Clinical trial NCT02718417: Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
Official title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: untreated epithelial ovarian
fallopian tube
primary peritoneal cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 998
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: This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.

The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.


Eligibility criteria: Key Inclusion Criteria:

* Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
* Patients must be candidates for platinum based chemotherapy and previously untreated
* Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
* Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
* ECOG PS 0-1
* Adequate hematological, renal, and liver function

Key Exclusion Criteria:

* Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
* Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
* Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
* Cancer for which intraperitoneal cytotoxic chemotherapy is planned
* Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

Primary outcomes:
measure: Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Progression-Free Survival (PFS) as Assessed by Investigator
timeFrame: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Percentage of Participants With Objective Response as Assessed by Investigator
timeFrame: Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
measure: Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
measure: Duration of Response (DOR) as Assessed by Investigator
timeFrame: First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)
timeFrame: From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)
measure: Maintenance Progression-Free Survival (PFS) as Assessed by Investigator
timeFrame: From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Progression-Free Survival 2 (PFS2)
timeFrame: Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months)
measure: Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria
timeFrame: Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
measure: Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment
timeFrame: Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)
measure: Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment
timeFrame: Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
measure: Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score
timeFrame: CP: Pre-dose on Day 1 of Cycles 2 to 6 (1 cycle= 21 days); MP/OP: Day 1 of Cycles 1 to 12 (1 cycle= 42 days), End of treatment (any time up to Month 27)
measure: European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
measure: Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)
timeFrame: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen)
timeFrame: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)
timeFrame: Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen)
timeFrame: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen)
timeFrame: Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)
timeFrame: Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen)
timeFrame: Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)
timeFrame: Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free)
timeFrame: Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
measure: Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab
timeFrame: Pre-dose (0 hour) on Day 1 of Cycle 2
measure: Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab
timeFrame: End of avelumab infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin
timeFrame: End of infusion on Day 1 of Cycle 2
measure: Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin
timeFrame: Pre-dose (0 hour) on Day 1 of Cycle 2
measure: Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
timeFrame: Up to 36 months
measure: Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
timeFrame: Up to 36 months
measure: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
timeFrame: Up to 36 months
measure: Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Alabama Oncology
state: Alabama
city: Bessemer
country: United States
facility: Alabama Oncology
state: Alabama
city: Birmingham
country: United States
facility: Alabama Oncology, Bruno Cancer Center
state: Alabama
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
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: Irvine
country: United States
facility: Oso HomeCare
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Los Angeles
country: United States
facility: Medical Center, Cedars-Sinai
state: California
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Hematology-Oncology Medical Group of Orange County
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
city: Orange
country: United States
facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Orange
country: United States
facility: University of California, Irvine/UC Irvine Health
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Medical Office Building
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Van Ness Campus
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Davies Campus
state: California
city: San Francisco
country: United States
facility: Bryan Hemming Cancer Care Center - California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Pacific Heights Outpatient Pharmacy
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center-Pacific Campus
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center-Research Institute
state: California
city: San Francisco
country: United States
facility: Palo Alto Medical Foundation Group
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: New Haven
country: United States
facility: C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: Washington
country: United States
facility: Johns Hopkins Sibley Memorial Hospital
state: District of Columbia
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Deerfield Beach
country: United States
facility: UHEALTH Deerfield Beach
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics
state: Florida
city: Orlando
country: United States
facility: Orlando Health Gynecological Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health UF Health Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Investigational Drug Service, Emory University Clinic
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: Rcca Md Llc
state: Maryland
city: Germantown
