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A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Primary Purpose

Ovarian Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

avelumab

PLD

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring platinum resistant, platinum refractory

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

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

Sites / Locations

Arizona Oncology Associates, PC - HAL
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
University of California, Irvine/UC Irvine Health
Sansum Clinic
Sansum Clinic
Rocky Mountain Cancer Centers
Rocky Mountain Cancer Centers
Rocky Mountain Cancer Centers
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Atlanta Gynecologic Oncology
Northside Hospital - Pharmacy
University Gynecologic Oncology
Northwest Georgia Oncology Centers, P.C.
Northwest Georgia Oncology Centers, P.C.
Northwest Georgia Oncology Centers, P.C.
Northwest Georgia Oncology Centers, P.C.
Northwest Georgia Oncology Centers, P.C.
The University of Kansas Clinical Research Center
The University of Kansas Cancer Center and Medical Pavilion
Norton Cancer Institute, Norton Healthcare Pavilion
Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D
Norton Hospital
Norton Cancer Institute, St. Matthews Campus
Norton Women's and Children's Hospital
Norton Brownsboro Hospital
Norton Cancer Institute, Brownsboro Hospital Campus
Maryland Oncology Hematology, P.A.
Maryland Oncology Hematology, P.A.
Maryland Oncology Hematology P.A.
Maryland Oncology Hematology P.A.
Massachusetts General Hospital
Brigham Women's Hospital
Dana Farber Cancer Institute
The University of Kansas Cancer Center, CCP - North
Center of Hope at Renown Regional Medical Center
Southwest GYN Oncology Associates, Inc.
University of New Mexico Comprehensive Cancer Center
Hope Women's Cancer Centers
Mission Hospital, Inc.
Novant Health Oncology Specialists
Novant Health Oncology Specialists
Cleveland Clinic Taussig Cancer Center
Fairview Hospital Moll Pavilion Cancer Center
Fairview Hospital Moll Pavilion Pharmacy
Cleveland Clinic Taussig Cancer Center
Cleveland Clinic
Hillcrest Hospital Hirsch Cancer Center Pharmacy
Hillcrest Hospital
Willamette Valley Cancer Institute and Research Center
Investigational Drug Services, University of Pennsylvania
The University of Pennsylvania Health System
Fox Chase Cancer Center
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
Texas Oncology -Fort Worth Cancer Center
US Oncology Investigational Products Center (IPC)
US Oncology Investigational Products Center
Texas Oncology - San Antonio Medical Center
Texas Oncology - The Woodlands, Gynecologic Oncology
Utah Cancer Specialists
Carilion Clinic Gynecologic Oncology
Carilion Clinic
Froedtert and The Medical College of Wisconsin
Froedtert Hospital
Epic Pharmacy,Newcastle Private Hospital
Newcastle Private Hospital Pty Limited
Icon Cancer Care Wesley
Rivercity Pharmacy
Mater Pharmacy Services
Icon Cancer Care Chermside
Clinical Research Unit
Metro North Hospital and Health Service
Oncology Pharmacy
Icon Cancer Care
Icon Cancer Foundation
Mater Cancer Care Centre
Icon Cancer Care Southport
Cabrini Health Limited
Cabrini Health Limited
Peter MacCallum Cancer Centre
Royal Melbourne Hospital
Pharmacy Department
The Royal Women's Hospital
Medizinische Universitat Graz, LKH-Univ. Klinikum Graz
Medizinische Universitat Innsbruck
University Hospital Gent
Institut Jules Bordet
AZ Groeninge Hospital
Universitaire Ziekenhuizen Leuven
CHU de Liege - Sart Tilman
Clinique et Maternite Sainte Elisabeth
Tom Baker Cancer Centre
Cross Cancer Institute
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
British Columbia Cancer Agency-Vancouver Centre
St. Boniface General Hospital
Health Sciences Centre
CancerCare Manitoba
Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre
Nova Scotia Health Authority, QEII Health Sciences Centre
The Ottawa Hospital
Sunnybrook Research Institute
Princess Margaret Cancer Centre
Jewish General Hospital
McGill University Health Centre - Glen Site
Oncology Pharmacy McGill University Health Centre
Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika
Fakultni nemocnice Olomouc
Fakultni nemocnice Ostrava
Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,
Vseobecna fakultni nemocnice v Praze, Neurologicka klinika
Vseobecna fakultni nemocnice v Praze
Fakultni nemocnice v Motole
Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z
Aalborg University Hospital
Rigshospitalet
Centre Francois Baclesse
Centre Leon Berard
Service de Radiologie
Centre Antoine Lacassagne
Hôpital Européen Georges Pompidou
Hôpital Européen Georges Pompidou
Centre Hospitalier Lyon Sud
Institut de Cancérologie de Lorraine
Gustave Roussy Cancer Campus
General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology
General Hospital of Athens Alexandra
Princess Margaret Hospital
University of Hong Kong
Orszagos Onkologiai Intezet, Gyogyszertar
Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
Debreceni Egyetem Klinikai Gyogyszertar
