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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: carboplatin; Drug: paclitaxel; Drug: Avelumab; Drug: Avelumab

• Study Type: Interventional
• Enrollment (Actual): 998
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1373
    • MHAT for Female Health-Nadezhda OOD
  • Sofia, Bulgaria, 1756
    • Shato Ead
• Canada
  • Quebec, Canada, G1R 2J6
    • CHU de Quebec-Universite Laval
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre-Glen Site
    • Montreal, Quebec, Canada, H4A 3J1
      • Oncology Pharmacy McGill University Health Centre
• Croatia
  • Split, Croatia, 21000
    • Klinicki Bolnicki Centar Split
  • Zagreb, Croatia, 10000
    • Klinički bolnički centar Sestre Milosrdnice
• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia, 11312
    • East-Tallinn Central Hospital, Center of Oncology
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation, Pharmacy
  • Tartu, Estonia, 51014
    • Tartu University Hospital, Hematology and Oncology Clinic
• Germany
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Chemnitz, Germany, 09113
    • Zentralapotheke Zytostatika
  • Groebenzell, Germany, 82194
    • Johannes Apotheke Klinikversorgung
  • Koeln, Germany, 50931
    • Radiologie Uniklinik Koeln
  • Koeln, Germany, 50931
    • Uniklinik Koeln Apotheke
  • Koeln, Germany, 50931
    • Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe
  • Muenchen, Germany, 80634
    • Radiologie Muenchen
  • Muenchen, Germany, 80637
    • Frauenklinik am Rotkreuzklinikum Muenchen
  • Potsdam, Germany, 14467
    • Diagnostische und Interventionelle Radiologie
  • Potsdam, Germany, 14467
    • Klinikum Ernst von Bergmann gGmbH
  • Wuerzburg, Germany, 97080
    • Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik
• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong
  • Hong Kong, Hong Kong
    • Queen Elizabeth Hospital
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem Onkologiai Központ
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Gyogyszertar
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
• Ireland
  • Cork, Ireland
    • Bon Secours Hospital
  • Cork, Ireland
    • Bon Secours Hospital Ireland
  • Dublin, Ireland, D7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, D7
    • Mater Private Hospital
  • Dublin 8, Ireland, 8
    • Pharmacy Department, St James's Hospital
  • Dublin 8, Ireland
    • St James's Hospital
  • Dublin
    • Dublin 7, Dublin, Ireland, 7
      • Mater Misericordiae University Hospital
    • Dublin 7, Dublin, Ireland, Dublin 7
      • Mater Private Hospital
• Italy
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale
  • Roma, Italy, 00168
    • Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente
  • BO
    • Bologna, BO, Italy, 40138
      • Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi
    • Bologna, BO, Italy, 40138
      • Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
  • GE
    • Genova, GE, Italy, 16128
      • E.O. Ospedali Galliera
    • Genova, GE, Italy, 16128
      • Farmacia Galliera
  • MI
    • Milano, MI, Italy, 20141
      • Istituto Europeo di Oncologia
    • Milano, MI, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
  • SO
    • Sondrio, SO, Italy, 23100
      • Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario
• Japan
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8567
      • The Jikei University Kashiwa Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Shikoku Cancer Center
    • Toon, Ehime, Japan, 791-0295
      • Ehime University Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
  • Kyoto
    • Sakyo-ku, Kyoto, Japan, 606-8507
      • Kyoto University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
    • Tokorozawa, Saitama, Japan, 359-8513
      • National Defense Medical College Hospital
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital, Clinical Trial Pharmacy
  • Seoul, Korea, Republic of, 03080
    • CTC Cancer Pharmacy, Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center, Clinical Research Pharmacy
  • Seoul, Korea, Republic of, 06351
    • Clinical Trial Pharmacy, Samsung Medical Center
  • Seoul, Korea, Republic of, 08308
    • Clinical Trial Pharmacy, Korea University Guro Hospital
  • Gyeonggi-do
    • Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
      • Center for Uterine Cancer, National Cancer Center
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • Clinical Trial Pharmacy, National Cancer Center
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University
• Latvia
  • Daugavpils, Latvia, LV5417
    • Daugavpils Regional Hospital, Oncology Department (11 floor)
  • Daugavpils, Latvia, LV5417
    • Daugavpils Regional Hospital
  • Daugavpils, Latvia, LV5417
    • Natalja Goncarova -Radiology Services
  • Liepaja, Latvia, LV-3414
    • Inga Vigule-Radiology services
  • Liepaja, Latvia, LV3414
    • Liepaja Regional Hospital
  • Riga, Latvia, LV 1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1010
    • Medical Society "ARS" Ltd
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Cancerologia
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Groningen, Netherlands, 9713 AP
    • Pharmacy Universitair Medisch Centrum Groningen
  • Leiden, Netherlands, 2333 ZA
    • LUMC
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum
  • Sittard-Geleen, Netherlands, 6162 AP
    • Pharmacy Zuyderland Medisch Centrum
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum
• Poland
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii
  • Krakow, Poland, 31-115
    • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna
  • Krakow, Poland, 31-115
    • Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie
  • Olsztyn, Poland, 10-561
    • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Olsztyn, Poland, 10-561
    • Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna
  • Opole, Poland, 45-061
    • Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
  • Poznan, Poland, 60-535
    • Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w
• Romania
  • Iasi, Romania, 700106
    • SC Centrul de Oncologie Euroclinic SRL
  • Cluj
    • Cluj Napoca, Cluj, Romania, 400641
      • SC Medisprof SRL
  • Dolj
    • Craiova, Dolj, Romania, 200385
      • Sc Oncolab Srl
• Russian Federation
  • Moscow, Russian Federation, 111123
    • SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department
  • Moscow, Russian Federation, 115478
    • FSBI National Research Medical Center of Oncology N.A.
