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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)

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Atezolizumab
Bevacizumab
Atezolizumab Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Placebo With Paclitaxel, Carboplatin and Bevacizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Overall Survival - ITT Population
Overall Survival (OS) is defined as the time from randomization to death from any cause.
Overall Survival - PD-L1-Positive Subpopulation
Overall Survival (OS) is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
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.
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
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.
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
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.
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
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.
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
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).
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
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).
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
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.
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
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.
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
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.
Percentage of Participants With at Least One Adverse Event
Percentage of participants with at least one adverse event.
Maximum Serum Concentration (Cmax) of Atezolizumab
Minimum Serum Concentration (Cmin) of Atezolizumab
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

Full Information

First Posted
January 30, 2017
Last Updated
February 15, 2023
Sponsor
Hoffmann-La Roche
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
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1. Study Identification

Unique Protocol Identification Number
NCT03038100
Brief Title
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Acronym
IMagyn050
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
Intervention Type
Drug
Intervention Name(s)
Atezolizumab Placebo
Intervention Description
Placebo matching to atezolizumab on Day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From randomization until disease progression or death from any cause (up to approximately 55 months)
Title
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
Description
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.
Time Frame
From randomization until disease progression or death from any cause (up to approximately 55 months)
Title
Overall Survival - ITT Population
Description
Overall Survival (OS) is defined as the time from randomization to death from any cause.
Time Frame
From randomization up to death from any cause (up to approximately 59 months)
Title
Overall Survival - PD-L1-Positive Subpopulation
Description
Overall Survival (OS) is defined as the time from randomization to death from any cause.
Time Frame
From randomization up to death from any cause (up to approximately 59 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
Description
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.
Time Frame
From randomization until disease progression or death from any cause (up to approximately 55 months)
Title
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
Description
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.
Time Frame
From randomization until disease progression or death from any cause (up to approximately 55 months)
Title
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
Description
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.
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)
Title
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
Description
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.
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)
Title
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Description
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).
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.
Title
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Description
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).
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.
Title
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Description
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.
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.
Title
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Description
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.
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.
Title
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Description
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.
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.
Title
Percentage of Participants With at Least One Adverse Event
Description
Percentage of participants with at least one adverse event.
Time Frame
From randomization up to approximately 59 months
Title
Maximum Serum Concentration (Cmax) of Atezolizumab
Time Frame
Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Title
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
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame
Baseline to approximately 55 months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33891472
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. Erratum In: J Clin Oncol. 2021 Jul 20;39(21):2420.
Results Reference
derived
PubMed Identifier
30630885
Citation
Moore KN, Pignata S. 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 Jan 10:ijgc-2018-000071. doi: 10.1136/ijgc-2018-000071. Online ahead of print.
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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

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