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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02580058
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Results First Posted : November 19, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Biological: avelumab
Drug: PLD
Enrollment 566
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles. PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Period Title: Overall Study
Started [1] 188 188 190
Treated [2] 187 182 177
Completed [3] 109 102 104
Not Completed 79 86 86
Reason Not Completed
Lost to Follow-up             4             5             4
Ongoing             51             55             46
Withdrawal by Subject             24             26             36
[1]
This table included all randomized participants.
[2]
Participants received at least 1 dose of study drug
[3]
Participants who died were considered as completed.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD) Total
Hide Arm/Group Description Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles. PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. Total of all reporting groups
Overall Number of Baseline Participants 188 188 190 566
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 188 participants 190 participants 566 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
111
  59.0%
124
  66.0%
114
  60.0%
349
  61.7%
>=65 years
77
  41.0%
64
  34.0%
76
  40.0%
217
  38.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 188 participants 188 participants 190 participants 566 participants
61.0  (10.26) 59.5  (10.05) 60.4  (10.64) 60.3  (10.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 188 participants 190 participants 566 participants
Female
188
 100.0%
188
 100.0%
190
 100.0%
566
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 188 participants 190 participants 566 participants
Hispanic or Latino
2
   1.1%
3
   1.6%
1
   0.5%
6
   1.1%
Not Hispanic or Latino
176
  93.6%
176
  93.6%
183
  96.3%
535
  94.5%
Unknown or Not Reported
10
   5.3%
9
   4.8%
6
   3.2%
25
   4.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 188 participants 188 participants 190 participants 566 participants
Black or African American
2
   1.1%
2
   1.1%
6
   3.2%
10
   1.8%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
Asian
34
  18.1%
53
  28.2%
46
  24.2%
133
  23.5%
Native Hawaiian or Other Pacific Islander
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
White
148
  78.7%
133
  70.7%
135
  71.1%
416
  73.5%
Other
1
   0.5%
0
   0.0%
2
   1.1%
3
   0.5%
Unknown
2
   1.1%
0
   0.0%
0
   0.0%
2
   0.4%
1.Primary Outcome
Title Overall Survival (OS)
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analyses of OS were performed based on the Full Analysis Set (FAS). The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Median (95% Confidence Interval)
Unit of Measure: months
11.8
(8.9 to 14.1)
15.7
(12.7 to 18.7)
13.1
(11.8 to 15.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Pegylated Liposomal Doxorubicin (PLD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8253
Comments [Not Specified]
Method Log Rank
Comments 1-sided
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.867 to 1.497
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Avelumab + PLD, Pegylated Liposomal Doxorubicin (PLD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2082
Comments [Not Specified]
Method Log Rank
Comments 1-sided
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.672 to 1.179
Estimation Comments [Not Specified]
2.Primary Outcome
Title Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analyses of PFS based on BICR assessment were performed using FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.8 to 1.9)
3.7
(3.3 to 5.1)
3.5
(2.1 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avelumab, Pegylated Liposomal Doxorubicin (PLD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Log Rank
Comments 1-sided
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
1.310 to 2.160
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Avelumab + PLD, Pegylated Liposomal Doxorubicin (PLD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0301
Comments [Not Specified]
Method Log Rank
Comments 1-sided
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.607 to 1.011
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR) Based on BICR Assessment
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.7
(1.5 to 7.5)
13.3
(8.8 to 19.0)
4.2
(1.8 to 8.1)
4.Secondary Outcome
Title ORR Based on Investigator Assessment
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.3
(2.6 to 9.6)
18.6
(13.3 to 24.9)
9.5
(5.7 to 14.6)
5.Secondary Outcome
Title PFS Based on Investigator Assessment According to RECIST Version 1.1
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Median (95% Confidence Interval)
Unit of Measure: month
1.9
(1.8 to 1.9)
4.7
(3.7 to 6.0)
3.7
(3.5 to 5.4)
6.Secondary Outcome
Title Duration of Response (DR) Based on BICR Assessment
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 7 25 8
Median (95% Confidence Interval)
Unit of Measure: months
9.2 [1] 
(6.4 to NA)
8.5 [2] 
(6.1 to NA)
13.1 [2] 
(5.5 to NA)
[1]
The upper limit of 95% confidence interval (CI) was not estimable due to the small number of events.