Debreceni Egyetem Klinikai Kozpont
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont
Mater Misericordiae University Hospital
Mater Private Hospital
Pharmacy Department
St Vincent's University Hospital
St James's Hospital
Mater Misericoridae University Hospital
Mater Private Hospital
University Hospital Waterford
Shaare Zedek Medical Center
Poliambulatorio Specialistico Villa Salute
Congregazione delle Suore Infermiere dell'Addolorata
ASST Fatebenefratelli Sacco
Servizio Sanitario Regionale Emilia-Romagna
Fondazione del Piemonte per l'Oncologia
Habilita, San Marco Bergamo
Humanitas Cliniche Gavazzeni
Humanitas, Unita Operativa di Cardiologia 2
Fondazione Poliambulanza Istituto Ospedelario
Congregazione delle Suore Infermiere dell'Addolorata
Fondazione Teresa Camplani
Regione Lombardia, A O Istituti Ospitalieri di Cremona
Regione Lombardia, ASST Cremona
Istituto Europeo di Oncologia
Ambulatorio dott. Francesco Cavanna, Medico Chirurgo
Azienda Unita Sanitaria Locale di Piacenza
Azienda USL 4 Prato
Azienda USL 4 Toscana Centro
Servizio Sanitario Regionale Emilia-Romagna
C D C, Sede di Torino Centro
Shikoku Cancer Center
Ehime University Hospital
Hokkaido University Hospital
Hyogo Cancer Center
University of Tsukuba Hospital
Tokai University Hospital
Nippon Medical School Musashikosugi Hospital
Yokohama City University Hospital
Tohoku University Hospital
Saitama Medical University International Medical Center
Saitama Cancer Center
National Defense Medical College Hospital
Seirei Hamamatsu General Hospital
Jichi Medical University Hospital
The University of Tokyo Hospital
National Cancer Center Hospital
Kagoshima University Hospital
Kagoshima City Hospital
Niigata Cancer Center Hospital
National Cancer Center
Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Seoul National University Hospital
Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy
Severance Hospital, Yonsei University Health System
Asan Medical Center
Samsung Medical Center Clinical Trial Pharmacy
Samsung Medical Center
Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital
The Catholic University of Korea, Seoul St. Mary's Hospital
The Catholic University of Korea
Universitair Medisch Centrum Groningen
Universitair Medisch Centrum Groningen
LUMC
Maastricht Universitair Medisch Centrum
Department of Obstetrics and Gynecology, Haukeland University Hospital
Sykehusapoteket i Bergen
Oslo Universitetssykehus
Sykehusapoteket Oslo
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
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare
State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary
Evimed Llc
State Budgetary Healthcare Institution
State Budgetary Healthcare Institution "Clinical oncology dispensary #1"
Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"
State Budgetary Healthcare Institution of Nizhegorogsky region
State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"
State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center
State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"
National University Hospital
National University Hospital
National Cancer Centre Singapore Pharmacy
National Cancer Centre Singapore
Raffles Hospital
Institut Catala d'Oncologia - Hospital Duran y Reynalds
Hospital Universitario Reina Sofia
lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta
Hospital MD Anderson
Hospital Universitario La Paz
Centro Integral Oncologico Clara Campal
Hospital Universitario Virgen de Valme
Universitatsspital Basel, Frauenklinik
Universitatsspital Basel
Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie
Oncology Institute of Southern Switzerland (IOSI)
Kantonsapotheke Zurich
Universitaetsspital Zurich, Klinik fuer Gynakologie
Universitatsspital Zurich, Clinical Trials Center
Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie
Universitatsspital Zurich, Universitares Herzzentrum Zurich
Clinical Trial Pharmacy, National Cheng Kung University Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Clinical Trial Pharmacy, Mackay Memorial Hospital
Mackay Memorial Hospital
Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
Koo Foundation Sun Yat-Sen Cancer Center
National Taiwan University Hospital
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
Cambridge University Hospitals NHS Foundation Trust
Ross Hall Hospital
The Clatterbridge Cancer Centre NHS Foundation Trust
The Clatterbridge Cancer Centre
East and North Hertfordshire NHS Trust
Northampton General Hospital NHS Trust
Oxford University Hospitals NHS Foundation Trust
The Royal Marsden NHS Foundation Trust
Spire Healthcare Limited (St. Anthony's Hospital)
NHS Greater Glasgow and Clyde
University College London Hospital NHS Foundation Trust
Guy's & St Thomas' NHS Foundation Trust
Guy's & St. Thomas' NHS Foundation Trust
The Royal Marsden NHS Foundation Trust
Imperial College Healthcare NHS Trust
University College London Hospital NHS Foundation Trust
The Christie Hospital NHS Foundation Trust
Nottingham University Hospital NHS Trust
Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

