Program
Sarasota, Florida, 34239, United States
Women's Cancer Associates
St. Petersburg, Florida, 33701, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northeast Georgia Medical Center; Oncology Research Dept-5C
Gainesville, Georgia, 30501, United States
Women's Cancer Center
Honolulu, Hawaii, 96826, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Univ of Chicago
Chicago, Illinois, 60637, United States
Sudarshan K. Sharma, MD, Ltd.
Hinsdale, Illinois, 60521, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
St.Vincent Health System; Gynecologic Oncology
Indianapolis, Indiana, 46260, United States
University of Iowa Hospital & Clinic; Division of Hematology/Oncology
Iowa City, Iowa, 52242, United States
University of Kentucky; Gynecologic Oncology
Lexington, Kansas, 40536, United States
St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood
Edgewood, Kentucky, 41017, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Maine Medical Partners Women's Health; Gyn-Oncology
Scarborough, Maine, 04074, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, 21237, United States
Frederick Health Hospital
Frederick, Maryland, 21701, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Sanford Health Bemidji
Bemidji, Minnesota, 56601, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Minnesota Oncology Hematology Woodbury
Woodbury, Minnesota, 55125, United States
St. Dominic-Jackson Memorial Hospital
Jackson, Mississippi, 39216, United States
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
St Louis, Missouri, 63108, United States
Billings Clinic; Cancer Center
Billings, Montana, 59101, United States
Community Cancer Care
Missoula, Montana, 59804, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-0600, United States
Women's Cancer Center
Las Vegas, Nevada, 89106, United States
Center of Hope
Reno, Nevada, 89511, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
MSK @Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Cooper Health System; MD Anderson Cancer Center
Camden, New Jersey, 08103, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center; MSK Monmouth
Middletown, New Jersey, 07748, United States
Jersey Shore Med Ctr; OB/GYN
Neptune City, New Jersey, 07753, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Southwest Gynecologic Oncology Associates, Inc.
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Womens Cancer Care Association
Albany, New York, 12208, United States
New York Presbyterian Queens
Flushing, New York, 11355, United States
Northwell Health; Monter Cancer Center
Lake Success, New York, 11042, United States
New York Univ Medical Center; Obstetrics & Gynecolog
New York, New York, 10016, United States
Mount Sinai Downtown Chelsea Centre
New York, New York, 10029-6574, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 11101, United States
Memorial Sloan-Kettering CC
Rockville Centre, New York, 11570, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Novant Health Presbyterain Medical Center
Charlotte, North Carolina, 28204, United States
Duke Medical Center
Durham, North Carolina, 27710, United States
Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Sanford Health Bismarck
Bismarck, North Dakota, 58506, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102, United States
University of Cincinnati
Cincinnati, Ohio, 45203-0542, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
Univ Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Fairview Hospital; Cleveland Clinic Cancer Center
Cleveland, Ohio, 44111, United States
Columbus NCORP
Columbus, Ohio, 43125, United States
Ohio State University, Arthur James Cancer Hospital
Columbus, Ohio, 43210, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146, United States
Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
Springfield, Oregon, 97477, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223, United States
University of Pennsylvania Health System; Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
Willow Grove, Pennsylvania, 19090, United States
WellSpan Gynecologic Oncology
York, Pennsylvania, 17403, United States
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina, 29607, United States
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, 57701, United States
Sanford Health System
Sioux Falls, South Dakota, 57105, United States
Dell Seton Medical Center at UT-Seton Infusion Center; Research Department
Austin, Texas, 78701, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Texas Oncology
Bedford, Texas, 76022, United States
UT Southwestern Medical Center at Dallas; Department of Pathology
Dallas, Texas, 75390-9016, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, 76104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Rocky Mountain Cancer Centers, LLP
Irving, Texas, 75063, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240, United States
Texas Oncology, P.A.
