A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Biological: avelumab; Drug: PLD

• Study Type: Interventional
• Enrollment (Actual): 566
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • Epic Pharmacy,Newcastle Private Hospital
    • Newcastle, New South Wales, Australia, 2305
      • Newcastle Private Hospital Pty Limited
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Care Wesley
    • Auchenflower, Queensland, Australia, 4066
      • Rivercity Pharmacy
    • Brisbane, Queensland, Australia, 4101
      • Mater Pharmacy Services
    • Chermside, Queensland, Australia, 4032
      • Icon Cancer Care Chermside
    • Herston, Queensland, Australia, 4029
      • Clinical Research Unit
    • Herston, Queensland, Australia, 4029
      • Metro North Hospital and Health Service
    • Herston, Queensland, Australia, 4029
      • Oncology Pharmacy
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
    • South Brisbane, Queensland, Australia, 4101
      • Mater Cancer Care Centre
    • Southport, Queensland, Australia, 4215
      • Icon Cancer Care Southport
  • Victoria
    • Brighton, Victoria, Australia, 3186
      • Cabrini Health Limited
    • Malvern, Victoria, Australia, 3144
      • Cabrini Health Limited
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3052
      • The Royal Women's Hospital
    • Parkville, Victoria, Australia, 3052
      • Pharmacy Department
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitat Graz, LKH-Univ. Klinikum Graz
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
• Belgium
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Kortrijk, Belgium, 8500
    • AZ Groeninge Hospital
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
  • Liege, Belgium, 4000
    • CHU de Liege - Sart Tilman
  • Namur, Belgium, 5000
    • Clinique et Maternite Sainte Elisabeth
  • EAST Flanders
    • Gent, EAST Flanders, Belgium, 9000
      • University Hospital Gent
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y5L3
      • British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency-Vancouver Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Health Authority, QEII Health Sciences Centre
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site
    • Montreal, Quebec, Canada, H4A 3J1
      • Oncology Pharmacy McGill University Health Centre
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Ostrava-Poruba, Czechia, 708 52
    • Fakultni nemocnice Ostrava
  • Praha 2, Czechia, 12851
    • Vseobecna fakultni nemocnice v Praze
  • Praha 2, Czechia, 120 00
    • Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,
  • Praha 2, Czechia, 120 00
    • Vseobecna fakultni nemocnice v Praze, Neurologicka klinika
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Usti nad Labem, Czechia, 401 13
    • Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z
  • Czech Republic
    • Praha 2, Czech Republic, Czechia, 120 00
      • Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• France
  • Caen Cedex 5, France, 14076
    • Centre Francois Baclesse
  • LYON cedex 8, France, 69373
    • Service de Radiologie
  • Lyon cedex 08, France, 69373
    • Centre Leon Berard
  • Nice cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris cedex 15, France, 75908
    • Hôpital Européen Georges Pompidou
  • Pierre Benite cedex, France, 69310
    • Centre Hospitalier Lyon Sud
  • Vandoeuvre-lès-Nancy, France, 54519
    • Institut de Cancérologie de Lorraine
  • Villejuif cedex, France, 94805
    • Gustave Roussy Cancer Campus
• Greece
  • Athens, Greece, 11528
    • General Hospital of Athens Alexandra
  • Athens/New Kifissia, Greece, 14564
    • General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology
• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet, Gyogyszertar
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Gyogyszertar
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
• Ireland
  • Dublin, Ireland, 8
    • St James's Hospital
  • Dublin, Ireland, D7
    • Mater Private Hospital
  • Dublin, Ireland, D7
    • Mater Misericoridae University Hospital
  • Dublin 4, Ireland
    • St Vincent's University Hospital
  • Dublin 4, Ireland
    • Pharmacy Department
  • Waterford, Ireland
    • University Hospital Waterford
  • Dublin
    • Dublin 7, Dublin, Ireland, 7
      • Mater Misericordiae University Hospital
    • Dublin 7, Dublin, Ireland, Dublin 7
      • Mater Private Hospital
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
• Italy
  • Bergamo, Italy, 24122
    • Habilita, San Marco Bergamo
  • Bergamo, Italy, 24125
    • Humanitas Cliniche Gavazzeni
  • Bergamo, Italy, 24125
    • Humanitas, Unita Operativa di Cardiologia 2
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza Istituto Ospedelario
  • Como, Italy, 22100