avelumab

avelumab plus pegylated liposomal doxorubicin (PLD)

PLD

Arm Description

Arm A: avelumab alone

Arm B: avelumab plus PLD

Arm C: PLD alone

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.

Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.

Secondary Outcome Measures

Objective Response Rate (ORR) Based on BICR Assessment

Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.

ORR Based on Investigator Assessment

Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.

PFS Based on Investigator Assessment According to RECIST Version 1.1

PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.

Duration of Response (DR) Based on BICR Assessment

DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

DR Based on Investigator Assessment

Disease Control (DC) Rate Based on BICR Assessment

Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.

DC Rate Based on Investigator Assessment

Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.

Number of Participants With Laboratory Abnormalities

The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).

Change From Baseline in Vital Signs - Blood Pressure

Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.

Change From Baseline in Vital Signs - Pulse Rate

Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.

Number of Participants With Electrocardiogram (ECG) Abnormalities

Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms.

Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline

LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized.

Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS

PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells.

Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS

Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor.

Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.

Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28.

Change From Baseline in EQ-VAS Score at End of Treatment

The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.

Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose

Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.

Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose

Cmax was defined as maximum observed serum concentration, and can be observed directly from data.

Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose

Cmax was defined as maximum observed serum concentration, and can be observed directly from data.

Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

AUC24 was defined as area under the concentration time profile from time zero to 24 hours.

Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

AUC336 was defined as area under the concentration time profile from time zero to 336 hours.

Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).

Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)

Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.

Number of Participants With Treatment-Induced ADA

Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.

Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)

Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.

Full Information

NCT ID

NCT02580058

First Posted

October 16, 2015

Last Updated

June 20, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02580058

Brief Title

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Official Title

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 21, 2015 (Actual)

Primary Completion Date

September 19, 2018 (Actual)

Study Completion Date

July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

platinum resistant, platinum refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

566 (Actual)

8. Arms, Groups, and Interventions

Arm Title

avelumab

Arm Type

Experimental

Arm Description

Arm A: avelumab alone

Arm Title

avelumab plus pegylated liposomal doxorubicin (PLD)

Arm Type

Experimental

Arm Description

Arm B: avelumab plus PLD

Arm Title

PLD

Arm Type

Active Comparator

Arm Description

Arm C: PLD alone

Intervention Type

Biological

Intervention Name(s)

avelumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PLD

Other Intervention Name(s)

doxorubicin, caelyx

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.

Time Frame

From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).

Title

Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Description

Time Frame

From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) Based on BICR Assessment

Description

Time Frame

Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.

Title

ORR Based on Investigator Assessment

Description

Time Frame

Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.

Title

PFS Based on Investigator Assessment According to RECIST Version 1.1

Description

Time Frame

From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.

Title

Duration of Response (DR) Based on BICR Assessment

Description

Time Frame

Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.

Title

DR Based on Investigator Assessment

Description

Time Frame

Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.

Title

Disease Control (DC) Rate Based on BICR Assessment

Description

Time Frame

Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.

