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Trial record 1 of 1 for:    B9991002
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A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

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ClinicalTrials.gov Identifier: NCT02493751
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : June 21, 2019
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Cancer
Interventions Drug: Avelumab (MSB0010718C)
Drug: Axitinib (AG-013736)
Enrollment 55
Recruitment Details  
Pre-assignment Details In this study, a lead-in period was conducted (only axitinib administered) in few participants prior to the administration of combination treatment (axitinib+avelumab) in treatment period. After 5 years from study initiation, the study was closed by Sponsor due to an internal decision (ie, end of study). No safety concerns were related to the study closure. Data reported based on last participant last visit (LPLV) date (04 March 2021).
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks). Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Period Title: Overall Study
Started 16 39
Completed 0 0
Not Completed 16 39
Reason Not Completed
Withdrawal by Subject             2             8
Death             6             13
Lost to Follow-up             2             3
Study closed by Sponsor due to an internal decision with no safety concerns related.             6             15
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab Total
Hide Arm/Group Description Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks). Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks). Total of all reporting groups
Overall Number of Baseline Participants 16 39 55
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 39 participants 55 participants
60.0  (8.45) 60.5  (8.89) 60.3  (8.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 39 participants 55 participants
Female
2
  12.5%
11
  28.2%
13
  23.6%
Male
14
  87.5%
28
  71.8%
42
  76.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 39 participants 55 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
16
 100.0%
35
  89.7%
51
  92.7%
Unknown or Not Reported
0
   0.0%
4
  10.3%
4
   7.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 39 participants 55 participants
Black or African American
1
   6.3%
2
   5.1%
3
   5.5%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
6
  15.4%
6
  10.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
White
15
  93.8%
29
  74.4%
44
  80.0%
Other
0
   0.0%
1
   2.6%
1
   1.8%
Unknown
0
   0.0%
1
   2.6%
1
   1.8%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description DLT: greater than or equal to (>=) Grade 3 hematologic/non-hematologic toxicity, Grade 3-4 liver-related laboratory test elevation (alanine aminotransferase, aspartate aminotransferase) with Grade 2 elevation of total bilirubin, non-hematologic Grade 3 laboratory abnormality (required medical intervention to treat participant/led to hospitalization), inability to complete >=75% of first 2 cycles doses of axitinib (from Cycle 1 Day 1 after completion of lead-in period) or 2 infusions of avelumab within DLT observation period due to investigational product related toxicity.
Time Frame DLT observation period (from the beginning of Cycle 1 up to the end of Cycle 2 [28 days])
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable analysis set: First 6 enrolled participants who received at least 1 dose of avelumab and axitinib, and either experienced DLT during DLT observation period or completed it. Data for this endpoint was only planned to be collected and analyzed for "Axitinib + Avelumab with Lead-in" arm.
Arm/Group Title Axitinib + Avelumab With Lead-in
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
2.Secondary Outcome
Title Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs)
Hide Description Adverse event (AE)=any untoward medical occurrence in participant who received study treatment without regard to causality. TEAE=event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or worsened relative to pretreatment state. Serious AE (SAE)=AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. AEs were graded by worst National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 severity grade. Grade 3 event=unacceptable or intolerable event, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 event caused participant to be in imminent danger of death. Grade 5 event=death related to AE. The results reflect data available on cutoff of LPLV (04 Mar 2021).
Time Frame Baseline up to 30 days after the last dose of study treatment (maximum of 259.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with TEAEs
16
 100.0%
39
 100.0%
Participants with Grade >=3 TEAEs
13
  81.3%
30
  76.9%
Participants with SAEs
6
  37.5%
18
  46.2%
3.Secondary Outcome
Title Number of Participants With Treatment-related TEAEs
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE=event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. AEs were graded by worst NCI CTCAE v4.03 severity grade. Grade 3 events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events caused participant to be in imminent danger of death. Grade 5 events=death related to an AE. Treatment-related AEs and SAEs were determined by the investigator. The results reflect data available on cutoff of LPLV (04 Mar 2021).
Time Frame Baseline up to 30 days after the last dose of study treatment (maximum of 259.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with treatment-related TEAEs
15
  93.8%
39
 100.0%
Participants with Grade >=3 treatment-related TEAEs
11
  68.8%
23
  59.0%
Participants with treatment-related SAEs
3
  18.8%
10
  25.6%
4.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities Graded by NCI CTCAE Version 4.03 - Hematology
Hide Description Laboratory abnormalities (hematology) reported included anemia, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Grade 1=mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2=therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours. Grade 3=prolonged; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4=life threatening consequences; urgent intervention indicated. Grade 5=death. The results reflect data available on cutoff of LPLV (04 Mar 2021).
Time Frame Baseline up to 30 days after the last dose of study treatment and 1 day before the start day of new anti-cancer drug therapy (maximum of 259.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with Grade >=1 anemia
8
  50.0%
24
  61.5%
Participants with Grade >=3 anemia
0
   0.0%
2
   5.1%
Participants with Grade >=1 platelet count decreased
4
  25.0%
11
  28.2%
Participants with Grade >=3 platelet count decreased
0
   0.0%
0
   0.0%
Participants with Grade >=1 lymphocyte count decreased
10
  62.5%
16
  41.0%
Participants with Grade >=3 lymphocyte count decreased
1
   6.3%
3
   7.7%
Participants with Grade >=1 neutrophil count decreased
1
   6.3%
4
  10.3%
Participants with Grade >=3 neutrophil count decreased
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities Graded by NCI CTCAE Version 4.03 - Chemistry
Hide Description Laboratory abnormalities (chemistry) reported included creatinine increased, serum amylase increased, lipase increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase increased, hypoglycemia, and hyperglycemia. Grade 1=mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2=therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours. Grade 3=prolonged; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4=life threatening consequences; urgent intervention indicated. Grade 5=death. The results reflect data available on cutoff of LPLV (04 Mar 2021).
Time Frame Baseline up to 30 days after the last dose of study treatment and 1 day before the start day of new anti-cancer drug therapy (maximum of 259.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with Grade >=1 creatinine increased
16
 100.0%
37
  94.9%
Participants with Grade >=3 creatinine increased
0
   0.0%
0
   0.0%
Participants with Grade >=1 serum amylase increased
11
  68.8%
16
  41.0%
Participants with Grade >=3 serum amylase increased
4
  25.0%
3
   7.7%
Participants with Grade >=1 lipase increased
9
  56.3%
16
  41.0%
Participants with Grade >=3 lipase increased
5
  31.3%
8
  20.5%
Participants with Grade >=1 ALT increased
8
  50.0%
20
  51.3%
Participants with Grade >=3 ALT increased
2
  12.5%
2
   5.1%
Participants with Grade >=1 AST increased
10
  62.5%
21
  53.8%
Participants with Grade >=3 AST increased
1
   6.3%
1
   2.6%
Participants with Grade >=1 blood bilirubin increased
2
  12.5%
7
  17.9%
Participants with Grade >=3 blood bilirubin increased
0
   0.0%
0
   0.0%
Participants with Grade >=1 creatine kinase increased
6
  37.5%
15
  38.5%
Participants with Grade >=3 creatine kinase increased
1
   6.3%
0
   0.0%
Participants with Grade >=1 hypoglycemia
4
  25.0%
4
  10.3%
Participants with Grade >=3 hypoglycemia
0
   0.0%
0
   0.0%
Participants with Grade >=1 hyperglycemia
5
  31.3%
13
  33.3%
Participants with Grade >=3 hyperglycemia
2
  12.5%
1
   2.6%
6.Secondary Outcome
Title Change From Baseline in Vital Signs - Sitting Diastolic Blood Pressure
Hide Description Blood pressure was taken with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment, which occurred on Day 1 in Lead-in period for participants with lead-in, and occurred on Cycle 1 Day 1 (C1D1) for participants without lead-in. The results reflect data available on cutoff of primary completion date (PCD) (03 Apr 2018).
Time Frame Baseline, Day 1 of each cycle, Day 8 of Cycles 1 and 2, end of treatment, Follow-up Days 30, 60, 90 for all participants in the analysis population, and Lead-in Day 7 for participants with lead-in (maximum of 139.6 weeks by PCD)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib (ie, safety analysis set). Number of Participants Analyzed represents the total number of participants in the safety analysis set. Number Analyzed in each row represents the number of participants in the safety analysis set with at least 1 baseline and 1 post-baseline assessments at the visit.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mm Hg)
Lead-in Day 7 Number Analyzed 16 participants 0 participants
5.4  (9.32)
C1D1 Number Analyzed 16 participants 0 participants
4.1  (9.36)
C1D8 Number Analyzed 12 participants 37 participants
3.2  (12.80) 9.8  (11.81)
C2D1 Number Analyzed 16 participants 38 participants
3.4  (13.15) 10.1  (10.03)
C2D8 Number Analyzed 6 participants 3 participants
1.8  (10.01) 14.7  (5.03)
C3D1 Number Analyzed 14 participants 37 participants
6.1  (12.16) 10.2  (11.80)
C4D1 Number Analyzed 14 participants 37 participants
3.6  (10.34) 8.8  (9.60)
C5D1 Number Analyzed 14 participants 34 participants
4.8  (10.53) 6.9  (11.64)
C6D1 Number Analyzed 14 participants 34 participants
3.0  (9.84) 7.5  (11.76)
C7D1 Number Analyzed 13 participants 33 participants
4.8  (11.82) 7.5  (12.50)
C8D1 Number Analyzed 14 participants 31 participants
5.7  (10.76) 9.0  (10.86)
C9D1 Number Analyzed 14 participants 30 participants
3.9  (10.80) 10.0  (13.44)
C10D1 Number Analyzed 12 participants 29 participants
7.3  (9.80) 7.7  (8.97)
C11D1 Number Analyzed 12 participants 27 participants
7.4  (8.98) 7.5  (11.09)
C12D1 Number Analyzed 12 participants 28 participants
5.3  (8.20) 6.6  (12.07)
C13D1 Number Analyzed 12 participants 27 participants
6.0  (7.71) 10.5  (11.92)
C14D1 Number Analyzed 12 participants 27 participants
5.4  (10.87) 7.2  (14.04)
C15D1 Number Analyzed 12 participants 25 participants
6.9  (6.56) 7.6  (12.13)
C16D1 Number Analyzed 10 participants 24 participants
7.5  (10.33) 5.8  (13.57)
C17D1 Number Analyzed 11 participants 24 participants
6.2  (9.84) 6.4  (13.20)
C18D1 Number Analyzed 11 participants 23 participants
4.3  (8.45) 5.1  (12.22)
C19D1 Number Analyzed 11 participants 22 participants
6.3  (7.58) 5.5  (10.67)
C20D1 Number Analyzed 10 participants 21 participants
7.9  (6.71) 6.9  (11.69)
C21D1 Number Analyzed 10 participants 22 participants
8.9  (9.35) 6.6  (10.22)
C22D1 Number Analyzed 10 participants 19 participants
7.2  (9.34) 6.2  (11.96)
C23D1 Number Analyzed 9 participants 19 participants
9.2  (9.54) 4.5  (11.52)
C24D1 Number Analyzed 10 participants 19 participants
7.3  (8.42) 4.3  (12.91)
C25D1 Number Analyzed 10 participants 20 participants
3.1  (9.62) 6.0  (13.34)
C26D1 Number Analyzed 10 participants 17 participants
5.6  (9.65) 7.8  (12.33)
C27D1 Number Analyzed 10 participants 18 participants
4.5  (8.64) 6.2  (13.39)
C28D1 Number Analyzed 10 participants 18 participants
4.9  (7.53) 6.2  (13.35)
C29D1 Number Analyzed 10 participants 19 participants
5.4  (9.90) 7.1  (11.13)
C30D1 Number Analyzed 10 participants 19 participants
5.6  (8.53) 6.1  (13.32)
C31D1 Number Analyzed 10 participants 18 participants
4.8  (11.40) 6.7  (10.41)
C32D1 Number Analyzed 10 participants 17 participants
7.1  (11.06) 7.6  (13.52)
C33D1 Number Analyzed 10 participants 17 participants
5.5  (6.59) 3.6  (13.67)
C34D1 Number Analyzed 10 participants 17 participants
3.5  (13.67) 5.0  (15.71)
C35D1 Number Analyzed 10 participants 16 participants
7.2  (9.76) 8.1  (12.46)
C36D1 Number Analyzed 10 participants 16 participants
7.5  (9.40) 10.9  (11.31)
C37D1 Number Analyzed 10 participants 16 participants
9.9  (10.47) 7.6  (13.32)
C38D1 Number Analyzed 10 participants 16 participants
5.0  (8.92) 6.9  (12.73)
C39D1 Number Analyzed 9 participants 15 participants
6.6  (10.10) 7.9  (14.61)
C40D1 Number Analyzed 10 participants 16 participants
7.8  (10.75) 6.0  (13.08)
C41D1 Number Analyzed 9 participants 15 participants
6.6  (9.76) 8.4  (11.70)
C42D1 Number Analyzed 9 participants 14 participants
5.9  (9.35) 5.7  (13.64)
C43D1 Number Analyzed 8 participants 13 participants
13.0  (11.53) 2.5  (7.73)
C44D1 Number Analyzed 8 participants 9 participants
8.3  (11.04) 6.6  (10.08)
C45D1 Number Analyzed 8 participants 8 participants
8.1  (10.23) 5.4  (13.16)
C46D1 Number Analyzed 8 participants 8 participants
11.1  (11.27) 3.0  (14.03)
C47D1 Number Analyzed 8 participants 8 participants
8.4  (13.62) 1.1  (12.01)
C48D1 Number Analyzed 8 participants 8 participants
6.3  (9.75) 3.9  (13.37)
C49D1 Number Analyzed 7 participants 8 participants
9.4  (10.67) 11.8  (11.44)
C50D1 Number Analyzed 6 participants 8 participants
9.0  (9.27) 7.0  (11.53)
C51D1 Number Analyzed 6 participants 7 participants
9.3  (10.17) 4.3  (10.14)
C52D1 Number Analyzed 6 participants 5 participants
9.3  (11.60) 8.2  (11.48)
C53D1 Number Analyzed 5 participants 4 participants
15.4  (18.37) 2.0  (14.72)
C54D1 Number Analyzed 4 participants 3 participants
12.5  (7.42) 0.3  (12.66)
C55D1 Number Analyzed 4 participants 1 participants
16.0  (19.71) -3.0 [1]   (NA)
C56D1 Number Analyzed 4 participants 1 participants
10.0  (13.74) 0.0 [1]   (NA)
C57D1 Number Analyzed 4 participants 0 participants
14.5  (12.15)
C58D1 Number Analyzed 4 participants 0 participants
16.5  (12.82)
C59D1 Number Analyzed 2 participants 0 participants
26.5  (9.19)
C60D1 Number Analyzed 2 participants 0 participants
22.5  (4.95)
C61D1 Number Analyzed 2 participants 0 participants
24.5  (4.95)
C62D1 Number Analyzed 2 participants 0 participants
22.0  (1.41)
End of Treatment Number Analyzed 8 participants 20 participants
-1.6  (10.38) 2.5  (13.05)
Follow-up Day 30 Number Analyzed 5 participants 11 participants
-3.2  (8.41) -2.9  (12.51)
Follow-up Day 60 Number Analyzed 3 participants 6 participants
-4.7  (10.26) 3.8  (8.33)
Follow-up Day 90 Number Analyzed 3 participants 4 participants
-2.0  (4.58) 1.3  (6.18)
[1]
Standard deviation was not calculated for n<3.
