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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
paclitaxel
Avelumab
Avelumab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring untreated epithelial ovarian, fallopian tube, primary peritoneal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Alabama Oncology
  • Alabama Oncology
  • Alabama Oncology, Bruno Cancer Center
  • Alabama Oncology
  • Alabama Oncology
  • Alabama Oncology
  • Alabama Oncology
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology Associates, PC-HOPE
  • Arizona Oncology Associates, PC-HOPE
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Oso HomeCare
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • Medical Center, Cedars-Sinai
  • Gynecologic Oncology Associates
  • Chao Family Comprehensive Cancer Center
  • Hematology-Oncology Medical Group of Orange County
  • Medical Oncology Care Associates
  • St. Joseph Hospital of Orange
  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
  • UC Irvine Health
  • University of California, Irvine/UC Irvine Health
  • California Pacific Medical Center - Medical Office Building
  • California Pacific Medical Center - Van Ness Campus
  • California Pacific Medical Center - Davies Campus
  • Bryan Hemming Cancer Care Center - California Pacific Medical Center
  • California Pacific Medical Center - Pacific Heights Outpatient Pharmacy
  • California Pacific Medical Center-Pacific Campus
  • California Pacific Medical Center-Research Institute
  • Palo Alto Medical Foundation Group
  • Sansum Clinic
  • Sansum Clinic
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
  • Smilow Cancer Hospital at Yale-New Haven
  • Smilow Cancer Hospital at Yale-New Haven
  • Johns Hopkins Sibley Memorial Hospital
  • Sibley Memorial Hospital
  • UHEALTH Deerfield Beach
  • University of Miami Hospital and Clinics
  • Orlando Health Gynecological Cancer Center
  • Orlando Health UF Health Cancer Center
  • Orlando Health, Inc.
  • Orlando Health, Inc
  • Emory University Hospital Midtown
  • Emory University Hospital
  • Investigational Drug Service, Emory University Clinic
  • The Emory Clinic
  • Winship Cancer Institute
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Rcca Md Llc
  • Rcca Md Llc
  • SKCCC at Johns Hopkins, Green Spring Station
  • Women's Health Specialists of Montgomery County
  • Holy Cross Resource Center
  • Maryland Oncology Hematology
  • Holy Cross Hospital, Pharmacy
  • Holy Cross Hospital
  • Maryland Oncology Hematology
  • Massachusetts General Hospital Attn: Svetlana Rashkova, RPh
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Beth Israel Deaconess Medical Center Attn: Nisha Sharma
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD
  • Dana-Farber Cancer Institute
  • Mercy Ministry Office
  • Mercy - Women's Oncology
  • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
  • Mercy Hospital Springfield
  • Summit Medical Group
  • Summit Medical Group PA
  • University Hospital, Investigational Drug Pharmacy
  • University Hospital
  • University Hospital, Ambulatory Care Center
  • University Hospital, The Cancer Center
  • Montefiore - Einstein Center for Cancer Care
  • Montefiore Medical Center
  • Montefiore Medical Center, Centennial Women's Center
  • Roswell Park Cancer Institute
  • Medical Arts Radiology
  • ProHealth Radiology
  • NYU Winthrop Hospital, Clinical Trials Center
  • NYU Winthrop Hospital, Gynecologic Oncology
  • NYU Winthrop Hospital, Infusion Center
  • NYU Winthrop Hospital, Research Pharmacy
  • NYU Winthrop Radiology
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • MetroHealth Medical Center
  • MetroHealth Medical Center
  • OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute
  • OSU Wexner Medical Center, Investigational Drug Services
  • OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center
  • Oncology Hematology Care, Inc.
  • OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
  • Willamette Valley Cancer Institute and Research Center
  • Asante Three Rivers Medical Center
  • Hematology Oncology Associates
  • Asante Pharmacy
  • Asante Rogue Regional Medical Center
  • Hematology Oncology Associates
  • Fox Chase Cancer Center
  • Magee-Women's Hospital of UPMC
  • University of Pittsburgh Cancer Institute Investigational Drug Service
  • University of Pittsburgh Medical Center
  • Avera Cancer Institute
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • The Sarah Cannon Research Institute
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Texas Oncology-Austin Central
  • Texas Oncology - South Austin
  • Texas Oncology Bedford
  • Parkland Health and Hospital System
  • University of Texas Southwestern Medical Center
  • UT Southwestern Medical Center-Clements University Hospital
  • UT Southwestern Medical Center-Zale Lipshy University Hospital
  • Texas Oncology - Fort Worth Cancer Center
  • US Oncology Investigational Products Center (IPC)
  • US Oncology Investigational Products Center
  • Texas Oncology - San Antonio Medical Center
  • Utah Cancer Specialists
  • Utah Cancer Specialists
  • Utah Cancer Specialists
  • Utah Cancer Specialists
  • Utah Cancer Specialists
  • Emily Couric Cancer Center
  • MHAT for Female Health-Nadezhda OOD
  • Shato Ead
  • Cross Cancer Institute
  • Juravinski Cancer Centre
  • Princess Margaret Cancer Centre
  • McGill University Health Centre-Glen Site
  • Oncology Pharmacy McGill University Health Centre
  • CHU de Quebec-Universite Laval
  • Klinicki bolnicki centar Split
  • Klinicki bolnicki centar Sestre milosrdnice
  • East Tallinn Central Hospital
  • East-Tallinn Central Hospital, Center of Oncology
  • North Estonia Medical Centre Foundation, Pharmacy
  • North Estonia Medical Centre Foundation
  • Tartu University Hospital, Hematology and Oncology Clinic
  • Zentralapotheke Zytostatika
  • Klinikum Chemnitz gGmbH
  • Johannes Apotheke Klinikversorgung
  • Radiologie Uniklinik Koeln
  • Uniklinik Koeln Apotheke
  • Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe
  • Radiologie Muenchen
  • Frauenklinik am Rotkreuzklinikum Muenchen
  • Diagnostische und Interventionelle Radiologie
  • Klinikum Ernst von Bergmann gGmbH
  • Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik
  • Queen Elizabeth Hospital
  • The University of Hong Kong
  • Semmelweis Egyetem Onkologiai Kozpont
  • Debreceni Egyetem Klinikai Gyogyszertar
  • Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
  • Mater Misericordiae University Hospital
  • Mater Private Hospital
  • Bon Secours Hospital Ireland
  • Bon Secours Hospital
  • Pharmacy Department, St James's Hospital
  • St James's Hospital
  • Mater Misericordiae University Hospital
  • Mater Private Hospital
  • Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi
  • E.O. Ospedali Galliera
  • Farmacia Galliera
  • Istituto Europeo di Oncologia
  • ASST Grande Ospedale Metropolitano Niguarda
  • Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario
  • Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale
  • Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente
  • The Jikei University Kashiwa Hospital
  • Shikoku Cancer Center
  • Ehime University Hospital
  • Kurume University Hospital
  • Hokkaido University Hospital
  • Hyogo Cancer Center
  • University of Tsukuba Hospital
  • Tokai University Hospital
  • Kyoto University Hospital
  • Tohoku University Hospital
  • Saitama Medical University International Medical Center
  • National Defense Medical College Hospital
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • The Jikei University Hospital
  • Niigata Cancer Center Hospital
  • Center for Uterine Cancer, National Cancer Center
  • Clinical Trial Pharmacy, National Cancer Center
  • CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy
  • CHA Bundang Medical Center, CHA University
  • Korea University Anam Hospital, Clinical Trial Pharmacy
  • Korea University Anam Hospital
  • CTC Cancer Pharmacy, Seoul National University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center, Clinical Research Pharmacy
  • Asan Medical Center
  • Clinical Trial Pharmacy, Samsung Medical Center
  • Samsung Medical Center
  • Clinical Trial Pharmacy, Korea University Guro Hospital
  • Korea University Guro Hospital
  • Daugavpils Regional Hospital, Oncology Department (11 floor)
  • Daugavpils Regional Hospital
  • Natalja Goncarova -Radiology Services
  • Inga Vigule-Radiology services
  • Liepaja Regional hospital
  • Pauls Stradins Clinical University Hospital
  • Medical Society "ARS" Ltd
  • Instituto Nacional de Cancerologia
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Academisch Medisch Centrum
  • Pharmacy Universitair Medisch Centrum Groningen
  • Universitair Medisch Centrum Groningen
  • LUMC
  • Maastricht Universitair Medisch Centrum
  • Pharmacy Zuyderland Medisch Centrum
  • Zuyderland Medisch Centrum
  • Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna
  • Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii
  • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna
  • Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie
  • Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna
  • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
  • Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w
  • SC Medisprof SRL
  • SC Oncolab SRL
  • SC Centrul de Oncologie Euroclinic SRL
  • Limited liability company (LLC) EVIMED
  • State Budgetary Healthcare Institution
  • Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary
  • FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre
  • SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)
  • SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"
  • SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department
  • FSBI National Research Medical Center of Oncology N.A.