Title

DC Rate Based on Investigator Assessment

Description

Time Frame

Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Description

Time Frame

From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.

Title

Number of Participants With Laboratory Abnormalities

Description

Time Frame

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

Title

Change From Baseline in Vital Signs - Blood Pressure

Description

Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.

Time Frame

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

Title

Change From Baseline in Vital Signs - Pulse Rate

Description

Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.

Time Frame

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

Title

Number of Participants With Electrocardiogram (ECG) Abnormalities

Description

Time Frame

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

Title

Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline

Description

Time Frame

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

Title

Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS

Description

Time Frame

Biomarkers are measured only at screening.

Title

Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS

Description

Time Frame

Biomarkers are measured only at screening.

Title

Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL

Description

Time Frame

Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.

Title

Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28

Description

Time Frame

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

Title

Change From Baseline in EQ-VAS Score at End of Treatment

Description

Time Frame

Baseline and end of treatment/withdrawal visit

Title

Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose

Description

Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.

Time Frame

At predose (0 H) on Cycle 2 Day 1

Title

Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose

Description

Cmax was defined as maximum observed serum concentration, and can be observed directly from data.

Time Frame

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

Title

Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose

Description

Cmax was defined as maximum observed serum concentration, and can be observed directly from data.

Time Frame

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

Title

Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

Description

AUC24 was defined as area under the concentration time profile from time zero to 24 hours.

Time Frame

From 0 through 24 hours postdose

Title

Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

Description

AUC336 was defined as area under the concentration time profile from time zero to 336 hours.

Time Frame

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

Title

Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

Description

AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).

Time Frame

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

Title

Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)

Description

Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.

Time Frame

At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab

Title

Number of Participants With Treatment-Induced ADA

Description

Time Frame

At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab

Title

Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)

Description

Time Frame

At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component. Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively. Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible. Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required. Exclusion Criteria: Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors). Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways). Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable. Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix. Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Oncology Associates, PC - HAL

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

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

University of California, Irvine/UC Irvine Health

City

Orange

State/Province

California

ZIP/Postal Code

92868

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

Florida Cancer Specialists

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Florida Cancer Specialists

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

Florida Cancer Specialists

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Atlanta Gynecologic Oncology

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Northside Hospital - Pharmacy

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

University Gynecologic Oncology

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Northwest Georgia Oncology Centers, P.C.

City

Austell

State/Province

Georgia

ZIP/Postal Code

30106

Country

United States

Facility Name

Northwest Georgia Oncology Centers, P.C.

City

Carrollton

State/Province

Georgia

ZIP/Postal Code

30117

Country

United States

Facility Name

Northwest Georgia Oncology Centers, P.C.

City

Cartersville

State/Province

Georgia

ZIP/Postal Code

30121

Country

United States

Facility Name

Northwest Georgia Oncology Centers, P.C.

City

Douglasville

State/Province

Georgia

ZIP/Postal Code

30134

Country

United States

Facility Name

Northwest Georgia Oncology Centers, P.C.

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

The University of Kansas Clinical Research Center

City

Fairway

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

The University of Kansas Cancer Center and Medical Pavilion

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Norton Cancer Institute, Norton Healthcare Pavilion

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Norton Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Norton Cancer Institute, St. Matthews Campus

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Norton Women's and Children's Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Norton Brownsboro Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Norton Cancer Institute, Brownsboro Hospital Campus

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Maryland Oncology Hematology, P.A.

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Maryland Oncology Hematology, P.A.

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Maryland Oncology Hematology P.A.

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Maryland Oncology Hematology P.A.

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20904

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

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

The University of Kansas Cancer Center, CCP - North

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64154

Country

United States

Facility Name

Center of Hope at Renown Regional Medical Center

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

Southwest GYN Oncology Associates, Inc.

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

University of New Mexico Comprehensive Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Hope Women's Cancer Centers

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Mission Hospital, Inc.

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Novant Health Oncology Specialists

City

Kernersville

State/Province

North Carolina

ZIP/Postal Code

27284

Country

United States

Facility Name

Novant Health Oncology Specialists

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Cleveland Clinic Taussig Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Fairview Hospital Moll Pavilion Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44111

Country

United States

Facility Name

Fairview Hospital Moll Pavilion Pharmacy

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44111

Country

United States

Facility Name

Cleveland Clinic Taussig Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Hillcrest Hospital Hirsch Cancer Center Pharmacy

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

Hillcrest Hospital

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

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

Investigational Drug Services, University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

The University of Pennsylvania Health System

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

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

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

Texas Oncology - The Woodlands, Gynecologic Oncology

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Utah Cancer Specialists

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Carilion Clinic Gynecologic Oncology

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24016

Country

United States

Facility Name

Carilion Clinic

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24016

Country

United States

Facility Name

Froedtert and The Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Froedtert Hospital

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Epic Pharmacy,Newcastle Private Hospital

City

New Lambton Heights

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Newcastle Private Hospital Pty Limited

City

Newcastle

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Icon Cancer Care Wesley

City

Auchenflower

State/Province

Queensland

ZIP/Postal Code

4066

Country

Australia

Facility Name

Rivercity Pharmacy

City

Auchenflower

State/Province

Queensland

ZIP/Postal Code

4066

Country

Australia

Facility Name

Mater Pharmacy Services

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Icon Cancer Care Chermside

City

Chermside

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

Clinical Research Unit

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Metro North Hospital and Health Service

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Oncology Pharmacy

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Icon Cancer Care

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Icon Cancer Foundation

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Mater Cancer Care Centre

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Icon Cancer Care Southport

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Cabrini Health Limited

City

Brighton

State/Province

Victoria

ZIP/Postal Code

3186

Country

Australia

Facility Name

Cabrini Health Limited

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Peter MacCallum Cancer Centre

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Pharmacy Department

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

The Royal Women's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Medizinische Universitat Graz, LKH-Univ. Klinikum Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Medizinische Universitat Innsbruck

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

University Hospital Gent

City

Gent

State/Province

EAST Flanders

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Institut Jules Bordet

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

AZ Groeninge Hospital

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Universitaire Ziekenhuizen Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU de Liege - Sart Tilman

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Clinique et Maternite Sainte Elisabeth

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

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

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y5L3

Country

Canada

Facility Name

British Columbia Cancer Agency-Vancouver Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

St. Boniface General Hospital

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

Health Sciences Centre

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

CancerCare Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

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

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Nova Scotia Health Authority, QEII Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Sunnybrook Research Institute

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

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

Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika

City

Praha 2

State/Province

Czech Republic

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava

City

Ostrava-Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze, Neurologicka klinika

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze

City

Praha 2

ZIP/Postal Code

12851

Country

Czechia

Facility Name

Fakultni nemocnice v Motole

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

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

City

Usti nad Labem

ZIP/Postal Code

401 13

Country

Czechia

Facility Name

Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Centre Francois Baclesse

City

Caen Cedex 5

ZIP/Postal Code

14076

Country

France

Facility Name

Centre Leon Berard

City

Lyon cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Service de Radiologie

City

LYON cedex 8

ZIP/Postal Code

69373

Country

France

Facility Name

Centre Antoine Lacassagne

City

Nice cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

Hôpital Européen Georges Pompidou

City

Paris cedex 15

ZIP/Postal Code

75908

Country

France

Facility Name

Hôpital Européen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Centre Hospitalier Lyon Sud

City

Pierre Benite cedex

ZIP/Postal Code

69310

Country

France

Facility Name

Institut de Cancérologie de Lorraine

City

Vandoeuvre-lès-Nancy

ZIP/Postal Code

54519

Country

France

Facility Name

Gustave Roussy Cancer Campus

City

Villejuif cedex

ZIP/Postal Code

94805

Country

France

Facility Name

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

City

Athens/New Kifissia

ZIP/Postal Code

14564

Country

Greece

Facility Name

General Hospital of Athens Alexandra

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Princess Margaret Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

University of Hong Kong

City

Hong Kong

Country

Hong Kong

Facility Name

Orszagos Onkologiai Intezet, Gyogyszertar

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Gyogyszertar

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont

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

Country

Ireland

Facility Name

Mater Private Hospital

City

Dublin 7

State/Province

Dublin

ZIP/Postal Code

Dublin 7

Country

Ireland

Facility Name

Pharmacy Department

City

Dublin 4

Country

Ireland

Facility Name

St Vincent's University Hospital

City

Dublin 4

Country

Ireland

Facility Name

St James's Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Mater Misericoridae University Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Mater Private Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

