Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Ovarian Cancer Clinical Trial

Official title:

A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02718417
• Other study ID #: B9991010
• Secondary ID: 2015-003239-36JA
• Status: Terminated
• Phase: Phase 3
• Start date: May 19, 2016
• Est. completion date: May 16, 2019

Study information

• Verified date: June 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.

The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 998
• Est. completion date: May 16, 2019
• Est. primary completion date: September 7, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component

• Patients must be candidates for platinum based chemotherapy and previously untreated

• Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy

• Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides

• ECOG PS 0-1

• Adequate hematological, renal, and liver function

Key Exclusion Criteria:

• Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors

• Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN a, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways

• Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.

• Cancer for which intraperitoneal cytotoxic chemotherapy is planned

• Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• carboplatin
Given Q3W during chemotherapy phase
• paclitaxel
Investigator choice of weekly or Q3W during chemotherapy phase
• Avelumab
Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion
• Avelumab
Given as single agent in maintenance portion Q2W

Locations

Country	Name	City	State
Bulgaria	MHAT for Female Health-Nadezhda OOD	Sofia
Bulgaria	Shato Ead	Sofia
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	McGill University Health Centre-Glen Site	Montreal	Quebec
Canada	Oncology Pharmacy McGill University Health Centre	Montreal	Quebec
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Croatia	Klinicki bolnicki centar Split	Split
Croatia	Klinicki bolnicki centar Sestre milosrdnice	Zagreb
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	East-Tallinn Central Hospital, Center of Oncology	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	North Estonia Medical Centre Foundation, Pharmacy	Tallinn
Estonia	Tartu University Hospital, Hematology and Oncology Clinic	Tartu
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Zentralapotheke Zytostatika	Chemnitz
Germany	Johannes Apotheke Klinikversorgung	Groebenzell
Germany	Radiologie Uniklinik Koeln	Koeln
Germany	Uniklinik Koeln Apotheke	Koeln
Germany	Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe	Koeln
Germany	Frauenklinik am Rotkreuzklinikum Muenchen	Muenchen
Germany	Radiologie Muenchen	Muenchen
Germany	Diagnostische und Interventionelle Radiologie	Potsdam
Germany	Klinikum Ernst von Bergmann gGmbH	Potsdam
Germany	Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik	Wuerzburg
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	The University of Hong Kong	Hong Kong
Hungary	Semmelweis Egyetem Onkologiai Kozpont	Budapest
Hungary	Debreceni Egyetem Klinikai Gyogyszertar	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika	Debrecen
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont	Szolnok
Ireland	Bon Secours Hospital	Cork
Ireland	Bon Secours Hospital Ireland	Cork
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	Mater Private Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin 7	Dublin
Ireland	Mater Private Hospital	Dublin 7	Dublin
Ireland	Pharmacy Department, St James's Hospital	Dublin 8
Ireland	St James's Hospital	Dublin 8
Italy	Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi	Bologna	BO
Italy	Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi	Bologna	BO
Italy	E.O. Ospedali Galliera	Genova	GE
Italy	Farmacia Galliera	Genova	GE
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano	MI
Italy	Istituto Europeo di Oncologia	Milano	MI
Italy	Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale	Napoli
Italy	Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente	Roma
Italy	Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario	Sondrio	SO
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	The Jikei University Kashiwa Hospital	Kashiwa-shi	Chiba
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	The Jikei University Hospital	Minato-ku	Tokyo
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Kyoto University Hospital	Sakyo-ku	Kyoto
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	National Defense Medical College Hospital	Tokorozawa	Saitama
Japan	Ehime University Hospital	Toon	Ehime
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki
Korea, Republic of	Center for Uterine Cancer, National Cancer Center	Goyang-Si	Gyeonggi-do
Korea, Republic of	Clinical Trial Pharmacy, National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy	Seongnam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center, Clinical Research Pharmacy	Seoul
Korea, Republic of	Clinical Trial Pharmacy, Korea University Guro Hospital	Seoul
Korea, Republic of	Clinical Trial Pharmacy, Samsung Medical Center	Seoul
Korea, Republic of	CTC Cancer Pharmacy, Seoul National University Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital, Clinical Trial Pharmacy	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Daugavpils Regional Hospital, Oncology Department (11 floor)	Daugavpils
Latvia	Natalja Goncarova -Radiology Services	Daugavpils
Latvia	Inga Vigule-Radiology services	Liepaja
Latvia	Liepaja Regional hospital	Liepaja
Latvia	Medical Society "ARS" Ltd	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Mexico	Instituto Nacional de Cancerologia	Mexico	Distrito Federal
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo LEON
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Pharmacy Universitair Medisch Centrum Groningen	Groningen
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	LUMC	Leiden