    • Congregazione delle Suore Infermiere dell'Addolorata
  • Cremona, Italy, 26100
    • Fondazione Teresa Camplani
  • Cremona, Italy, 26100
    • Regione Lombardia, A O Istituti Ospitalieri di Cremona
  • Cremona, Italy, 26100
    • Regione Lombardia, ASST Cremona
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia
  • Piacenza, Italy, 29121
    • Ambulatorio dott. Francesco Cavanna, Medico Chirurgo
  • Piacenza, Italy, 29121
    • Azienda Unita Sanitaria Locale Di Piacenza
  • Prato, Italy, 59100
    • Azienda USL 4 Prato
  • Prato, Italy, 59100
    • Azienda USL 4 Toscana Centro
  • Rimini, Italy, 47921
    • Servizio Sanitario Regionale Emilia-Romagna
  • Torino, Italy, 10122
    • C D C, Sede di Torino Centro
  • Brescia
    • Manerbio, Brescia, Italy, 25025
      • Poliambulatorio Specialistico Villa Salute
  • Lecco
    • Costa Masnaga, Lecco, Italy, 23845
      • Congregazione delle Suore Infermiere dell'Addolorata
  • Milano
    • Miano, Milano, Italy, 20121
      • ASST Fatebenefratelli Sacco
  • Ravenna
    • Lugo, Ravenna, Italy, 48022
      • Servizio Sanitario Regionale Emilia-Romagna
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Fondazione del Piemonte per l'Oncologia
• Japan
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kagoshima, Japan, 890-8760
    • Kagoshima City Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Shikoku Cancer Center
    • Toon, Ehime, Japan, 791-0295
      • Ehime 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
    • Kawasaki, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashikosugi Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
    • Kita-adachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
    • Tokorozawa, Saitama, Japan, 359-8513
      • National Defense Medical College hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 430-8558
      • Seirei Hamamatsu General Hospital
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • The University of Tokyo Hospital
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41931
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of, 41931
    • Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center
  • 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, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center Clinical Trial Pharmacy
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy
  • Seoul, Korea, Republic of, 06591
    • Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital
  • Gyeonggi-do
    • Goyangsi, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Groningen, Netherlands, 9713 AP
    • Universitair Medisch Centrum Groningen
  • Leiden, Netherlands, 2333 ZA
    • LUMC
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum
• Norway
  • Bergen, Norway, 5021
    • Department of Obstetrics and Gynecology, Haukeland University Hospital
  • Bergen, Norway, 5053
    • Sykehusapoteket i Bergen
  • Oslo, Norway, 0379
    • Oslo Universitetssykehus
  • Oslo, Norway, 0379
    • Sykehusapoteket Oslo
• Poland
  • 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
  • Poznan, Poland, 60-569
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w
  • Poznan, Poland, 60-569
    • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Evimed Llc
  • Chelyabinsk, Russian Federation, 454087
    • State Budgetary Healthcare Institution
  • Krasnodar, Russian Federation, 350040
    • State Budgetary Healthcare Institution "Clinical oncology dispensary #1"
  • Moscow, Russian Federation, 115478
    • Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"
  • Nizhniy Novgorod, Russian Federation, 603081
    • State Budgetary Healthcare Institution of Nizhegorogsky region
  • Orenburg, Russian Federation, 460021
    • State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"
  • Saint Petersburg, Russian Federation, 197758
    • State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center
  • Velikiy Novgorod, Russian Federation, 173016
    • State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"
  • Krasnodar Region
    • Sochi, Krasnodar Region, Russian Federation, 354057
      • State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357502
      • State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore
  • Singapore, Singapore, 188770
    • Raffles Hospital
  • Singapore, Singapore, 119082
    • National University Hospital
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore Pharmacy
• Spain
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28050
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain, 28033
    • Hospital MD Anderson
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Institut Catala d'Oncologia - Hospital Duran y Reynalds
• Switzerland
  • Zurich, Switzerland, 8006
    • Kantonsapotheke Zurich
  • Zurich, Switzerland, 8091
