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

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: NCT02718417
Recruitment Status : Terminated (The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.)
First Posted : March 24, 2016
Results First Posted : December 18, 2019
Last Update Posted : July 14, 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 Drug: carboplatin
Drug: paclitaxel
Drug: Avelumab
Enrollment 998
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Period Title: Chemotherapy Phase (CP)
Started 332 331 335
Safety Population [1] 328 329 334
Completed 280 294 289
Not Completed 52 37 46
Reason Not Completed
Adverse Event             9             14             13
Death leading to discontinuation             5             4             1
Global deterioration of health status             3             2             1
No longer met eligibility criteria             4             2             1
Physician's decision             5             0             4
Progressive disease             11             7             10
Withdrawal by Subject             13             8             15
Other             2             0             1
[1]
Participants who had received at least one dose of study drug
Period Title: Maintenance Phase (MP)
Started 267 [1] 288 [1] 0 [2]
Completed 1 1 0
Not Completed 266 287 0
Reason Not Completed
Adverse Event             21             26             0
Death leading to discontinuation             1             1             0
Global deterioration of health status             5             3             0
No longer met eligibility criteria             0             1             0
Physician's decision             6             7             0
Progressive disease             100             88             0
Other             2             1             0
Withdrawal by Subject             17             20             0
Study terminated by sponsor             114             140             0
[1]
Included participants without evidence of disease progression at the end of Chemotherapy phase.
[2]
After completing CP, participants moved to observation phase. MP was not applicable for this arm.
Period Title: Observation Phase (OP)
Started 0 [1] 0 [1] 284 [2]
Completed 0 0 2
Not Completed 0 0 282
Reason Not Completed
Adverse Event             0             0             1
Death leading to discontinuation             0             0             2
Lost to Follow-up             0             0             1
Physician Decision             0             0             9
Progressive disease             0             0             92
Study terminated by sponsor             0             0             135
Withdrawal by Subject             0             0             34
Global deterioration of health status             0             0             1
Other             0             0             7
[1]
After completing MP, participants moved to follow-up phase. OP was not applicable.
[2]
Included participants without evidence of disease progression at the end of Chemotherapy phase.
Period Title: Follow-up Phase
Started 238 [1] 263 [1] 39 [2]
Completed 103 91 20
Not Completed 135 172 19
Reason Not Completed
Adverse Event             3             1             1
Other             4             6             4
Withdrawal by Subject             19             17             5
Study terminated by sponsor             100             138             6
Lost to Follow-up             2             3             0
Death leading to discontinuation             7             7             3
[1]
Participants not completing MP could also start this phase.
[2]
Participants not completing OP could also start this phase.
Period Title: Long-term Follow-up Phase
Started 139 [1] 112 [1] 135 [2]
Completed 0 0 0
Not Completed 139 112 135
Reason Not Completed
Death leading to discontinuation             20             17             11
Lost to Follow-up             8             4             3
Study terminated by sponsor             105             80             112
Withdrawal by Subject             6             9             9
Other             0             2             0
[1]
Participants not completing follow-up phase could also start this phase.
[2]
Participants not completing follow-up could also start this phase.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation Total
Hide Arm/Group Description In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. Total of all reporting groups
Overall Number of Baseline Participants 332 331 335 998
Hide Baseline Analysis Population Description
The full analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean Number Analyzed 332 participants 331 participants 335 participants 998 participants
58.34  (11.00) 58.16  (10.85) 57.10  (11.27) 57.86  (11.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 332 participants 331 participants 335 participants 998 participants
Female
332
 100.0%
331
 100.0%
335
 100.0%
998
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 332 participants 331 participants 335 participants 998 participants
Black or African American
2
   0.6%
4
   1.2%
1
   0.3%
7
   0.7%
American Indian or Alaska Native
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
Asian
86
  25.9%
82
  24.8%
95
  28.4%
263
  26.4%
White
236
  71.1%
238
  71.9%
236
  70.4%
710
  71.1%
Other
7
   2.1%
7
   2.1%
3
   0.9%
17
   1.7%
1.Primary Outcome
Title Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Hide Description BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 332 331 335
Median (95% Confidence Interval)
Unit of Measure: months
16.8 [1] 
(13.5 to NA)
18.1 [1] 
(14.8 to NA)
NA [2] 
(18.2 to NA)
[1]
The upper limit of 95% CI was not estimable due to limited number of events.
[2]
The median and upper limit of 95% CI was not estimable due to limited number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy Followed by Avelumab, Chemotherapy Followed by Observation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9890
Comments One-sided log-rank test was used.
Method Log Rank
Comments Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
1.051 to 1.946
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Avelumab Followed by Avelumab, Chemotherapy Followed by Observation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7935
Comments One-sided log-rank test was used.
Method Log Rank
Comments Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.832 to 1.565
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Time Frame Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 332 331 335
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% CI were not estimable due to limited number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy Followed by Avelumab, Chemotherapy Followed by Observation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8848
Comments One-sided log-rank test was used.
Method Log Rank
Comments Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.760 to 3.080
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Avelumab Followed by Avelumab, Chemotherapy Followed by Observation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8953
Comments One-sided log-rank test was used.
Method Log Rank
Comments Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
0.776 to 3.111
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-Free Survival (PFS) as Assessed by Investigator
Hide Description Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
Time Frame Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 332 331 335
Median (95% Confidence Interval)
Unit of Measure: months
13.8
(12.1 to 15.9)
16.1
(13.9 to 19.4)
15.0
(13.2 to 18.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy Followed by Avelumab, Chemotherapy Followed by Observation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9278
Comments One-sided log-rank test was used.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.935 to 1.578
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Avelumab Followed by Avelumab, Chemotherapy Followed by Observation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2367
Comments One-sided log-rank test was used.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.688 to 1.189
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Objective Response as Assessed by Investigator
Hide Description Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Time Frame Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 332 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.9
(21.3 to 31.0)
31.1
(26.2 to 36.4)
27.8
(23.0 to 32.9)
5.Secondary Outcome
Title Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)
Hide Description BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
Time Frame Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 332 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.4
(25.5 to 35.7)
36.0
(30.8 to 41.4)
30.4
(25.6 to 35.7)
6.Secondary Outcome
Title Duration of Response (DOR) as Assessed by Investigator
Hide Description Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subset of randomized participants, who had objective response, as assessed by Investigator.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 86 103 93
Median (95% Confidence Interval)
Unit of Measure: months
10.6
(8.3 to 20.2)
NA [1] 
(11.7 to NA)
15.4
(8.3 to 18.4)
[1]
Median and upper limit of 95% CI was not estimable due to limited number of events.
