Clinical trial NCT02580058: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: platinum resistant
platinum refractory
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 566
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 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).
measure: Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: 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:
measure: Objective Response Rate (ORR) Based on BICR Assessment
timeFrame: 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.
measure: ORR Based on Investigator Assessment
timeFrame: 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.
measure: PFS Based on Investigator Assessment According to RECIST Version 1.1
timeFrame: 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.
measure: Duration of Response (DR) Based on BICR Assessment
timeFrame: 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.
measure: DR Based on Investigator Assessment
timeFrame: 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.
measure: Disease Control (DC) Rate Based on BICR Assessment
timeFrame: 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.
measure: DC Rate Based on Investigator Assessment
timeFrame: 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.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: 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.
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
measure: Change From Baseline in Vital Signs - Blood Pressure
timeFrame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
measure: Change From Baseline in Vital Signs - Pulse Rate
timeFrame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
measure: Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline
timeFrame: Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
measure: Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS
timeFrame: Biomarkers are measured only at screening.
measure: Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS
timeFrame: Biomarkers are measured only at screening.
measure: Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL
timeFrame: 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.
measure: Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28
timeFrame: From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
measure: Change From Baseline in EQ-VAS Score at End of Treatment
timeFrame: Baseline and end of treatment/withdrawal visit
measure: Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose
timeFrame: At predose (0 H) on Cycle 2 Day 1
measure: Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose
timeFrame: At postdose (end of infusion, 1H) on Cycle 2 Day 1
measure: Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose
timeFrame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
measure: Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
timeFrame: From 0 through 24 hours postdose
measure: Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
timeFrame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
measure: Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
timeFrame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
measure: Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)
timeFrame: 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
measure: Number of Participants With Treatment-Induced ADA
timeFrame: 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
measure: Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)
timeFrame: 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
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Tempe
country: United States
facility: Arizona Oncology Associates, PC-HAL
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Orange
country: United States
facility: University of California, Irvine/UC Irvine Health
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Solvang
country: United States
facility: Sansum Clinic
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Daytona Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Wellington
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gynecologic Oncology
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital - Pharmacy
state: Georgia
city: Atlanta
country: United States
facility: University Gynecologic Oncology
state: Georgia
city: Austell
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Carrollton
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Cartersville
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Douglasville
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Fairway
country: United States
facility: The University of Kansas Clinical Research Center
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute, Norton Healthcare Pavilion
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, St. Matthews Campus
state: Kentucky
city: Louisville
country: United States
facility: Norton Women's and Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Brownsboro Hospital Campus
state: Kentucky
city: Bethesda
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology P.A.
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology P.A.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, CCP - North
state: Missouri
city: Reno
country: United States
facility: Center of Hope at Renown Regional Medical Center
state: Nevada
city: Albuquerque
country: United States
facility: Southwest GYN Oncology Associates, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Asheville
country: United States
facility: Hope Women's Cancer Centers
state: North Carolina
city: Asheville
country: United States
facility: Mission Hospital, Inc.
state: North Carolina
city: Kernersville
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital Moll Pavilion Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital Moll Pavilion Pharmacy
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital Hirsch Cancer Center Pharmacy
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Investigational Drug Services, University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Shelbyville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Central
state: Texas
city: Austin
country: United States
facility: Texas Oncology-South Austin
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology -Fort Worth Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands, Gynecologic Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Roanoke
country: United States
facility: Carilion Clinic Gynecologic Oncology
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
city: New Lambton Heights
country: Australia
facility: Epic Pharmacy,Newcastle Private Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Newcastle Private Hospital Pty Limited
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Auchenflower
country: Australia
facility: Rivercity Pharmacy
state: Queensland
city: Brisbane
country: Australia
facility: Mater Pharmacy Services
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: Herston
country: Australia
facility: Clinical Research Unit
state: Queensland
city: Herston
country: Australia
facility: Metro North Hospital and Health Service
state: Queensland
city: Herston
country: Australia
facility: Oncology Pharmacy
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Care Southport
state: Queensland
city: Brighton
country: Australia
facility: Cabrini Health Limited
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health Limited
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Parkville
country: Australia
facility: Pharmacy Department
state: Victoria
city: Parkville
country: Australia
facility: The Royal Women's Hospital