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Pharmacy Zuyderland Medisch Centrum	Sittard-Geleen
Netherlands	Zuyderland Medisch Centrum	Sittard-Geleen
Poland	Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna	Gdynia
Poland	Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii	Gdynia
Poland	Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna	Krakow
Poland	Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie	Krakow
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna	Olsztyn
Poland	Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu	Opole
Poland	Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w	Poznan
Romania	SC Medisprof SRL	Cluj Napoca	Cluj
Romania	SC Oncolab SRL	Craiova	Dolj
Romania	SC Centrul de Oncologie Euroclinic SRL	Iasi
Russian Federation	Limited liability company (LLC) EVIMED	Chelyabinsk	Chelyabinsk Region
Russian Federation	State Budgetary Healthcare Institution	Chelyabinsk	Chelyabinsk Region
Russian Federation	Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary	Ivanovo	Ivanovo Region
Russian Federation	SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"	Kazan	Tatarstan Republic
Russian Federation	Clinic	Moscow
Russian Federation	FSBI National Research Medical Center of Oncology N.A.	Moscow
Russian Federation	Limited liability company VitaMed-LLC VitaMed	Moscow
Russian Federation	SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department	Moscow
Russian Federation	FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre	Obninsk	Kaluga Region
Russian Federation	SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)	Orenburg	Orenburg Region
Russian Federation	SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care	Saint Petersburg
Singapore	National University Hospital	Singapore
Singapore	National University Hospital, Pharmacy @ NCIS	Singapore
Singapore	Raffles Hospital	Singapore
Slovakia	NsP sv. Jakuba, n.o. , Bardejov	Bardejov
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	Onkologicky ustav sv. Alzbety a.s.	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav, a.s.	Kosice
Slovakia	POKO Poprad s.r.o.	Poprad
Switzerland	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona	Ticino
Switzerland	Ospedale San Giovanni	Bellinzona	Ticino
Switzerland	Radiologia ORBV	Bellinzona	Ticino
Switzerland	Kantonsspital Winterthur	Winterthur	Zuerich
Switzerland	Kantonsspital Winterthur	Winterthur	Zurich
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Clinical Trial Pharmacy, Taipei Veterans General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Cathay General Hospital	Taipei City
Taiwan	Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center	Taipei City
Taiwan	Clinical Trial Pharmacy, MacKay Memorial Hospital	Taipei city
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei City
Taiwan	Mackay Memorial Hospital	Taipei City
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital - Linkou Branch	Taoyuan City
Taiwan	Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch	Taoyuan City
Turkey	Baskent University Adana Training and Research Hospital	Adana
Turkey	Baskent University Ankara Hospital, Department of Oncology	Ankara
Turkey	Bezmialem Vakif University Medical Faculty Hospital	Istanbul
Turkey	Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty	Istanbul
Turkey	Istanbul University Oncology Institute	Istanbul
Turkey	Ege University Faculty of Medicine Hospital	Izmir
Ukraine	Communal Institution Chernivtsi Regional Clinical Oncology Dispensary	Chernivtsi
Ukraine	Cl Dnipropetrovsk City Multifield Clinical Hospital	Dnipropetrovsk
Ukraine	Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council	Kryviy Rig
Ukraine	Clinic of National Cancer Institute	Kyiv
Ukraine	CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"	Lviv
Ukraine	Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department	Uzhhorod
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Bebington, Wirral	Merseyside
United Kingdom	University Hospitals Bristol NHS Foundation trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford	Surrey
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Headington	Oxford
United Kingdom	University College London Hospital NHS Foundation Trust	Islington	London
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospital	London
United Kingdom	University College London Hospital NHS Foundation Trust	London
United Kingdom	University College London Hospital NHS Foundation Trust	London
United Kingdom	The Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	East Kent Hospitals University NHS Foundation Trust	Margate	Kent
United Kingdom	East and North Hertfordshire NHS Trust	Northwood	Middlesex
United Kingdom	Baxter Healthcare	Stockport
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey
United Kingdom	Torbay and South Devon NHS Foundation Trust	Torquay	Devon
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Wirral	Merseyside
United States	Alabama Oncology	Alabaster	Alabama
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Investigational Drug Service, Emory University Clinic	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
United States	Winship Cancer Institute	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Texas Oncology - South Austin	Austin	Texas
United States	Texas Oncology-Austin Central	Austin	Texas
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University	Baltimore	Maryland
United States	Texas Oncology Bedford	Bedford	Texas
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Alabama Oncology	Bessemer	Alabama
United States	Rcca Md Llc	Bethesda	Maryland
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology, Bruno Cancer Center	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Beth Israel Deaconess Medical Center Attn: Nisha Sharma	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital Attn: Svetlana Rashkova, RPh	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Montefiore - Einstein Center for Cancer Care	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Montefiore Medical Center, Centennial Women's Center	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Emily Couric Cancer Center	Charlottesville	Virginia
United States	Mercy Ministry Office	Chesterfield	Missouri
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute	Columbus	Ohio
United States	OSU Wexner Medical Center, Investigational Drug Services	Columbus	Ohio
United States	OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center	Columbus	Ohio
United States	Parkland Health and Hospital System	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center-Clements University Hospital	Dallas	Texas
United States	UT Southwestern Medical Center-Zale Lipshy University Hospital	Dallas	Texas
United States	UHEALTH Deerfield Beach	Deerfield Beach	Florida
United States	Tennessee Oncology, PLLC	Dickson	Tennessee
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Oncology Hematology Care, Inc.	Fairfield	Ohio
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Summit Medical Group PA	Florham Park	New Jersey
United States	Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	Tennessee Oncology, PLLC	Franklin	Tennessee
United States	Tennessee Oncology, PLLC	Gallatin	Tennessee
United States	Rcca Md Llc	Germantown	Maryland
United States	Asante Three Rivers Medical Center	Grants Pass	Oregon
United States	Hematology Oncology Associates	Grants Pass	Oregon
United States	Tennessee Oncology, PLLC	Hermitage	Tennessee
United States	OSU Wexner Medical Center, Gynecologic Oncology at Mill Run	Hilliard	Ohio
United States	Medical Arts Radiology	Huntington	New York
United States	ProHealth Radiology	Huntington	New York
United States	Oso HomeCare	Irvine	California
United States	US Oncology Investigational Products Center	Irving	Texas
United States	US Oncology Investigational Products Center (IPC)	Irving	Texas
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Utah Cancer Specialists	Layton	Utah
United States	Tennessee Oncology, PLLC	Lebanon	Tennessee
United States	Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	Medical Center, Cedars-Sinai	Los Angeles	California
United States	SKCCC at Johns Hopkins, Green Spring Station	Lutherville	Maryland
United States	Asante Pharmacy	Medford	Oregon
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	Hematology Oncology Associates	Medford	Oregon
United States	University of Miami Hospital and Clinics	Miami	Florida
United States	NYU Winthrop Hospital, Clinical Trials Center	Mineola	New York
United States	NYU Winthrop Hospital, Gynecologic Oncology	Mineola	New York
United States	NYU Winthrop Hospital, Infusion Center	Mineola	New York
United States	NYU Winthrop Hospital, Research Pharmacy	Mineola	New York
United States	NYU Winthrop Radiology	Mineola	New York
United States	Tennessee Oncology, PLLC	Murfreesboro	Tennessee
United States	Utah Cancer Specialists	Murray	Utah
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	University Hospital	Newark	New Jersey
United States	University Hospital, Ambulatory Care Center	Newark	New Jersey
United States	University Hospital, Investigational Drug Pharmacy	Newark	New Jersey
United States	University Hospital, The Cancer Center	Newark	New Jersey
United States	Gynecologic Oncology Associates	Newport Beach	California
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Hematology-Oncology Medical Group of Orange County	Orange	California
United States	Medical Oncology Care Associates	Orange	California
United States	St. Joseph Hospital of Orange	Orange	California
United States	The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange	Orange	California
United States	UC Irvine Health	Orange	California
United States	University of California, Irvine/UC Irvine Health	Orange	California
United States	Orlando Health Gynecological Cancer Center	Orlando	Florida
United States	Orlando Health UF Health Cancer Center	Orlando	Florida
United States	Orlando Health, Inc	Orlando	Florida
United States	Orlando Health, Inc.	Orlando	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Arizona Oncology Associates, PC - HAL	Phoenix	Arizona
United States	Arizona Oncology Associates, PC - HAL	Phoenix	Arizona
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute Investigational Drug Service	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Women's Health Specialists of Montgomery County	Rockville	Maryland
United States	Highlands Oncology Group	Rogers	Arkansas
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Texas Oncology - San Antonio Medical Center	San Antonio	Texas
United States	Bryan Hemming Cancer Care Center - California Pacific Medical Center	San Francisco	California
United States	California Pacific Medical Center - Davies Campus	San Francisco	California
United States	California Pacific Medical Center - Medical Office Building	San Francisco	California
United States	California Pacific Medical Center - Pacific Heights Outpatient Pharmacy	San Francisco	California
United States	California Pacific Medical Center - Van Ness Campus	San Francisco	California
United States	California Pacific Medical Center-Pacific Campus	San Francisco	California
United States	California Pacific Medical Center-Research Institute	San Francisco	California
United States	Palo Alto Medical Foundation Group	San Francisco	California
United States	Sansum Clinic	Santa Barbara	California
United States	Arizona Oncology Associates, PC - HAL	Scottsdale	Arizona
United States	Tennessee Oncology, PLLC	Shelbyville	Tennessee
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Holy Cross Hospital, Pharmacy	Silver Spring	Maryland
United States	Holy Cross Resource Center	Silver Spring	Maryland
United States	Maryland Oncology Hematology	Silver Spring	Maryland
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Tennessee Oncology, PLLC	Smyrna	Tennessee
United States	Sansum Clinic	Solvang	California