University Hospital Waterford

City

Waterford

Country

Ireland

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Facility Name

Poliambulatorio Specialistico Villa Salute

City

Manerbio

State/Province

Brescia

ZIP/Postal Code

25025

Country

Italy

Facility Name

Congregazione delle Suore Infermiere dell'Addolorata

City

Costa Masnaga

State/Province

Lecco

ZIP/Postal Code

23845

Country

Italy

Facility Name

ASST Fatebenefratelli Sacco

City

Miano

State/Province

Milano

ZIP/Postal Code

20121

Country

Italy

Facility Name

Servizio Sanitario Regionale Emilia-Romagna

City

Lugo

State/Province

Ravenna

ZIP/Postal Code

48022

Country

Italy

Facility Name

Fondazione del Piemonte per l'Oncologia

City

Candiolo

State/Province

Torino

ZIP/Postal Code

10060

Country

Italy

Facility Name

Habilita, San Marco Bergamo

City

Bergamo

ZIP/Postal Code

24122

Country

Italy

Facility Name

Humanitas Cliniche Gavazzeni

City

Bergamo

ZIP/Postal Code

24125

Country

Italy

Facility Name

Humanitas, Unita Operativa di Cardiologia 2

City

Bergamo

ZIP/Postal Code

24125

Country

Italy

Facility Name

Fondazione Poliambulanza Istituto Ospedelario

City

Brescia

ZIP/Postal Code

25124

Country

Italy

Facility Name

Congregazione delle Suore Infermiere dell'Addolorata

City

Como

ZIP/Postal Code

22100

Country

Italy

Facility Name

Fondazione Teresa Camplani

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Regione Lombardia, A O Istituti Ospitalieri di Cremona

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Regione Lombardia, ASST Cremona

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Istituto Europeo di Oncologia

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Ambulatorio dott. Francesco Cavanna, Medico Chirurgo

City

Piacenza

ZIP/Postal Code

29121

Country

Italy

Facility Name

Azienda Unita Sanitaria Locale di Piacenza

City

Piacenza

ZIP/Postal Code

29121

Country

Italy

Facility Name

Azienda USL 4 Prato

City

Prato

ZIP/Postal Code

59100

Country

Italy

Facility Name

Azienda USL 4 Toscana Centro

City

Prato

ZIP/Postal Code

59100

Country

Italy

Facility Name

Servizio Sanitario Regionale Emilia-Romagna

City

Rimini

ZIP/Postal Code

47921

Country

Italy

Facility Name

C D C, Sede di Torino Centro

City

Torino

ZIP/Postal Code

10122

Country

Italy

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

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

Nippon Medical School Musashikosugi Hospital

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

211-8533

Country

Japan

Facility Name

Yokohama City University Hospital

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0004

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

Saitama Cancer Center

City

Kita-adachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

National Defense Medical College Hospital

City

Tokorozawa

State/Province

Saitama

ZIP/Postal Code

359-8513

Country

Japan

Facility Name

Seirei Hamamatsu General Hospital

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

430-8558

Country

Japan

Facility Name

Jichi Medical University Hospital

City

Shimotsuke

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

The University of Tokyo Hospital

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

National Cancer Center Hospital

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Kagoshima University Hospital

City

Kagoshima

ZIP/Postal Code

890-8520

Country

Japan

Facility Name

Kagoshima City Hospital

City

Kagoshima

ZIP/Postal Code

890-8760

Country

Japan

Facility Name

Niigata Cancer Center Hospital

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

National Cancer Center

City

Goyangsi

State/Province

Gyeonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center

City

Daegu

ZIP/Postal Code

41931

Country

Korea, Republic of

Facility Name

Keimyung University Dongsan Medical Center

City

Daegu

ZIP/Postal Code

41931

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

02841

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, Clinical Trial Pharmacy

City

Seoul

ZIP/Postal Code

03722

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

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center Clinical Trial Pharmacy