The Woodlands, Texas, 77060, United States
Texas Oncology- Northeast Texas
Tyler, Texas, 75702, United States
Huntsman Cancer Institute; Oncology
Salt Lake City, Utah, 84112, United States
Dixie Medical Center
St. George, Utah, 84790, United States
University of Virginia
Charlottesville, Virginia, 22906, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Henrico Doctors' Hospital - Forest
Richmond, Virginia, 23229, United States
Shenandoah Oncology Associates
Winchester, Virginia, 22601, United States
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
DN Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
The Royal North Shore Hospital; Northern Sydney Cancer Centre
St Leonards, New South Wales, 2065, Australia
Cabrini Hospital; Cabrini Foundation
Malvern, Victoria, 3144, Australia
Peter MacCallum Cancer Center
North Melbourne, Victoria, 3051, Australia
Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie
Graz, 8020, Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck, 6020, Austria
Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, 1090, Austria
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001, Brazil
Peking Union Medical College Hospital
Beijing, 100032, China
Beijing Cancer Hospital
Beijing, 100142, China
West China Second University Hospital
Chengdu, 610066, China
Chongqing Cancer Hospital
Chongqing, 400030, China
Sun Yet-sen University Cancer Center
Guangzhou, 510663, China
Women's hospital school of medicine Zhejiang University
Hangzhou, 310006, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, 210009, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Tianjin Central Hospital of Gynecology Obstetrics.
Tianjin, 300052, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
University Hospital Ostrava; Fakultní nemocnice
Ostrava-Poruba, 70852, Czechia
Gynekologicko-porodnicka klinika
Prague, 120 00, Czechia
Onkologicka klinika UK 2.LF a FN v Motole
Prague, 15006, Czechia
Rigshospitalet; Onkologisk Klinik
København Ø, 2100, Denmark
Kuopio University Hospital
Kuopio, 70211, Finland
Tampereen yliopistollinen sairaala
Tampere, 33520, Finland
Turku Uni Central Hospital; Gynaecology Dept
Turku, 20521, Finland
Clinique Sainte Catherine; Hopital De Semaine
Avignon, 84918, France
Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
Le Mans, 72000, France
Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
Lyon, 69373, France
l'Hôpital privé du Confluent SAS
Nantes, 44202, France
Hopital Des Diaconesses; Oncologie
Paris, 75571, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Rene Huguenin; CONSULT SPECIALISEES
Saint-Cloud, 92210, France
Institut Gustave Roussy
Villejuif, 94805, France
Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
Berlin, 13353, Germany
Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe
Dresden, 01307, Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, 45122, Germany
Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
Essen, 45136, Germany
Universitätsklinikum Freiburg; Frauenklinik
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
Greifswald, 17475, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
Hamburg, 20246, Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hanover, 30625, Germany
Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120, Germany
Klinikum Konstanz, Frauenklinik
Konstanz, 78464, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, 23538, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131, Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
München, 81377, Germany
Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
München, 81675, Germany
Klinikum Südstadt
Rostock, 18059, Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
Ulm, 89075, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
Wiesbaden, 65199, Germany
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens, 115 28, Greece
Uni Hospital of Ioannina; Oncology Dept.
Ioannina, 455 00, Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, 145 64, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare
Thessaloniki, 546 45, Greece
Hillel Yaffe MC; Gynaecology
Hadera, 3810101, Israel
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, 9103102, Israel
Meir Medical Center; Obstetrics and Gynecology
Kfar Saba, 4428164, Israel
Chaim Sheba Medical Center; Obstetrics and Gynecology
Ramat Gan, 5262100, Israel
Kaplan Medical Center; Oncology Inst.