  • Clinic
  • Limited liability company VitaMed-LLC VitaMed
  • SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care
  • National University Hospital
  • National University Hospital, Pharmacy @ NCIS
  • Raffles Hospital
  • NsP sv. Jakuba, n.o. , Bardejov
  • Onkologicky ustav sv. Alzbety a.s.
  • Narodny onkologicky ustav
  • Vychodoslovensky onkologicky ustav, a.s.
  • POKO Poprad s.r.o.
  • Oncology Institute of Southern Switzerland (IOSI)
  • Ospedale San Giovanni
  • Radiologia ORBV
  • Kantonsspital Winterthur
  • Kantonsspital Winterthur
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Clinical Trial Pharmacy, MacKay Memorial Hospital
  • Mackay Memorial Hospital
  • Cathay General Hospital
  • Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
  • Koo Foundation Sun Yat-Sen Cancer Center
  • Clinical Trial Pharmacy, Taipei Veterans General Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital - Linkou Branch
  • Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch
  • Baskent University Adana Training and Research Hospital
  • Baskent University Ankara Hospital, Department of Oncology
  • Bezmialem Vakif University Medical Faculty Hospital
  • Istanbul University Oncology Institute
  • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
  • Ege University Faculty of Medicine Hospital
  • Communal Institution Chernivtsi Regional Clinical Oncology Dispensary
  • Cl Dnipropetrovsk City Multifield Clinical Hospital
  • Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council
  • Clinic of National Cancer Institute
  • CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"
  • Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department
  • Torbay and South Devon NHS Foundation Trust
  • East Kent Hospitals University NHS Foundation Trust
  • University College London Hospital NHS Foundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • East and North Hertfordshire NHS Trust
  • Oxford University Hospitals NHS Foundation Trust
  • Royal Surrey County Hospital NHS Foundation Trust
  • Royal Marsden NHS Foundation Trust
  • The Royal Marsden NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation trust
  • Cambridge University Hospitals NHS Foundation Trust
  • University College London Hospital NHS Foundation Trust
  • University College London Hospital NHS Foundation Trust
  • Guy's & St Thomas' NHS Foundation Trust
  • Royal Marsden NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • University College London Hospital
  • The Christie Hospital NHS Foundation Trust
  • Baxter Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Chemotherapy followed by observation

Chemotherapy followed by avelumab in maintenance

Chemotherapy in combination with avelumab followed by avelumab in maintenance

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.

Secondary Outcome Measures

Overall Survival
Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Progression-Free Survival (PFS) as Assessed by Investigator
Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Percentage of Participants With Objective Response as Assessed by Investigator
Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)
BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Duration of Response (DOR) as Assessed by Investigator
Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)
BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)
BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Maintenance Progression-Free Survival (PFS) as Assessed by Investigator
Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method
Percentage of Participants With Pathological Complete Response (pCR)
pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease.
Progression-Free Survival 2 (PFS2)
PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria
PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125.
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN].
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment
Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment
Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Number of Participants With Electrocardiogram (ECG) Abnormalities
ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.
Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score
National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'.
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)
Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen)
Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)
Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen)
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen)
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen)
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free)
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.
Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab
Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab
Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin
Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin
Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (>=) 1 percent (%) tumor cells or >= 5% immune cells and were otherwise considered negative.
Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated >= 1% CD8 positive cells and were otherwise considered negative.

Full Information

First Posted
March 15, 2016
Last Updated
June 19, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02718417
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.
Study Start Date
May 19, 2016 (Actual)
Primary Completion Date
September 7, 2018 (Actual)
Study Completion Date
May 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
untreated epithelial ovarian, fallopian tube, primary peritoneal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
998 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Chemotherapy followed by observation
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Chemotherapy followed by avelumab in maintenance
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Chemotherapy in combination with avelumab followed by avelumab in maintenance
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Given Q3W during chemotherapy phase
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Investigator choice of weekly or Q3W during chemotherapy phase
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
Given as single agent in maintenance portion Q2W
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Description
BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Title
Progression-Free Survival (PFS) as Assessed by Investigator
Description
Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Time Frame
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Title
Percentage of Participants With Objective Response as Assessed by Investigator
Description
Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Time Frame
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)
Title
Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)
Description
BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Time Frame
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)
Title
Duration of Response (DOR) as Assessed by Investigator
Description
Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame
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)
Title
Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)
Description
BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame
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)
Title
Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)
Description
BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame
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)
Title
Maintenance Progression-Free Survival (PFS) as Assessed by Investigator
Description
Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method
Time Frame
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)
Title
Percentage of Participants With Pathological Complete Response (pCR)
Description
pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease.
Time Frame
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Title
Progression-Free Survival 2 (PFS2)
Description
PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame
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)
Title
Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria
Description
PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125.
Time Frame
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)
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
Title
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
Description
As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN].
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Title
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
Description
Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Time Frame
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)
Title
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
Description
Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Time Frame
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)
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Title
Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score
Description
National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'.
Time Frame
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)
Title
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score
Description
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
Title
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)
Description
Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Time Frame
Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen)
Description
Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Time Frame
Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)
Description
Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.
Time Frame
Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen)
Description
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time Frame
Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen)
Description
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time Frame
Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)
Description
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time Frame
Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen)
Description
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Time Frame
Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)
Description
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Time Frame
Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free)
Description
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.
Time Frame
Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
Title
Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab
Description
Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame
Pre-dose (0 hour) on Day 1 of Cycle 2
Title
Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab
Description
Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame
End of avelumab infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin
Description
Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame
End of infusion on Day 1 of Cycle 2
Title
Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin
Description
Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame
Pre-dose (0 hour) on Day 1 of Cycle 2
Title
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
Description
ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Time Frame
Up to 36 months
Title
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
Description
nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Time Frame
Up to 36 months
Title
Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Description
PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (>=) 1 percent (%) tumor cells or >= 5% immune cells and were otherwise considered negative.
Time Frame
Up to 36 months
Title
Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Description
CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated >= 1% CD8 positive cells and were otherwise considered negative.
Time Frame
Up to 36 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bradley Monk, MD
Organizational Affiliation
Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathan Ledermann, MD
Organizational Affiliation
UCL Cancer Institute, UK
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Oncology
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Facility Name
Alabama Oncology
City
Bessemer
