AzTrials
AzTrials

Ovarian CancerPhase 3NCT02580058

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 study testing avelumab and PLD in people with Ovarian Cancer, run by Pfizer at 295 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. 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?
avelumab and PLD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
566 participants
Where
295 sitesin 25 countries
Study dates
21 Dec 2015to 12 Jul 2022
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 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.

Who cannot join

  • 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.

Trial locations and contacts

295 sites in 25 countries.

295 sites in 25 countries

United States87 sites

  • Southwest GYN Oncology Associates, Inc.

    Albuquerque, New Mexico, 87106

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87106

  • Hope Women's Cancer Centers

    Asheville, North Carolina, 28806

  • Mission Hospital, Inc.

    Asheville, North Carolina, 28806

  • Atlanta Gynecologic Oncology

    Atlanta, Georgia, 30342

  • Northside Hospital - Pharmacy

    Atlanta, Georgia, 30342

  • University Gynecologic Oncology

    Atlanta, Georgia, 30342

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Northwest Georgia Oncology Centers, P.C.

    Austell, Georgia, 30106

  • Texas Oncology-Austin Central

    Austin, Texas, 78731

  • Texas Oncology-South Austin

    Austin, Texas, 78745

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Maryland Oncology Hematology, P.A.

    Bethesda, Maryland, 20817

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Northwest Georgia Oncology Centers, P.C.

    Carrollton, Georgia, 30117

  • Northwest Georgia Oncology Centers, P.C.

    Cartersville, Georgia, 30121

  • Arizona Oncology Associates, PC - HAL

    Chandler, Arizona, 85224

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44106

  • Fairview Hospital Moll Pavilion Cancer Center

    Cleveland, Ohio, 44111

  • Fairview Hospital Moll Pavilion Pharmacy

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Northwest Georgia Oncology Centers, P.C.

    Douglasville, Georgia, 30134

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Texas Oncology -Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Products Center

    Irving, Texas, 75063

  • The University of Kansas Cancer Center, CCP - North

    Kansas City, Missouri, 64154

  • Novant Health Oncology Specialists

    Kernersville, North Carolina, 27284

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Norton Cancer Institute, Norton Healthcare Pavilion

    Louisville, Kentucky, 40202

  • Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207

  • Norton Women's and Children's Hospital

    Louisville, Kentucky, 40207

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Hillcrest Hospital Hirsch Cancer Center Pharmacy

    Mayfield Heights, Ohio, 44124

  • Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • 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

  • University of California, Irvine/UC Irvine Health

    Orange, California, 92868

  • Investigational Drug Services, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85027

  • Center of Hope at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Carilion Clinic Gynecologic Oncology

    Roanoke, Virginia, 24016

  • Carilion Clinic

    Roanoke, Virginia, 24016

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Arizona Oncology Associates, PC - HAL

    Scottsdale, Arizona, 85258

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Maryland Oncology Hematology P.A.

    Silver Spring, Maryland, 20902

  • Maryland Oncology Hematology P.A.

    Silver Spring, Maryland, 20904

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Sansum Clinic

    Solvang, California, 93463

  • Arizona Oncology Associates, PC-HAL

    Tempe, Arizona, 85284

  • Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • Florida Cancer Specialists

    Wellington, Florida, 33414

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • The University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

Italy20 sites

  • Habilita, San Marco Bergamo

    Bergamo, 24122

  • Humanitas Cliniche Gavazzeni

    Bergamo, 24125

  • Humanitas, Unita Operativa di Cardiologia 2

    Bergamo, 24125

  • Fondazione Poliambulanza Istituto Ospedelario

    Brescia, 25124

  • Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060

  • Congregazione delle Suore Infermiere dell'Addolorata

    Como, 22100

  • Congregazione delle Suore Infermiere dell'Addolorata

    Costa Masnaga, Lecco, 23845

  • Fondazione Teresa Camplani

    Cremona, 26100

  • Regione Lombardia, A O Istituti Ospitalieri di Cremona

    Cremona, 26100

  • Regione Lombardia, ASST Cremona

    Cremona, 26100

  • Servizio Sanitario Regionale Emilia-Romagna

    Lugo, Ravenna, 48022

  • Poliambulatorio Specialistico Villa Salute

    Manerbio, Brescia, 25025

  • ASST Fatebenefratelli Sacco

    Miano, Milano, 20121

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Ambulatorio dott. Francesco Cavanna, Medico Chirurgo

    Piacenza, 29121

  • Azienda Unita Sanitaria Locale di Piacenza

    Piacenza, 29121

  • Azienda USL 4 Prato

    Prato, 59100

  • Azienda USL 4 Toscana Centro

    Prato, 59100

  • Servizio Sanitario Regionale Emilia-Romagna

    Rimini, 47921

  • C D C, Sede di Torino Centro

    Torino, 10122

Other trials in Italy

Australia19 sites

  • Icon Cancer Care Wesley

    Auchenflower, Queensland, 4066

  • Rivercity Pharmacy

    Auchenflower, Queensland, 4066

  • Cabrini Health Limited

    Brighton, Victoria, 3186

  • Mater Pharmacy Services

    Brisbane, Queensland, 4101

  • Icon Cancer Care Chermside

    Chermside, Queensland, 4032

  • Clinical Research Unit

    Herston, Queensland, 4029

  • Metro North Hospital and Health Service

    Herston, Queensland, 4029

  • Oncology Pharmacy

    Herston, Queensland, 4029

  • Cabrini Health Limited

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Epic Pharmacy,Newcastle Private Hospital

    New Lambton Heights, New South Wales, 2305

  • Newcastle Private Hospital Pty Limited

    Newcastle, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Pharmacy Department

    Parkville, Victoria, 3052

  • The Royal Women's Hospital

    Parkville, Victoria, 3052

  • Icon Cancer Care

    South Brisbane, Queensland, 4101

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

  • Mater Cancer Care Centre

    South Brisbane, Queensland, 4101

  • Icon Cancer Care Southport

    Southport, Queensland, 4215

Other trials in Australia

Japan19 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kagoshima City Hospital

    Kagoshima, 890-8760

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki, Kanagawa, 211-8533

  • Saitama Cancer Center

    Kita-adachi-gun, Saitama, 362-0806

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • National Defense Medical College Hospital

    Tokorozawa, Saitama, 359-8513

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

United Kingdom19 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, Merseyside, CH63 4JY

  • The Clatterbridge Cancer Centre

    Bebington, Wirral, Merseyside, CH63 4JY

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0QQ

  • Ross Hall Hospital

    Glasgow, CITY of Glasgow, G52 3NQ

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

  • Oxford University Hospitals NHS Foundation Trust

    Headington, Oxford, OX3 7LE

  • University College London Hospital NHS Foundation Trust

    London, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Guy's & St. Thomas' NHS Foundation Trust

    London, SE1 9RT

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • University College London Hospital NHS Foundation Trust

    London, WC1E 6AG

  • The Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • Northampton General Hospital NHS Trust

    Northampton, Northamptonshire, NN1 5BD

  • East and North Hertfordshire NHS Trust

    Northwood, Middlesex, HA6 2RN

  • Nottingham University Hospital NHS Trust

    Nottingham, NG5 1PB

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • Spire Healthcare Limited (St. Anthony's Hospital)

    Sutton, Surrey, SM3 9DW

Other trials in United Kingdom

Canada15 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Nova Scotia Health Authority, QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

    Kelowna, British Columbia, V1Y5L3

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • Oncology Pharmacy McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency-Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

South Korea13 sites

  • Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy

    Seoul, 03722

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center Clinical Trial Pharmacy

    Seoul, 06351

  • Samsung Medical Center

    Seoul, 06351

  • Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea

    Seoul, 06591

Other trials in South Korea

Taiwan11 sites

  • Clinical Trial Pharmacy, National Cheng Kung University Hospital

    Tainan, 701

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Clinical Trial Pharmacy, Mackay Memorial Hospital

    Taipei, 10449

  • Mackay Memorial Hospital

    Taipei, 104

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

    Taipei, 11259

  • 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

Russia10 sites

  • Evimed Llc

    Chelyabinsk, 454048

  • State Budgetary Healthcare Institution

    Chelyabinsk, 454087

  • State Budgetary Healthcare Institution "Clinical oncology dispensary #1"

    Krasnodar, 350040

  • Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"

    Moscow, 115478

  • State Budgetary Healthcare Institution of Nizhegorogsky region

    Nizhny Novgorod, 603081

  • State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"

    Orenburg, 460021

  • State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary

    Pyatigorsk, Stavropol Kray, 357502

  • State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center

    Saint Petersburg, 197758

  • State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare

    Sochi, Krasnodarskiy Kray, 354057

  • State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"

    Velikiy Novgorod, 173016

Other trials in Russia

France9 sites

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Leon Berard

    Lyon, 69373

  • Service de Radiologie

    Lyon, 69373

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy Cancer Campus

    Villejuif, 94805

Other trials in France

Switzerland9 sites

  • Universitatsspital Basel, Frauenklinik

    Basel, Canton of Basel-City, 4031

  • Universitatsspital Basel

    Basel, Canton of Basel-City, 4031

  • Oncology Institute of Southern Switzerland (IOSI)

    Bellinzona, Canton Ticino, 6500

  • Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie

    Lucerne, Canton of Lucerne, 6000

  • Kantonsapotheke Zurich

    Zurich, 8006

  • Universitaetsspital Zurich, Klinik fuer Gynakologie

    Zurich, 8091

  • Universitatsspital Zurich, Clinical Trials Center

    Zurich, 8091

  • Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie

    Zurich, 8091

  • Universitatsspital Zurich, Universitares Herzzentrum Zurich

    Zurich, 8091

Other trials in Switzerland

Czechia8 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika

    Prague, Czech Republic, 120 00

  • Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,

    Prague, 120 00

  • Vseobecna fakultni nemocnice v Praze, Neurologicka klinika

    Prague, 120 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12851

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z

    Ústí nad Labem, 401 13

Other trials in Czechia

Ireland8 sites

  • Mater Misericordiae University Hospital

    Dublin, Dublin, 7

  • Mater Private Hospital

    Dublin, Dublin, Dublin 7

  • St James's Hospital

    Dublin, 8

  • Mater Misericoridae University Hospital

    Dublin, D7

  • Mater Private Hospital

    Dublin, D7

  • Pharmacy Department

    Dublin

  • St Vincent's University Hospital

    Dublin

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Poland8 sites

  • 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

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w

    Poznan, 60-569

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

    Poznan, 60-569

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna

    Rybnik, 44-200

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

    Rybnik, 44-200

Other trials in Poland

Spain7 sites

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta

    Girona, 17007

  • Institut Catala d'Oncologia - Hospital Duran y Reynalds

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital MD Anderson

    Madrid, 28033

  • Hospital Universitario La Paz

    Madrid, 28046

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Virgen de Valme

    Seville, 41014

Other trials in Spain

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • University Hospital Gent

    Ghent, EAST Flanders, 9000

  • AZ Groeninge Hospital

    Kortrijk, 8500

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

  • CHU de Liege - Sart Tilman

    Liège, 4000

  • Clinique et Maternite Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Hungary5 sites

  • Orszagos Onkologiai Intezet, Gyogyszertar

    Budapest, 1122

  • Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

    Budapest, 1122

  • Debreceni Egyetem Klinikai Gyogyszertar

    Debrecen, 4032

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

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

    Szolnok, 5000

Other trials in Hungary

Singapore5 sites

  • National University Hospital

    Singapore, 119074

  • National University Hospital

    Singapore, 119082

  • National Cancer Centre Singapore Pharmacy

    Singapore, 169610

  • National Cancer Centre Singapore

    Singapore, 169610

  • Raffles Hospital

    Singapore, 188770

Other trials in Singapore

Netherlands4 sites

  • 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

Other trials in Netherlands

Norway4 sites

  • Department of Obstetrics and Gynecology, Haukeland University Hospital

    Bergen, 5021

  • Sykehusapoteket i Bergen

    Bergen, 5053

  • Oslo Universitetssykehus

    Oslo, 0379

  • Sykehusapoteket Oslo

    Oslo, 0379

Other trials in Norway

Austria2 sites

  • Medizinische Universitat Graz, LKH-Univ. Klinikum Graz

    Graz, 8036

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

Other trials in Austria

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Greece2 sites

  • General Hospital of Athens Alexandra

    Athens, 11528

  • General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology

    Athens/New Kifissia, 14564

Other trials in Greece

Hong Kong2 sites

  • Princess Margaret Hospital

    Hong Kong

  • University of Hong Kong

    Hong Kong

Other trials in Hong Kong

Israel1 site

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

Other trials in Israel

About this study

Official title: 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.

Conditions
Ovarian Cancer
Being tested
avelumab, PLD
Keywords
platinum resistant, platinum refractory
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • avelumabBiological

    10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles

  • PLDDrug

    Also called doxorubicin, caelyx

    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

Study groups in NCT02580058
Study groupRoleWhat they receive
avelumabExperimentalArm A: avelumab alone
Receives: Biological: avelumab
avelumab plus pegylated liposomal doxorubicin (PLD)ExperimentalArm B: avelumab plus PLD
Receives: Biological: avelumab; Drug: PLD
PLDActive comparatorArm C: PLD alone
Receives: Drug: PLD

What is being measured

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

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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 outcomes (27)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: 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.

  8. 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.

    Measured: 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.

  9. 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).

    Measured: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.

  10. 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.

    Measured: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.

  11. 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.

    Measured: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.

  12. 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.

    Measured: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.

  13. 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.

    Measured: Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.

  14. 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.

    Measured: Biomarkers are measured only at screening.

  15. 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.

    Measured: Biomarkers are measured only at screening.

  16. 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.

    Measured: 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.

  17. 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.

    Measured: From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.

  18. 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.

    Measured: Baseline and end of treatment/withdrawal visit

  19. 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.

    Measured: At predose (0 H) on Cycle 2 Day 1

  20. 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.

    Measured: At postdose (end of infusion, 1H) on Cycle 2 Day 1

  21. 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.

    Measured: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose

  22. 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.

    Measured: From 0 through 24 hours postdose

  23. 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.

    Measured: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose

  24. 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).

    Measured: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose

  25. 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.

    Measured: 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

  26. 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.

    Measured: 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

  27. 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.

    Measured: 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

Timeline

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

  1. First posted20 Oct 2015 (estimated)
  2. Study start21 Dec 2015
  3. Primary completion19 Sep 2018
  4. Study completion12 Jul 2022

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
566 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02580058
Sponsor's protocol ID
B9991009
Other IDs
2015-003091-77, JAVELIN OVARIAN 200, 2015
Status last verified
Jun 2023
First submitted
16 Oct 2015
Last updated
10 Jul 2023
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

  • Bonaca MP, Moslehi JJ, Ledermann JA, Michelon E, Wei C, Moran M, Monk BJ, Pujade-Lauraine E. Left Ventricular Ejection Fraction in Patients With Ovarian Cancer Treated With Avelumab, Pegylated Liposomal Doxorubicin, or Both. Oncologist. 2023 Oct 3;28(10):e977-e980. doi: 10.1093/oncolo/oyad213.

    PubMed 37665777

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

  • 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.

    PubMed 34143970

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing avelumab and PLD in people with Ovarian Cancer, run by Pfizer at 295 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: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 295 sites in United States, Italy, Australia, Japan, United Kingdom 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 19 Nov 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?

Overall Survival (OS) (time frame: 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).). The study lists 2 primary outcomes in all. 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 NCT02580058, which also lists 3 linked publications.

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 10 Jul 2023.

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