United States	Mercy - Women's Oncology	Springfield	Missouri
United States	Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center	Springfield	Missouri
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Arizona Oncology Associates, PC - HAL	Tempe	Arizona
United States	Arizona Oncology Associates, PC-HOPE	Tucson	Arizona
United States	Arizona Oncology Associates, PC-HOPE	Tucson	Arizona
United States	Johns Hopkins Sibley Memorial Hospital	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Utah Cancer Specialists	West Jordan	Utah
United States	Maryland Oncology Hematology	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Croatia,  Estonia,  Germany,  Hong Kong,  Hungary,  Ireland,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)	BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.	Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Overall Survival	Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Progression-Free Survival (PFS) as Assessed by Investigator	Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.	Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Percentage of Participants With Objective Response as Assessed by Investigator	Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)	BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Duration of Response (DOR) as Assessed by Investigator	Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.	First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)	BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.	First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)	BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.	From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)
Secondary	Maintenance Progression-Free Survival (PFS) as Assessed by Investigator	Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method	From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)
Secondary	Percentage of Participants With Pathological Complete Response (pCR)	pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease.	Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Progression-Free Survival 2 (PFS2)	PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.	Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months)
Secondary	Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria	PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125.	Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
Secondary	Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03	As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN].	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment	Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.	Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)
Secondary	Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment	Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.	Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)
Secondary	Number of Participants With Electrocardiogram (ECG) Abnormalities	ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary	Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score	National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'.	CP: Pre-dose on Day 1 of Cycles 2 to 6 (1 cycle= 21 days); MP/OP: Day 1 of Cycles 1 to 12 (1 cycle= 42 days), End of treatment (any time up to Month 27)
Secondary	European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score	EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
Secondary	Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)	Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.	Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen)	Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.	Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)	Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.	Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen)	AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.	Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen)	AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.	Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)	AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.	Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen)	AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).	Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)	AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).	Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free)	AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.	Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
Secondary	Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab	Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).	Pre-dose (0 hour) on Day 1 of Cycle 2
Secondary	Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab	Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).	End of avelumab infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin	Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).	End of infusion on Day 1 of Cycle 2
Secondary	Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin	Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).	Pre-dose (0 hour) on Day 1 of Cycle 2
Secondary	Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status	ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.	Up to 36 months
Secondary	Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status	nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.	Up to 36 months
Secondary	Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)	PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (>=) 1 percent (%) tumor cells or >= 5% immune cells and were otherwise considered negative.	Up to 36 months
Secondary	Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)	CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated >= 1% CD8 positive cells and were otherwise considered negative.	Up to 36 months

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