State/Province
Alabama
ZIP/Postal Code
35022
Country
United States
Facility Name
Alabama Oncology, Bruno Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Arizona Oncology Associates, PC-HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates, PC-HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Oso HomeCare
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Medical Center, Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Gynecologic Oncology Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Hematology-Oncology Medical Group of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California, Irvine/UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Pacific Medical Center - Medical Office Building
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
California Pacific Medical Center - Van Ness Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
California Pacific Medical Center - Davies Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Bryan Hemming Cancer Care Center - California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Pacific Medical Center - Pacific Heights Outpatient Pharmacy
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Pacific Medical Center-Pacific Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Pacific Medical Center-Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Palo Alto Medical Foundation Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Sansum Clinic
City
Solvang
State/Province
California
ZIP/Postal Code
93463
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Johns Hopkins Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
UHEALTH Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
University of Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Health Gynecological Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Health UF Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Health, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Health, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Drug Service, Emory University Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Rcca Md Llc
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Rcca Md Llc
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20874
Country
United States
Facility Name
SKCCC at Johns Hopkins, Green Spring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Women's Health Specialists of Montgomery County
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Holy Cross Resource Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Maryland Oncology Hematology
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Holy Cross Hospital, Pharmacy
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Maryland Oncology Hematology
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Massachusetts General Hospital Attn: Svetlana Rashkova, RPh
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center Attn: Nisha Sharma
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mercy Ministry Office
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Mercy - Women's Oncology
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Summit Medical Group
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
Facility Name
Summit Medical Group PA
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
University Hospital, Investigational Drug Pharmacy
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-6750
Country
United States
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-6750
Country
United States
Facility Name
University Hospital, Ambulatory Care Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University Hospital, The Cancer Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Montefiore - Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center, Centennial Women's Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Medical Arts Radiology
City
Huntington
State/Province
New York
ZIP/Postal Code
11743
Country
United States
Facility Name
ProHealth Radiology
City
Huntington
State/Province
New York
ZIP/Postal Code
11743
Country
United States
Facility Name
NYU Winthrop Hospital, Clinical Trials Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Winthrop Hospital, Gynecologic Oncology
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Winthrop Hospital, Infusion Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Winthrop Hospital, Research Pharmacy
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Winthrop Radiology
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OSU Wexner Medical Center, Investigational Drug Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Asante Three Rivers Medical Center
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Hematology Oncology Associates
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Asante Pharmacy
City
Medford
State/Province
Oregon
ZIP/Postal Code
97501
Country
United States
Facility Name
Asante Rogue Regional Medical Center
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Hematology Oncology Associates
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Magee-Women's Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Cancer Institute Investigational Drug Service
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Texas Oncology-Austin Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern Medical Center-Clements University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern Medical Center-Zale Lipshy University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology - Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
US Oncology Investigational Products Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
US Oncology Investigational Products Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Utah Cancer Specialists
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Utah Cancer Specialists
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Utah Cancer Specialists
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Emily Couric Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
MHAT for Female Health-Nadezhda OOD
City
Sofia
ZIP/Postal Code
1373
Country
Bulgaria
Facility Name
Shato Ead
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre-Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Oncology Pharmacy McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Klinicki bolnicki centar Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Klinicki bolnicki centar Sestre milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
East-Tallinn Central Hospital, Center of Oncology
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation, Pharmacy
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital, Hematology and Oncology Clinic
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Zentralapotheke Zytostatika
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Johannes Apotheke Klinikversorgung
City
Groebenzell
ZIP/Postal Code
82194
Country
Germany
Facility Name
Radiologie Uniklinik Koeln
City
Koeln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Uniklinik Koeln Apotheke
City
Koeln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe
City
Koeln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Radiologie Muenchen
City
Muenchen
ZIP/Postal Code
80634
Country
Germany
Facility Name
Frauenklinik am Rotkreuzklinikum Muenchen
City
Muenchen
ZIP/Postal Code
80637
Country
Germany
Facility Name
Diagnostische und Interventionelle Radiologie
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Klinikum Ernst von Bergmann gGmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Semmelweis Egyetem Onkologiai Kozpont
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Gyogyszertar
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Mater Misericordiae University Hospital
City
Dublin 7
State/Province
