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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02580058
Registration number
NCT02580058
Ethics application status
Date submitted
16/10/2015
Date registered
20/10/2015
Date last updated
10/07/2023
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)
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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
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Secondary ID [1]
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2015-003091-77
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Secondary ID [2]
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B9991009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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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).
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Primary outcome [2]
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Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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Assessment method [2]
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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.
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Timepoint [2]
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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.
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Secondary outcome [1]
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Objective Response Rate (ORR) Based on BICR Assessment
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [2]
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ORR Based on Investigator Assessment
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Assessment method [2]
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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.
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Timepoint [2]
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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.
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Secondary outcome [3]
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PFS Based on Investigator Assessment According to RECIST Version 1.1
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Assessment method [3]
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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.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Duration of Response (DR) Based on BICR Assessment
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Assessment method [4]
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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.
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Timepoint [4]
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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.
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Secondary outcome [5]
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DR Based on Investigator Assessment
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Assessment method [5]
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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.
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Timepoint [5]
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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.
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Secondary outcome [6]
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Disease Control (DC) Rate Based on BICR Assessment
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Assessment method [6]
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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.
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Timepoint [6]
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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.
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Secondary outcome [7]
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DC Rate Based on Investigator Assessment
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Assessment method [7]
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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.
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Timepoint [7]
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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.
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Secondary outcome [8]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [8]
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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.
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Timepoint [8]
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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.
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Secondary outcome [9]
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Number of Participants With Laboratory Abnormalities
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Assessment method [9]
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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).
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Timepoint [9]
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From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
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Secondary outcome [10]
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Change From Baseline in Vital Signs - Blood Pressure
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Assessment method [10]
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Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.
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Timepoint [10]
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From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
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Secondary outcome [11]
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Change From Baseline in Vital Signs - Pulse Rate
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Assessment method [11]
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Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.
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Timepoint [11]
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From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
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Secondary outcome [12]
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Number of Participants With Electrocardiogram (ECG) Abnormalities
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Assessment method [12]
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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.
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Timepoint [12]
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From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
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Secondary outcome [13]
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Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline
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Assessment method [13]
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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.
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Timepoint [13]
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Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
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Secondary outcome [14]
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Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS
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Assessment method [14]
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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.
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Timepoint [14]
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Biomarkers are measured only at screening.
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Secondary outcome [15]
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Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS
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Assessment method [15]
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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.
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Timepoint [15]
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Biomarkers are measured only at screening.
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Secondary outcome [16]
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Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL
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Assessment method [16]
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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.
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Timepoint [16]
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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.
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Secondary outcome [17]
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Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28
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Assessment method [17]
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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.
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Timepoint [17]
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From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
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Secondary outcome [18]
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Change From Baseline in EQ-VAS Score at End of Treatment
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline and end of treatment/withdrawal visit
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Secondary outcome [19]
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Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose
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Assessment method [19]
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Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.
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Timepoint [19]
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At predose (0 H) on Cycle 2 Day 1
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Secondary outcome [20]
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Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose
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Assessment method [20]
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Cmax was defined as maximum observed serum concentration, and can be observed directly from data.
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Timepoint [20]
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At postdose (end of infusion, 1H) on Cycle 2 Day 1
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Secondary outcome [21]
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Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose
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Assessment method [21]
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Cmax was defined as maximum observed serum concentration, and can be observed directly from data.
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Timepoint [21]
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From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
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Secondary outcome [22]
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Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
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Assessment method [22]
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AUC24 was defined as area under the concentration time profile from time zero to 24 hours.
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Timepoint [22]
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From 0 through 24 hours postdose
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Secondary outcome [23]
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Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
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Assessment method [23]
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AUC336 was defined as area under the concentration time profile from time zero to 336 hours.
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Timepoint [23]
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From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
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Secondary outcome [24]
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Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
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Assessment method [24]
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AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).
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Timepoint [24]
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From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
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Secondary outcome [25]
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Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)
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Assessment method [25]
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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.
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Timepoint [25]
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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
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Secondary outcome [26]
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Number of Participants With Treatment-Induced ADA
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Assessment method [26]
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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.
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Timepoint [26]
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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
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Secondary outcome [27]
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Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)
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Assessment method [27]
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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.
