AzTrials
AzTrials

Ovarian CancerPhase 3NCT02718417

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

A Phase 3 study testing carboplatin, paclitaxel and Avelumab in people with Ovarian Cancer, run by Pfizer at 319 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
carboplatin, paclitaxel and Avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
998 participants
Where
319 sitesin 25 countries
Study dates
19 May 2016to 16 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

319 sites in 25 countries.

319 sites in 25 countries

United States146 sites

  • Alabama Oncology

    Alabaster, Alabama, 35007

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Investigational Drug Service, Emory University Clinic

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Texas Oncology-Austin Central

    Austin, Texas, 78731

  • Texas Oncology - South Austin

    Austin, Texas, 78745

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

    Baltimore, Maryland, 21287

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • Texas Oncology Bedford

    Bedford, Texas, 76022

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Alabama Oncology

    Bessemer, Alabama, 35022

  • Rcca Md Llc

    Bethesda, Maryland, 20817

  • Alabama Oncology, Bruno Cancer Center

    Birmingham, Alabama, 35205

  • Alabama Oncology

    Birmingham, Alabama, 35209

  • Alabama Oncology

    Birmingham, Alabama, 35211

  • Alabama Oncology

    Birmingham, Alabama, 35235

  • Alabama Oncology

    Birmingham, Alabama, 35243

  • Massachusetts General Hospital Attn: Svetlana Rashkova, RPh

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center Attn: Nisha Sharma

    Boston, Massachusetts, 02215

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Emily Couric Cancer Center

    Charlottesville, Virginia, 22903

  • Mercy Ministry Office

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45211

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45245

  • MetroHealth Medical Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute

    Columbus, Ohio, 43210

  • OSU Wexner Medical Center, Investigational Drug Services

    Columbus, Ohio, 43210

  • OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

  • Parkland Health and Hospital System

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • UT Southwestern Medical Center-Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern Medical Center-Zale Lipshy University Hospital

    Dallas, Texas, 75390

  • UHEALTH Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Oncology Hematology Care, Inc.

    Fairfield, Ohio, 45014

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Summit Medical Group PA

    Florham Park, New Jersey, 07932

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Rcca Md Llc

    Germantown, Maryland, 20874

  • Asante Three Rivers Medical Center

    Grants Pass, Oregon, 97527

  • Hematology Oncology Associates

    Grants Pass, Oregon, 97527

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • OSU Wexner Medical Center, Gynecologic Oncology at Mill Run

    Hilliard, Ohio, 43026

  • Medical Arts Radiology

    Huntington, New York, 11743

  • ProHealth Radiology

    Huntington, New York, 11743

  • Oso HomeCare

    Irvine, California, 92614

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Products Center

    Irving, Texas, 75063

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Utah Cancer Specialists

    Layton, Utah, 84041

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Medical Center, Cedars-Sinai

    Los Angeles, California, 90048

  • SKCCC at Johns Hopkins, Green Spring Station

    Lutherville, Maryland, 21093

  • Asante Pharmacy

    Medford, Oregon, 97501

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504

  • Hematology Oncology Associates

    Medford, Oregon, 97504

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • NYU Winthrop Hospital, Clinical Trials Center

    Mineola, New York, 11501

  • NYU Winthrop Hospital, Gynecologic Oncology

    Mineola, New York, 11501

  • NYU Winthrop Hospital, Infusion Center

    Mineola, New York, 11501

  • NYU Winthrop Hospital, Research Pharmacy

    Mineola, New York, 11501

  • NYU Winthrop Radiology

    Mineola, New York, 11501

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • Utah Cancer Specialists

    Murray, Utah, 84157

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06520

  • University Hospital, Investigational Drug Pharmacy

    Newark, New Jersey, 07103-6750

  • University Hospital

    Newark, New Jersey, 07103-6750

  • University Hospital, Ambulatory Care Center

    Newark, New Jersey, 07103

  • University Hospital, The Cancer Center

    Newark, New Jersey, 07103

  • Gynecologic Oncology Associates

    Newport Beach, California, 92663

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Hematology-Oncology Medical Group of Orange County

    Orange, California, 92868

  • Medical Oncology Care Associates

    Orange, California, 92868

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

    Orange, California, 92868

  • UC Irvine Health

    Orange, California, 92868

  • University of California, Irvine/UC Irvine Health

    Orange, California, 92868

  • Orlando Health Gynecological Cancer Center

    Orlando, Florida, 32806

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806

  • Orlando Health, Inc.

