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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02718417
Other study ID # B9991010
Secondary ID 2015-003239-36JA
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


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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