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Timepoint [27]
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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
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/07/2022
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Sample size
Target
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Accrual to date
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Final
566
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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0
Epic Pharmacy,Newcastle Private Hospital - New Lambton Heights
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Recruitment hospital [2]
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0
Newcastle Private Hospital Pty Limited - Newcastle
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Recruitment hospital [3]
0
0
Icon Cancer Care Wesley - Auchenflower
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Recruitment hospital [4]
0
0
Rivercity Pharmacy - Auchenflower
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Recruitment hospital [5]
0
0
Mater Pharmacy Services - Brisbane
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Recruitment hospital [6]
0
0
Icon Cancer Care Chermside - Chermside
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Recruitment hospital [7]
0
0
Clinical Research Unit - Herston
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Recruitment hospital [8]
0
0
Metro North Hospital and Health Service - Herston
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Recruitment hospital [9]
0
0
Oncology Pharmacy - Herston
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Recruitment hospital [10]
0
0
Icon Cancer Care - South Brisbane
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Recruitment hospital [11]
0
0
Icon Cancer Foundation - South Brisbane
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Recruitment hospital [12]
0
0
Mater Cancer Care Centre - South Brisbane
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Recruitment hospital [13]
0
0
Icon Cancer Care Southport - Southport
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Recruitment hospital [14]
0
0
Cabrini Health Limited - Brighton
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Recruitment hospital [15]
0
0
Cabrini Health Limited - Malvern
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Recruitment hospital [16]
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0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [17]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment hospital [18]
0
0
Pharmacy Department - Parkville
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Recruitment hospital [19]
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0
The Royal Women's Hospital - Parkville
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Recruitment postcode(s) [1]
0
0
2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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0
2305 - Newcastle
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Recruitment postcode(s) [3]
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0
4066 - Auchenflower
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Recruitment postcode(s) [4]
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0
4101 - Brisbane
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Recruitment postcode(s) [5]
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0
4032 - Chermside
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Recruitment postcode(s) [6]
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0
4029 - Herston
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Recruitment postcode(s) [7]
0
0
4101 - South Brisbane
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Recruitment postcode(s) [8]
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0
4215 - Southport
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Recruitment postcode(s) [9]
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0
3186 - Brighton
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Recruitment postcode(s) [10]
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0
3144 - Malvern
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Recruitment postcode(s) [11]
0
0
3000 - Melbourne
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Recruitment postcode(s) [12]
0
0
3050 - Parkville
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Recruitment postcode(s) [13]
0
0
3052 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Kansas
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kentucky
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Nevada
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Mexico
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Country [14]
0
0
United States of America
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State/province [14]
0
0
North Carolina
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Country [15]
0
0
United States of America
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Ohio
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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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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Belgium
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EAST Flanders
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Belgium
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Brussels
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Namur
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Czech Republic
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Czechia
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Olomouc
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Czechia
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Ostrava-Poruba
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Czechia
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Praha 2
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Czechia
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Praha 5
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Czechia
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Usti nad Labem
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Denmark
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Aalborg
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Denmark
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Copenhagen
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France
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Caen Cedex 5
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France
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Lyon cedex 08
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France
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LYON cedex 8
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Country [48]
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France
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State/province [48]
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Nice cedex 2
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Country [49]
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France
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Paris cedex 15
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Country [50]
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France
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Paris
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Country [51]
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France
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Pierre Benite cedex
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France
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Vandoeuvre-lès-Nancy
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France
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Villejuif cedex
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Greece
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Athens/New Kifissia
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Greece
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Athens
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szolnok
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Country [60]
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Ireland
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Dublin
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Ireland
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Dublin 4
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Ireland
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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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Country [65]
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Italy
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Lecco
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Country [66]
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Italy
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Milano
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Country [67]
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Italy
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Ravenna
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Country [68]
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Italy
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Torino
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Country [69]
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Italy
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Bergamo
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Country [70]
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Italy
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Como
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Country [71]
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Italy
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Cremona
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Country [72]
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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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Country [77]
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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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Japan
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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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Netherlands
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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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Poland
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Poznan
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Poland
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Rybnik
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Country [99]
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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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Russian Federation
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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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Spain
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Barcelona
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Spain
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Cordoba
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Country [111]
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Spain
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Girona
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Spain
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Madrid
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Spain
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Sevilla
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Switzerland
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Basel-stadt
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Switzerland
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Luzern
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Switzerland
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Ticino
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Switzerland
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Zurich
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Taiwan
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Taiwan
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Taipei
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United Kingdom
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Cambridgeshire
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United Kingdom
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CITY OF Glasgow
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United Kingdom
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Merseyside
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United Kingdom
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United Kingdom
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Northamptonshire
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United Kingdom
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Oxford
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United Kingdom
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Surrey
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Country [131]
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United Kingdom
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Glasgow
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Country [132]
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02580058
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02580058
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