    Orlando, Florida, 32806

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85027

  • Magee-Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Cancer Institute Investigational Drug Service

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Women's Health Specialists of Montgomery County

    Rockville, Maryland, 20852

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84102

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • California Pacific Medical Center - Medical Office Building

    San Francisco, California, 94109

  • California Pacific Medical Center - Van Ness Campus

    San Francisco, California, 94109

  • California Pacific Medical Center - Davies Campus

    San Francisco, California, 94114

  • Bryan Hemming Cancer Care Center - California Pacific Medical Center

    San Francisco, California, 94115

  • California Pacific Medical Center - Pacific Heights Outpatient Pharmacy

    San Francisco, California, 94115

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • California Pacific Medical Center-Research Institute

    San Francisco, California, 94115

  • Palo Alto Medical Foundation Group

    San Francisco, California, 94118

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Arizona Oncology Associates, PC - HAL

    Scottsdale, Arizona, 85258

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Holy Cross Resource Center

    Silver Spring, Maryland, 20902

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

  • Holy Cross Hospital, Pharmacy

    Silver Spring, Maryland, 20910

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Sansum Clinic

    Solvang, California, 93463

  • Mercy - Women's Oncology

    Springfield, Missouri, 65804

  • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Arizona Oncology Associates, PC - HAL

    Tempe, Arizona, 85284

  • Montefiore - Einstein Center for Cancer Care

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center, Centennial Women's Center

    The Bronx, New York, 10467

  • Arizona Oncology Associates, PC-HOPE

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC-HOPE

    Tucson, Arizona, 85711

  • Johns Hopkins Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Utah Cancer Specialists

    West Jordan, Utah, 84088

  • Maryland Oncology Hematology

    Wheaton, Maryland, 20902

Other trials in United States

United Kingdom20 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, Merseyside, CH63 4JY

  • University Hospitals Bristol NHS Foundation trust

    Bristol, BS2 8ED

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford, Surrey, GU2 7XX

  • Oxford University Hospitals NHS Foundation Trust

    Headington, Oxford, OX3 7LE

  • University College London Hospital NHS Foundation Trust

    Islington, London, N79NH

  • University College London Hospital NHS Foundation Trust

    London, NW1 2BU

  • University College London Hospital NHS Foundation Trust

    London, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • University College London Hospital

    London, WC1E 6AG

  • The Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • East Kent Hospitals University NHS Foundation Trust

    Margate, KENT, CT9 4AN

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY

  • East and North Hertfordshire NHS Trust

    Northwood, Middlesex, HA6 2RN

  • Baxter Healthcare

    Stockport, SK4 5GA

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • Torbay and South Devon NHS Foundation Trust

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Japan16 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • The Jikei University Kashiwa Hospital

    Kashiwa-shi, Chiba, 277-8567

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • The Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Kyoto University Hospital

    Sakyo-ku, Kyoto, 606-8507

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • National Defense Medical College Hospital

    Tokorozawa, Saitama, 359-8513

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

South Korea15 sites

  • Center for Uterine Cancer, National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Clinical Trial Pharmacy, National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy

    Seongnam-si, Gyeonggi-do, 13496

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Korea University Anam Hospital, Clinical Trial Pharmacy

    Seoul, 02841

  • Korea University Anam Hospital

    Seoul, 02841

  • CTC Cancer Pharmacy, Seoul National University Hospital

    Seoul, 03080

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center, Clinical Research Pharmacy

    Seoul, 05505

  • Asan Medical Center

    Seoul, 05505

  • Clinical Trial Pharmacy, Samsung Medical Center

    Seoul, 06351

  • Samsung Medical Center

    Seoul, 06351

  • Clinical Trial Pharmacy, Korea University Guro Hospital

    Seoul, 08308

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Germany11 sites

  • Zentralapotheke Zytostatika

    Chemnitz, 09113

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Radiologie Uniklinik Koeln

    Cologne, 50931

  • Uniklinik Koeln Apotheke

    Cologne, 50931

  • Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe

    Cologne, 50931

  • Johannes Apotheke Klinikversorgung

    Gröbenzell, 82194

  • Radiologie Muenchen

    München, 80634

  • Frauenklinik am Rotkreuzklinikum Muenchen

    München, 80637

  • Diagnostische und Interventionelle Radiologie

    Potsdam, 14467

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam, 14467

  • Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik

    Würzburg, 97080

Other trials in Germany

Russia11 sites

  • Limited liability company (LLC) EVIMED

    Chelyabinsk, Chelyabinsk Oblast, 454048

  • State Budgetary Healthcare Institution

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary

    Ivanovo, Ivanovo Oblast, 153040

  • SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"

    Kazan', Tatarstan Republic, 420029

  • SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department

    Moscow, 111123

  • FSBI National Research Medical Center of Oncology N.A.