country: United States
facility: Rcca Md Llc
state: Maryland
city: Lutherville
country: United States
facility: SKCCC at Johns Hopkins, Green Spring Station
state: Maryland
city: Rockville
country: United States
facility: Women's Health Specialists of Montgomery County
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Resource Center
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital, Pharmacy
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Wheaton
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Attn: Svetlana Rashkova, RPh
state: Massachusetts
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: Beth Israel Deaconess Medical Center Attn: Nisha Sharma
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Chesterfield
country: United States
facility: Mercy Ministry Office
state: Missouri
city: Springfield
country: United States
facility: Mercy - Women's Oncology
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group PA
state: New Jersey
city: Newark
country: United States
facility: University Hospital, Investigational Drug Pharmacy
state: New Jersey
city: Newark
country: United States
facility: University Hospital
state: New Jersey
city: Newark
country: United States
facility: University Hospital, Ambulatory Care Center
state: New Jersey
city: Newark
country: United States
facility: University Hospital, The Cancer Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore - Einstein Center for Cancer Care
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center, Centennial Women's Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Huntington
country: United States
facility: Medical Arts Radiology
state: New York
city: Huntington
country: United States
facility: ProHealth Radiology
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital, Clinical Trials Center
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital, Gynecologic Oncology
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital, Infusion Center
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital, Research Pharmacy
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Radiology
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center, Investigational Drug Services
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center
state: Ohio
city: Fairfield
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Hilliard
country: United States
facility: OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Grants Pass
country: United States
facility: Asante Three Rivers Medical Center
state: Oregon
city: Grants Pass
country: United States
facility: Hematology Oncology Associates
state: Oregon
city: Medford
country: United States
facility: Asante Pharmacy
state: Oregon
city: Medford
country: United States
facility: Asante Rogue Regional Medical Center
state: Oregon
city: Medford
country: United States
facility: Hematology Oncology Associates
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute Investigational Drug Service
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
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: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-Clements University Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-Zale Lipshy University Hospital
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: Layton
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Murray
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: West Jordan
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charlottesville
country: United States
facility: Emily Couric Cancer Center
state: Virginia
city: Sofia
country: Bulgaria
facility: MHAT for Female Health-Nadezhda OOD
city: Sofia
country: Bulgaria
facility: Shato Ead
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
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: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval
city: Split
country: Croatia
facility: Klinicki bolnicki centar Split
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Sestre milosrdnice
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital, Center of Oncology
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation, Pharmacy
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital, Hematology and Oncology Clinic
city: Chemnitz
country: Germany
facility: Zentralapotheke Zytostatika
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Groebenzell
country: Germany
facility: Johannes Apotheke Klinikversorgung
city: Koeln
country: Germany
facility: Radiologie Uniklinik Koeln
city: Koeln
country: Germany
facility: Uniklinik Koeln Apotheke
city: Koeln
country: Germany
facility: Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe
city: Muenchen
country: Germany
facility: Radiologie Muenchen
city: Muenchen
country: Germany
facility: Frauenklinik am Rotkreuzklinikum Muenchen
city: Potsdam
country: Germany
facility: Diagnostische und Interventionelle Radiologie
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Onkologiai Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Gyogyszertar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
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: Cork
country: Ireland
facility: Bon Secours Hospital Ireland
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Dublin 8
country: Ireland
facility: Pharmacy Department, St James's Hospital
city: Dublin 8
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Bologna
country: Italy
facility: Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi
state: BO
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi
state: BO
city: Genova
country: Italy
facility: E.O. Ospedali Galliera
state: GE
city: Genova
country: Italy
facility: Farmacia Galliera
state: GE
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: MI
city: Sondrio
country: Italy
facility: Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario
state: SO
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale
city: Roma
country: Italy
facility: Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente
city: Kashiwa-shi
country: Japan
facility: The Jikei University Kashiwa Hospital
state: Chiba
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
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: Sakyo-ku
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Tokorozawa
country: Japan
facility: National Defense Medical College Hospital
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Goyang-Si
country: Korea, Republic of
