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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02580058




Registration number
NCT02580058
Ethics application status
Date submitted
16/10/2015
Date registered
20/10/2015
Date last updated
19/11/2019

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
2015-003091-77
Secondary ID [2] 0 0
B9991009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - avelumab
Treatment: Drugs - PLD

Experimental: avelumab - Arm A: avelumab alone

Experimental: avelumab plus pegylated liposomal doxorubicin (PLD) - Arm B: avelumab plus PLD

Active Comparator: PLD - Arm C: PLD alone


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

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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
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 [1] 0 0
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.
Timepoint [1] 0 0
Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
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 [4] 0 0
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.
Timepoint [4] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [5] 0 0
DR Based on Investigator Assessment - DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
Timepoint [5] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
From Cycle 1 Day 1 to 90 days after the last dose of study treatment (up to 2.7 years by primary completion date of 19 September 2018).
Secondary outcome [9] 0 0
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).
Timepoint [9] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Biomarkers are measured only at screening.
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Biomarkers are measured only at screening.
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
Secondary outcome [18] 0 0
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.
Timepoint [18] 0 0
Baseline and end of treatment/withdrawal visit

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Epic Pharmacy,Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Newcastle Private Hospital Pty Limited - Newcastle
Recruitment hospital [3] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [4] 0 0
Rivercity Pharmacy - Auchenflower
Recruitment hospital [5] 0 0
Mater Pharmacy Services - Brisbane
Recruitment hospital [6] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [7] 0 0
Clinical Research Unit - Herston
Recruitment hospital [8] 0 0
Metro North Hospital and Health Service - Herston
Recruitment hospital [9] 0 0
Oncology Pharmacy - Herston
Recruitment hospital [10] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [11] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [12] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [13] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [14] 0 0
Cabrini Health Limited - Brighton
Recruitment hospital [15] 0 0
Cabrini Health Limited - Malvern
Recruitment hospital [16] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [18] 0 0
Pharmacy Department - Parkville
Recruitment hospital [19] 0 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
3186 - Brighton
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3000 - Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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Georgia
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Missouri
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Nevada
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New Mexico
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Austria
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Graz
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Austria
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Innsbruck
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EAST Flanders
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Brussels
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Aalborg
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Caen Cedex 5
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Budapest
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Debrecen
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Szolnok
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Dublin 4
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Waterford
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Israel
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Jerusalem
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Italy
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Brescia
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Italy
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Lecco
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Italy
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Milano
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Italy
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Ravenna
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Italy
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Torino
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Bergamo
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Italy
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Como
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Italy
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Cremona
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Italy
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Piacenza
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Italy
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Prato
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Italy
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Rimini
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Saitama
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Kagoshima
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Japan
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Niigata
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Netherlands
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Groningen
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Leiden
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Netherlands
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Maastricht
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Norway
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Bergen
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Norway
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Oslo
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Poland
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Krakow
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Poland
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Olsztyn
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Poznan
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Poland
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Rybnik
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Russian Federation
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Krasnodar Region
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Russian Federation
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Stavropol Region
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Russian Federation
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Chelyabinsk
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Orenburg
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Saint Petersburg
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Russian Federation
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Velikiy Novgorod
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Singapore
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Singapore
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Barcelona
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Spain
State/province [111] 0 0
Madrid
Country [112] 0 0
Spain
State/province [112] 0 0
Sevilla
Country [113] 0 0
Switzerland
State/province [113] 0 0
Basel-stadt
Country [114] 0 0
Switzerland
State/province [114] 0 0
Luzern
Country [115] 0 0
Switzerland
State/province [115] 0 0
Ticino
Country [116] 0 0
Switzerland
State/province [116] 0 0
Zurich
Country [117] 0 0
Taiwan
State/province [117] 0 0
Tainan city
Country [118] 0 0
Taiwan
State/province [118] 0 0
Tainan City
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taipei city
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei City
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taipei
Country [122] 0 0
Taiwan
State/province [122] 0 0
Taoyuan City
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Cambridgeshire
Country [124] 0 0
United Kingdom
State/province [124] 0 0
CITY OF Glasgow
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Merseyside
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Middlesex
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Northamptonshire
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Oxford
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Surrey
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Glasgow
Country [131] 0 0
United Kingdom
State/province [131] 0 0
London
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Manchester
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Nottingham
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Stockport

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02580058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications