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)

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580058
• Other study ID #: B9991009
• Secondary ID: 2015-003091-77JA
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2015
• Est. completion date: July 12, 2022

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: July 12, 2022
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
• Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
• Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
• Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible. Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Drug:
• PLD
PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles

Locations

Country	Name	City	State
Australia	Icon Cancer Care Wesley	Auchenflower	Queensland
Australia	Rivercity Pharmacy	Auchenflower	Queensland
Australia	Cabrini Health Limited	Brighton	Victoria
Australia	Mater Pharmacy Services	Brisbane	Queensland
Australia	Icon Cancer Care Chermside	Chermside	Queensland
Australia	Clinical Research Unit	Herston	Queensland
Australia	Metro North Hospital and Health Service	Herston	Queensland
Australia	Oncology Pharmacy	Herston	Queensland
Australia	Cabrini Health Limited	Malvern	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Epic Pharmacy,Newcastle Private Hospital	New Lambton Heights	New South Wales
Australia	Newcastle Private Hospital Pty Limited	Newcastle	New South Wales
Australia	Pharmacy Department	Parkville	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	The Royal Women's Hospital	Parkville	Victoria
Australia	Icon Cancer Care	South Brisbane	Queensland
Australia	Icon Cancer Foundation	South Brisbane	Queensland
Australia	Mater Cancer Care Centre	South Brisbane	Queensland
Australia	Icon Cancer Care Southport	Southport	Queensland
Austria	Medizinische Universitat Graz, LKH-Univ. Klinikum Graz	Graz
Austria	Medizinische Universitat Innsbruck	Innsbruck
Belgium	Institut Jules Bordet	Brussels
Belgium	University Hospital Gent	Gent	EAST Flanders
Belgium	AZ Groeninge Hospital	Kortrijk
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Belgium	CHU de Liege - Sart Tilman	Liege
Belgium	Clinique et Maternite Sainte Elisabeth	Namur
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Nova Scotia Health Authority, QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior	Kelowna	British Columbia
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	Oncology Pharmacy McGill University Health Centre	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	British Columbia Cancer Agency-Vancouver Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika	Praha 2	Czech Republic
Czechia	Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,	Praha 2
Czechia	Vseobecna fakultni nemocnice v Praze, Neurologicka klinika	Praha 2
Czechia	Fakultni nemocnice v Motole	Praha 5
Czechia	Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z	Usti nad Labem
Denmark	Aalborg University Hospital	Aalborg
Denmark	Rigshospitalet	Copenhagen
France	Centre Francois Baclesse	Caen Cedex 5
France	Centre Leon Berard	Lyon cedex 08
France	Service de Radiologie	LYON cedex 8
France	Centre Antoine Lacassagne	Nice cedex 2
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Européen Georges Pompidou	Paris cedex 15
France	Centre Hospitalier Lyon Sud	Pierre Benite cedex
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy
France	Gustave Roussy Cancer Campus	Villejuif cedex
Greece	General Hospital of Athens Alexandra	Athens
Greece	General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology	Athens/New Kifissia
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	University of Hong Kong	Hong Kong
Hungary	Orszagos Onkologiai Intezet, Gyogyszertar	Budapest
Hungary	Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly	Budapest
Hungary	Debreceni Egyetem Klinikai Gyogyszertar	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont	Szolnok
Ireland	Mater Misericoridae University Hospital	Dublin
Ireland	Mater Private Hospital	Dublin
Ireland	St James's Hospital	Dublin
Ireland	Pharmacy Department	Dublin 4
Ireland	St Vincent's University Hospital	Dublin 4
Ireland	Mater Misericordiae University Hospital	Dublin 7	Dublin
Ireland	Mater Private Hospital	Dublin 7	Dublin
Ireland	University Hospital Waterford	Waterford
Israel	Shaare Zedek Medical Center	Jerusalem
Italy	Habilita, San Marco Bergamo	Bergamo
Italy	Humanitas Cliniche Gavazzeni	Bergamo
Italy	Humanitas, Unita Operativa di Cardiologia 2	Bergamo
Italy	Fondazione Poliambulanza Istituto Ospedelario	Brescia
Italy	Fondazione del Piemonte per l'Oncologia	Candiolo	Torino
Italy	Congregazione delle Suore Infermiere dell'Addolorata	Como
Italy	Congregazione delle Suore Infermiere dell'Addolorata	Costa Masnaga	Lecco
Italy	Fondazione Teresa Camplani	Cremona
Italy	Regione Lombardia, A O Istituti Ospitalieri di Cremona	Cremona
Italy	Regione Lombardia, ASST Cremona	Cremona
Italy	Servizio Sanitario Regionale Emilia-Romagna	Lugo	Ravenna
Italy	Poliambulatorio Specialistico Villa Salute	Manerbio	Brescia
Italy	ASST Fatebenefratelli Sacco	Miano	Milano
Italy	Istituto Europeo di Oncologia	Milano
Italy	Ambulatorio dott. Francesco Cavanna, Medico Chirurgo	Piacenza
Italy	Azienda Unita Sanitaria Locale di Piacenza	Piacenza
Italy	Azienda USL 4 Prato	Prato
Italy	Azienda USL 4 Toscana Centro	Prato
Italy	Servizio Sanitario Regionale Emilia-Romagna	Rimini
Italy	C D C, Sede di Torino Centro	Torino
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Kagoshima City Hospital	Kagoshima
Japan	Kagoshima University Hospital	Kagoshima
Japan	Nippon Medical School Musashikosugi Hospital	Kawasaki	Kanagawa
Japan	Saitama Cancer Center	Kita-adachi-gun	Saitama
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	National Defense Medical College Hospital	Tokorozawa	Saitama
Japan	Ehime University Hospital	Toon	Ehime
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Korea, Republic of	Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	National Cancer Center	Goyangsi	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center Clinical Trial Pharmacy	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy	Seoul
Korea, Republic of	The Catholic University of Korea	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	LUMC	Leiden
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Norway	Department of Obstetrics and Gynecology, Haukeland University Hospital	Bergen
Norway	Sykehusapoteket i Bergen	Bergen
Norway	Oslo Universitetssykehus	Oslo
Norway	Sykehusapoteket Oslo	Oslo
Poland	Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie	Krakow
Poland	Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna	Krakow
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna	Olsztyn
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego	Poznan
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w	Poznan
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku	Rybnik
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna	Rybnik
Russian Federation	Evimed Llc	Chelyabinsk
Russian Federation	State Budgetary Healthcare Institution	Chelyabinsk
Russian Federation	State Budgetary Healthcare Institution "Clinical oncology dispensary #1"	Krasnodar
Russian Federation	Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"	Moscow
Russian Federation	State Budgetary Healthcare Institution of Nizhegorogsky region	Nizhniy Novgorod
Russian Federation	State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"	Orenburg
Russian Federation	State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary	Pyatigorsk	Stavropol Region
Russian Federation	State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center	Saint Petersburg
Russian Federation	State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare	Sochi	Krasnodar Region
Russian Federation	State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"	Velikiy Novgorod
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National Cancer Centre Singapore Pharmacy	Singapore
Singapore	National University Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Raffles Hospital	Singapore
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta	Girona
Spain	Institut Catala d'Oncologia - Hospital Duran y Reynalds	L'Hospitalet de Llobregat	Barcelona
Spain	Centro Integral Oncologico Clara Campal	Madrid
Spain	Hospital MD Anderson	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen de Valme	Sevilla
Switzerland	Universitatsspital Basel	Basel	Basel-stadt
Switzerland	Universitatsspital Basel, Frauenklinik	Basel	Basel-stadt
Switzerland	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona	Ticino
Switzerland	Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie	Luzern 16	Luzern
Switzerland	Kantonsapotheke Zurich	Zurich
Switzerland	Universitaetsspital Zurich, Klinik fuer Gynakologie	Zurich
Switzerland	Universitatsspital Zurich, Clinical Trials Center	Zurich
Switzerland	Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie	Zurich
Switzerland	Universitatsspital Zurich, Universitares Herzzentrum Zurich	Zurich
Taiwan	Clinical Trial Pharmacy, National Cheng Kung University Hospital	Tainan city
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	Clinical Trial Pharmacy, Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center	Taipei City
Taiwan	Clinical Trial Pharmacy, Mackay Memorial Hospital	Taipei City
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei City
Taiwan	Mackay Memorial Hospital	Taipei City
Taiwan	National Taiwan University Hospital	Taipei city
Taiwan	Chang Gung Memorial Hospital - Linkou Branch	Taoyuan City
Taiwan	Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch	Taoyuan City
United Kingdom	The Clatterbridge Cancer Centre	Bebington, Wirral	Merseyside
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Bebington, Wirral	Merseyside
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Ross Hall Hospital	Glasgow	CITY OF Glasgow
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Headington	Oxford
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London
United Kingdom	Guy's & St. Thomas' NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospital NHS Foundation Trust	London
United Kingdom	University College London Hospital NHS Foundation Trust	London
United Kingdom	The Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Northampton General Hospital NHS Trust	Northampton	Northamptonshire
United Kingdom	East and North Hertfordshire NHS Trust	Northwood	Middlesex
United Kingdom	Nottingham University Hospital NHS Trust	Nottingham
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Spire Healthcare Limited (St. Anthony's Hospital)	Sutton	Surrey
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey
United States	Southwest GYN Oncology Associates, Inc.	Albuquerque	New Mexico
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	Hope Women's Cancer Centers	Asheville	North Carolina
United States	Mission Hospital, Inc.	Asheville	North Carolina
United States	Atlanta Gynecologic Oncology	Atlanta	Georgia
United States	Northside Hospital - Pharmacy	Atlanta	Georgia
United States	University Gynecologic Oncology	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Northwest Georgia Oncology Centers, P.C.	Austell	Georgia
United States	Texas Oncology-Austin Central	Austin	Texas
United States	Texas Oncology-South Austin	Austin	Texas
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Maryland Oncology Hematology, P.A.	Bethesda	Maryland
United States	Brigham Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Northwest Georgia Oncology Centers, P.C.	Carrollton	Georgia
United States	Northwest Georgia Oncology Centers, P.C.	Cartersville	Georgia
United States	Arizona Oncology Associates, PC - HAL	Chandler	Arizona
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Fairview Hospital Moll Pavilion Cancer Center	Cleveland	Ohio
United States	Fairview Hospital Moll Pavilion Pharmacy	Cleveland	Ohio
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Florida Cancer Specialists	Daytona Beach	Florida
United States	Tennessee Oncology, PLLC	Dickson	Tennessee
United States	Northwest Georgia Oncology Centers, P.C.	Douglasville	Georgia
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	The University of Kansas Clinical Research Center	Fairway	Kansas
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Texas Oncology -Fort Worth Cancer Center	Fort Worth	Texas
United States	Tennessee Oncology, PLLC	Franklin	Tennessee
United States	Tennessee Oncology, PLLC	Gallatin	Tennessee
United States	Tennessee Oncology, PLLC	Hermitage	Tennessee
United States	US Oncology Investigational Products Center	Irving	Texas
United States	US Oncology Investigational Products Center (IPC)	Irving	Texas
United States	The University of Kansas Cancer Center, CCP - North	Kansas City	Missouri
United States	Novant Health Oncology Specialists	Kernersville	North Carolina
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Tennessee Oncology, PLLC	Lebanon	Tennessee
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Norton Cancer Institute, Brownsboro Hospital Campus	Louisville	Kentucky
United States	Norton Cancer Institute, Norton Healthcare Pavilion	Louisville	Kentucky
United States	Norton Cancer Institute, St. Matthews Campus	Louisville	Kentucky
United States	Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D	Louisville	Kentucky
United States	Norton Hospital	Louisville	Kentucky
United States	Norton Women's and Children's Hospital	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Hillcrest Hospital	Mayfield Heights	Ohio
United States	Hillcrest Hospital Hirsch Cancer Center Pharmacy	Mayfield Heights	Ohio
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	Tennessee Oncology, PLLC	Murfreesboro	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	University of California, Irvine/UC Irvine Health	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Investigational Drug Services, University of Pennsylvania	Philadelphia	Pennsylvania
United States	The University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Arizona Oncology Associates, PC - HAL	Phoenix	Arizona
United States	Arizona Oncology Associates, PC - HAL	Phoenix	Arizona
United States	Center of Hope at Renown Regional Medical Center	Reno	Nevada
United States	Carilion Clinic	Roanoke	Virginia
United States	Carilion Clinic Gynecologic Oncology	Roanoke	Virginia
United States	Highlands Oncology Group	Rogers	Arkansas
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Texas Oncology - San Antonio Medical Center	San Antonio	Texas
United States	Sansum Clinic	Santa Barbara	California
United States	Arizona Oncology Associates, PC - HAL	Scottsdale	Arizona
United States	Tennessee Oncology, PLLC	Shelbyville	Tennessee
United States	Maryland Oncology Hematology P.A.	Silver Spring	Maryland
United States	Maryland Oncology Hematology P.A.	Silver Spring	Maryland
United States	Tennessee Oncology, PLLC	Smyrna	Tennessee
United States	Sansum Clinic	Solvang	California
United States	Arizona Oncology Associates, PC-HAL	Tempe	Arizona
United States	Texas Oncology - The Woodlands, Gynecologic Oncology	The Woodlands	Texas
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Florida Cancer Specialists	Wellington	Florida
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	The University of Kansas Cancer Center and Medical Pavilion	Westwood	Kansas
United States	Novant Health Oncology Specialists	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

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

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