7.Secondary Outcome
Title Change From Baseline in Vital Signs - Sitting Systolic Blood Pressure
Hide Description Blood pressure was taken with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment, which occurred on Day 1 in Lead-in period for participants with lead-in, and occurred on Cycle 1 Day 1 (C1D1) for participants without lead-in. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Baseline, Day 1 of each cycle, Day 8 of Cycles 1 and 2, end of treatment, Follow-up Days 30, 60, 90 for all participants in the analysis population, and Lead-in Day 7 for participants with lead-in (maximum of 139.6 weeks by PCD)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib (ie, safety analysis set). Number of Participants Analyzed represents the total number of participants in the safety analysis set. Number Analyzed in each row represents the number of participants in the safety analysis set with at least 1 baseline and 1 post-baseline assessments at the visit.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Mean (Standard Deviation)
Unit of Measure: mm Hg
Lead-in Day 7 Number Analyzed 16 participants 0 participants
9.7  (13.44)
C1D1 Number Analyzed 16 participants 0 participants
11.0  (18.20)
C1D8 Number Analyzed 12 participants 37 participants
8.0  (18.94) 10.3  (16.12)
C2D1 Number Analyzed 16 participants 38 participants
4.6  (18.49) 11.2  (11.47)
C2D8 Number Analyzed 6 participants 3 participants
0.8  (15.63) 17.7  (6.66)
C3D1 Number Analyzed 14 participants 37 participants
9.9  (18.96) 8.7  (15.05)
C4D1 Number Analyzed 14 participants 37 participants
6.7  (15.61) 5.8  (11.73)
C5D1 Number Analyzed 14 participants 34 participants
6.2  (19.45) 6.7  (14.90)
C6D1 Number Analyzed 14 participants 34 participants
6.5  (15.05) 5.2  (13.34)
C7D1 Number Analyzed 13 participants 33 participants
10.2  (14.46) 6.1  (14.49)
C8D1 Number Analyzed 14 participants 31 participants
13.5  (12.07) 8.0  (15.14)
C9D1 Number Analyzed 14 participants 30 participants
11.4  (14.24) 10.2  (16.29)
C10D1 Number Analyzed 12 participants 29 participants
8.9  (16.83) 8.4  (15.69)
C11D1 Number Analyzed 12 participants 27 participants
7.8  (15.36) 7.2  (14.83)
C12D1 Number Analyzed 12 participants 28 participants
6.8  (11.27) 4.1  (14.29)
C13D1 Number Analyzed 12 participants 27 participants
7.3  (11.17) 8.6  (16.01)
C14D1 Number Analyzed 12 participants 27 participants
5.8  (15.49) 3.9  (17.66)
C15D1 Number Analyzed 12 participants 25 participants
7.3  (13.89) 7.3  (20.46)
C16D1 Number Analyzed 10 participants 24 participants
6.2  (13.46) 5.5  (16.80)
C17D1 Number Analyzed 11 participants 24 participants
7.3  (15.55) 3.5  (17.32)
C18D1 Number Analyzed 11 participants 23 participants
3.5  (14.67) 4.2  (15.07)
C19D1 Number Analyzed 11 participants 22 participants
5.8  (16.04) 2.6  (14.15)
C20D1 Number Analyzed 10 participants 21 participants
8.3  (9.67) 1.1  (12.20)
C21D1 Number Analyzed 10 participants 22 participants
5.0  (14.14) 3.1  (10.17)
C22D1 Number Analyzed 10 participants 19 participants
2.9  (14.53) 0.2  (14.31)
C23D1 Number Analyzed 9 participants 19 participants
9.3  (14.19) 1.5  (15.05)
C24D1 Number Analyzed 10 participants 19 participants
9.1  (12.55) -0.1  (16.57)
C25D1 Number Analyzed 10 participants 20 participants
4.0  (12.78) 3.5  (15.28)
C26D1 Number Analyzed 10 participants 17 participants
2.8  (15.86) 3.4  (15.82)
C27D1 Number Analyzed 10 participants 18 participants
5.4  (14.74) 1.6  (16.13)
C28D1 Number Analyzed 10 participants 18 participants
7.8  (14.49) 2.1  (16.65)
C29D1 Number Analyzed 10 participants 19 participants
3.3  (14.28) 4.1  (11.82)
C30D1 Number Analyzed 10 participants 19 participants
6.4  (13.57) 2.9  (15.17)
C31D1 Number Analyzed 10 participants 18 participants
2.7  (13.14) 1.7  (10.52)
C32D1 Number Analyzed 10 participants 17 participants
8.6  (16.71) 3.8  (14.22)
C33D1 Number Analyzed 10 participants 17 participants
2.9  (16.07) 0.2  (15.02)
C34D1 Number Analyzed 10 participants 17 participants
2.8  (18.79) 2.5  (15.97)
C35D1 Number Analyzed 10 participants 16 participants
10.3  (13.47) 2.9  (12.89)
C36D1 Number Analyzed 10 participants 16 participants
9.0  (12.92) 5.3  (19.01)
C37D1 Number Analyzed 10 participants 16 participants
10.2  (11.48) 2.7  (16.02)
C38D1 Number Analyzed 10 participants 16 participants
8.3  (11.83) 4.9  (14.66)
C39D1 Number Analyzed 9 participants 15 participants
3.8  (13.33) 4.3  (15.83)
C40D1 Number Analyzed 10 participants 16 participants
10.9  (14.13) 3.8  (12.86)
C41D1 Number Analyzed 9 participants 15 participants
7.9  (16.74) 3.7  (14.22)
C42D1 Number Analyzed 9 participants 14 participants
11.6  (15.74) 0.9  (15.02)
C43D1 Number Analyzed 8 participants 13 participants
12.3  (13.20) -1.9  (11.49)
C44D1 Number Analyzed 8 participants 9 participants
9.6  (21.41) 0.8  (5.70)
C45D1 Number Analyzed 8 participants 8 participants
9.1  (17.71) -3.5  (14.18)
C46D1 Number Analyzed 8 participants 8 participants
6.1  (11.28) -3.4  (10.65)
C47D1 Number Analyzed 8 participants 8 participants
6.6  (18.31) 2.8  (13.29)
C48D1 Number Analyzed 8 participants 8 participants
-0.1  (15.04) -1.3  (9.50)
C49D1 Number Analyzed 7 participants 8 participants
5.4  (13.73) 7.0  (14.11)
C50D1 Number Analyzed 6 participants 8 participants
9.7  (10.50) 0.9  (10.06)
C51D1 Number Analyzed 6 participants 7 participants
13.5  (13.85) 1.4  (10.01)
C52D1 Number Analyzed 6 participants 5 participants
4.3  (16.17) 5.4  (17.74)
C53D1 Number Analyzed 5 participants 4 participants
17.0  (16.29) 1.5  (17.94)
C54D1 Number Analyzed 4 participants 3 participants
10.8  (14.20) 0.0  (18.36)
C55D1 Number Analyzed 4 participants 1 participants
15.8  (19.17) 6.0 [1]   (NA)
C56D1 Number Analyzed 4 participants 1 participants
8.5  (11.62) 3.0 [1]   (NA)
C57D1 Number Analyzed 4 participants 0 participants
11.5  (12.23)
C58D1 Number Analyzed 4 participants 0 participants
8.0  (17.45)
C59D1 Number Analyzed 2 participants 0 participants
21.5  (4.95)
C60D1 Number Analyzed 2 participants 0 participants
22.0  (19.80)
C61D1 Number Analyzed 2 participants 0 participants
20.0  (15.56)
C62D1 Number Analyzed 2 participants 0 participants
14.5  (13.44)
End of Treatment Number Analyzed 8 participants 20 participants
11.3  (25.45) 3.5  (18.94)
Follow-up Day 30 Number Analyzed 5 participants 11 participants
15.0  (20.65) 1.7  (18.67)
Follow-up Day 60 Number Analyzed 3 participants 6 participants
16.0  (9.54) 15.3  (15.68)
Follow-up Day 90 Number Analyzed 3 participants 4 participants
20.7  (13.32) 9.3  (10.24)
[1]
Standard deviation was not calculated for n<3.
8.Secondary Outcome
Title Change From Baseline in Vital Signs - Pulse Rate
Hide Description Pulse rate was taken with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. Baseline was defined as the last assessment prior to the date/time of the first dose of study treatment, which occurred on Day 1 in Lead-in period for participants with lead-in, and occurred on Cycle 1 Day 1 (C1D1) for participants without lead-in. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Baseline, Day 1 of each cycle, Day 8 of Cycles 1 and 2, end of treatment, Follow-up Days 30, 60, 90 for all participants in the analysis population, and Lead-in Day 7 for participants with lead-in (maximum of 139.6 weeks by PCD)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib (ie, safety analysis set). Number of Participants Analyzed represents the total number of participants in the safety analysis set. Number Analyzed in each row represents the number of participants in the safety analysis set with at least 1 baseline and 1 post-baseline assessments at the visit.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Median (Full Range)
Unit of Measure: beats per minute (bpm)
Lean-in Day 7 Number Analyzed 16 participants 0 participants
-0.5
(-16.0 to 28.0)
C1D1 Number Analyzed 16 participants 0 participants
-1.0
(-21.0 to 19.0)
C1D8 Number Analyzed 12 participants 37 participants
-2.0
(-20.0 to 24.0)
-2.0
(-27.0 to 41.0)
C2D1 Number Analyzed 16 participants 38 participants
3.0
(-20.0 to 24.0)
4.0
(-30.0 to 29.0)
C2D8 Number Analyzed 6 participants 3 participants
8.0
(-6.0 to 25.0)
2.0
(-14.0 to 10.0)
C3D1 Number Analyzed 14 participants 37 participants
4.0
(-25.0 to 29.0)
2.0
(-34.0 to 35.0)
C4D1 Number Analyzed 14 participants 37 participants
1.5
(-20.0 to 24.0)
4.0
(-28.0 to 48.0)
C5D1 Number Analyzed 14 participants 34 participants
0.0
(-27.0 to 16.0)
2.5
(-40.0 to 26.0)
C6D1 Number Analyzed 14 participants 34 participants
-3.5
(-27.0 to 35.0)
3.5
(-32.0 to 35.0)
C7D1 Number Analyzed 13 participants 33 participants
1.0
(-26.0 to 20.0)
1.0
(-42.0 to 34.0)
C8D1 Number Analyzed 14 participants 31 participants
-6.5
(-34.0 to 13.0)
-1.0
(-40.0 to 46.0)
C9D1 Number Analyzed 14 participants 30 participants
-1.5
(-26.0 to 25.0)
1.0
(-35.0 to 30.0)
C10D1 Number Analyzed 12 participants 29 participants
-3.0
(-33.0 to 17.0)
3.0
(-34.0 to 43.0)
C11D1 Number Analyzed 12 participants 27 participants
-2.0
(-30.0 to 22.0)
3.0
(-37.0 to 41.0)
C12D1 Number Analyzed 12 participants 28 participants
-6.0
(-33.0 to 5.0)
1.5
(-23.0 to 33.0)
C13D1 Number Analyzed 12 participants 27 participants
-1.5
(-33.0 to 25.0)
2.0
(-28.0 to 44.0)
C14D1 Number Analyzed 12 participants 27 participants
1.5
(-32.0 to 29.0)
5.0
(-37.0 to 45.0)
C15D1 Number Analyzed 12 participants 25 participants
-4.5
(-31.0 to 42.0)
-3.0
(-31.0 to 32.0)
C16D1 Number Analyzed 10 participants 24 participants
-1.0
(-18.0 to 30.0)
1.5
(-36.0 to 40.0)
C17D1 Number Analyzed 11 participants 24 participants
-6.0
(-38.0 to 32.0)
1.5
(-32.0 to 41.0)
C18D1 Number Analyzed 11 participants 23 participants
0.0
(-30.0 to 21.0)
3.0
(-37.0 to 41.0)
C19D1 Number Analyzed 11 participants 22 participants
-1.0
(-28.0 to 29.0)
-3.0
(-43.0 to 22.0)
C20D1 Number Analyzed 10 participants 21 participants
2.0
(-30.0 to 26.0)
1.0
(-35.0 to 24.0)
C21D1 Number Analyzed 10 participants 22 participants
-1.5
(-21.0 to 24.0)
2.5
(-31.0 to 59.0)
C22D1 Number Analyzed 10 participants 19 participants
0.0
(-12.0 to 27.0)
-6.0
(-33.0 to 20.0)
C23D1 Number Analyzed 9 participants 19 participants
2.0
(-20.0 to 17.0)
-3.0
(-33.0 to 24.0)
C24D1 Number Analyzed 10 participants 19 participants
-3.5
(-25.0 to 12.0)
0.0
(-30.0 to 25.0)
C25D1 Number Analyzed 10 participants 20 participants
0.0
(-15.0 to 16.0)
-4.5
(-29.0 to 18.0)
C26D1 Number Analyzed 10 participants 17 participants
-4.0
(-25.0 to 17.0)
-3.0
(-30.0 to 19.0)
C27D1 Number Analyzed 10 participants 18 participants
1.5
(-11.0 to 11.0)
0.5
(-28.0 to 19.0)
C28D1 Number Analyzed 10 participants 18 participants
-8.5
(-21.0 to 9.0)
0.5
(-29.0 to 34.0)
C29D1 Number Analyzed 10 participants 19 participants
-6.0
(-17.0 to 12.0)
-4.0
(-31.0 to 22.0)
C30D1 Number Analyzed 10 participants 19 participants
-3.0
(-16.0 to 17.0)
-2.0
(-26.0 to 17.0)
C31D1 Number Analyzed 10 participants 18 participants
1.5
(-22.0 to 11.0)
-3.5
(-20.0 to 24.0)
C32D1 Number Analyzed 10 participants 17 participants
2.0
(-22.0 to 12.0)
2.0
(-32.0 to 38.0)
C33D1 Number Analyzed 10 participants 17 participants
-4.0
(-26.0 to 13.0)
1.0
(-25.0 to 14.0)
C34D1 Number Analyzed 10 participants 17 participants
-1.0
(-25.0 to 38.0)
1.0
(-19.0 to 14.0)
C35D1 Number Analyzed 10 participants 16 participants
-2.0
(-27.0 to 21.0)
2.5
(-19.0 to 27.0)
C36D1 Number Analyzed 10 participants 16 participants
1.0
(-20.0 to 14.0)
0.0
(-19.0 to 28.0)
C37D1 Number Analyzed 10 participants 16 participants
1.5
(-26.0 to 19.0)
0.0
(-14.0 to 24.0)
C38D1 Number Analyzed 10 participants 16 participants
-1.0
(-24.0 to 26.0)
2.0
(-16.0 to 24.0)
C39D1 Number Analyzed 9 participants 15 participants
0.0
(-24.0 to 12.0)
-1.0
(-13.0 to 23.0)
C40D1 Number Analyzed 10 participants 16 participants
-3.0
(-29.0 to 24.0)
2.5
(-18.0 to 25.0)
C41D1 Number Analyzed 9 participants 15 participants
-5.0
(-28.0 to 21.0)
1.0
(-18.0 to 17.0)
C42D1 Number Analyzed 9 participants 14 participants
-3.0
(-24.0 to 12.0)
0.0
(-17.0 to 14.0)
C43D1 Number Analyzed 8 participants 13 participants
4.5
(-16.0 to 12.0)
1.0
(-19.0 to 20.0)
C44D1 Number Analyzed 8 participants 9 participants
2.0
(-13.0 to 19.0)
5.0
(-7.0 to 29.0)
C45D1 Number Analyzed 8 participants 8 participants
2.5
(-12.0 to 18.0)
9.5
(-8.0 to 18.0)
C46D1 Number Analyzed 8 participants 8 participants
1.0
(-16.0 to 25.0)
11.5
(-4.0 to 22.0)
C47D1 Number Analyzed 8 participants 8 participants
5.0
(-7.0 to 35.0)
5.5
(-5.0 to 24.0)
C48D1 Number Analyzed 8 participants 8 participants
-3.0
(-20.0 to 29.0)
4.5
(-13.0 to 16.0)
C49D1 Number Analyzed 7 participants 8 participants
10.0
(-14.0 to 23.0)
-0.5
(-12.0 to 13.0)
C50D1 Number Analyzed 6 participants 8 participants
-2.0
(-14.0 to 11.0)
4.0
(-16.0 to 15.0)
C51D1 Number Analyzed 6 participants 7 participants
0.0
(-8.0 to 11.0)
6.0
(-4.0 to 14.0)
C52D1 Number Analyzed 6 participants 5 participants
0.5
(-12.0 to 12.0)
3.0
(-6.0 to 20.0)
C53D1 Number Analyzed 5 participants 4 participants
6.0
(-14.0 to 11.0)
10.0
(-3.0 to 17.0)
C54D1 Number Analyzed 4 participants 3 participants
2.5
(-6.0 to 6.0)
1.0
(-2.0 to 4.0)
C55D1 Number Analyzed 4 participants 1 participants
-6.5
(-9.0 to 7.0)
5.0
(5.0 to 5.0)
C56D1 Number Analyzed 4 participants 1 participants
1.5
(-10.0 to 10.0)
1.0
(1.0 to 1.0)
C57D1 Number Analyzed 4 participants 0 participants
-4.0
(-17.0 to 6.0)
C58D1 Number Analyzed 4 participants 0 participants
4.0
(-15.0 to 9.0)
C59D1 Number Analyzed 2 participants 0 participants
2.0
(-7.0 to 11.0)
C60D1 Number Analyzed 2 participants 0 participants
1.5
(-11.0 to 14.0)
C61D1 Number Analyzed 2 participants 0 participants
2.0
(-8.0 to 12.0)
C62D1 Number Analyzed 2 participants 0 participants
9.0
(-1.0 to 19.0)
End of Treatment Number Analyzed 8 participants 20 participants
2.5
(-32.0 to 9.0)
6.5
(-25.0 to 44.0)
Follow-up Day 30 Number Analyzed 5 participants 11 participants
-1.0
(-26.0 to 2.0)
-2.0
(-38.0 to 51.0)
Follow-up Day 60 Number Analyzed 3 participants 6 participants
2.0
(-23.0 to 29.0)
3.0
(-11.0 to 43.0)
Follow-up Day 90 Number Analyzed 3 participants 4 participants
9.0
(-23.0 to 11.0)
5.5
(-7.0 to 50.0)
9.Secondary Outcome
Title Number of Participants Achieving Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Hide Description Confirmed OR was defined as complete response (CR) or partial response (PR) according to RECIST v1.1 from the start date until disease progression or death due to any cause. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Cycle 1 Day 1 up to 30 months after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all participants who received at least 1 dose of study drug (axitinib or avelumab) and all participants who were randomized independent of whether they had received a dose of study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
CR
2
  12.5%
2
   5.1%
PR
8
  50.0%
21
  53.8%
10.Secondary Outcome
Title Number of Participants Achieving Disease Control (DC) Based on RECIST Version 1.1
Hide Description DC was defined as OR (CR or PR) or stable disease (SD) per RECIST v1.1 from the start date until the first documentation of objective disease progression or death due to any cause. SD was defined as not qualifying for CR, PR, or progression (PD). PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Cycle 1 Day 1 up to 30 months after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all participants who received at least 1 dose of study drug (axitinib or avelumab) and all participants who were randomized independent of whether they had received a dose of study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
15
  93.8%
28
  71.8%
11.Secondary Outcome
Title Duration of Response (DR) Based on RECIST Version 1.1
Hide Description DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Cycle 1 Day 1 up to 30 months after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all participants who received at least 1 dose of study drug (axitinib or avelumab), all participants who were randomized independent of whether they had received a dose of study drug, and all participants who had achieved confirmed CR or PR.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 10 23
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(4.2 to NA)
NA [1] 
(9.6 to NA)
[1]
Median and upper limit were not estimable. The median DR based on the Kaplan-Meier method had not been reached at the time of data cutoff (03 April 2018).
12.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as defined as the time from the start date to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurred first. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. All target lesions must have been assessed. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Cycle 1 Day 1 up to 30 months after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all participants who received at least 1 dose of study drug (axitinib or avelumab) and all participants who were randomized independent of whether they had received a dose of study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Median (95% Confidence Interval)
Unit of Measure: months
19.2 [1] 
(4.4 to NA)
7.6 [1] 
(4.1 to NA)
[1]
Upper limit was not estimable. The upper limit for PFS based on the Kaplan-Meier method had not been reached at the time of data cutoff (03 April 2018).
13.Secondary Outcome
Title Time to Tumor Response (TTR) Based on RECIST Version 1.1
Hide Description TTR was defined as the time from start date to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Cycle 1 Day 1 up to 30 months after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all participants who received at least 1 dose of study drug (axitinib or avelumab), all participants who were randomized independent of whether they had received a dose of study drug, and all participants who had achieved confirmed CR or PR.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 10 23
Median (Full Range)
Unit of Measure: months
1.6
(1.3 to 5.8)
1.4
(1.2 to 9.6)
14.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the start date to the date of death due to any cause. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Cycle 1 Day 1 up to 30 months after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all participants who received at least 1 dose of study drug (axitinib or avelumab) and all participants who were randomized independent of whether they had received a dose of study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(23.0 to NA)
NA [1] 
(20.1 to NA)
[1]
Median and upper limit were not estimable. The median and upper limit for OS based on the Kaplan-Meier method had not been reached at the time of data cutoff (03 April 2018).
15.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for Axitinib When Dosed Alone and in Combination With Avelumab
Hide Description Cmax for axitinib when dosed alone on Lead-in Day 7 and in combination with avelumab on Cycle 4 Day 1 for Axitinib + Avelumab with Lead-in Arm. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Predose, 1, 2, 3, 4, 6, and 8 hours post dose on Lead-in Day 7 and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib and who had at least 1 of the pharmacokinetic (PK) parameters of interest of either study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
Lean-in Day 7
23.1947
(178%)
Cycle 4 Day 1
16.5806
(254%)
16.Secondary Outcome
Title Time for Cmax (Tmax) for Axitinib When Dosed Alone and in Combination With Avelumab
Hide Description Tmax for axitinib when dosed alone on Lead-in Day 7 and in combination with avelumab on Cycle 4 Day 1 for Axitinib + Avelumab with Lead-in Arm. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Predose, 1, 2, 3, 4, 6, and 8 hours post dose on Lead-in Day 7 and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib and who had at least 1 of the pharmacokinetic (PK) parameters of interest of either study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: hours (hrs)
Lean-in Day 7
2.0900
(0.0170 to 4.1800)
Cycle 4 Day 1
1.9850
(1.0000 to 3.0200)
17.Secondary Outcome
Title Area Under the Plasma Concentration Time Profile From Time Zero to the Next Dose at Steady State (AUCtau) for Axitinib When Dosed Alone and in Combination With Avelumab
Hide Description AUCtau was defined as area under the plasma concentration time profile from time zero to time tau, the dosing interval at steady state. tau = 12 hrs for Axitinib. AUCtau for Axitinib when dosed alone on Lead-in Day 7 and in combination with avelumab on Cycle 4 Day 1 for Axitinib + Avelumab with Lead-in Arm was reported. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Predose, 1, 2, 3, 4, 6, and 8 hours post dose on Lead-in Day 7 and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib and who had at least 1 of the pharmacokinetic (PK) parameters of interest of either study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*hr/mL)
Lean-in Day 7
113.11
(206%)
Cycle 4 Day 1
95.60
(162%)
18.Secondary Outcome
Title Terminal Half-Life (t1/2) for Axitinib When Dosed Alone and in Combination With Avelumab
Hide Description t1/2 was calculated by Log e(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time-curve. Only those data points judged to describe the terminal log linear decline were used in the regression. t1/2 for Axitinib when dosed alone on Lead-in Day 7 and in combination with avelumab on Cycle 4 Day 1 for Axitinib + Avelumab with Lead-in Arm was reported. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Predose, 1, 2, 3, 4, 6, and 8 hours post dose on Lead-in Day 7 and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib and who had at least 1 of the pharmacokinetic (PK) parameters of interest of either study drug.
Arm/Group Title Axitinib + Avelumab With Lead-in
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: hrs
Lean-in Day 7 2.755  (1.5417)
Cycle 4 Day 1 3.252  (1.3389)
19.Secondary Outcome
Title Predose Concentration During Multiple Dosing (Ctrough) for Avelumab
Hide Description Ctrough was directly observed from data. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Predose on Day 1 of Cycles 1, 2, 3, 4, 6, 8, 14, 20, 26, 32, 38, 44, and 50
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib and who had at least 1 of the pharmacokinetic (PK) parameters of interest of either study drug.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per milliliter (ug/mL)
Cycle 1 Day 1 (C1D1) Number Analyzed 50 participants
1.0
(181%)
C2D1 Number Analyzed 51 participants
20.3
(82%)
C3D1 Number Analyzed 32 participants
23.9
(151%)
C4D1 Number Analyzed 36 participants
23.4
(103%)
C6D1 Number Analyzed 31 participants
26.3
(134%)
C8D1 Number Analyzed 30 participants
28.3
(106%)
C14D1 Number Analyzed 28 participants
36.1
(59%)
C20D1 Number Analyzed 21 participants
41.0
(60%)
C26D1 Number Analyzed 14 participants
38.4
(77%)
C32D1 Number Analyzed 14 participants
40.8
(72%)
C38D1 Number Analyzed 13 participants
44.5
(68%)
C44D1 Number Analyzed 4 participants
67.5
(52%)
C50D1 Number Analyzed 2 participants
40.5
(121%)
20.Secondary Outcome
Title Cmax for Avelumab
Hide Description Cmax for avelumab on Cycle 1 Day (C1D1) and C1D4 were reported. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Predose, 1 hour, and 168 hours post dose on Cycle 1 Day 1; predose and 1 hour post dose on Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who received at least 1 dose of avelumab or axitinib and who had at least 1 of the pharmacokinetic (PK) parameters of interest of either study drug.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Overall Number of Participants Analyzed 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
C1D1 Number Analyzed 50 participants
233.4
(27%)
C4D1 Number Analyzed 40 participants
278.0
(60%)
21.Secondary Outcome
Title Number of Participants With Their Target Programmed Death-Ligand (PD-L1) Status at Baseline
Hide Description Number of participants with PD-L1 positive (PD-L1 >=1%) status in immune cell (IC), tumor cell (TC), or both IC and TC. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome measure included all enrolled participants who had at least 1 screening biomarker assessment and who received at least 1 dose of avelumab or axitinib.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 16 39
Measure Type: Count of Participants
Unit of Measure: Participants
IC
11
  68.8%
30
  76.9%
TC
3
  18.8%
15
  38.5%
IC+TC
11
  68.8%
32
  82.1%
22.Secondary Outcome
Title Number of Participants With Anti-drug Antibody (ADA) Against Avelumab When Combined With Axitinib by Never and Ever Positive Status
Hide Description Whole blood specimens were collected at the designated times (Day 1 of Cycles 1-4, 6, and 8, then every 12 weeks until Cycle 50, and Follow-up Day 30) to provide serum for evaluation of avelumab immunogenicity. Human serum ADA specimens were analyzed for the presence or absence of anti-avelumab antibodies with quasi-quantitative enzyme-linked immunosorbent assay, following a tiered approach using screening, confirmation and titer/quantitation. ADA serum specimens were screened at tier 1. In the event that there were no positive specimens, no further analyses were to be conducted. If positive specimens were identified, these specimens were further tested with the confirmatory assay to confirm as positive. Number of participants with ADA positive at baseline, ADA never-positive, ADA ever-positive, treatment-boosted ADA, treatment-induced ADA, transient ADA response, or persistent ADA response from baseline up to 2 years. The results reflect data available on cutoff of PCD (03 Apr 2018).
Time Frame Pre-dose on Day 1 of Cycles 1-4, 6, 8, then every 12 weeks thereafter until Cycle 50, and on Follow-up Day 30 (maximum of 2 years)
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Hide Analysis Population Description
The analysis population (ie, Number of Participants Analyzed)=number of participants (#p) received at least 1 dose of study drug and with at least 1 ADA sample collected. Number Analyzed =Number of Participants Analyzed for ADA_p and ADA_n; = #p with valid baseline ADA result for ADA_bp; = #p with valid baseline and at least 1 valid post-baseline ADA results for Tb_ADA; = #p with at least 1 valid post-baseline ADA result and without positive baseline ADA result for Ti_ADA, t_ADA, and p_ADA.
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description:
Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks).
Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
Overall Number of Participants Analyzed 15 39
Measure Type: Count of Participants
Unit of Measure: Participants
ADA positive at baseline (ADA_bp) Number Analyzed 15 participants 36 participants
2
  13.3%
0
   0.0%
ADA never-positive (ADA_n) Number Analyzed 15 participants 39 participants
12
  80.0%
31
  79.5%
ADA ever-positive (ADA_p) Number Analyzed 15 participants 39 participants
3
  20.0%
8
  20.5%
Treatment-boosted ADA (Tb_ADA) Number Analyzed 15 participants 35 participants
0
   0.0%
0
   0.0%
Treatment-induced ADA (Ti_ADA) Number Analyzed 13 participants 38 participants
1
   7.7%
8
  21.1%
Transient ADA response (t_ADA) Number Analyzed 13 participants 38 participants
0
   0.0%
5
  13.2%
Persistent ADA response (p_ADA) Number Analyzed 13 participants 38 participants
1
   7.7%
3
   7.9%
Time Frame Baseline up to 30 days after last dose of study treatment (maximum duration of 259.7 weeks for participants with Lead-in, and maximum duration of 244.4 weeks for participants without lead-in)
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (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.
 
Arm/Group Title Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Hide Arm/Group Description Participants received 5 mg axitinib tablets orally twice daily for 7 days in lead-in period (7 days) followed by 10 milligram/ kilogram (mg/kg) avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 255.4 weeks). Participants received 10 mg/kg avelumab intravenously every 2 weeks along with 5 mg axitinib tablets orally twice daily, on Day 1 of each treatment cycle (duration of each cycle=14 days) in treatment period (up to maximum of 240.1 weeks).
All-Cause Mortality
Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Affected / at Risk (%) Affected / at Risk (%)
Total   6/16 (37.50%)   14/39 (35.90%) 
Hide Serious Adverse Events
Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Affected / at Risk (%) Affected / at Risk (%)
Total   6/16 (37.50%)   18/39 (46.15%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/16 (0.00%)  1/39 (2.56%) 
Neutropenia * 1  0/16 (0.00%)  1/39 (2.56%) 
Cardiac disorders     
Myocarditis * 1  1/16 (6.25%)  0/39 (0.00%) 
Palpitations * 1  0/16 (0.00%)  1/39 (2.56%) 
Tachycardia * 1  0/16 (0.00%)  1/39 (2.56%) 
Endocrine disorders     
Adrenal insufficiency * 1  0/16 (0.00%)  1/39 (2.56%) 
Gastrointestinal disorders     
Diarrhoea * 1  0/16 (0.00%)  1/39 (2.56%) 
Nausea * 1  1/16 (6.25%)  0/39 (0.00%) 
Vomiting * 1  1/16 (6.25%)  0/39 (0.00%) 
Pancreatitis * 2  0/16 (0.00%)  1/39 (2.56%) 
General disorders     
Adverse drug reaction * 1  0/16 (0.00%)  1/39 (2.56%) 
Disease progression * 1  0/16 (0.00%)  2/39 (5.13%) 
Pyrexia * 1  0/16 (0.00%)  1/39 (2.56%) 
Immune system disorders     
Anaphylactic shock * 2  0/16 (0.00%)  1/39 (2.56%) 
Infections and infestations     
Sepsis * 1  0/16 (0.00%)  1/39 (2.56%) 
Tooth abscess * 1  1/16 (6.25%)  0/39 (0.00%) 
Injury, poisoning and procedural complications     
Infusion related reaction * 1  0/16 (0.00%)  2/39 (5.13%) 
Lower limb fracture * 1  0/16 (0.00%)  1/39 (2.56%) 
Rib fracture * 1  0/16 (0.00%)  1/39 (2.56%) 
Spinal fracture * 1  0/16 (0.00%)  1/39 (2.56%) 
Investigations     
Alanine aminotransferase increased * 1  1/16 (6.25%)  1/39 (2.56%) 
Amylase increased * 1  1/16 (6.25%)  0/39 (0.00%) 
Aspartate aminotransferase increased * 1  0/16 (0.00%)  1/39 (2.56%) 
Lipase increased * 1  1/16 (6.25%)  0/39 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/16 (0.00%)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/16 (0.00%)  1/39 (2.56%) 
Muscular weakness * 1  0/16 (0.00%)  1/39 (2.56%) 
Nervous system disorders     
Presyncope * 1  0/16 (0.00%)  2/39 (5.13%) 
Spinal cord compression * 1  0/16 (0.00%)  2/39 (5.13%) 
Psychiatric disorders     
Substance-induced psychotic disorder * 2  1/16 (6.25%)  0/39 (0.00%) 
Renal and urinary disorders     
Haematuria * 2  0/16 (0.00%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  1/16 (6.25%)  1/39 (2.56%) 
Pleural effusion * 1  0/16 (0.00%)  1/39 (2.56%) 
Pulmonary embolism * 1  0/16 (0.00%)  1/39 (2.56%) 
Skin and subcutaneous tissue disorders     
Drug eruption * 1  0/16 (0.00%)  1/39 (2.56%) 
Vascular disorders     
Haematoma * 1  0/16 (0.00%)  2/39 (5.13%) 
Haemorrhage * 1  0/16 (0.00%)  1/39 (2.56%) 
Venous thrombosis * 1  0/16 (0.00%)  1/39 (2.56%) 
1
Term from vocabulary, MedDRA v21.0
2
Term from vocabulary, MedDRA v23.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Axitinib + Avelumab With Lead-in Axitinib + Avelumab
Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   39/39 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/16 (12.50%)  5/39 (12.82%) 
Leukocytosis * 1  1/16 (6.25%)  0/39 (0.00%) 
Leukopenia * 1  1/16 (6.25%)  0/39 (0.00%) 
Lymphopenia * 1  1/16 (6.25%)  0/39 (0.00%) 
Cardiac disorders     
Palpitations * 1  0/16 (0.00%)  2/39 (5.13%) 
Sinus bradycardia * 1  1/16 (6.25%)  1/39 (2.56%) 
Sinus tachycardia * 1  1/16 (6.25%)  1/39 (2.56%) 
Ventricular arrhythmia * 1  1/16 (6.25%)  0/39 (0.00%) 
Ear and labyrinth disorders     
Ear discomfort * 1  0/16 (0.00%)  2/39 (5.13%) 
Hypoacusis * 1  2/16 (12.50%)  0/39 (0.00%) 
Ear congestion * 2  1/16 (6.25%)  0/39 (0.00%) 
Endocrine disorders     
Hyperthyroidism * 1  2/16 (12.50%)  3/39 (7.69%) 
Hypothyroidism * 1  4/16 (25.00%)  11/39 (28.21%) 
Eye disorders     
Dry eye * 1  1/16 (6.25%)  3/39 (7.69%) 
Eye haemorrhage * 1  1/16 (6.25%)  0/39 (0.00%) 
Eyelid irritation * 1  1/16 (6.25%)  0/39 (0.00%) 
Vision blurred * 1  1/16 (6.25%)  1/39 (2.56%) 
Blepharitis * 2  0/16 (0.00%)  2/39 (5.13%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/16 (6.25%)  1/39 (2.56%) 
Abdominal pain * 1  2/16 (12.50%)  6/39 (15.38%) 
Abdominal pain upper * 1  1/16 (6.25%)  2/39 (5.13%) 
Anal haemorrhage * 1  1/16 (6.25%)  1/39 (2.56%) 
Constipation * 1  8/16 (50.00%)  12/39 (30.77%) 
Dental caries * 1  1/16 (6.25%)  4/39 (10.26%) 
Diarrhoea * 1  13/16 (81.25%)  26/39 (66.67%) 
Diverticulum * 1  1/16 (6.25%)  1/39 (2.56%) 
Dry mouth * 1  3/16 (18.75%)  5/39 (12.82%) 
Dyspepsia * 1  1/16 (6.25%)  3/39 (7.69%) 
Flatulence * 1  2/16 (12.50%)  2/39 (5.13%) 
Gastrooesophageal reflux disease * 1  1/16 (6.25%)  5/39 (12.82%) 
Gingival hypertrophy * 1  1/16 (6.25%)  0/39 (0.00%) 
Lip pain * 1  1/16 (6.25%)  0/39 (0.00%) 
Mouth ulceration * 1  0/16 (0.00%)  2/39 (5.13%) 
Nausea * 1  7/16 (43.75%)  8/39 (20.51%) 
Oral pain * 1  1/16 (6.25%)  3/39 (7.69%) 
Rectal haemorrhage * 1  1/16 (6.25%)  1/39 (2.56%) 
Stomatitis * 1  4/16 (25.00%)  4/39 (10.26%) 
Tongue discomfort * 1  1/16 (6.25%)  0/39 (0.00%) 
Toothache * 1  1/16 (6.25%)  3/39 (7.69%) 
Vomiting * 1  4/16 (25.00%)  10/39 (25.64%) 
Haemorrhoids * 2  0/16 (0.00%)  2/39 (5.13%) 
Hyperaesthesia teeth * 2  1/16 (6.25%)  0/39 (0.00%) 
Retching * 2  1/16 (6.25%)  0/39 (0.00%) 
Defaecation urgency * 2  1/16 (6.25%)  0/39 (0.00%) 
General disorders     
Axillary pain * 1  0/16 (0.00%)  2/39 (5.13%) 
Chest discomfort * 1  2/16 (12.50%)  1/39 (2.56%) 
Chest pain * 1  2/16 (12.50%)  0/39 (0.00%) 
Chills * 1  2/16 (12.50%)  7/39 (17.95%) 
Fatigue * 1  10/16 (62.50%)  20/39 (51.28%) 
Feeling abnormal * 1  1/16 (6.25%)  0/39 (0.00%) 
Feeling cold * 1  1/16 (6.25%)  1/39 (2.56%) 
Gait disturbance * 1  0/16 (0.00%)  2/39 (5.13%) 
Malaise * 1  0/16 (0.00%)  2/39 (5.13%) 
Mucosal inflammation * 1  2/16 (12.50%)  11/39 (28.21%) 
Oedema * 1  0/16 (0.00%)  2/39 (5.13%) 
Oedema peripheral * 1  2/16 (12.50%)  6/39 (15.38%) 