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Mater Private Hospital
City
Dublin 7
State/Province
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
Bon Secours Hospital Ireland
City
Cork
Country
Ireland
Facility Name
Bon Secours Hospital
City
Cork
Country
Ireland
Facility Name
Pharmacy Department, St James's Hospital
City
Dublin 8
ZIP/Postal Code
8
Country
Ireland
Facility Name
St James's Hospital
City
Dublin 8
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D7
Country
Ireland
Facility Name
Mater Private Hospital
City
Dublin
ZIP/Postal Code
D7
Country
Ireland
Facility Name
Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
E.O. Ospedali Galliera
City
Genova
State/Province
GE
ZIP/Postal Code
16128
Country
Italy
Facility Name
Farmacia Galliera
City
Genova
State/Province
GE
ZIP/Postal Code
16128
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario
City
Sondrio
State/Province
SO
ZIP/Postal Code
23100
Country
Italy
Facility Name
Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
The Jikei University Kashiwa Hospital
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8567
Country
Japan
Facility Name
Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hyogo Cancer Center
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kyoto University Hospital
City
Sakyo-ku
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
National Defense Medical College Hospital
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Center for Uterine Cancer, National Cancer Center
City
Goyang-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy, National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital, Clinical Trial Pharmacy
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
CTC Cancer Pharmacy, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center, Clinical Research Pharmacy
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy, Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy, Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital, Oncology Department (11 floor)
City
Daugavpils
ZIP/Postal Code
LV5417
Country
Latvia
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV5417
Country
Latvia
Facility Name
Natalja Goncarova -Radiology Services
City
Daugavpils
ZIP/Postal Code
LV5417
Country
Latvia
Facility Name
Inga Vigule-Radiology services
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
Liepaja Regional hospital
City
Liepaja
ZIP/Postal Code
LV3414
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Medical Society "ARS" Ltd
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Facility Name
Instituto Nacional de Cancerologia
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Pharmacy Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 AP
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Pharmacy Zuyderland Medisch Centrum
City
Sittard-Geleen
ZIP/Postal Code
6162 AP
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
SC Medisprof SRL
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400641
Country
Romania
Facility Name
SC Oncolab SRL
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200385
Country
Romania
Facility Name
SC Centrul de Oncologie Euroclinic SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Limited liability company (LLC) EVIMED
City
Chelyabinsk
State/Province
Chelyabinsk Region
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution
City
Chelyabinsk
State/Province
Chelyabinsk Region
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary
City
Ivanovo
State/Province
Ivanovo Region
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre
City
Obninsk
State/Province
Kaluga Region
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD)
City
Orenburg
State/Province
Orenburg Region
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
SAHI "Republican Clinical Oncology Dispensary of the MoH of TR"
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
FSBI National Research Medical Center of Oncology N.A.
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Clinic
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Limited liability company VitaMed-LLC VitaMed
City
Moscow
ZIP/Postal Code
129515
Country
Russian Federation
Facility Name
SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National University Hospital, Pharmacy @ NCIS
City
Singapore
ZIP/Postal Code
119082
Country
Singapore
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
NsP sv. Jakuba, n.o. , Bardejov
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Onkologicky ustav sv. Alzbety a.s.
City
Bratislava
ZIP/Postal Code
81250
Country
Slovakia
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Vychodoslovensky onkologicky ustav, a.s.
City
Kosice
ZIP/Postal Code
04191
Country
Slovakia
Facility Name
POKO Poprad s.r.o.
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
Oncology Institute of Southern Switzerland (IOSI)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Ospedale San Giovanni
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Radiologia ORBV
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zuerich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Clinical Trial Pharmacy, MacKay Memorial Hospital
City
Taipei city
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei City
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei City
ZIP/Postal Code
106
Country
Taiwan
Facility Name
Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Clinical Trial Pharmacy, Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Baskent University Adana Training and Research Hospital
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Baskent University Ankara Hospital, Department of Oncology
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Bezmialem Vakif University Medical Faculty Hospital
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Oncology Institute
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege University Faculty of Medicine Hospital
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Communal Institution Chernivtsi Regional Clinical Oncology Dispensary
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Cl Dnipropetrovsk City Multifield Clinical Hospital
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council
City
Kryviy Rig
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Clinic of National Cancer Institute
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre"
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Torbay and South Devon NHS Foundation Trust
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
East Kent Hospitals University NHS Foundation Trust
City
Margate
State/Province
Kent
ZIP/Postal Code
CT9 4AN
Country
United Kingdom
Facility Name
University College London Hospital NHS Foundation Trust
City
Islington
State/Province
London
ZIP/Postal Code
N79NH
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington, Wirral
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
East and North Hertfordshire NHS Trust
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University College London Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
University College London Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's & St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
WC1E 6AG
Country
United Kingdom
Facility Name
The Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Baxter Healthcare
City
Stockport
ZIP/Postal Code
SK4 5GA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34363762
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.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B9991010
Description
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Learn more about this trial

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

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