Rehovot, 7610001, Israel
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, 72100, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli, Campania, 80131, Italy
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
Bologna, Emilia-Romagna, 40138, Italy
Ospedale Degli Infermi - Faenza; Oncologia Medica
Faenza, Emilia-Romagna, 48018, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
Policlinico A. Gemelli e C.I.C.; Area Salute della Donna
Rome, Lazio, 00168, Italy
A.O.Spedali Civili; Ostetricia e Ginecologia
Brescia, Lombardy, 25123, Italy
IRCCS S. Raffaele; Ginecologia Oncologica
Milan, Lombardy, 20132, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
Milan, Lombardy, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milan, Lombardy, 20141, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
A.O. San Gerardo; Ginecologia
Monza, Lombardy, 20052, Italy
A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica
Turin, Piedmont, 10126, Italy
Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia
Turin, Piedmont, 10128, Italy
Ospedale Silvestrini; Oncologia ed Ematologia
Perugia, Umbria, 06123, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padua, Veneto, 35128, Italy
Nagoya University Hospital
Aichi, 466-8560, Japan
National Hospital Organization Shikoku Cancer Center
Ehime, 791-0280, Japan
Ehime University Hospital
Ehime, 791-0295, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Kure Medical Center
Hiroshima, 737-0023, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Hyōgo, 673-0021, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Yokohama City University Hospital
Kanagawa, 236-0004, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Mie University Hospital
Mie, 514-8507, Japan
Tohoku University Hospital
Miyagi, 980-8574, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Iwate Medical University Hospital
Numakunai, 028-3695, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
The Jikei University Hospital
Tokyo, 105-8471, Japan
The University of Tokyo Hospital
Tokyo, 113-8655, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Keio University Hospital
Tokyo, 160-8582, Japan
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo, 0310, Norway
St. Olavs Hospital
Trondheim, 7006, Norway
Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej
Krakow, 31-115, Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej
Późna, 60-569, Poland
Icu Spsk - 2
Szczecin, 70-111, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
Warsaw, 02-781, Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', 420029, Russia
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, 105229, Russia
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 8208, Spain
Fundacion Hospital de Alcorcon; Servicio de Oncologia
Alcorcón, Madrid, 28922, Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
Barcelona, 08028, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Madrid, 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, 46026, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, 58185, Sweden
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm, 171 76, Sweden
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, 01230, Turkey (Türkiye)
Ankara University Medical Faculty; Medikal Onkoloji
Ankara, 06100, Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü
Ankara, 06490, Turkey (Türkiye)
Koc University Medical Faculty; Department of Gynecology & Obstetrics
Istanbul, 34010, Turkey (Türkiye)
Istanbul Uni Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology
Istanbul, 34098, Turkey (Türkiye)
Related Publications (4)
Pignata S, Bookman M, Sehouli J, Miller A, Penson RT, Taskiran C, Anderson C, Hietanen S, Myers T, Madry R, Willmott L, Lortholary A, Thomes-Pepin J, Aghajanian C, McCourt C, Stuckey A, Wu X, Nishio S, Copeland LJ, He Y, Molinero L, Patel S, Lin YG, Khor VK, Moore KN. Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer. Gynecol Oncol. 2023 Oct;177:20-31. doi: 10.1016/j.ygyno.2023.06.018. Epub 2023 Aug 23.
PMID: 37625235DERIVEDLanden CN, Molinero L, Hamidi H, Sehouli J, Miller A, Moore KN, Taskiran C, Bookman M, Lindemann K, Anderson C, Berger R, Myers T, Beiner M, Reid T, Van Nieuwenhuysen E, Green A, Okamoto A, Aghajanian C, Thaker PH, Blank SV, Khor VK, Chang CW, Lin YG, Pignata S. Influence of Genomic Landscape on Cancer Immunotherapy for Newly Diagnosed Ovarian Cancer: Biomarker Analyses from the IMagyn050 Randomized Clinical Trial. Clin Cancer Res. 2023 May 1;29(9):1698-1707. doi: 10.1158/1078-0432.CCR-22-2032.
PMID: 36595569DERIVEDMoore 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.
PMID: 33891472DERIVEDMoore 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.
PMID: 30630885DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2017
First Posted
January 31, 2017
Study Start
March 8, 2017
Primary Completion
February 8, 2022
Study Completion
August 12, 2022
Last Updated
February 17, 2023
Results First Posted
February 17, 2023
Record last verified: 2023-02