7.Secondary Outcome
Title Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)
Hide Description BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subset of randomized participants, who had objective response, as assessed by BICR.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 101 119 102
Median (95% Confidence Interval)
Unit of Measure: months
11.9 [1] 
(8.9 to NA)
14.5 [1] 
(11.7 to NA)
NA [2] 
(16.1 to NA)
[1]
The upper limit of 95% CI was not estimable due to limited number of events.
[2]
The median and upper limit of 95% CI was not estimable due to limited number of events.
8.Secondary Outcome
Title Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)
Hide Description BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by BICR assessment during the chemotherapy phase.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 248 267 247
Median (95% Confidence Interval)
Unit of Measure: months
13.6 [1] 
(9.3 to NA)
13.8 [1] 
(11.1 to NA)
NA [2] 
(13.8 to NA)
[1]
The upper limit of 95% CI was not estimable due to limited number of events.
[2]
The median and upper limit of 95% CI was not estimable due to limited number of events.
9.Secondary Outcome
Title Maintenance Progression-Free Survival (PFS) as Assessed by Investigator
Hide Description Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method
Time Frame From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by investigator assessment during the chemotherapy phase.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 252 271 252
Median (95% Confidence Interval)
Unit of Measure: months
10.4
(8.2 to 13.6)
11.6
(9.9 to 13.8)
12.7 [1] 
(9.5 to NA)
[1]
The upper limit of 95% CI was not estimable due to limited number of events.
10.Secondary Outcome
Title Percentage of Participants With Pathological Complete Response (pCR)
Hide Description pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease.
Time Frame Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset of randomized participants which included neoadjuvant participants who underwent IDS.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 108 115 116
Measure Type: Number
Unit of Measure: percentage of participants
15.7 17.4 25.9
11.Secondary Outcome
Title Progression-Free Survival 2 (PFS2)
Hide Description PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Time Frame Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria
Hide Description PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125.
Time Frame Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
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The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
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In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
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The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
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In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 323 328 321
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
11
   3.4%
13
   4.0%
15
   4.7%
Grade 2
89
  27.6%
77
  23.5%
96
  29.9%
Grade 3
151
  46.7%
148
  45.1%
131
  40.8%
Grade 4
67
  20.7%
84
  25.6%
76
  23.7%
Grade 5
5
   1.5%
6
   1.8%
3
   0.9%
14.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Hide Description As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN].
Time Frame Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
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The safety analysis set included all participants who received at least one dose of study drug. Here, 'Number analyzed' = Participants evaluable for this outcome measure for each specified row.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
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In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 328 329 334
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia Number Analyzed 326 participants 326 participants 328 participants
73
  22.4%
68
  20.9%
63
  19.2%
Platelet Count Decreased Number Analyzed 326 participants 326 participants 328 participants
20
   6.1%
35
  10.7%
38
  11.6%
Lymphocyte Count Decreased Number Analyzed 326 participants 326 participants 328 participants
35
  10.7%
63
  19.3%
29
   8.8%
Neutrophil Count Decreased Number Analyzed 326 participants 326 participants 328 participants
144
  44.2%
159
  48.8%
156
  47.6%
Creatinine Increased Number Analyzed 324 participants 326 participants 327 participants
2
   0.6%
7
   2.1%
0
   0.0%
Serum Amylase Increased Number Analyzed 321 participants 322 participants 326 participants
5
   1.6%
9
   2.8%
10
   3.1%
Lipase Increased Number Analyzed 323 participants 323 participants 325 participants
19
   5.9%
24
   7.4%
11
   3.4%
ALT or AST Number Analyzed 324 participants 326 participants 327 participants
0
   0.0%
1
   0.3%
0
   0.0%
15.Secondary Outcome
Title Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment
Hide Description Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Time Frame Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)
