AzTrials
AzTrials

Ovarian CancerPhase 3IMagyn050NCT03038100

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

A Phase 3 study testing Paclitaxel, Carboplatin and Atezolizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Hoffmann-La Roche at 268 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Paclitaxel, Carboplatin and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,301 participants
Where
268 sitesin 22 countries
Study dates
8 Mar 2017to 12 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

268 sites in 22 countries.

268 sites in 22 countries

United States127 sites

  • Womens Cancer Care Association

    Albany, New York, 12208

  • Southwest Gynecologic Oncology Associates, Inc.

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Dell Seton Medical Center at UT-Seton Infusion Center; Research Department

    Austin, Texas, 78701

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Weinberg CA Inst Franklin Sq

    Baltimore, Maryland, 21237

  • MSK @Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Texas Oncology

    Bedford, Texas, 76022

  • Sanford Health Bemidji

    Bemidji, Minnesota, 56601

  • Billings Clinic; Cancer Center

    Billings, Montana, 59101

  • Sanford Health Bismarck

    Bismarck, North Dakota, 58506

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cooper Health System; MD Anderson Cancer Center

    Camden, New Jersey, 08103

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Novant Health Presbyterain Medical Center

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22906

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Univ of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45203-0542

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • Univ Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Fairview Hospital; Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44111

  • Columbus NCORP

    Columbus, Ohio, 43125

  • Ohio State University, Arthur James Cancer Hospital

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center at Dallas; Department of Pathology

    Dallas, Texas, 75390-9016

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Medical Center

    Durham, North Carolina, 27710

  • St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood

    Edgewood, Kentucky, 41017

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58102

  • New York Presbyterian Queens

    Flushing, New York, 11355

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • Frederick Health Hospital

    Frederick, Maryland, 21701

  • Northeast Georgia Medical Center; Oncology Research Dept-5C

    Gainesville, Georgia, 30501

  • Bon Secours - St. Francis Hospital

    Greenville, South Carolina, 29607

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Sudarshan K. Sharma, MD, Ltd.

    Hinsdale, Illinois, 60521

  • Women's Cancer Center

    Honolulu, Hawaii, 96826

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • St.Vincent Health System; Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • University of Iowa Hospital & Clinic; Division of Hematology/Oncology

    Iowa City, Iowa, 52242

  • Rocky Mountain Cancer Centers, LLP

    Irving, Texas, 75063

  • St. Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Moores Cancer Center at UC San Diego Health

    La Jolla, California, 92093

  • Northwell Health; Monter Cancer Center

    Lake Success, New York, 11042

  • Women's Cancer Center

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky; Gynecologic Oncology

    Lexington, Kansas, 40536

  • LAC + USC Medical Center

    Los Angeles, California, 90033

  • UCLA - School of Medicine

    Los Angeles, California, 90095

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Sylvester Comprehensive Cent.

    Miami, Florida, 33136

  • Miami Cancer Institute of Baptist Health, Inc.

    Miami, Florida, 33176

  • Memorial Sloan Kettering Cancer Center; MSK Monmouth

    Middletown, New Jersey, 07748

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Community Cancer Care

    Missoula, Montana, 59804

  • DN Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Jersey Shore Med Ctr; OB/GYN

    Neptune City, New Jersey, 07753

  • New York Univ Medical Center; Obstetrics & Gynecolog

    New York, New York, 10016

  • Mount Sinai Downtown Chelsea Centre

    New York, New York, 10029-6574

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11101

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Eastern Connecticut Hematology and Oncology Associates; (ECHO)

    Norwich, Connecticut, 06360

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • University of Oklahoma; Stephenson Oklahoma Canc Ctr

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-0600

  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

    Orange, California, 92868

  • UC Irvine Medical Center

    Orange, California, 92868

  • Stanford University

    Palo Alto, California, 94305

  • University of Pennsylvania Health System; Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • St. Joseph'S Hospital & Medical Center

    Phoenix, Arizona, 85013

  • Magee-Woman's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

  • Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota, 57701

  • Center of Hope

    Reno, Nevada, 89511

  • Henrico Doctors' Hospital - Forest

    Richmond, Virginia, 23229

  • Memorial Sloan-Kettering CC

    Rockville Centre, New York, 11570

  • Kaiser Permanente - Sacramento

    Roseville, California, 95661

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute; Oncology

    Salt Lake City, Utah, 84112

  • Texas Oncology San Antonio Medical Center

    San Antonio, Texas, 78240

  • Southern California Kaiser Permanente

    San Diego, California, 92108

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115

  • K. Permanente - San Fransisco

    San Francisco, California, 94115

  • University of California San Francisco Cancer Center

    San Francisco, California, 94158

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • Sarasota Memorial Health Care System; Cancer Research Program

    Sarasota, Florida, 34239

  • Maine Medical Partners Women's Health; Gyn-Oncology

    Scarborough, Maine, 04074

  • Arizona Oncology Associates, PC - HAL

    Scottsdale, Arizona, 85258

  • University of Washington Seattle Cancer Care Alliance

    Seattle, Washington, 98195

  • Sanford Health System

    Sioux Falls, South Dakota, 57105

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

    Springfield, Oregon, 97477

  • Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

    St Louis, Missouri, 63108

  • Dixie Medical Center

    St. George, Utah, 84790

  • Women's Cancer Associates

    St. Petersburg, Florida, 33701

  • Olive View/Ucla Medical Center

    Sylmar, California, 91342

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Texas Oncology, P.A.

    The Woodlands, Texas, 77060

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon, 97223

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Arizona Oncology - HOPE Wilmot

    Tucson, Arizona, 85710

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins

    Willow Grove, Pennsylvania, 19090

  • Shenandoah Oncology Associates

    Winchester, Virginia, 22601

  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology Woodbury

    Woodbury, Minnesota, 55125

  • WellSpan Gynecologic Oncology

    York, Pennsylvania, 17403

Other trials in United States

Japan22 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • Ehime University Hospital

    Ehime, 791-0295

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Kure Medical Center

    Hiroshima, 737-0023

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hyogo Cancer Center

    Hyōgo, 673-0021

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Yokohama City University Hospital

    Kanagawa, 236-0004

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Mie University Hospital

    Mie, 514-8507

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Iwate Medical University Hospital

    Numakunai, 028-3695

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • The Jikei University Hospital

    Tokyo, 105-8471

  • The University of Tokyo Hospital

    Tokyo, 113-8655

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

Italy18 sites

  • Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

    Bologna, Emilia-Romagna, 40138

  • A.O.Spedali Civili; Ostetricia e Ginecologia

    Brescia, Lombardy, 25123

  • Ospedale Antonio Perrino; Oncologia Medica

    Brindisi, Apulia, 72100

  • Ospedale Degli Infermi - Faenza; Oncologia Medica

    Faenza, Emilia-Romagna, 48018

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • IRCCS S. Raffaele; Ginecologia Oncologica

    Milan, Lombardy, 20132

  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milan, Lombardy, 20141

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • A.O. San Gerardo; Ginecologia

    Monza, Lombardy, 20052

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

    Naples, Campania, 80131

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

    Padova, Veneto, 35128

  • Ospedale Silvestrini; Oncologia ed Ematologia

    Perugia, Umbria, 06123

  • Arcispedale Santa Maria Nuova; Oncologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Policlinico A. Gemelli e C.I.C.; Area Salute della Donna

    Rome, Lazio, 00168

  • A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica

    Turin, Piedmont, 10126

  • Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia

    Turin, Piedmont, 10128

Other trials in Italy

Germany17 sites

  • Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

    Berlin, 13353

  • Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe

    Dresden, 01307

  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

    Essen, 45122

  • Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

    Essen, 45136

  • Universitätsklinikum Freiburg; Frauenklinik

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

    Greifswald, 17475

  • Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625

  • Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

  • Klinikum Konstanz, Frauenklinik

    Konstanz, 78464

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

    Mainz, 55131

  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

    München, 81377

  • Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

    München, 81675

  • Klinikum Südstadt

    Rostock, 18059

  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

    Ulm, 89075

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

    Wiesbaden, 65199

Other trials in Germany

China14 sites

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Beijing Cancer Hospital

    Beijing, 100142

  • West China Second University Hospital

    Chengdu, 610066

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510663

  • Women's hospital school of medicine Zhejiang University

    Hangzhou, 310006

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, 210009

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Tianjin Central Hospital of Gynecology Obstetrics.

    Tianjin, 300052

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain9 sites

  • Fundacion Hospital de Alcorcon; Servicio de Oncologia

    Alcorcón, Madrid, 28922

  • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

    Barcelona, 08028

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Centro Integral Oncologico Clara Campal; Servicio de Oncología

    Madrid, 28050

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

France8 sites

  • Clinique Sainte Catherine; Hopital De Semaine

    Avignon, 84918

  • Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

    Le Mans, 72000

  • Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes

    Lyon, 69373

  • l'Hôpital privé du Confluent SAS

    Nantes, 44202

  • Hopital Des Diaconesses; Oncologie

    Paris, 75571

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Rene Huguenin; CONSULT SPECIALISEES

    Saint-Cloud, 92210

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Turkey (Türkiye)6 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

    Adana, 01230

  • Ankara University Medical Faculty; Medikal Onkoloji

    Ankara, 06100

  • Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü

    Ankara, 06490

  • Koc University Medical Faculty; Department of Gynecology & Obstetrics

    Istanbul, 34010

  • Istanbul Uni Istanbul Medical Faculty

    Istanbul, 34093

  • Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology

    Istanbul, 34098

Other trials in Turkey (Türkiye)

Greece5 sites

  • Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

    Athens, 115 28

  • Uni Hospital of Ioannina; Oncology Dept.

    Ioannina, 455 00

  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

    Kifissia, 145 64

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare

    Thessaloniki, 546 45

Other trials in Greece

Israel5 sites

  • Hillel Yaffe MC; Gynaecology

    Hadera, 3810101

  • Shaare Zedek Medical Center; Oncology Dept

    Jerusalem, 9103102

  • Meir Medical Center; Obstetrics and Gynecology

    Kfar Saba, 4428164

  • Chaim Sheba Medical Center; Obstetrics and Gynecology

    Ramat Gan, 5262100

  • Kaplan Medical Center; Oncology Inst.

    Rehovot, 7610001

Other trials in Israel

Austria4 sites

  • Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie

    Graz, 8020

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

    Innsbruck, 6020

  • Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • University Hospital Ostrava; Fakultní nemocnice

    Ostrava-Poruba, 70852

  • Gynekologicko-porodnicka klinika

    Prague, 120 00

  • Onkologicka klinika UK 2.LF a FN v Motole

    Prague, 15006

Other trials in Czechia

Poland4 sites

  • Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej

    Krakow, 31-115

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej

    Późna, 60-569

  • Icu Spsk - 2

    Szczecin, 70-111

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

    Warsaw, 02-781

Other trials in Poland

Russia4 sites

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', 420029

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

    Moscow, 105229

  • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

    Saint Petersburg, 197022

Other trials in Russia

South Korea4 sites

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Australia3 sites

  • Cabrini Hospital; Cabrini Foundation

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Center

    North Melbourne, Victoria, 3051

  • The Royal North Shore Hospital; Northern Sydney Cancer Centre

    St Leonards, New South Wales, 2065

Other trials in Australia

Finland3 sites

  • Kuopio University Hospital

    Kuopio, 70211

  • Tampereen yliopistollinen sairaala

    Tampere, 33520

  • Turku Uni Central Hospital; Gynaecology Dept

    Turku, 20521

Other trials in Finland

Brazil2 sites

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001

Other trials in Brazil

Norway2 sites

  • Oslo Universitetssykehus HF; Radiumhospitalet

    Oslo, 0310

  • St. Olavs Hospital

    Trondheim, 7006

Other trials in Norway

Sweden2 sites

  • Uni Hospital Linkoeping; Dept. of Oncology

    Linköping, 58185

  • Karolinska Hospital; Oncology - Radiumhemmet

    Stockholm, 171 76

Other trials in Sweden

Denmark1 site

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

Other trials in Denmark

About this study

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

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.

Being tested
Paclitaxel, Carboplatin, Atezolizumab, Bevacizumab, Atezolizumab Placebo
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle

  • CarboplatinDrug

    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

  • AtezolizumabDrug

    Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle

  • BevacizumabDrug

    Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms

  • Atezolizumab PlaceboDrug

    Placebo matching to atezolizumab on Day 1 of each 21-day cycle

Study groups in NCT03038100
Study groupRoleWhat they receive
Atezolizumab With Paclitaxel, Carboplatin and BevacizumabExperimentalParticipants 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.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Atezolizumab; Drug: Bevacizumab
Placebo With Paclitaxel, Carboplatin and BevacizumabPlacebo 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.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab; Drug: Atezolizumab Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization until disease progression or death from any cause (up to approximately 55 months)

  2. 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.

    Measured: From randomization until disease progression or death from any cause (up to approximately 55 months)

  3. Overall Survival - ITT Population

    Overall Survival (OS) is defined as the time from randomization to death from any cause.

    Measured: From randomization up to death from any cause (up to approximately 59 months)

  4. Overall Survival - PD-L1-Positive Subpopulation

    Overall Survival (OS) is defined as the time from randomization to death from any cause.

    Measured: From randomization up to death from any cause (up to approximately 59 months)

Secondary outcomes (13)

  1. 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.

    Measured: From randomization until disease progression or death from any cause (up to approximately 55 months)

  2. 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.

    Measured: From randomization until disease progression or death from any cause (up to approximately 55 months)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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).

    Measured: 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.

  6. 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).

    Measured: 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.

  7. 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.

    Measured: 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. 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.

    Measured: 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.

  9. 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.

    Measured: 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.

  10. Percentage of Participants With at Least One Adverse Event

    Percentage of participants with at least one adverse event.

    Measured: From randomization up to approximately 59 months

  11. Maximum Serum Concentration (Cmax) of Atezolizumab

    Measured: Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose

  12. Minimum Serum Concentration (Cmin) of Atezolizumab

    Measured: 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

  13. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

    Measured: Baseline to approximately 55 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2017 (estimated)
  2. Study start8 Mar 2017
  3. Primary completion8 Feb 2022
  4. Study completion12 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038100
Sponsor's protocol ID
YO39523
Other IDs
2016-003472-52, 2016
Acronym
IMagyn050
Status last verified
Feb 2023
First submitted
30 Jan 2017
Last updated
17 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37625235

  • Landen 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.

    PubMed 36595569

  • 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.

    PubMed 33891472

  • Moore KN, Pignata S; IMagyn050 Steering Committee. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Int J Gynecol Cancer. 2019 Feb 4;29(2):430-433. doi: 10.1136/ijgc-2018-000071.

    PubMed 30630885

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, Carboplatin and Atezolizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Hoffmann-La Roche at 268 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Japan, Italy, Germany, China and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population (time frame: From randomization until disease progression or death from any cause (up to approximately 55 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03038100, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.

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