  • Moscow, Russian Federation, 121309
    • Clinic
  • Moscow, Russian Federation, 129515
    • Limited liability company VitaMed-LLC VitaMed
  • Saint Petersburg, Russian Federation, 197758
    • SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care
  • Chelyabinsk Region
    • Chelyabinsk, Chelyabinsk Region, Russian Federation, 454048
      • Limited liability company (LLC) EVIMED
    • Chelyabinsk, Chelyabinsk Region, Russian Federation, 454087
      • State Budgetary Healthcare Institution
  • Ivanovo Region
    • Ivanovo, Ivanovo Region, Russian Federation, 153040
      • Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary
  • Kaluga Region
    • Obninsk, Kaluga Region, Russian Federation, 249036
      • FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre
  • Orenburg Region
    • Orenburg, Orenburg Region, Russian Federation, 460021
      • SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)
  • Tatarstan Republic
    • Kazan, Tatarstan Republic, Russian Federation, 420029
      • SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 188770
    • Raffles Hospital
  • Singapore, Singapore, 119082
    • National University Hospital, Pharmacy @ NCIS
• Slovakia
  • Bardejov, Slovakia, 08501
    • NsP sv. Jakuba, n.o. , Bardejov
  • Bratislava, Slovakia, 83310
    • Narodny Onkologicky Ustav
  • Bratislava, Slovakia, 81250
    • Onkologicky ustav sv. Alzbety a.s.
  • Kosice, Slovakia, 04191
    • Vychodoslovensky onkologicky ustav, a.s.
  • Poprad, Slovakia, 05801
    • POKO Poprad s.r.o.
• Switzerland
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Oncology Institute of Southern Switzerland (IOSI)
    • Bellinzona, Ticino, Switzerland, 6500
      • Ospedale San Giovanni
    • Bellinzona, Ticino, Switzerland, 6500
      • Radiologia ORBV
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8401
      • Kantonsspital Winterthur
  • Zurich
    • Winterthur, Zurich, Switzerland, 8401
      • Kantonsspital Winterthur
• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Clinical Trial Pharmacy, Taipei Veterans General Hospital
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei City, Taiwan, 104
    • Mackay Memorial Hospital
  • Taipei City, Taiwan, 106
    • Cathay General Hospital
  • Taipei City, Taiwan, 112
    • Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei City, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei city, Taiwan, 10449
    • Clinical Trial Pharmacy, Mackay Memorial Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital - Linkou Branch
  • Taoyuan City, Taiwan, 333
    • Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch
• Turkey
  • Adana, Turkey, 01120
    • Baskent University Adana Training and Research Hospital
  • Ankara, Turkey, 06490
    • Baskent University Ankara Hospital, Department of Oncology
  • Istanbul, Turkey, 34093
    • Istanbul University Oncology Institute
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif University Medical Faculty Hospital
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
  • Izmir, Turkey, 35100
    • Ege University Faculty of Medicine Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Communal Institution Chernivtsi Regional Clinical Oncology Dispensary
  • Dnipropetrovsk, Ukraine, 49102
    • Cl Dnipropetrovsk City Multifield Clinical Hospital
  • Kryviy Rig, Ukraine, 50048
    • Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council
  • Kyiv, Ukraine, 03022
    • Clinic of National Cancer Institute
  • Lviv, Ukraine, 79031
    • CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"
  • Uzhhorod, Ukraine, 88000
    • Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • University Hospitals Bristol NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • University College London Hospital NHS Foundation Trust
  • London, United Kingdom, NW1 2BU
    • University College London Hospital NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's & St Thomas' NHS Foundation Trust
  • London, United Kingdom, WC1E 6AG
    • University College London Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital NHS Foundation Trust
  • Stockport, United Kingdom, SK4 5GA
    • Baxter Healthcare
  • Devon
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Torbay and South Devon NHS Foundation Trust
  • Kent
    • Margate, Kent, United Kingdom, CT9 4AN
      • East Kent Hospitals University NHS Foundation Trust
  • London
    • Islington, London, United Kingdom, N79NH
      • University College London Hospital NHS Foundation Trust
  • Merseyside
    • Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY
      • The Clatterbridge Cancer Centre NHS Foundation Trust
    • Wirral, Merseyside, United Kingdom, CH63 4JY
      • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • East and North Hertfordshire NHS Trust
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LE
      • Oxford University Hospitals NHS Foundation Trust
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Royal Surrey County Hospital NHS Foundation Trust
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden NHS Foundation Trust
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
      • Alabama Oncology
    • Bessemer, Alabama, United States, 35022
      • Alabama Oncology
    • Birmingham, Alabama, United States, 35205
      • Alabama Oncology, Bruno Cancer Center
    • Birmingham, Alabama, United States, 35209
      • Alabama Oncology
    • Birmingham, Alabama, United States, 35211
      • Alabama Oncology
    • Birmingham, Alabama, United States, 35235
      • Alabama Oncology
    • Birmingham, Alabama, United States, 35243
      • Alabama Oncology
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
    • Phoenix, Arizona, United States, 85027
      • Arizona Oncology Associates, PC - HAL
    • Scottsdale, Arizona, United States, 85258
      • Arizona Oncology Associates, PC - HAL
    • Tempe, Arizona, United States, 85284
      • Arizona Oncology Associates, PC - HAL
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC-Hope
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC-Hope
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Rogers, Arkansas, United States, 72758
      • Highlands Oncology Group
  • California
    • Irvine, California, United States, 92614
      • Oso HomeCare
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Los Angeles, California, United States, 90048
      • Medical Center, Cedars-Sinai
    • Newport Beach, California, United States, 92663
      • Gynecologic Oncology Associates
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
    • Orange, California, United States, 92868
      • UC Irvine Health
    • Orange, California, United States, 92868
      • Hematology-Oncology Medical Group of Orange County
    • Orange, California, United States, 92868
      • Medical Oncology Care Associates
    • Orange, California, United States, 92868
      • St. Joseph Hospital of Orange
    • Orange, California, United States, 92868
      • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
    • Orange, California, United States, 92868
      • University of California, Irvine/UC Irvine Health
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center-Pacific Campus
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Medical Office Building
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus
    • San Francisco, California, United States, 94114
      • California Pacific Medical Center - Davies Campus
    • San Francisco, California, United States, 94115
      • Bryan Hemming Cancer Care Center - California Pacific Medical Center
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center - Pacific Heights Outpatient Pharmacy
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center-Research Institute
    • San Francisco, California, United States, 94118
      • Palo Alto Medical Foundation Group
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Solvang, California, United States, 93463
      • Sansum Clinic
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale-New Haven
    • New Haven, Connecticut, United States, 06520
      • Smilow Cancer Hospital at Yale-New Haven
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
    • Washington, District of Columbia, United States, 20016
      • Johns Hopkins Sibley Memorial Hospital
  • Florida
    • Deerfield Beach, Florida, United States, 33442
      • UHealth Deerfield Beach
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Orlando, Florida, United States, 32806
      • Orlando Health Gynecological Cancer Center
    • Orlando, Florida, United States, 32806
      • Orlando Health UF Health Cancer Center
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute
    • Atlanta, Georgia, United States, 30322
      • Investigational Drug Service, Emory University Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
    • Bethesda, Maryland, United States, 20817
      • Rcca Md Llc
    • Germantown, Maryland, United States, 20874
      • Rcca Md Llc
    • Lutherville, Maryland, United States, 21093
      • SKCCC at Johns Hopkins, Green Spring Station
    • Rockville, Maryland, United States, 20852
      • Women's Health Specialists of Montgomery County
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital
    • Silver Spring, Maryland, United States, 20904
      • Maryland Oncology Hematology
    • Silver Spring, Maryland, United States, 20902
      • Holy Cross Resource Center
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital, Pharmacy
    • Wheaton, Maryland, United States, 20902
      • Maryland Oncology Hematology
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Attn: Svetlana Rashkova, RPh
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center Attn: Nisha Sharma
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Mercy Ministry Office
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
    • Springfield, Missouri, United States, 65804
      • Mercy - Women's Oncology
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group PA
    • Newark, New Jersey, United States, 07103-6750
      • University Hospital, Investigational Drug Pharmacy
    • Newark, New Jersey, United States, 07103-6750
      • University Hospital
    • Newark, New Jersey, United States, 07103
      • University Hospital, Ambulatory Care Center
    • Newark, New Jersey, United States, 07103
      • University Hospital, The Cancer Center
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore - Einstein Center for Cancer Care
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center, Centennial Women's Center
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Huntington, New York, United States, 11743
      • Medical Arts Radiology
    • Huntington, New York, United States, 11743
      • ProHealth Radiology
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital, Clinical Trials Center
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital, Gynecologic Oncology
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital, Infusion Center
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital, Research Pharmacy
    • Mineola, New York, United States, 11501
      • NYU Winthrop Radiology
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45211
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45236
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45245
      • Oncology Hematology Care, Inc.
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43210
      • OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute
    • Columbus, Ohio, United States, 43210
      • OSU Wexner Medical Center, Investigational Drug Services
    • Columbus, Ohio, United States, 43212
      • OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center
    • Fairfield, Ohio, United States, 45014
      • Oncology Hematology Care, Inc.
    • Hilliard, Ohio, United States, 43026
      • OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Institute and Research Center
    • Grants Pass, Oregon, United States, 97527
      • Asante Three Rivers Medical Center
    • Grants Pass, Oregon, United States, 97527
      • Hematology Oncology Associates
    • Medford, Oregon, United States, 97504
      • Hematology Oncology Associates
    • Medford, Oregon, United States, 97501
      • Asante Pharmacy
    • Medford, Oregon, United States, 97504
      • Asante Rogue Regional Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute Investigational Drug Service
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Tennessee
    • Dickson, Tennessee, United States, 37055
      • Tennessee Oncology, PLLC
    • Franklin, Tennessee, United States, 37067
      • Tennessee Oncology, PLLC
    • Gallatin, Tennessee, United States, 37066
      • Tennessee Oncology, PLLC
    • Hermitage, Tennessee, United States, 37076
      • Tennessee Oncology, PLLC
    • Lebanon, Tennessee, United States, 37090
      • Tennessee Oncology, PLLC
    • Murfreesboro, Tennessee, United States, 37129
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • The Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37205
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37207
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37211
      • Tennessee Oncology, PLLC
    • Shelbyville, Tennessee, United States, 37160
      • Tennessee Oncology, PLLC
    • Smyrna, Tennessee, United States, 37167
      • Tennessee Oncology, PLLC
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology - South Austin
    • Austin, Texas, United States, 78731
      • Texas Oncology-Austin Central
    • Bedford, Texas, United States, 76022
      • Texas Oncology Bedford
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hospital System
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center-Clements University Hospital
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center-Zale Lipshy University Hospital
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio Medical Center
  • Utah
    • Layton, Utah, United States, 84041
      • Utah Cancer Specialists
    • Murray, Utah, United States, 84157
      • Utah Cancer Specialists
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
    • Salt Lake City, Utah, United States, 84102
      • Utah Cancer Specialists
    • West Jordan, Utah, United States, 84088
      • Utah Cancer Specialists
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Emily Couric Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 α, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Chemotherapy followed by observation	Drug: carboplatin; Given Q3W during chemotherapy phase; Drug: paclitaxel; Investigator choice of weekly or Q3W during chemotherapy phase
Experimental: Arm B; Chemotherapy followed by avelumab in maintenance	Drug: carboplatin; Given Q3W during chemotherapy phase; Drug: paclitaxel; Investigator choice of weekly or Q3W during chemotherapy phase; Drug: Avelumab; Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion; Drug: Avelumab; Given as single agent in maintenance portion Q2W
Experimental: Arm C; Chemotherapy in combination with avelumab followed by avelumab in maintenance	Drug: carboplatin; Given Q3W during chemotherapy phase; Drug: paclitaxel; Investigator choice of weekly or Q3W during chemotherapy phase; Drug: Avelumab; Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion; Drug: Avelumab; Given as single agent in maintenance portion Q2W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Chair: Bradley Monk, MD, Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA; Study Chair: Jonathan Ledermann, MD, UCL Cancer Institute, UK

Publications and helpful links

General Publications

• Monk BJ, Colombo N, Oza AM, Fujiwara K, Birrer MJ, Randall L, Poddubskaya EV, Scambia G, Shparyk YV, Lim MC, Bhoola SM, Sohn J, Yonemori K, Stewart RA, Zhang X, Perkins Smith J, Linn C, Ledermann JA. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Sep;22(9):1275-1289. doi: 10.1016/S1470-2045(21)00342-9. Epub 2021 Aug 4.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2016
• Primary Completion (Actual): September 7, 2018
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: primary peritoneal cancer; fallopian tube; untreated epithelial ovarian
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Carboplatin; Paclitaxel; Avelumab; Antibodies, Monoclonal
• Other Study ID Numbers: B9991010; 2015-003239-36 (EudraCT Number); JAVELIN OVARIAN 100 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.