    Moscow, 115478

  • Clinic

    Moscow, 121309

  • Limited liability company VitaMed-LLC VitaMed

    Moscow, 129515

  • FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre

    Obninsk, Kaluga Oblast, 249036

  • SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)

    Orenburg, Orenburg Oblast, 460021

  • SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care

    Saint Petersburg, 197758

Other trials in Russia

Taiwan11 sites

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 100

  • Clinical Trial Pharmacy, MacKay Memorial Hospital

    Taipei, 10449

  • Mackay Memorial Hospital

    Taipei, 104

  • Cathay General Hospital

    Taipei, 106

  • Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Clinical Trial Pharmacy, Taipei Veterans General Hospital

    Taipei, 112

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan City, 333

  • Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Italy9 sites

  • Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi

    Bologna, BO, 40138

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi

    Bologna, BO, 40138

  • E.O. Ospedali Galliera

    Genova, GE, 16128

  • Farmacia Galliera

    Genova, GE, 16128

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

  • Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale

    Naples, 80131

  • Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente

    Roma, 00168

  • Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario

    Sondrio, SO, 23100

Other trials in Italy

Ireland8 sites

  • Bon Secours Hospital Ireland

    Cork

  • Bon Secours Hospital

    Cork

  • Mater Misericordiae University Hospital

    Dublin, Dublin, 7

  • Mater Private Hospital

    Dublin, Dublin, Dublin 7

  • Pharmacy Department, St James's Hospital

    Dublin, 8

  • Mater Misericordiae University Hospital

    Dublin, D7

  • Mater Private Hospital

    Dublin, D7

  • St James's Hospital

    Dublin

Other trials in Ireland

Poland8 sites

  • Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna

    Gdynia, 81-519

  • Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii

    Gdynia, 81-519

  • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna

    Krakow, 31-115

  • Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie

    Krakow, 31-115

  • Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna

    Olsztyn, 10-561

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561

  • Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

    Opole, 45-061

  • Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w

    Poznan, 60-535

Other trials in Poland

Latvia7 sites

  • Daugavpils Regional Hospital, Oncology Department (11 floor)

    Daugavpils, LV5417

  • Daugavpils Regional Hospital

    Daugavpils, LV5417

  • Natalja Goncarova -Radiology Services

    Daugavpils, LV5417

  • Inga Vigule-Radiology services

    Liepāja, LV-3414

  • Liepaja Regional hospital

    Liepāja, LV3414

  • Pauls Stradins Clinical University Hospital

    Riga, LV 1002

  • Medical Society "ARS" Ltd

    Riga, LV-1010

Other trials in Latvia

Netherlands7 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Pharmacy Universitair Medisch Centrum Groningen

    Groningen, 9713 AP

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • LUMC

    Leiden, 2333 ZA

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Pharmacy Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 AP

  • Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • McGill University Health Centre-Glen Site

    Montreal, Quebec, H4A 3J1

  • Oncology Pharmacy McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • CHU de Quebec-Universite Laval

    Québec, Quebec, G1R 2J6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Turkey (Türkiye)6 sites

  • Baskent University Adana Training and Research Hospital

    Adana, 01120

  • Baskent University Ankara Hospital, Department of Oncology

    Ankara, 06490

  • Bezmialem Vakif University Medical Faculty Hospital

    Istanbul, 34093

  • Istanbul University Oncology Institute

    Istanbul, 34093

  • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Ege University Faculty of Medicine Hospital

    Izmir, 35100

Other trials in Turkey (Türkiye)

Ukraine6 sites

  • Communal Institution Chernivtsi Regional Clinical Oncology Dispensary

    Chernivtsi, 58013

  • Cl Dnipropetrovsk City Multifield Clinical Hospital

    Dnipropetrovsk, 49102

  • Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council

    Kryviy Rig, 50048

  • Clinic of National Cancer Institute

    Kyiv, 03022

  • CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"

    Lviv, 79031

  • Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department

    Uzhhorod, 88000

Other trials in Ukraine

Estonia5 sites

  • East Tallinn Central Hospital

    Tallinn, 10138

  • East-Tallinn Central Hospital, Center of Oncology

    Tallinn, 11312

  • North Estonia Medical Centre Foundation, Pharmacy

    Tallinn, 13419

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital, Hematology and Oncology Clinic

    Tartu, 51014

Other trials in Estonia

Slovakia5 sites

  • NsP sv. Jakuba, n.o. , Bardejov

    Bardejov, 08501

  • Onkologicky ustav sv. Alzbety a.s.