    • Universitaetsspital Zurich, Klinik fuer Gynakologie
  • Zurich, Switzerland, 8091
    • Universitatsspital Zurich, Clinical Trials Center
  • Zurich, Switzerland, 8091
    • Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie
  • Zurich, Switzerland, 8091
    • Universitatsspital Zurich, Universitares Herzzentrum Zurich
  • Basel-stadt
    • Basel, Basel-stadt, Switzerland, 4031
      • Universitätsspital Basel
    • Basel, Basel-stadt, Switzerland, 4031
      • Universitatsspital Basel, Frauenklinik
  • Luzern
    • Luzern 16, Luzern, Switzerland, 6000
      • Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Oncology Institute of Southern Switzerland (IOSI)
• Taiwan
  • Tainan City, Taiwan, 704
    • National Cheng Kung University Hospital
  • Tainan city, Taiwan, 701
    • Clinical Trial Pharmacy, National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Clinical Trial Pharmacy, Taipei Veterans General Hospital
  • Taipei City, Taiwan, 104
    • Mackay Memorial Hospital
  • Taipei City, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei City, Taiwan, 10449
    • Clinical Trial Pharmacy, Mackay Memorial Hospital
  • Taipei City, Taiwan, 11259
    • Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei city, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital - Linkou Branch
  • Taoyuan City, Taiwan, 333
    • Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch
• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom, NW1 2PG
    • University College London Hospital NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's & St Thomas' NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's & St. Thomas' NHS Foundation Trust
  • London, United Kingdom, WC1E 6AG
    • University College London Hospital NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital NHS Foundation Trust
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospital NHS Trust
  • CITY OF Glasgow
    • Glasgow, CITY OF Glasgow, United Kingdom, G52 3NQ
      • Ross Hall Hospital
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals NHS Foundation Trust
  • Merseyside
    • Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY
      • The Clatterbridge Cancer Centre NHS Foundation Trust
    • Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY
      • The Clatterbridge Cancer Centre
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • East and North Hertfordshire NHS Trust
  • Northamptonshire
    • Northampton, Northamptonshire, United Kingdom, NN1 5BD
      • Northampton General Hospital NHS Trust
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LE
      • Oxford University Hospitals NHS Foundation Trust
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
    • Sutton, Surrey, United Kingdom, SM3 9DW
      • Spire Healthcare Limited (St. Anthony's Hospital)
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Oncology Associates, PC - HAL
    • 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, 85711
      • Arizona Oncology Associates, PC - HOPE
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC - HOPE
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Rogers, Arkansas, United States, 72758
      • Highlands Oncology Group
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine/UC Irvine Health
    • 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
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Florida Cancer Specialists
    • Wellington, Florida, United States, 33414
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • University Gynecologic Oncology
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gynecologic Oncology
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital - Pharmacy
    • Austell, Georgia, United States, 30106
      • Northwest Georgia Oncology Centers, P.C.
    • Carrollton, Georgia, United States, 30117
      • Northwest Georgia Oncology Centers, P.C.
    • Cartersville, Georgia, United States, 30121
      • Northwest Georgia Oncology Centers, P.C.
    • Douglasville, Georgia, United States, 30134
      • Northwest Georgia Oncology Centers, P.C.
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, P.C.
  • Kansas
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Clinical Research Center
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center and Medical Pavilion
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute, St. Matthews Campus
    • Louisville, Kentucky, United States, 40207
      • Norton Women's and Children's Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute, Norton Healthcare Pavilion
    • Louisville, Kentucky, United States, 40241
      • Norton Brownsboro Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute, Brownsboro Hospital Campus
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Maryland Oncology Hematology, P.A.
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, P.A.
    • Silver Spring, Maryland, United States, 20902
      • Maryland Oncology Hematology P.A.
    • Silver Spring, Maryland, United States, 20904
      • Maryland Oncology Hematology P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham Women's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • The University of Kansas Cancer Center, CCP - North
  • Nevada
    • Reno, Nevada, United States, 89502
      • Center of Hope at Renown Regional Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Comprehensive Cancer Center
    • Albuquerque, New Mexico, United States, 87106
      • Southwest GYN Oncology Associates, Inc.
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Hope Women's Cancer Centers
    • Asheville, North Carolina, United States, 28806
      • Mission Hospital, Inc.
    • Kernersville, North Carolina, United States, 27284
      • Novant Health Oncology Specialists
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Oncology Specialists
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44111
      • Fairview Hospital Moll Pavilion Cancer Center
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44111
      • Fairview Hospital Moll Pavilion Pharmacy
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital Hirsch Cancer Center Pharmacy
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Institute and Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • The University of Pennsylvania Health System
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Drug Services, University of Pennsylvania
  • 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, 78731
      • Texas Oncology-Austin Central
    • Austin, Texas, United States, 78745
      • Texas Oncology-South Austin
    • Bedford, Texas, United States, 76022
      • Texas Oncology - Bedford
    • 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
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands, Gynecologic Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic Gynecologic Oncology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and the Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
• Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
• Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
• Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

• Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
• Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
• Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
• Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
• Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.

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
Experimental: avelumab; Arm A: avelumab alone	Biological: avelumab; 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
Experimental: avelumab plus pegylated liposomal doxorubicin (PLD); Arm B: avelumab plus PLD	Biological: avelumab; 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles; Drug: PLD; PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles; Other Names: doxorubicin, caelyx
Active Comparator: PLD; Arm C: PLD alone	Drug: PLD; PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles; Other Names: doxorubicin, caelyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.	From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).
Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.	From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Based on BICR Assessment	Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.	Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.
ORR Based on Investigator Assessment	Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.	Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
PFS Based on Investigator Assessment According to RECIST Version 1.1	PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.	From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.
Duration of Response (DR) Based on BICR Assessment	DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.	Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
DR Based on Investigator Assessment	DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.	Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Disease Control (DC) Rate Based on BICR Assessment	Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.	Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
DC Rate Based on Investigator Assessment	Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.	Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Number of Participants With Laboratory Abnormalities	The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).	From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Change From Baseline in Vital Signs - Blood Pressure	Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.	From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Change From Baseline in Vital Signs - Pulse Rate	Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.	From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Number of Participants With Electrocardiogram (ECG) Abnormalities	Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms.	From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline	LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized.	Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS	PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells.	Biomarkers are measured only at screening.
Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS	Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor.	Biomarkers are measured only at screening.
Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.	Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.
Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28.	From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
Change From Baseline in EQ-VAS Score at End of Treatment	The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.	Baseline and end of treatment/withdrawal visit
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.	From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.
Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose	Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.	At predose (0 H) on Cycle 2 Day 1
Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose	Cmax was defined as maximum observed serum concentration, and can be observed directly from data.	At postdose (end of infusion, 1H) on Cycle 2 Day 1
Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose	Cmax was defined as maximum observed serum concentration, and can be observed directly from data.	From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose	AUC24 was defined as area under the concentration time profile from time zero to 24 hours.	From 0 through 24 hours postdose
Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose	AUC336 was defined as area under the concentration time profile from time zero to 336 hours.	From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose	AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).	From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)	Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.	At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab
Number of Participants With Treatment-Induced ADA	Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.	At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab
Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)	Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.	At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2015
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimated): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: platinum resistant; platinum refractory
• 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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Doxorubicin; Avelumab
• Other Study ID Numbers: B9991009; 2015-003091-77 (EudraCT Number); JAVELIN OVARIAN 200 (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.