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The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified rows.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 318 317 316
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury
CP: Change at Day 1, Cycle 2: Sitting DBP Number Analyzed 310 participants 305 participants 301 participants
0.00  (9.28) 0.10  (9.86) 0.70  (9.33)
CP: Change at Day 1, Cycle 3: Sitting DBP Number Analyzed 305 participants 299 participants 295 participants
-0.50  (10.18) 0.50  (10.84) 1.00  (9.69)
CP: Change at Day 1, Cycle 4: Sitting DBP Number Analyzed 287 participants 291 participants 289 participants
-0.10  (10.48) -0.50  (10.89) -0.40  (10.19)
MP/OP: Change at Day 1, Cycle 1: Sitting DBP Number Analyzed 253 participants 266 participants 253 participants
-2.20  (10.36) -1.30  (10.74) -0.90  (10.54)
MP/OP: Change at Day 15, Cycle 1: Sitting DBP Number Analyzed 241 participants 249 participants 3 participants
-2.10  (10.04) -1.80  (10.57) -9.70  (5.69)
MP/OP: Change at Day 29, Cycle 1: Sitting DBP Number Analyzed 233 participants 249 participants 3 participants
-1.70  (10.29) -1.80  (11.24) -8.30  (6.03)
MP/OP: Change at Day 1, Cycle 2: Sitting DBP Number Analyzed 229 participants 247 participants 226 participants
-2.30  (10.26) -1.70  (10.63) -0.70  (10.67)
MP/OP: Change at Day 15, Cycle 2: Sitting DBP Number Analyzed 219 participants 236 participants 0 participants
-2.00  (10.71) -2.40  (10.82)
MP/OP: Change at Day 29, Cycle 2: Sitting DBP Number Analyzed 215 participants 225 participants 0 participants
-2.60  (10.86) -1.90  (10.16)
Change at EOT : Sitting DBP Number Analyzed 137 participants 116 participants 120 participants
-0.70  (11.36) 0.00  (12.45) 0.70  (10.00)
CP: Change at Day 1, Cycle 2: Sitting SBP Number Analyzed 310 participants 305 participants 301 participants
2.30  (14.91) 0.70  (15.32) 1.00  (14.00)
CP: Change at Day 1, Cycle 3: Sitting SBP Number Analyzed 305 participants 299 participants 295 participants
1.50  (14.00) -0.30  (15.48) 1.70  (14.80)
CP: Change at Day 1, Cycle 4: Sitting SBP Number Analyzed 287 participants 291 participants 289 participants
1.00  (14.60) 0.10  (16.75) 0.60  (15.61)
MP/OP: Change at Day 1, Cycle 1: Sitting SBP Number Analyzed 253 participants 266 participants 253 participants
-1.80  (15.12) -1.60  (16.64) 0.00  (14.81)
MP/OP: Change at Day 15, Cycle 1: Sitting SBP Number Analyzed 241 participants 249 participants 3 participants
-1.10  (14.37) -3.20  (16.44) -4.70  (10.21)
MP/OP: Change at Day 29, Cycle 1: Sitting SBP Number Analyzed 233 participants 249 participants 3 participants
-2.20  (15.81) -2.80  (15.93) -9.30  (8.14)
MP/OP: Change at Day 1, Cycle 2: Sitting SBP Number Analyzed 229 participants 247 participants 226 participants
-1.20  (15.16) -0.60  (15.46) -0.50  (14.43)
MP/OP: Change at Day 15, Cycle 2: Sitting SBP Number Analyzed 219 participants 236 participants 0 participants
-2.10  (14.44) -3.90  (16.20)
MP/OP: Change at Day 29, Cycle 2: Sitting SBP Number Analyzed 215 participants 225 participants 0 participants
-2.70  (13.79) -2.90  (15.28)
Change at EOT: Sitting SBP Number Analyzed 137 participants 116 participants 120 participants
1.70  (16.96) -1.00  (17.56) 2.90  (16.69)
16.Secondary Outcome
Title Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment
Hide Description Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Time Frame Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)
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The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified rows.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 318 317 316
Mean (Standard Deviation)
Unit of Measure: beats per minute
CP: Change at Day 1, Cycle 2 Number Analyzed 310 participants 304 participants 301 participants
-0.5  (12.34) 1.80  (12.04) -0.70  (11.42)
CP: Change at Day 1, Cycle 3 Number Analyzed 305 participants 298 participants 295 participants
-0.20  (12.71) 2.90  (13.64) -0.0  (12.29)
CP: Change at Day 1, Cycle 4 Number Analyzed 287 participants 290 participants 289 participants
-0.30  (13.49) 1.90  (13.86) -0.30  (14.02)
MP/OP: Change at Day 1, Cycle 1 Number Analyzed 253 participants 266 participants 253 participants
-1.90  (13.70) -0.10  (13.99) -0.70  (13.02)
MP/OP: Change at Day 15, Cycle 1 Number Analyzed 241 participants 249 participants 3 participants
-2.90  (12.94) -2.40  (13.57) -11.70  (15.14)
MP/OP: Change at Day 29, Cycle 1 Number Analyzed 233 participants 249 participants 3 participants
-3.10  (12.48) -3.60  (13.48) -4.00  (7.55)
MP/OP: Change at Day 1, Cycle 2 Number Analyzed 228 participants 247 participants 226 participants
-3.50  (13.71) -4.70  (13.09) -3.40  (13.11)
MP/OP: Change at Day 15, Cycle 2 Number Analyzed 219 participants 236 participants 0 participants
-5.10  (13.73) -4.90  (13.67)
MP/OP: Change at Day 29, Cycle 2 Number Analyzed 215 participants 225 participants 0 participants
-5.60  (13.71) -5.20  (12.79)
Change at EOT Number Analyzed 136 participants 116 participants 119 participants
-1.60  (14.47) -1.50  (15.22) -3.70  (15.03)
17.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide Description ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.
Time Frame Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
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Hide Analysis Population Description
The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = participants in the safety analysis set who had at least one baseline and post-baseline ECG assessment.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 317 321 320
Measure Type: Count of Participants
Unit of Measure: Participants
QT increase from baseline >30 ms Number Analyzed 314 participants 314 participants 314 participants
128
  40.8%
152
  48.4%
106
  33.8%
QT increase from baseline >60 ms Number Analyzed 314 participants 314 participants 314 participants
31
   9.9%
60
  19.1%
35
  11.1%
QT >450 ms Number Analyzed 317 participants 321 participants 320 participants
12
   3.8%
30
   9.3%
20
   6.3%
QT >480 ms Number Analyzed 317 participants 321 participants 320 participants
2
   0.6%
10
   3.1%
7
   2.2%
QT >500 ms Number Analyzed 317 participants 321 participants 320 participants
1
   0.3%
6
   1.9%
5
   1.6%
QTcB increase from baseline >30 ms Number Analyzed 300 participants 303 participants 306 participants
107
  35.7%
137
  45.2%
116
  37.9%
QTcB increase from baseline >60 ms Number Analyzed 300 participants 303 participants 306 participants
19
   6.3%
38
  12.5%
25
   8.2%
QTcB >450 ms Number Analyzed 303 participants 312 participants 313 participants
135
  44.6%
185
  59.3%
165
  52.7%
QTcB >480 ms Number Analyzed 303 participants 312 participants 313 participants
29
   9.6%
63
  20.2%
32
  10.2%
QTcB >500 ms Number Analyzed 303 participants 312 participants 313 participants
16
   5.3%
29
   9.3%
17
   5.4%
QTcF increase from baseline >30 ms Number Analyzed 300 participants 303 participants 306 participants
90
  30.0%
125
  41.3%
89
  29.1%
QTcF increase from baseline >60 ms Number Analyzed 300 participants 303 participants 306 participants
14
   4.7%
34
  11.2%
17
   5.6%
QTcF >450 ms Number Analyzed 303 participants 312 participants 313 participants
44
  14.5%
83
  26.6%
53
  16.9%
QTcF >480 ms Number Analyzed 303 participants 312 participants 313 participants
10
   3.3%
25
   8.0%
15
   4.8%
QTcF >500 ms Number Analyzed 303 participants 312 participants 313 participants
6
   2.0%
11
   3.5%
11
   3.5%
Heart rate <=50 bpm and decrease >= 20 bpm Number Analyzed 300 participants 303 participants 306 participants
1
   0.3%
1
   0.3%
3
   1.0%
Heart rate >=120 bpm and increase >= 20 bpm Number Analyzed 300 participants 303 participants 306 participants
7
   2.3%
10
   3.3%
6
   2.0%
PR >=220 ms and increase from baseline >=20 ms Number Analyzed 312 participants 311 participants 313 participants
7
   2.2%
6
   1.9%
6
   1.9%
QRS >=120 ms Number Analyzed 317 participants 321 participants 320 participants
7
   2.2%
9
   2.8%
16
   5.0%
18.Secondary Outcome
Title Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score
Hide Description National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'.
Time Frame CP: Pre-dose on Day 1 of Cycles 2 to 6 (1 cycle= 21 days); MP/OP: Day 1 of Cycles 1 to 12 (1 cycle= 42 days), End of treatment (any time up to Month 27)
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Hide Analysis Population Description
The full analysis set included all randomized participants. Here, 'Number analyzed' = participants evaluable for this outcome measure at specified rows. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 332 331 335
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
CP: Day 1, Cycle 2 Number Analyzed 313 participants 311 participants 321 participants
54.33
(53.5 to 55.2)
53.88
(53.0 to 54.7)
54.27
(53.4 to 55.1)
CP: Day 1, Cycle 3 Number Analyzed 312 participants 311 participants 317 participants
54.61
(53.8 to 55.5)
54.10
(53.2 to 54.9)
54.51
(53.6 to 55.4)
CP: Day 1, Cycle 4 Number Analyzed 296 participants 309 participants 308 participants
54.88
(54.0 to 55.7)
54.31
(53.5 to 55.1)
54.75
(53.9 to 55.6)
CP: Day 1, Cycle 5 Number Analyzed 292 participants 300 participants 303 participants
55.16
(54.3 to 56.0)
54.53
(53.7 to 55.4)
54.99
(54.1 to 55.8)
CP: Day 1, Cycle 6 Number Analyzed 282 participants 295 participants 297 participants
55.43
(54.6 to 56.3)
54.74
(53.9 to 55.6)
55.23
(54.4 to 56.1)
MP/OP: Day 1, Cycle 1 Number Analyzed 262 participants 277 participants 266 participants
55.70
(54.9 to 56.5)
54.96
(54.1 to 55.8)
55.47
(54.6 to 56.3)
MP/OP: Day 1, Cycle 2 Number Analyzed 248 participants 264 participants 243 participants
56.25
(55.4 to 57.1)
55.39
(54.6 to 56.2)
55.95
(55.1 to 56.8)
MP/OP: Day 1, Cycle 3 Number Analyzed 234 participants 242 participants 233 participants
56.80
(55.9 to 57.7)
55.82
(55.0 to 56.7)
56.43
(55.6 to 57.3)
MP/OP: Day 1, Cycle 4 Number Analyzed 212 participants 227 participants 208 participants
57.35
(56.5 to 58.2)
56.25
(55.4 to 57.1)
56.91
(56.0 to 57.8)
MP/OP: Day 1, Cycle 5 Number Analyzed 180 participants 198 participants 189 participants
57.90
(57.0 to 58.8)
56.69
(55.8 to 57.6)
57.39
(56.4 to 58.3)
MP/OP: Day 1, Cycle 6 Number Analyzed 143 participants 167 participants 148 participants
58.45
(57.5 to 59.4)
57.12
(56.1 to 58.1)
57.87
(56.9 to 58.9)
MP/OP: Day 1, Cycle 7 Number Analyzed 116 participants 131 participants 120 participants
59.00
(57.9 to 60.1)
57.55
(56.5 to 58.6)
58.36
(57.3 to 59.4)
MP/OP: Day 1, Cycle 8 Number Analyzed 94 participants 104 participants 98 participants
59.55
(58.4 to 60.7)
57.98
(56.9 to 59.1)
58.84
(57.7 to 60.0)
MP/OP: Day 1, Cycle 9 Number Analyzed 73 participants 82 participants 77 participants
60.09
(58.9 to 61.3)
58.41
(57.2 to 59.6)
59.32
(58.1 to 60.5)
MP/OP: Day 1, Cycle 10 Number Analyzed 57 participants 59 participants 64 participants
60.64
(59.4 to 61.9)
58.84
(57.6 to 60.1)
59.80
(58.5 to 61.1)
MP/OP: Day 1, Cycle 11 Number Analyzed 42 participants 38 participants 52 participants
61.19
(59.8 to 62.6)
59.28
(57.9 to 60.6)
60.28
(58.9 to 61.7)
MP/OP: Day 1, Cycle 12 Number Analyzed 22 participants 27 participants 37 participants
61.74
(60.3 to 63.2)
59.71
(58.3 to 61.1)
60.76
(59.3 to 62.2)
End of treatment Number Analyzed 301 participants 301 participants 297 participants
57.04
(56.2 to 57.9)
56.01
(55.1 to 56.9)
56.64
(55.8 to 57.5)
19.Secondary Outcome
Title European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score
Hide Description EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.