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universitat Graz, LKH-Univ. Klinikum Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: Gent
country: Belgium
facility: University Hospital Gent
state: EAST Flanders
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Kortrijk
country: Belgium
facility: AZ Groeninge Hospital
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Liege
country: Belgium
facility: CHU de Liege - Sart Tilman
city: Namur
country: Belgium
facility: Clinique et Maternite Sainte Elisabeth
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency-Vancouver Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, QEII Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Montreal
country: Canada
facility: Oncology Pharmacy McGill University Health Centre
state: Quebec
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika
state: Czech Republic
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze, Neurologicka klinika
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Caen Cedex 5
country: France
facility: Centre Francois Baclesse
city: Lyon cedex 08
country: France
facility: Centre Leon Berard
city: LYON cedex 8
country: France
facility: Service de Radiologie
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris cedex 15
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pierre Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif cedex
country: France
facility: Gustave Roussy Cancer Campus
city: Athens/New Kifissia
country: Greece
facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology
city: Athens
country: Greece
facility: General Hospital of Athens Alexandra
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, Gyogyszertar
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Gyogyszertar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital
state: Dublin
city: Dublin 7
country: Ireland
facility: Mater Private Hospital
state: Dublin
city: Dublin 4
country: Ireland
facility: Pharmacy Department
city: Dublin 4
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: Mater Misericoridae University Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Manerbio
country: Italy
facility: Poliambulatorio Specialistico Villa Salute
state: Brescia
city: Costa Masnaga
country: Italy
facility: Congregazione delle Suore Infermiere dell'Addolorata
state: Lecco
city: Miano
country: Italy
facility: ASST Fatebenefratelli Sacco
state: Milano
city: Lugo
country: Italy
facility: Servizio Sanitario Regionale Emilia-Romagna
state: Ravenna
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia
state: Torino
city: Bergamo
country: Italy
facility: Habilita, San Marco Bergamo
city: Bergamo
country: Italy
facility: Humanitas Cliniche Gavazzeni
city: Bergamo
country: Italy
facility: Humanitas, Unita Operativa di Cardiologia 2
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedelario
city: Como
country: Italy
facility: Congregazione delle Suore Infermiere dell'Addolorata
city: Cremona
country: Italy
facility: Fondazione Teresa Camplani
city: Cremona
country: Italy
facility: Regione Lombardia, A O Istituti Ospitalieri di Cremona
city: Cremona
country: Italy
facility: Regione Lombardia, ASST Cremona
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Piacenza
country: Italy
facility: Ambulatorio dott. Francesco Cavanna, Medico Chirurgo
city: Piacenza
country: Italy
facility: Azienda Unita Sanitaria Locale di Piacenza
city: Prato
country: Italy
facility: Azienda USL 4 Prato
city: Prato
country: Italy
facility: Azienda USL 4 Toscana Centro
city: Rimini
country: Italy
facility: Servizio Sanitario Regionale Emilia-Romagna
city: Torino
country: Italy
facility: C D C, Sede di Torino Centro
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Kita-adachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Tokorozawa
country: Japan
facility: National Defense Medical College Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima City Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Goyangsi
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center Clinical Trial Pharmacy
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Bergen
country: Norway
facility: Department of Obstetrics and Gynecology, Haukeland University Hospital
city: Bergen
country: Norway
facility: Sykehusapoteket i Bergen
city: Oslo
country: Norway
facility: Oslo Universitetssykehus
city: Oslo
country: Norway
facility: Sykehusapoteket Oslo
city: Krakow
country: Poland
facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna
city: Krakow
country: Poland
facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
city: Sochi
country: Russian Federation
facility: State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare
state: Krasnodar Region
city: Pyatigorsk
country: Russian Federation
facility: State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary
state: Stavropol Region
city: Chelyabinsk
country: Russian Federation
facility: Evimed Llc
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution "Clinical oncology dispensary #1"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"
city: Nizhniy Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution of Nizhegorogsky region
city: Orenburg
country: Russian Federation
facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center
city: Velikiy Novgorod
country: Russian Federation
facility: State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore Pharmacy
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Raffles Hospital
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia - Hospital Duran y Reynalds
state: Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Girona
country: Spain
facility: lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital MD Anderson
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Basel
country: Switzerland
facility: Universitatsspital Basel, Frauenklinik
state: Basel-stadt
city: Basel
country: Switzerland
facility: Universitatsspital Basel
state: Basel-stadt
city: Luzern 16
country: Switzerland
facility: Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie
state: Luzern
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
state: Ticino
city: Zurich
country: Switzerland
facility: Kantonsapotheke Zurich
city: Zurich
country: Switzerland
facility: Universitaetsspital Zurich, Klinik fuer Gynakologie
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich, Clinical Trials Center
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich, Universitares Herzzentrum Zurich
city: Tainan city
country: Taiwan
facility: Clinical Trial Pharmacy, National Cheng Kung University Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Clinical Trial Pharmacy, Mackay Memorial Hospital
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei City
country: Taiwan
facility: Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei City
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Clinical Trial Pharmacy, Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
city: Taoyuan City
country: Taiwan
facility: Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Ross Hall Hospital
state: CITY OF Glasgow
city: Bebington, Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Merseyside
city: Bebington, Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre
state: Merseyside
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Middlesex
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
state: Northamptonshire
city: Headington
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxford
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Sutton
country: United Kingdom
facility: Spire Healthcare Limited (St. Anthony's Hospital)
state: Surrey
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's & St. Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.