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

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

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

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

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

The Catholic University of Korea

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

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

Department of Obstetrics and Gynecology, Haukeland University Hospital

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Sykehusapoteket i Bergen

City

Bergen

ZIP/Postal Code

5053

Country

Norway

Facility Name

Oslo Universitetssykehus

City

Oslo

ZIP/Postal Code

0379

Country

Norway

Facility Name

Sykehusapoteket Oslo

City

Oslo

ZIP/Postal Code

0379

Country

Norway

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

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

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

City

Sochi

State/Province

Krasnodar Region

ZIP/Postal Code

354057

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary

City

Pyatigorsk

State/Province

Stavropol Region

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

Evimed Llc

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Clinical oncology dispensary #1"

City

Krasnodar

ZIP/Postal Code

350040

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Nizhegorogsky region

City

Nizhniy Novgorod

ZIP/Postal Code

603081

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"

City

Orenburg

ZIP/Postal Code

460021

Country

Russian Federation

Facility Name

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

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"

City

Velikiy Novgorod

ZIP/Postal Code

173016

Country

Russian Federation

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119082

Country

Singapore

Facility Name

National Cancer Centre Singapore Pharmacy

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

National Cancer Centre Singapore

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Raffles Hospital

City

Singapore

ZIP/Postal Code

188770

Country

Singapore

Facility Name

Institut Catala d'Oncologia - Hospital Duran y Reynalds

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital Universitario Reina Sofia

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

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

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Hospital MD Anderson

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Centro Integral Oncologico Clara Campal

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Universitario Virgen de Valme

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Universitatsspital Basel, Frauenklinik

City

Basel

State/Province

Basel-stadt

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Universitatsspital Basel

City

Basel

State/Province

Basel-stadt

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie

City

Luzern 16

State/Province

Luzern

ZIP/Postal Code

6000

Country

Switzerland

Facility Name

Oncology Institute of Southern Switzerland (IOSI)

City

Bellinzona

State/Province

Ticino

ZIP/Postal Code

6500

Country

Switzerland

Facility Name

Kantonsapotheke Zurich

City

Zurich

ZIP/Postal Code

8006

Country

Switzerland

Facility Name

Universitaetsspital Zurich, Klinik fuer Gynakologie

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Universitatsspital Zurich, Clinical Trials Center

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Universitatsspital Zurich, Universitares Herzzentrum Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Clinical Trial Pharmacy, National Cheng Kung University Hospital

City

Tainan city

ZIP/Postal Code

701

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan City

ZIP/Postal Code

704

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

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

City

Taipei City

ZIP/Postal Code

11259

Country

Taiwan

Facility Name

Koo Foundation Sun Yat-Sen Cancer Center

City

Taipei City

ZIP/Postal Code

112

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

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

Cambridge University Hospitals NHS Foundation Trust

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Ross Hall Hospital

City

Glasgow

State/Province

CITY OF Glasgow

ZIP/Postal Code

G52 3NQ

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

City

Bebington, 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

Northampton General Hospital NHS Trust

City

Northampton

State/Province

Northamptonshire

ZIP/Postal Code

NN1 5BD

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

The Royal Marsden NHS Foundation Trust

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Spire Healthcare Limited (St. Anthony's Hospital)

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM3 9DW

Country

United Kingdom

Facility Name

NHS Greater Glasgow and Clyde

City

Glasgow

ZIP/Postal Code

G12 0YN

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

Guy's & St. Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

The 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 NHS Foundation Trust

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

Nottingham University Hospital NHS Trust

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Nottingham University Hospitals NHS Trust

City

Nottingham

ZIP/Postal Code

NG5 1PB

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

34143970

Citation

Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B9991009&StudyName=A%20Phase%203%2C%20Multicenter%2C%20Randomized%2C%20Open-label%20Study%20Of%20Avelumab%20%28msb0010718c%29%20Alone%20Or%20In%20Combination%20With%20Pegylated%20Liposomal%20Doxorubicin%20Versus%20Pegylated%20Liposomal%20Doxorubicin%20Alone%20In%20Patients%20With%20Platinum-resistant%2Frefractory%20Ovarian%20Cancer

Description

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URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B9991009&StudyName=A+Phase+3%2C+Multicenter%2C+Randomized%2C+Open-label+Study+Of+Avelumab+%28msb0010718c%29+Alone+Or+In+Combination+With+Pegylated+Liposomal+Doxorubicin+Versus+Pegylated+Liposomal+Doxorubicin+Alone+In+Patients+With+Platinum-resistant%2Frefractory+Ovarian+Cancer

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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