[2]
The upper limit of 95% CI was not estimable due to the small number of events.
7.Secondary Outcome
Title DR Based on Investigator Assessment
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 10 35 18
Median (95% Confidence Interval)
Unit of Measure: months
10.4 [1] 
(3.7 to NA)
7.6
(5.6 to 9.1)
7.4
(3.6 to 11.2)
[1]
The upper limit of 95% CI was not estimable due to the small number of events.
8.Secondary Outcome
Title Disease Control (DC) Rate Based on BICR Assessment
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.0
(26.3 to 40.2)
57.4
(50.0 to 64.6)
48.9
(41.6 to 56.3)
9.Secondary Outcome
Title DC Rate Based on Investigator Assessment
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.0
(27.3 to 41.3)
61.7
(54.3 to 68.7)
54.7
(47.4 to 62.0)
10.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 187 182 177
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
180
  96.3%
180
  98.9%
173
  97.7%
Treatment emergent SAEs
71
  38.0%
75
  41.2%
51
  28.8%
11.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description 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).
Time Frame From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Hide Outcome Measure Data
Hide Analysis Population Description
'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who can be evaluated for CTCAE criteria for each parameter in each treatment group.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 187 182 177
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia Number Analyzed 186 participants 178 participants 172 participants
Any grade >=1
135
  72.6%
155
  87.1%
144
  83.7%
Lymphocyte count decreased Number Analyzed 185 participants 178 participants 171 participants
Any grade >=1
89
  48.1%
148
  83.1%
107
  62.6%
Neutrophil count decreased Number Analyzed 185 participants 177 participants 172 participants
Any grade >=1
26
  14.1%
80
  45.2%
62
  36.0%
Platelet count decreased Number Analyzed 186 participants 178 participants 172 participants
Any grade >=1
33
  17.7%
48
  27.0%
50
  29.1%
Creatinine increased Number Analyzed 186 participants 178 participants 172 participants
Any grade >=1
154
  82.8%
151
  84.8%
120
  69.8%
Serum amylase increased Number Analyzed 180 participants 172 participants 161 participants
Any grade >=1
43
  23.9%
35
  20.3%
27
  16.8%
Lipase increased Number Analyzed 175 participants 173 participants 159 participants
Any grade >=1
27
  15.4%
33
  19.1%
21
  13.2%
12.Secondary Outcome
Title Change From Baseline in Vital Signs - Blood Pressure
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 187 182 177
Mean (Standard Deviation)
Unit of Measure: mm Hg
DBP Cycle 1 Day 15 Number Analyzed 180 participants 170 participants 142 participants
0.1  (9.79) -2.2  (9.12) 0.7  (8.89)
DBP Cycle 2 Day 1 Number Analyzed 164 participants 168 participants 156 participants
-1.1  (9.61) -2.8  (8.01) -0.1  (9.34)
DBP Cycle 2 Day 15 Number Analyzed 138 participants 157 participants 124 participants
0.1  (10.05) -2.8  (9.19) -0.1  (8.83)
DBP Cycle 3 Day 1 Number Analyzed 104 participants 141 participants 106 participants
0  (10.81) -2.7  (8.95) -0.2  (8.96)
DBP Cycle 3 Day 15 Number Analyzed 95 participants 128 participants 84 participants
-0.6  (9.25) -2.3  (8.56) -0.5  (8.67)
DBP End of Treatment Number Analyzed 146 participants 138 participants 136 participants
1.1  (10.87) -0.3  (11.08) 0.8  (10.40)
SBP Cycle 1 Day 15 Number Analyzed 180 participants 170 participants 142 participants
-0.9  (14.35) -2.3  (13.12) -1.0  (13.94)
SBP Cycle 2 Day 1 Number Analyzed 164 participants 168 participants 156 participants
-2.2  (14.44) -3.4  (13.70) -2.8  (13.39)
SBP Cycle 2 Day 15 Number Analyzed 138 participants 157 participants 124 participants
-0.6  (14.11) -3.7  (14.78) -1.8  (14.98)
SBP Cycle 3 Day 1 Number Analyzed 104 participants 141 participants 106 participants
-0.2  (15.59) -2.7  (14.36) -1.5  (14.14)
SBP Cycle 3 Day 15 Number Analyzed 95 participants 128 participants 84 participants
-0.2  (13.78) -2.1  (15.30) -2.2  (13.96)
SBP End of Treatment Number Analyzed 146 participants 138 participants 136 participants
-0.9  (17.21) -1.0  (16.83) -3.2  (15.92)
13.Secondary Outcome
Title Change From Baseline in Vital Signs - Pulse Rate
Hide 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.
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Hide Analysis Population Description
'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 187 182 177
Mean (Standard Deviation)
Unit of Measure: bpm
Cycle 1 Day 15 Number Analyzed 180 participants 170 participants 142 participants
2.9  (9.95) 1.8  (12.10) 3.5  (10.70)
Cycle 2 Day 1 Number Analyzed 164 participants 167 participants 155 participants
2.6  (10.92) 2.9  (11.18) 1.7  (9.71)
Cycle 2 Day 15 Number Analyzed 138 participants 157 participants 124 participants
2.9  (11.19) 3.5  (11.79) 3.2  (11.54)
Cycle 3 Day 1 Number Analyzed 104 participants 141 participants 106 participants
2.4  (10.00) 2.1  (11.78) 1.4  (11.14)
Cycle 3 Day 15 Number Analyzed 95 participants 128 participants 84 participants
3.0  (12.23) 1.4  (11.44) 2.4  (10.41)
End of Treatment Number Analyzed 146 participants 138 participants 136 participants
7.7  (14.27) 7.4  (13.70) 5.7  (14.10)
14.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide Description 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.
Time Frame From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Hide Outcome Measure Data
Hide Analysis Population Description
'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who had a at least 1 post-baseline ECG assessment performed.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 187 182 177
Measure Type: Count of Participants
Unit of Measure: Participants
QT increase from baseline >30 ms Number Analyzed 183 participants 176 participants 169 participants
26
  14.2%
40
  22.7%
47
  27.8%
QT increase from baseline >60 ms Number Analyzed 183 participants 176 participants 169 participants
5
   2.7%
9
   5.1%
4
   2.4%
QT >450 ms Number Analyzed 183 participants 176 participants 169 participants
6
   3.3%
10
   5.7%
5
   3.0%
QT >480 ms Number Analyzed 183 participants 176 participants 169 participants
1
   0.5%
2
   1.1%
2
   1.2%
QT >500 ms Number Analyzed 183 participants 176 participants 169 participants
1
   0.5%
1
   0.6%
1
   0.6%
QTcB increase from baseline >30 ms Number Analyzed 154 participants 153 participants 143 participants
33
  21.4%
36
  23.5%
22
  15.4%
QTcB increase from baseline >60 ms Number Analyzed 154 participants 153 participants 143 participants
9
   5.8%
7
   4.6%
8
   5.6%
QTcB >450 ms Number Analyzed 161 participants 160 participants 145 participants
56
  34.8%
63
  39.4%
45
  31.0%
QTcB >480 ms Number Analyzed 161 participants 160 participants 145 participants
9
   5.6%
19
  11.9%
9
   6.2%
QTcB >500 ms Number Analyzed 161 participants 160 participants 145 participants
5
   3.1%
9
   5.6%
5
   3.4%
QTcF increase from baseline >30 ms Number Analyzed 154 participants 153 participants 143 participants
19
  12.3%
24
  15.7%
13
   9.1%
QTcF increase from baseline >60 ms Number Analyzed 154 participants 153 participants 143 participants
6
   3.9%
5
   3.3%
5
   3.5%
QTcF >450 ms Number Analyzed 161 participants 160 participants 145 participants
18
  11.2%
27
  16.9%
14
   9.7%
QTcF >480 ms Number Analyzed 161 participants 160 participants 145 participants
4
   2.5%
8
   5.0%
5
   3.4%
QTcF >500 ms Number Analyzed 161 participants 160 participants 145 participants
3
   1.9%
2
   1.3%
4
   2.8%
QTcP increase from baseline >30 ms Number Analyzed 154 participants 153 participants 143 participants
17
  11.0%
23
  15.0%
12
   8.4%
QTcP increase from baseline >60 ms Number Analyzed 154 participants 153 participants 143 participants
6
   3.9%
5
   3.3%
4
   2.8%
QTcP >450 ms Number Analyzed 161 participants 160 participants 145 participants
19
  11.8%
29
  18.1%
17
  11.7%
QTcP >480 ms Number Analyzed 161 participants 160 participants 145 participants
2
   1.2%
7
   4.4%
2
   1.4%
QTcP >500 ms Number Analyzed 161 participants 160 participants 145 participants
1
   0.6%
2
   1.3%
2
   1.4%
Heart rate <=50 bpm and decrease >= 20 bpm Number Analyzed 154 participants 153 participants 143 participants
0
   0.0%
1
   0.7%
0
   0.0%
Heart rate >=120 bpm and increase >= 20 bpm Number Analyzed 154 participants 153 participants 143 participants
5
   3.2%
5
   3.3%
3
   2.1%
PR >=220 ms and increase from baseline >=20 ms Number Analyzed 182 participants 176 participants 168 participants
3
   1.6%
4
   2.3%
2
   1.2%
QRS >=120 ms Number Analyzed 183 participants 176 participants 169 participants
7
   3.8%
9
   5.1%
9
   5.3%
15.Secondary Outcome
Title Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
'Number of Participants Analyzed' is based on number of participants in the safety analysis set with a baseline and a post-baseline assessment within each treatment group.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 129 154 132
Measure Type: Count of Participants
Unit of Measure: Participants
>= 10 point decrease from baseline MUGA/ECHO
8
   6.2%
22
  14.3%
13
   9.8%
>= 15 point decrease from baseline MUGA/ECHO
3
   2.3%
8
   5.2%
3
   2.3%
16.Secondary Outcome
Title Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS
Hide Description 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.
Time Frame Biomarkers are measured only at screening.
Hide Outcome Measure Data
Hide Analysis Population Description
The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported PD-L1 status.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 170 173 165
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
100
  58.8%
100
  57.8%
88
  53.3%
17.Secondary Outcome
Title Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS
Hide Description 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.
Time Frame Biomarkers are measured only at screening.
Hide Outcome Measure Data
Hide Analysis Population Description
The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported CD8 status.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 165 171 164
Measure Type: Count of Participants
Unit of Measure: Participants
Positive
76
  46.1%
80
  46.8%
72
  43.9%
18.Secondary Outcome
Title Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL
Hide Description 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 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.
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Hide Analysis Population Description
The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' in represents number of participants in the FAS with a score at baseline and post-baseline.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 152 166 148
Measure Type: Count of Participants
Unit of Measure: Participants
Deterioration
46
  30.3%
65
  39.2%
46
  31.1%
Improved
23
  15.1%
20
  12.0%
26
  17.6%
Stable
83
  54.6%
81
  48.8%
76
  51.4%
19.Secondary Outcome
Title Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28
Hide Description 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.
Time Frame 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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Hide Analysis Population Description
The analysis is based on the FAS. The FAS included all participants who were randomized.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 188 188 190
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
11.1 [2] 
(6.5 to NA)
10.6 [2] 
(9.2 to NA)
[1]
The median estimates of time to event, upper and lower limits of 95% CI were not estimable due to the small number of events.
[2]
The upper limit of 95% CI was not estimable due to the small number of events.
20.Secondary Outcome
Title Change From Baseline in EQ-VAS Score at End of Treatment
Hide Description 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.
Time Frame Baseline and end of treatment/withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' represents number of participants in the FAS with an assessment at the visit or with at least a baseline and post-baseline assessment at visit.
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description:
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Overall Number of Participants Analyzed 111 116 111
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-13.6  (20.56) -11.2  (19.79) -7.7  (22.26)
Time Frame AEs (serious and non-serious) should be reported from the time the participant has taken at least 1 dose of study treatment through 90 calendar days after the last administration of the study treatment (up to 2.7 years by primary completion date of 19 September 2018).
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. The mortality analysis set included all randomized participants. The AE and SAE analysis set included participants who received at least 1 dose of study drug.
 
Arm/Group Title Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Hide Arm/Group Description Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles. PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
All-Cause Mortality
Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   109/188 (57.98%)      102/188 (54.26%)      104/190 (54.74%)    
Hide Serious Adverse Events
Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/187 (37.97%)      75/182 (41.21%)      51/177 (28.81%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Febrile neutropenia * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 3/177 (1.69%)  3
Neutropenia * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Thrombocytopenia * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 1/177 (0.56%)  1
Cardiac disorders       
Atrial fibrillation * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Myocardial infarction * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Tachycardia * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Endocrine disorders       
Adrenal insufficiency * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Basedow's disease * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Hypopituitarism * 1  0/187 (0.00%)  0 2/182 (1.10%)  2 0/177 (0.00%)  0
Eye disorders       
Retinal detachment * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension * 1  3/187 (1.60%)  3 1/182 (0.55%)  1 1/177 (0.56%)  1
Abdominal pain * 1  9/187 (4.81%)  10 6/182 (3.30%)  6 6/177 (3.39%)  6
Abdominal pain upper * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 1/177 (0.56%)  1
Ascites * 1  2/187 (1.07%)  3 1/182 (0.55%)  2 1/177 (0.56%)  1
Colitis * 1  0/187 (0.00%)  0 1/182 (0.55%)  3 0/177 (0.00%)  0
Constipation * 1  2/187 (1.07%)  2 5/182 (2.75%)  5 1/177 (0.56%)  1
Diarrhoea * 1  4/187 (2.14%)  4 1/182 (0.55%)  1 1/177 (0.56%)  1
Faecaloma * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Haematemesis * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Ileus * 1  1/187 (0.53%)  1 4/182 (2.20%)  4 2/177 (1.13%)  2
Intestinal obstruction * 1  11/187 (5.88%)  16 9/182 (4.95%)  9 6/177 (3.39%)  6
Intestinal pseudo-obstruction * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Intussusception * 1  0/187 (0.00%)  1/182 (0.55%)  0/177 (0.00%) 
Large intestinal obstruction * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Malignant bowel obstruction * 1  1/187 (0.53%)  1 1/182 (0.55%)  1 1/177 (0.56%)  1
Mechanical ileus * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Nausea * 1  7/187 (3.74%)  7 4/182 (2.20%)  4 1/177 (0.56%)  1
Obstruction gastric * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Oesophagitis * 1  1/187 (0.53%)  0/182 (0.00%)  0/177 (0.00%) 
Pancreatitis acute * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Small intestinal obstruction * 1  5/187 (2.67%)  5 4/182 (2.20%)  4 2/177 (1.13%)  2
Stomatitis * 1  0/187 (0.00%)  0 2/182 (1.10%)  2 1/177 (0.56%)  1
Subileus * 1  1/187 (0.53%)  1 1/182 (0.55%)  1 2/177 (1.13%)  2
Umbilical hernia * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Vomiting * 1  7/187 (3.74%)  8 4/182 (2.20%)  4 3/177 (1.69%)  5
General disorders       
Administration site extravasation * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Asthenia * 1  0/187 (0.00%)  0 2/182 (1.10%)  2 0/177 (0.00%)  0
Chest discomfort * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Chills * 1  1/187 (0.53%)  1 1/182 (0.55%)  1 0/177 (0.00%)  0
Complication associated with device * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Disease progression * 1  9/187 (4.81%)  9 5/182 (2.75%)  5 2/177 (1.13%)  2
Fatigue * 1  0/187 (0.00%)  0 2/182 (1.10%)  2 0/177 (0.00%)  0
General physical health deterioration * 1  2/187 (1.07%)  2 2/182 (1.10%)  2 0/177 (0.00%)  0
Influenza like illness * 1  1/187 (0.53%)  2 0/182 (0.00%)  0 0/177 (0.00%)  0
Localised oedema * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Malaise * 1  0/187 (0.00%)  0 2/182 (1.10%)  2 0/177 (0.00%)  0
Mucosal inflammation * 1  0/187 (0.00%)  0 1/182 (0.55%)  2 0/177 (0.00%)  0
Oedema peripheral * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Pain * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Pyrexia * 1  7/187 (3.74%)  8 9/182 (4.95%)  10 1/177 (0.56%)  3
Hepatobiliary disorders       
Autoimmune hepatitis * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Drug-induced liver injury * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Hepatic failure * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Immune system disorders       
Anaphylactic reaction * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Cytokine release syndrome * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Hypersensitivity * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Immune-mediated adverse reaction * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Infections and infestations       
Bacteraemia * 1  1/187 (0.53%)  1 1/182 (0.55%)  1 0/177 (0.00%)  0
Cellulitis * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Cholangitis infective * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Cystitis * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Device related infection * 1  1/187 (0.53%)  1 1/182 (0.55%)  2 1/177 (0.56%)  2
Erysipelas * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Gastroenteritis * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 1/177 (0.56%)  1
Infectious pleural effusion * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Influenza * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 2/177 (1.13%)  2
Lymph gland infection * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Medical device site infection * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Meningitis * 1  0/187 (0.00%)  0 1/182 (0.55%)  2 0/177 (0.00%)  0
Nail infection * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Oral fungal infection * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Peritonitis * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Peritonitis bacterial * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Pneumonia * 1  3/187 (1.60%)  3 3/182 (1.65%)  3 0/177 (0.00%)  0
Pyelonephritis * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 1/177 (0.56%)  1
Respiratory tract infection * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Sepsis * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 2/177 (1.13%)  3
Septic embolus * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Septic shock * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Sinusitis * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Staphylococcal infection * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 1/177 (0.56%)  1
Urinary tract infection * 1  1/187 (0.53%)  1 1/182 (0.55%)  1 2/177 (1.13%)  2
Urosepsis * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Viral upper respiratory tract infection * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Injury, poisoning and procedural complications       
Infusion related reaction * 1  1/187 (0.53%)  1 3/182 (1.65%)  3 1/177 (0.56%)  1
Patella fracture * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Stoma complication * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Upper limb fracture * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Vascular access complication * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Investigations       
Aspartate aminotransferase increased * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Blood creatine phosphokinase increased * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Haemoglobin decreased * 1  1/187 (0.53%)  2 0/182 (0.00%)  0 0/177 (0.00%)  0
Neutrophil count decreased * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Urine output decreased * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
White blood cell count decreased * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Metabolism and nutrition disorders       
Decreased appetite * 1  3/187 (1.60%)  3 1/182 (0.55%)  1 1/177 (0.56%)  1
Dehydration * 1  2/187 (1.07%)  2 1/182 (0.55%)  1 1/177 (0.56%)  1
Hypercalcaemia * 1  0/187 (0.00%)  0 5/182 (2.75%)  7 1/177 (0.56%)  2
Hypokalaemia * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Hypomagnesaemia * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Hyponatraemia * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 2/177 (1.13%)  2
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 2/177 (1.13%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant neoplasm progression * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Nervous system disorders       
Aphasia * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Clonic convulsion * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Tremor * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Product Issues       
Device dislocation * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Psychiatric disorders       
Confusional state * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 1/177 (0.56%)  1
Mental status changes * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Chronic kidney disease * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Haematuria * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Obstructive nephropathy * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Renal failure * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Urinary tract obstruction * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Reproductive system and breast disorders       
Vaginal haemorrhage * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Dyspnoea * 1  4/187 (2.14%)  4 5/182 (2.75%)  7 0/177 (0.00%)  0
Lung disorder * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  2
Oropharyngeal pain * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Pleural effusion * 1  2/187 (1.07%)  3 0/182 (0.00%)  0 0/177 (0.00%)  0
Pneumonia aspiration * 1  1/187 (0.53%)  2 0/182 (0.00%)  0 0/177 (0.00%)  0
Pneumonitis * 1  1/187 (0.53%)  1 1/182 (0.55%)  1 1/177 (0.56%)  1
Productive cough * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Pulmonary embolism * 1  2/187 (1.07%)  2 4/182 (2.20%)  4 2/177 (1.13%)  2
Respiratory failure * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis exfoliative generalised * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 1/177 (0.56%)  1
Palmar-plantar erythrodysaesthesia syndrome * 1  0/187 (0.00%)  0 2/182 (1.10%)  2 1/177 (0.56%)  1
Vasculitic ulcer * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Vascular disorders       
Deep vein thrombosis * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Embolism * 1  0/187 (0.00%)  0 0/182 (0.00%)  0 3/177 (1.69%)  3
Embolism venous * 1  0/187 (0.00%)  0 1/182 (0.55%)  1 0/177 (0.00%)  0
Hypotension * 1  1/187 (0.53%)  1 0/182 (0.00%)  0 0/177 (0.00%)  0
1
Term from vocabulary, MedDRA v21.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avelumab Avelumab + PLD Pegylated Liposomal Doxorubicin (PLD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   172/187 (91.98%)      176/182 (96.70%)      167/177 (94.35%)    
Blood and lymphatic system disorders       
Anaemia * 1  32/187 (17.11%)  68 55/182 (30.22%)  119 42/177 (23.73%)  77
Neutropenia * 1  1/187 (0.53%)  2 26/182 (14.29%)  48 25/177 (14.12%)  52
Endocrine disorders       
Hypothyroidism * 1  8/187 (4.28%)  10 19/182 (10.44%)  21 2/177 (1.13%)  2
Gastrointestinal disorders       
Abdominal distension * 1  14/187 (7.49%)  19 17/182 (9.34%)  20 18/177 (10.17%)  20
Abdominal pain * 1  54/187 (28.88%)  68 46/182 (25.27%)  66 38/177 (21.47%)  48
Abdominal pain upper * 1  10/187 (5.35%)  10 17/182 (9.34%)  22 12/177 (6.78%)  12
Ascites * 1  12/187 (6.42%)  16 5/182 (2.75%)  9 4/177 (2.26%)  7
Constipation * 1  35/187 (18.72%)  47 46/182 (25.27%)  66 45/177 (25.42%)  57
Diarrhoea * 1  42/187 (22.46%)  61 36/182 (19.78%)  54 32/177 (18.08%)  45
Dyspepsia * 1  7/187 (3.74%)  7 18/182 (9.89%)  25 14/177 (7.91%)  15
Gastrooesophageal reflux disease * 1  9/187 (4.81%)  9 9/182 (4.95%)  11 14/177 (7.91%)  17
Nausea * 1  53/187 (28.34%)  66 87/182 (47.80%)  129 76/177 (42.94%)  117
Stomatitis * 1  8/187 (4.28%)  13 53/182 (29.12%)  125 35/177 (19.77%)  73
Vomiting * 1  43/187 (22.99%)  63 42/182 (23.08%)  62 44/177 (24.86%)  58
General disorders       
Asthenia * 1  18/187 (9.63%)  27 29/182 (15.93%)  65 14/177 (7.91%)  18
Chills * 1  18/187 (9.63%)  20 14/182 (7.69%)  15 3/177 (1.69%)  3
Fatigue * 1  63/187 (33.69%)  88 76/182 (41.76%)  140 55/177 (31.07%)  78
Influenza like illness * 1  6/187 (3.21%)  7 10/182 (5.49%)  13 1/177 (0.56%)  1
Malaise * 1  5/187 (2.67%)  5 11/182 (6.04%)  14 6/177 (3.39%)  6
Mucosal inflammation * 1  4/187 (2.14%)  7 24/182 (13.19%)  45 19/177 (10.73%)  29
Oedema peripheral * 1  13/187 (6.95%)  16 25/182 (13.74%)  33 14/177 (7.91%)  16
Pyrexia * 1  27/187 (14.44%)  32 34/182 (18.68%)  56 16/177 (9.04%)  20
Infections and infestations       
Urinary tract infection * 1  15/187 (8.02%)  22 19/182 (10.44%)  28 12/177 (6.78%)  21
Injury, poisoning and procedural complications       
Infusion related reaction * 1  13/187 (6.95%)  17 17/182 (9.34%)  20 15/177 (8.47%)  15
Investigations       
Alanine aminotransferase increased * 1  4/187 (2.14%)  8 16/182 (8.79%)  22 2/177 (1.13%)  3
Aspartate aminotransferase increased * 1  4/187 (2.14%)  7 18/182 (9.89%)  30 2/177 (1.13%)  2
Blood alkaline phosphatase increased * 1  4/187 (2.14%)  5 11/182 (6.04%)  20 2/177 (1.13%)  4
Gamma-glutamyltransferase increased * 1  13/187 (6.95%)  16 13/182 (7.14%)  30 6/177 (3.39%)  9
Lymphocyte count decreased * 1  1/187 (0.53%)  1 13/182 (7.14%)  54 4/177 (2.26%)  4
Neutrophil count decreased * 1  4/187 (2.14%)  10 17/182 (9.34%)  84 9/177 (5.08%)  33
Platelet count decreased * 1  5/187 (2.67%)  8 10/182 (5.49%)  22 7/177 (3.95%)  16
Weight decreased * 1  10/187 (5.35%)  11 13/182 (7.14%)  19 13/177 (7.34%)  19
White blood cell count decreased * 1  6/187 (3.21%)  7 15/182 (8.24%)  70 14/177 (7.91%)  39
Metabolism and nutrition disorders       
Decreased appetite * 1  36/187 (19.25%)  41 50/182 (27.47%)  67 36/177 (20.34%)  44
Hypoalbuminaemia * 1  7/187 (3.74%)  15 13/182 (7.14%)  24 6/177 (3.39%)  8
Hypokalaemia * 1  5/187 (2.67%)  12 12/182 (6.59%)  17 11/177 (6.21%)  19
Hypomagnesaemia * 1  10/187 (5.35%)  12 8/182 (4.40%)  16 7/177 (3.95%)  7
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  15/187 (8.02%)  17 16/182 (8.79%)  19 11/177 (6.21%)  11
Back pain * 1  22/187 (11.76%)  25 17/182 (9.34%)  26 21/177 (11.86%)  25
Myalgia * 1  9/187 (4.81%)  11 14/182 (7.69%)  20 10/177 (5.65%)  10
Pain in extremity * 1  4/187 (2.14%)  4 18/182 (9.89%)  20 13/177 (7.34%)  14
Nervous system disorders       
Dizziness * 1  5/187 (2.67%)  5 15/182 (8.24%)  17 8/177 (4.52%)  8
Dysgeusia * 1  3/187 (1.60%)  3 12/182 (6.59%)  14 7/177 (3.95%)  7
Headache * 1  15/187 (8.02%)  16 27/182 (14.84%)  32 11/177 (6.21%)  12
Respiratory, thoracic and mediastinal disorders       
Cough * 1  17/187 (9.09%)  17 27/182 (14.84%)  43 24/177 (13.56%)  27
Dyspnoea * 1  34/187 (18.18%)  45 31/182 (17.03%)  43 25/177 (14.12%)  32
Oropharyngeal pain * 1  2/187 (1.07%)  2 12/182 (6.59%)  12 8/177 (4.52%)  8
Skin and subcutaneous tissue disorders       
Alopecia * 1  3/187 (1.60%)  3 16/182 (8.79%)  16 7/177 (3.95%)  7
Dry skin * 1  5/187 (2.67%)  5 22/182 (12.09%)  23 8/177 (4.52%)  9
Palmar-plantar erythrodysaesthesia syndrome * 1  1/187 (0.53%)  1 61/182 (33.52%)  163 40/177 (22.60%)  74
Pruritus * 1  13/187 (6.95%)  14 21/182 (11.54%)  34 8/177 (4.52%)  9
Rash * 1  11/187 (5.88%)  20 51/182 (28.02%)  124 19/177 (10.73%)  24
Rash maculo-papular * 1  4/187 (2.14%)  5 14/182 (7.69%)  40 11/177 (6.21%)  19
Skin hyperpigmentation * 1  0/187 (0.00%)  0 10/182 (5.49%)  10 10/177 (5.65%)  10
1
Term from vocabulary, MedDRA v21.0
*
Indicates events were collected by non-systematic assessment
The report results were based on the data cut off at primary completion date (19 September 2018).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02580058    
Other Study ID Numbers: B9991009
2015-003091-77 ( EudraCT Number )
JAVELIN OVARIAN 200 ( Other Identifier: Alias Study Number )
First Submitted: October 16, 2015
First Posted: October 20, 2015
Results First Submitted: September 9, 2019
Results First Posted: November 19, 2019
Last Update Posted: June 4, 2020