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

Ovarian Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038100
• Other study ID #: YO39523
• Secondary ID: 2016-003472-52
• Status: Completed
• Phase: Phase 3
• Start date: March 8, 2017
• Est. completion date: August 12, 2022

Study information

• Verified date: February 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1301
• Est. completion date: August 12, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Paclitaxel
Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
• Carboplatin
Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
• Atezolizumab
Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
• Bevacizumab
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
• Atezolizumab Placebo
Placebo matching to atezolizumab on Day 1 of each 21-day cycle

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Hoffmann-La Roche	European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population	Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.	From randomization until disease progression or death from any cause (up to approximately 55 months)
Primary	PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation	Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.	From randomization until disease progression or death from any cause (up to approximately 55 months)
Primary	Overall Survival - ITT Population	Overall Survival (OS) is defined as the time from randomization to death from any cause.	From randomization up to death from any cause (up to approximately 59 months)
Primary	Overall Survival - PD-L1-Positive Subpopulation	Overall Survival (OS) is defined as the time from randomization to death from any cause.	From randomization up to death from any cause (up to approximately 59 months)
Secondary	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.	From randomization until disease progression or death from any cause (up to approximately 55 months)
Secondary	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.	From randomization until disease progression or death from any cause (up to approximately 55 months)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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).	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.
Secondary	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).	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	Percentage of Participants With at Least One Adverse Event	Percentage of participants with at least one adverse event.	From randomization up to approximately 59 months
Secondary	Maximum Serum Concentration (Cmax) of Atezolizumab		Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Secondary	Minimum Serum Concentration (Cmin) of Atezolizumab		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
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab		Baseline to approximately 55 months