Time Frame Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months)
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Hide Analysis Population Description
The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)
Hide Description Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Time Frame Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase, participants received paclitaxel once every three weeks (Q3W) (or once weekly [QW] on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab once every 2 weeks (Q2W) on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 6 4 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2880
(44%)
2678
(22%)
2649
(35%)
21.Secondary Outcome
Title Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen)
Hide Description Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
Time Frame Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 7 5 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
5646
(68%)
4775
(24%)
4694
(28%)
22.Secondary Outcome
Title Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)
Hide Description Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.
Time Frame Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
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Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 11 7 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Total Carboplatin
23580
(34%)
18350
(44%)
18990
(31%)
Free Carboplatin
21740
(39%)
15350
(65%)
17090
(33%)
23.Secondary Outcome
Title Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen)
Hide Description AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time Frame Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 5 4 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
5138
(39%)
4997
(15%)
4921
(18%)
24.Secondary Outcome
Title Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen)
Hide Description AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time Frame Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
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Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 7 4 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
18070
(58%)
16190
(25%)
17470
(26%)
25.Secondary Outcome
Title Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)
Hide Description AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time Frame Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 11 6 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
Total Carboplatin Number Analyzed 1 participants 5 participants 5 participants
87600
100500
(13%)
90430
(18%)
Free Carboplatin Number Analyzed 11 participants 6 participants 13 participants
55840
(25%)
52000
(29%)
52300
(25%)
26.Secondary Outcome
Title Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen)
Hide Description AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Time Frame Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
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Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 6 4 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
4960
(38%)
4572
(16%)
4304
(24%)
27.Secondary Outcome
Title Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)
Hide Description AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Time Frame Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
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Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 7 5 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
17540
(60%)
15870
(21%)
16390
(26%)
28.Secondary Outcome
Title Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free)
Hide Description AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.
Time Frame Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab PK: Chemotherapy + Avelumab Followed by Avelumab PK: Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
Overall Number of Participants Analyzed 11 7 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
Total Carboplatin
84380
(22%)
84100
(12%)
80960
(17%)
Free Carboplatin
56880
(25%)
52100
(26%)
52590
(24%)
29.Secondary Outcome
Title Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab
Hide Description Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame Pre-dose (0 hour) on Day 1 of Cycle 2
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Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
Overall Number of Participants Analyzed 209
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
29.18
(57%)
30.Secondary Outcome
Title Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab
Hide Description Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame End of avelumab infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy Followed by Avelumab
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
Overall Number of Participants Analyzed 174
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
205.6
(50%)
31.Secondary Outcome
Title Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin
Hide Description Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame End of infusion on Day 1 of Cycle 2
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Hide Analysis Population Description
Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy + Avelumab Followed by Avelumab
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
Overall Number of Participants Analyzed 220
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
162.9
(139%)
32.Secondary Outcome
Title Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin
Hide Description Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Time Frame Pre-dose (0 hour) on Day 1 of Cycle 2
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Hide Analysis Population Description
Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies only those participants who had data available for this outcome measure.
Arm/Group Title PK: Chemotherapy + Avelumab Followed by Avelumab
Hide Arm/Group Description:
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
Overall Number of Participants Analyzed 251
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
3.607
(113%)
33.Secondary Outcome
Title Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
Hide Description ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Time Frame Up to 36 months
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The immunogenicity analysis set included all participants who had received at least one dose of study drug and who had at least one ADA sample collected for avelumab in the avelumab containing arms. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title Immunogenicity: Chemotherapy Followed by Avelumab Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
Overall Number of Participants Analyzed 272 328
Measure Type: Count of Participants
Unit of Measure: Participants
Never-positive
231
  84.9%
197
  60.1%
Ever-positve
41
  15.1%
131
  39.9%
34.Secondary Outcome
Title Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
Hide Description nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis set included all participants who had received at least one dose of study drug and who had at least one nAb sample collected for avelumab in the avelumab containing arms. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Arm/Group Title Immunogenicity: Chemotherapy Followed by Avelumab Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
Overall Number of Participants Analyzed 272 328
Measure Type: Count of Participants
Unit of Measure: Participants
Never-positive
256
  94.1%
282
  86.0%
Ever-positive
16
   5.9%
46
  14.0%
35.Secondary Outcome
Title Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Hide Description PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (>=) 1 percent (%) tumor cells or >= 5% immune cells and were otherwise considered negative.
Time Frame Up to 36 months
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PD-L1 biomarker analysis set included all participants who had received at least one dose of study drug and who had at least one screening biomarker assessment for PD-L1.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 270 263 280
Measure Type: Count of Participants
Unit of Measure: Participants
158
  58.5%
160
  60.8%
169
  60.4%
36.Secondary Outcome
Title Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Hide Description CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated >= 1% CD8 positive cells and were otherwise considered negative.
Time Frame Up to 36 months
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Hide Analysis Population Description
CD8 biomarker analysis set included all participants who had received at least one dose of study drug and who had at least one screening biomarker assessment for CD8.
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description:
In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
Overall Number of Participants Analyzed 250 250 257
Measure Type: Count of Participants
Unit of Measure: Participants
107
  42.8%
107
  42.8%
118
  45.9%
Time Frame Baseline up to maximum duration of 36 months
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
 
Arm/Group Title Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Hide Arm/Group Description In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
All-Cause Mortality
Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/328 (10.37%)   31/329 (9.42%)   20/334 (5.99%) 
Hide Serious Adverse Events
Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   92/328 (28.05%)   118/329 (35.87%)   64/334 (19.16%) 
Blood and lymphatic system disorders       
Anaemia * 1  6/328 (1.83%)  8/329 (2.43%)  6/334 (1.80%) 
Febrile neutropenia * 1  10/328 (3.05%)  8/329 (2.43%)  7/334 (2.10%) 
Leukopenia * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Neutropenia * 1  2/328 (0.61%)  0/329 (0.00%)  1/334 (0.30%) 
Pancytopenia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Thrombocytopenia * 1  2/328 (0.61%)  5/329 (1.52%)  1/334 (0.30%) 
Cardiac disorders       
Atrial fibrillation * 1  1/328 (0.30%)  1/329 (0.30%)  0/334 (0.00%) 
Cardiopulmonary failure * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Myocardial infarction * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Palpitations * 1  1/328 (0.30%)  1/329 (0.30%)  0/334 (0.00%) 
Tachycardia * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Endocrine disorders       
Adrenal insufficiency * 2  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Hypercalcaemia of malignancy * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Hyperthyroidism * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Hypopituitarism * 1  0/328 (0.00%)  2/329 (0.61%)  0/334 (0.00%) 
Gastrointestinal disorders       
Abdominal distension * 1  1/328 (0.30%)  0/329 (0.00%)  1/334 (0.30%) 
Abdominal hernia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Abdominal pain * 1  3/328 (0.91%)  3/329 (0.91%)  4/334 (1.20%) 
Abdominal pain lower * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Abdominal pain upper * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Anal haemorrhage * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Ascites * 1  5/328 (1.52%)  2/329 (0.61%)  1/334 (0.30%) 
Colitis * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Constipation * 1  3/328 (0.91%)  2/329 (0.61%)  3/334 (0.90%) 
Diaphragmatic hernia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Diarrhoea * 1  4/328 (1.22%)  3/329 (0.91%)  1/334 (0.30%) 
Enteritis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Faecaloma * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Food poisoning * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Gastrointestinal obstruction * 1  2/328 (0.61%)  1/329 (0.30%)  0/334 (0.00%) 
Ileus * 1  3/328 (0.91%)  4/329 (1.22%)  9/334 (2.69%) 
Ileus paralytic * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Intestinal dilatation * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Intestinal haemorrhage * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Intestinal obstruction * 1  4/328 (1.22%)  6/329 (1.82%)  6/334 (1.80%) 
Large intestinal obstruction * 1  0/328 (0.00%)  2/329 (0.61%)  0/334 (0.00%) 
Large intestine perforation * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Nausea * 1  4/328 (1.22%)  5/329 (1.52%)  2/334 (0.60%) 
Peritoneal adhesions * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Small intestinal haemorrhage * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Small intestinal obstruction * 1  3/328 (0.91%)  7/329 (2.13%)  1/334 (0.30%) 
Subileus * 1  0/328 (0.00%)  1/329 (0.30%)  2/334 (0.60%) 
Volvulus * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Vomiting * 1  6/328 (1.83%)  7/329 (2.13%)  6/334 (1.80%) 
Immune-mediated enterocolitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Gastrointestinal mucosal disorder * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
General disorders       
Asthenia * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Chest pain * 1  3/328 (0.91%)  2/329 (0.61%)  0/334 (0.00%) 
Death * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Disease progression * 1  1/328 (0.30%)  3/329 (0.91%)  0/334 (0.00%) 
Fatigue * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
General physical health deterioration * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Hyperpyrexia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Incarcerated hernia * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Mucosal inflammation * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Multiple organ dysfunction syndrome * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Non-cardiac chest pain * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Perforation * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Pyrexia * 1  6/328 (1.83%)  10/329 (3.04%)  1/334 (0.30%) 
Malaise * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Cholelithiasis * 1  1/328 (0.30%)  1/329 (0.30%)  0/334 (0.00%) 
Immune-mediated hepatitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Immune system disorders       
Anaphylactic shock * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Contrast media allergy * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Drug hypersensitivity * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Sarcoidosis * 1  1/328 (0.30%)  1/329 (0.30%)  0/334 (0.00%) 
Infections and infestations       
Abdominal abscess * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Abdominal wall abscess * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Bacteraemia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Bronchitis * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Cellulitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Clostridium difficile colitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Cystitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Device related infection * 1  1/328 (0.30%)  2/329 (0.61%)  1/334 (0.30%) 
Empyema * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Escherichia infection * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Escherichia urinary tract infection * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Herpes zoster * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Infected lymphocele * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Infection * 1  1/328 (0.30%)  1/329 (0.30%)  1/334 (0.30%) 
Influenza * 1  0/328 (0.00%)  2/329 (0.61%)  0/334 (0.00%) 
Lower respiratory tract infection * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Lymph gland infection * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Meningitis bacterial * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Pelvic infection * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Pelvic inflammatory disease * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Peritonitis * 1  1/328 (0.30%)  0/329 (0.00%)  1/334 (0.30%) 
Pneumonia * 1  3/328 (0.91%)  2/329 (0.61%)  1/334 (0.30%) 
Postoperative wound infection * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Pseudomembranous colitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Pyelonephritis * 1  1/328 (0.30%)  2/329 (0.61%)  0/334 (0.00%) 
Sepsis * 1  2/328 (0.61%)  1/329 (0.30%)  0/334 (0.00%) 
Septic shock * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Tooth abscess * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Tooth infection * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Upper respiratory tract infection * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Urinary tract infection * 1  7/328 (2.13%)  7/329 (2.13%)  2/334 (0.60%) 
Urosepsis * 1  2/328 (0.61%)  1/329 (0.30%)  0/334 (0.00%) 
Viral infection * 1  2/328 (0.61%)  0/329 (0.00%)  0/334 (0.00%) 
Viral upper respiratory tract infection * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Vulval abscess * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Wound infection * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Respiratory tract infection * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Gastroenteritis * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Injury, poisoning and procedural complications       
Anastomotic leak * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Concussion * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Craniocerebral injury * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Fall * 1  1/328 (0.30%)  0/329 (0.00%)  1/334 (0.30%) 
Femoral neck fracture * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Femur fracture * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Incisional hernia * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Infusion related reaction * 1  0/328 (0.00%)  4/329 (1.22%)  0/334 (0.00%) 
Procedural intestinal perforation * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Subdural haematoma * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Vaginal cuff dehiscence * 1  1/328 (0.30%)  1/329 (0.30%)  1/334 (0.30%) 
Wound dehiscence * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Investigations       
Aspartate aminotransferase increased * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Lipase increased * 1  0/328 (0.00%)  2/329 (0.61%)  0/334 (0.00%) 
Lymphocyte count decreased * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Neutrophil count decreased * 1  1/328 (0.30%)  0/329 (0.00%)  1/334 (0.30%) 
Blood creatine phosphokinase increased * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Dehydration * 1  1/328 (0.30%)  3/329 (0.91%)  1/334 (0.30%) 
Diabetes mellitus * 1  1/328 (0.30%)  0/329 (0.00%)  1/334 (0.30%) 
Hypocalcaemia * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Hypoglycaemia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Hypokalaemia * 1  1/328 (0.30%)  1/329 (0.30%)  1/334 (0.30%) 
Hyponatraemia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Hypophagia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Hypovolaemia * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Malnutrition * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Type 1 diabetes mellitus * 1  2/328 (0.61%)  0/329 (0.00%)  0/334 (0.00%) 
Hyperglycaemia * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Back pain * 1  1/328 (0.30%)  1/329 (0.30%)  1/334 (0.30%) 
Bone pain * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Fistula * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Flank pain * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Musculoskeletal pain * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Polymyositis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Systemic lupus erythematosus * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-cell lymphoma * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Breast cancer * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Breast cancer stage I * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Malignant neoplasm progression * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Myelodysplastic syndrome * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Nervous system disorders       
Cerebrovascular accident * 1  1/328 (0.30%)  1/329 (0.30%)  0/334 (0.00%) 
Facial nerve disorder * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Headache * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Lethargy * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Peripheral sensorimotor neuropathy * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Presyncope * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Seizure * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Psychiatric disorders       
Depression suicidal * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Persistent depressive disorder * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Renal and urinary disorders       
Acute kidney injury * 1  2/328 (0.61%)  0/329 (0.00%)  0/334 (0.00%) 
Haematuria * 1  2/328 (0.61%)  0/329 (0.00%)  0/334 (0.00%) 
Hydronephrosis * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Nephrolithiasis * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Urinary tract obstruction * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Urogenital fistula * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Renal colic * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Reproductive system and breast disorders       
Female genital tract fistula * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Menorrhagia * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Vaginal perforation * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
Dyspnoea * 1  3/328 (0.91%)  3/329 (0.91%)  1/334 (0.30%) 
Hypoxia * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Pleural effusion * 1  1/328 (0.30%)  2/329 (0.61%)  1/334 (0.30%) 
Pneumonitis * 1  0/328 (0.00%)  2/329 (0.61%)  0/334 (0.00%) 
Pneumothorax * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Pulmonary embolism * 1  7/328 (2.13%)  3/329 (0.91%)  3/334 (0.90%) 
Pulmonary infarction * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Pulmonary oedema * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Respiratory distress * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Skin and subcutaneous tissue disorders       
Drug eruption * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Rash * 1  0/328 (0.00%)  2/329 (0.61%)  1/334 (0.30%) 
Rash maculo-papular * 1  1/328 (0.30%)  1/329 (0.30%)  0/334 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  0/328 (0.00%)  1/329 (0.30%)  1/334 (0.30%) 
Embolism * 1  1/328 (0.30%)  2/329 (0.61%)  0/334 (0.00%) 
Flushing * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Haematoma * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Hypotension * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Lymphocele * 1  2/328 (0.61%)  0/329 (0.00%)  0/334 (0.00%) 
Phlebitis * 1  0/328 (0.00%)  1/329 (0.30%)  0/334 (0.00%) 
Subclavian vein occlusion * 1  0/328 (0.00%)  0/329 (0.00%)  1/334 (0.30%) 
Essential hypertension * 1  1/328 (0.30%)  0/329 (0.00%)  0/334 (0.00%) 
1
Term from vocabulary, MedDRA v22.1
2
Term from vocabulary, MMedDRA v22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy Followed by Avelumab Chemotherapy + Avelumab Followed by Avelumab Chemotherapy Followed by Observation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   320/328 (97.56%)   325/329 (98.78%)   317/334 (94.91%) 
Blood and lymphatic system disorders       
Anaemia * 1  148/328 (45.12%)  151/329 (45.90%)  140/334 (41.92%) 
Leukopenia * 1  27/328 (8.23%)  28/329 (8.51%)  20/334 (5.99%) 
Neutropenia * 1  112/328 (34.15%)  125/329 (37.99%)  113/334 (33.83%) 
Thrombocytopenia * 1  46/328 (14.02%)  62/329 (18.84%)  59/334 (17.66%) 
Endocrine disorders       
Hypothyroidism * 1  34/328 (10.37%)  33/329 (10.03%)  5/334 (1.50%) 
Gastrointestinal disorders       
Abdominal distension * 1  22/328 (6.71%)  17/329 (5.17%)  18/334 (5.39%) 
Abdominal pain * 1  69/328 (21.04%)  68/329 (20.67%)  58/334 (17.37%) 
Abdominal pain upper * 1  32/328 (9.76%)  39/329 (11.85%)  24/334 (7.19%) 
Constipation * 1  113/328 (34.45%)  100/329 (30.40%)  95/334 (28.44%) 
Diarrhoea * 1  84/328 (25.61%)  101/329 (30.70%)  63/334 (18.86%) 
Dyspepsia * 1  31/328 (9.45%)  24/329 (7.29%)  22/334 (6.59%) 
Gastrooesophageal reflux disease * 1  11/328 (3.35%)  18/329 (5.47%)  11/334 (3.29%) 
Nausea * 1  153/328 (46.65%)  149/329 (45.29%)  152/334 (45.51%) 
Stomatitis * 1  28/328 (8.54%)  24/329 (7.29%)  20/334 (5.99%) 
Vomiting * 1  86/328 (26.22%)  74/329 (22.49%)  66/334 (19.76%) 
Dry mouth * 1  17/328 (5.18%)  10/329 (3.04%)  5/334 (1.50%) 
General disorders       
Asthenia * 1  35/328 (10.67%)  46/329 (13.98%)  22/334 (6.59%) 
Fatigue * 1  123/328 (37.50%)  115/329 (34.95%)  110/334 (32.93%) 
Malaise * 1  22/328 (6.71%)  17/329 (5.17%)  14/334 (4.19%) 
Oedema peripheral * 1  27/328 (8.23%)  29/329 (8.81%)  23/334 (6.89%) 
Pain * 1  21/328 (6.40%)  23/329 (6.99%)  14/334 (4.19%) 
Pyrexia * 1  33/328 (10.06%)  42/329 (12.77%)  23/334 (6.89%) 
Infections and infestations       
Cystitis * 1  19/328 (5.79%)  7/329 (2.13%)  8/334 (2.40%) 
Upper respiratory tract infection * 1  27/328 (8.23%)  28/329 (8.51%)  14/334 (4.19%) 
Urinary tract infection * 1  36/328 (10.98%)  46/329 (13.98%)  28/334 (8.38%) 
Nasopharyngitis * 1  18/328 (5.49%)  16/329 (4.86%)  10/334 (2.99%) 
Injury, poisoning and procedural complications       
Infusion related reaction * 1  26/328 (7.93%)  30/329 (9.12%)  19/334 (5.69%) 
Procedural pain * 1  27/328 (8.23%)  22/329 (6.69%)  12/334 (3.59%) 
Investigations       
Alanine aminotransferase increased * 1  28/328 (8.54%)  33/329 (10.03%)  20/334 (5.99%) 
Aspartate aminotransferase increased * 1  18/328 (5.49%)  28/329 (8.51%)  21/334 (6.29%) 
Neutrophil count decreased * 1  60/328 (18.29%)  54/329 (16.41%)  75/334 (22.46%) 
Platelet count decreased * 1  25/328 (7.62%)  39/329 (11.85%)  44/334 (13.17%) 
White blood cell count decreased * 1  32/328 (9.76%)  31/329 (9.42%)  34/334 (10.18%) 
Weight decreased * 1  15/328 (4.57%)  17/329 (5.17%)  13/334 (3.89%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  64/328 (19.51%)  55/329 (16.72%)  37/334 (11.08%) 
Hypokalaemia * 1  22/328 (6.71%)  27/329 (8.21%)  20/334 (5.99%) 
Hypomagnesaemia * 1  32/328 (9.76%)  42/329 (12.77%)  27/334 (8.08%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  76/328 (23.17%)  85/329 (25.84%)  57/334 (17.07%) 
Back pain * 1  31/328 (9.45%)  36/329 (10.94%)  31/334 (9.28%) 
Musculoskeletal pain * 1  20/328 (6.10%)  15/329 (4.56%)  13/334 (3.89%) 
Myalgia * 1  67/328 (20.43%)  53/329 (16.11%)  43/334 (12.87%) 
Pain in extremity * 1  30/328 (9.15%)  32/329 (9.73%)  37/334 (11.08%) 
Nervous system disorders       
Dizziness * 1  45/328 (13.72%)  38/329 (11.55%)  28/334 (8.38%) 
Dysgeusia * 1  22/328 (6.71%)  20/329 (6.08%)  18/334 (5.39%) 
Headache * 1  55/328 (16.77%)  51/329 (15.50%)  30/334 (8.98%) 
Hypoaesthesia * 1  12/328 (3.66%)  21/329 (6.38%)  13/334 (3.89%) 
Neuropathy peripheral * 1  63/328 (19.21%)  77/329 (23.40%)  65/334 (19.46%) 
Paraesthesia * 1  18/328 (5.49%)  26/329 (7.90%)  10/334 (2.99%) 
Peripheral sensory neuropathy * 1  91/328 (27.74%)  76/329 (23.10%)  82/334 (24.55%) 
Psychiatric disorders       
Anxiety * 1  14/328 (4.27%)  18/329 (5.47%)  15/334 (4.49%) 
Insomnia * 1  52/328 (15.85%)  39/329 (11.85%)  32/334 (9.58%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  36/328 (10.98%)  55/329 (16.72%)  22/334 (6.59%) 
Dyspnoea * 1  38/328 (11.59%)  47/329 (14.29%)  29/334 (8.68%) 
Epistaxis * 1  22/328 (6.71%)  12/329 (3.65%)  12/334 (3.59%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  167/328 (50.91%)  169/329 (51.37%)  177/334 (52.99%) 
Pruritus * 1  38/328 (11.59%)  37/329 (11.25%)  19/334 (5.69%) 
Rash * 1  59/328 (17.99%)  66/329 (20.06%)  25/334 (7.49%) 
Rash maculo-papular * 1  13/328 (3.96%)  21/329 (6.38%)  5/334 (1.50%) 
Vascular disorders       
Hot flush * 1  23/328 (7.01%)  18/329 (5.47%)  16/334 (4.79%) 
Hypertension * 1  16/328 (4.88%)  19/329 (5.78%)  13/334 (3.89%) 
1
Term from vocabulary, MedDRA v22.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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: 8007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02718417    
Other Study ID Numbers: B9991010
2015-003239-36 ( EudraCT Number )
JAVELIN OVARIAN 100 ( Other Identifier: Alias Study Number )
First Submitted: March 15, 2016
First Posted: March 24, 2016
Results First Submitted: September 6, 2019
Results First Posted: December 18, 2019
Last Update Posted: July 14, 2020