    Bratislava, 81250

  • Narodny onkologicky ustav

    Bratislava, 83310

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 04191

  • POKO Poprad s.r.o.

    Poprad, 05801

Other trials in Slovakia

Hungary4 sites

  • Semmelweis Egyetem Onkologiai Kozpont

    Budapest, 1083

  • Debreceni Egyetem Klinikai Gyogyszertar

    Debrecen, 4032

  • Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika

    Debrecen, 4032

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont

    Szolnok, 5000

Other trials in Hungary

Switzerland4 sites

  • Oncology Institute of Southern Switzerland (IOSI)

    Bellinzona, Canton Ticino, 6500

  • Ospedale San Giovanni

    Bellinzona, Canton Ticino, 6500

  • Radiologia ORBV

    Bellinzona, Canton Ticino, 6500

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8401

Other trials in Switzerland

Romania3 sites

  • SC Medisprof SRL

    Cluj-Napoca, Cluj, 400641

  • SC Oncolab SRL

    Craiova, Dolj, 200385

  • SC Centrul de Oncologie Euroclinic SRL

    Iași, 700106

Other trials in Romania

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • National University Hospital, Pharmacy @ NCIS

    Singapore, 119082

  • Raffles Hospital

    Singapore, 188770

Other trials in Singapore

Bulgaria2 sites

  • MHAT for Female Health-Nadezhda OOD

    Sofia, 1373

  • Shato Ead

    Sofia, 1756

Other trials in Bulgaria

Croatia2 sites

  • Klinicki bolnicki centar Split

    Split, 21000

  • Klinicki bolnicki centar Sestre milosrdnice

    Zagreb, 10000

Other trials in Croatia

Hong Kong2 sites

  • Queen Elizabeth Hospital

    Hong Kong

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

Mexico2 sites

  • Instituto Nacional de Cancerologia

    Mexico City, Mexico City, 14080

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

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

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.

Conditions
Ovarian Cancer
Keywords
untreated epithelial ovarian, fallopian tube, primary peritoneal cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    Given Q3W during chemotherapy phase

  • paclitaxelDrug

    Investigator choice of weekly or Q3W during chemotherapy phase

  • AvelumabDrug

    Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion

  • AvelumabDrug

    Given as single agent in maintenance portion Q2W

Study groups in NCT02718417
Study groupRoleWhat they receive
Arm AActive comparatorChemotherapy followed by observation
Receives: Drug: carboplatin; Drug: paclitaxel
Arm BExperimentalChemotherapy followed by avelumab in maintenance
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: Avelumab
Arm CExperimentalChemotherapy in combination with avelumab followed by avelumab in maintenance
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

Secondary outcomes (35)

  1. 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.

    Measured: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

  2. 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.

    Measured: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

  8. 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

    Measured: 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)

  9. 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.

    Measured: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

  10. 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.

    Measured: 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)

  11. 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.

    Measured: 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)

  12. 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.

    Measured: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)

  13. 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].

    Measured: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

  14. 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.

    Measured: 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)

  15. 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.

    Measured: 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)

  16. 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.

    Measured: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

  17. 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'.

    Measured: 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)

  18. 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.

    Measured: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)

  19. 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.

    Measured: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

  20. 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.

    Measured: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

  21. 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.

    Measured: Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2

  22. 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.

    Measured: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

  23. 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.

    Measured: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

  24. 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.

    Measured: Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2

  25. 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).

    Measured: Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

  26. 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).

    Measured: Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

  27. 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.

    Measured: Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2

  28. 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).

    Measured: Pre-dose (0 hour) on Day 1 of Cycle 2

  29. 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).

    Measured: End of avelumab infusion on Day 1 of Cycle 2

  30. 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).

    Measured: End of infusion on Day 1 of Cycle 2

  31. 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).

    Measured: Pre-dose (0 hour) on Day 1 of Cycle 2

  32. 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.

    Measured: Up to 36 months

  33. 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.

    Measured: Up to 36 months

  34. 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.

    Measured: Up to 36 months

  35. 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.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2016 (estimated)
  2. Study start19 May 2016
  3. Primary completion7 Sep 2018
  4. Study completion16 May 2019

Why it stopped: The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
998 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718417
Sponsor's protocol ID
B9991010
Other IDs
2015-003239-36, JAVELIN OVARIAN 100, 2015
Status last verified
Jun 2020
First submitted
15 Mar 2016
Last updated
14 Jul 2020
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 34363762

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, paclitaxel and Avelumab in people with Ovarian Cancer, run by Pfizer at 319 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 319 sites in United States, United Kingdom, Japan, South Korea, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (time frame: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718417, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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