facility: Center for Uterine Cancer, National Cancer Center
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Clinical Trial Pharmacy, National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital, Clinical Trial Pharmacy
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: CTC Cancer Pharmacy, Seoul National University 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
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Clinical Research Pharmacy
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Pharmacy, Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Pharmacy, Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital, Oncology Department (11 floor)
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Daugavpils
country: Latvia
facility: Natalja Goncarova -Radiology Services
city: Liepaja
country: Latvia
facility: Inga Vigule-Radiology services
city: Liepaja
country: Latvia
facility: Liepaja Regional hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Medical Society "ARS" Ltd
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo LEON
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Groningen
country: Netherlands
facility: Pharmacy 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: Sittard-Geleen
country: Netherlands
facility: Pharmacy Zuyderland Medisch Centrum
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna
city: Gdynia
country: Poland
facility: Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii
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: Opole
country: Poland
facility: Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
city: Poznan
country: Poland
facility: Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w
city: Cluj Napoca
country: Romania
facility: SC Medisprof SRL
state: Cluj
city: Craiova
country: Romania
facility: SC Oncolab SRL
state: Dolj
city: Iasi
country: Romania
facility: SC Centrul de Oncologie Euroclinic SRL
city: Chelyabinsk
country: Russian Federation
facility: Limited liability company (LLC) EVIMED
state: Chelyabinsk Region
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution
state: Chelyabinsk Region
city: Ivanovo
country: Russian Federation
facility: Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary
state: Ivanovo Region
city: Obninsk
country: Russian Federation
facility: FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre
state: Kaluga Region
city: Orenburg
country: Russian Federation
facility: SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)
state: Orenburg Region
city: Kazan
country: Russian Federation
facility: SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"
state: Tatarstan Republic
city: Moscow
country: Russian Federation
facility: SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department
city: Moscow
country: Russian Federation
facility: FSBI National Research Medical Center of Oncology N.A.
city: Moscow
country: Russian Federation
facility: Clinic
city: Moscow
country: Russian Federation
facility: Limited liability company VitaMed-LLC VitaMed
city: Saint Petersburg
country: Russian Federation
facility: SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National University Hospital, Pharmacy @ NCIS
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Bardejov
country: Slovakia
facility: NsP sv. Jakuba, n.o. , Bardejov
city: Bratislava
country: Slovakia
facility: Onkologicky ustav sv. Alzbety a.s.
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Kosice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav, a.s.
city: Poprad
country: Slovakia
facility: POKO Poprad s.r.o.
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
state: Ticino
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
state: Ticino
city: Bellinzona
country: Switzerland
facility: Radiologia ORBV
state: Ticino
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zuerich
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
city: Taichung
country: Taiwan
facility: Taichung Veterans General 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: Cathay General 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: 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: Adana
country: Turkey
facility: Baskent University Adana Training and Research Hospital
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital, Department of Oncology
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Oncology Institute
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine Hospital
city: Chernivtsi
country: Ukraine
facility: Communal Institution Chernivtsi Regional Clinical Oncology Dispensary
city: Dnipropetrovsk
country: Ukraine
facility: Cl Dnipropetrovsk City Multifield Clinical Hospital
city: Kryviy Rig
country: Ukraine
facility: Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council
city: Kyiv
country: Ukraine
facility: Clinic of National Cancer Institute
city: Lviv
country: Ukraine
facility: CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"
city: Uzhhorod
country: Ukraine
facility: Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department
city: Torquay
country: United Kingdom
facility: Torbay and South Devon NHS Foundation Trust
state: Devon
city: Margate
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
state: Kent
city: Islington
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
state: London
city: Bebington, Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Merseyside
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Merseyside
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Middlesex
city: Headington
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxford
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
state: Surrey
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
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: 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
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust
city: Stockport
country: United Kingdom
facility: Baxter Healthcare
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA
name: Bradley Monk, MD
role: STUDY_CHAIR
affiliation: UCL Cancer Institute, UK
name: Jonathan Ledermann, MD
role: STUDY_CHAIR
References:
citation: Monk BJ, Colombo N, Oza AM, Fujiwara K, Birrer MJ, Randall L, Poddubskaya EV, Scambia G, Shparyk YV, Lim MC, Bhoola SM, Sohn J, Yonemori K, Stewart RA, Zhang X, Perkins Smith J, Linn C, Ledermann JA. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Sep;22(9):1275-1289. doi: 10.1016/S1470-2045(21)00342-9. Epub 2021 Aug 4.