Pain * 1  1/16 (6.25%)  4/39 (10.26%) 
Peripheral swelling * 1  0/16 (0.00%)  2/39 (5.13%) 
Pyrexia * 1  1/16 (6.25%)  5/39 (12.82%) 
Immune system disorders     
Multiple allergies * 2  1/16 (6.25%)  0/39 (0.00%) 
Infections and infestations     
Cellulitis * 1  1/16 (6.25%)  0/39 (0.00%) 
Lower respiratory tract infection * 1  2/16 (12.50%)  1/39 (2.56%) 
Nasopharyngitis * 1  4/16 (25.00%)  5/39 (12.82%) 
Rhinitis * 1  0/16 (0.00%)  3/39 (7.69%) 
Sinusitis * 1  1/16 (6.25%)  2/39 (5.13%) 
Tooth infection * 1  2/16 (12.50%)  1/39 (2.56%) 
Upper respiratory tract infection * 1  2/16 (12.50%)  7/39 (17.95%) 
Urinary tract infection * 1  2/16 (12.50%)  5/39 (12.82%) 
Viral infection * 1  1/16 (6.25%)  0/39 (0.00%) 
Viral upper respiratory tract infection * 1  2/16 (12.50%)  0/39 (0.00%) 
Eye infection * 2  1/16 (6.25%)  0/39 (0.00%) 
Gingivitis * 2  1/16 (6.25%)  0/39 (0.00%) 
Hordeolum * 2  1/16 (6.25%)  1/39 (2.56%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/16 (6.25%)  3/39 (7.69%) 
Epicondylitis * 1  1/16 (6.25%)  0/39 (0.00%) 
Fall * 1  1/16 (6.25%)  2/39 (5.13%) 
Infusion related reaction * 1  1/16 (6.25%)  8/39 (20.51%) 
Procedural pain * 1  1/16 (6.25%)  0/39 (0.00%) 
Eye contusion * 2  1/16 (6.25%)  0/39 (0.00%) 
Incisional hernia * 2  1/16 (6.25%)  0/39 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  6/16 (37.50%)  12/39 (30.77%) 
Amylase increased * 1  9/16 (56.25%)  10/39 (25.64%) 
Aspartate aminotransferase increased * 1  4/16 (25.00%)  14/39 (35.90%) 
Blood alkaline phosphatase increased * 1  1/16 (6.25%)  6/39 (15.38%) 
Blood bilirubin increased * 1  1/16 (6.25%)  2/39 (5.13%) 
Blood cholesterol increased * 1  2/16 (12.50%)  3/39 (7.69%) 
Blood corticotrophin decreased * 1  1/16 (6.25%)  0/39 (0.00%) 
Blood creatine phosphokinase increased * 1  3/16 (18.75%)  3/39 (7.69%) 
Blood creatinine increased * 1  5/16 (31.25%)  4/39 (10.26%) 
Blood lactate dehydrogenase increased * 1  1/16 (6.25%)  1/39 (2.56%) 
Blood magnesium decreased * 1  2/16 (12.50%)  0/39 (0.00%) 
Blood phosphorus decreased * 1  3/16 (18.75%)  0/39 (0.00%) 
Blood sodium decreased * 1  2/16 (12.50%)  0/39 (0.00%) 
Blood thyroid stimulating hormone decreased * 1  1/16 (6.25%)  1/39 (2.56%) 
Blood thyroid stimulating hormone increased * 1  2/16 (12.50%)  1/39 (2.56%) 
Blood triglycerides increased * 1  0/16 (0.00%)  3/39 (7.69%) 
Blood uric acid increased * 1  1/16 (6.25%)  1/39 (2.56%) 
C-reactive protein increased * 1  1/16 (6.25%)  0/39 (0.00%) 
Cardiac murmur * 1  1/16 (6.25%)  0/39 (0.00%) 
Ejection fraction decreased * 1  1/16 (6.25%)  2/39 (5.13%) 
Gamma-glutamyltransferase increased * 1  3/16 (18.75%)  4/39 (10.26%) 
Haemoglobin increased * 1  1/16 (6.25%)  0/39 (0.00%) 
Lipase increased * 1  6/16 (37.50%)  7/39 (17.95%) 
Lymphocyte count decreased * 1  2/16 (12.50%)  2/39 (5.13%) 
Platelet count decreased * 1  2/16 (12.50%)  4/39 (10.26%) 
Weight decreased * 1  2/16 (12.50%)  9/39 (23.08%) 
Weight increased * 1  1/16 (6.25%)  3/39 (7.69%) 
Activated partial thromboplastin time prolonged * 2  1/16 (6.25%)  0/39 (0.00%) 
Blood corticotrophin increased * 2  0/16 (0.00%)  2/39 (5.13%) 
White blood cell count decreased * 2  1/16 (6.25%)  1/39 (2.56%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  3/16 (18.75%)  10/39 (25.64%) 
Dehydration * 1  1/16 (6.25%)  3/39 (7.69%) 
Gout * 1  2/16 (12.50%)  1/39 (2.56%) 
Hypercalcaemia * 1  1/16 (6.25%)  2/39 (5.13%) 
Hyperglycaemia * 1  2/16 (12.50%)  1/39 (2.56%) 
Hyperkalaemia * 1  2/16 (12.50%)  4/39 (10.26%) 
Hypernatraemia * 1  1/16 (6.25%)  2/39 (5.13%) 
Hypertriglyceridaemia * 1  3/16 (18.75%)  4/39 (10.26%) 
Hyperuricaemia * 1  1/16 (6.25%)  6/39 (15.38%) 
Hypoalbuminaemia * 1  2/16 (12.50%)  3/39 (7.69%) 
Hypokalaemia * 1  0/16 (0.00%)  5/39 (12.82%) 
Hypomagnesaemia * 1  0/16 (0.00%)  3/39 (7.69%) 
Hyponatraemia * 1  5/16 (31.25%)  5/39 (12.82%) 
Hypophosphataemia * 1  1/16 (6.25%)  8/39 (20.51%) 
Hyperlipidaemia * 2  0/16 (0.00%)  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  7/16 (43.75%)  12/39 (30.77%) 
Back pain * 1  4/16 (25.00%)  5/39 (12.82%) 
Flank pain * 1  2/16 (12.50%)  1/39 (2.56%) 
Joint swelling * 1  3/16 (18.75%)  0/39 (0.00%) 
Muscle spasms * 1  3/16 (18.75%)  7/39 (17.95%) 
Muscular weakness * 1  1/16 (6.25%)  2/39 (5.13%) 
Musculoskeletal pain * 1  1/16 (6.25%)  2/39 (5.13%) 
Musculoskeletal stiffness * 1  1/16 (6.25%)  2/39 (5.13%) 
Myalgia * 1  3/16 (18.75%)  8/39 (20.51%) 
Neck pain * 1  0/16 (0.00%)  2/39 (5.13%) 
Pain in extremity * 1  3/16 (18.75%)  4/39 (10.26%) 
Gouty arthritis * 2  1/16 (6.25%)  0/39 (0.00%) 
Musculoskeletal chest pain * 2  1/16 (6.25%)  0/39 (0.00%) 
Nervous system disorders     
Ataxia * 1  1/16 (6.25%)  0/39 (0.00%) 
Dizziness * 1  5/16 (31.25%)  4/39 (10.26%) 
Dysgeusia * 1  1/16 (6.25%)  6/39 (15.38%) 
Headache * 1  7/16 (43.75%)  8/39 (20.51%) 
Hyperaesthesia * 1  2/16 (12.50%)  0/39 (0.00%) 
Hypoaesthesia * 1  2/16 (12.50%)  1/39 (2.56%) 
Lethargy * 1  3/16 (18.75%)  1/39 (2.56%) 
Paraesthesia * 1  2/16 (12.50%)  3/39 (7.69%) 
Tremor * 1  2/16 (12.50%)  1/39 (2.56%) 
Cognitive disorder * 2  0/16 (0.00%)  3/39 (7.69%) 
Neurotoxicity * 2  1/16 (6.25%)  0/39 (0.00%) 
Taste disorder * 2  1/16 (6.25%)  0/39 (0.00%) 
Psychiatric disorders     
Confusional state * 1  1/16 (6.25%)  2/39 (5.13%) 
Dysphoria * 1  1/16 (6.25%)  0/39 (0.00%) 
Insomnia * 1  2/16 (12.50%)  6/39 (15.38%) 
Mood altered * 1  1/16 (6.25%)  0/39 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  1/16 (6.25%)  0/39 (0.00%) 
Proteinuria * 1  3/16 (18.75%)  6/39 (15.38%) 
Urinary incontinence * 1  0/16 (0.00%)  2/39 (5.13%) 
Haematuria * 2  1/16 (6.25%)  1/39 (2.56%) 
Reproductive system and breast disorders     
Balanoposthitis * 1  2/16 (12.50%)  0/39 (0.00%) 
Breast mass * 1  1/16 (6.25%)  0/39 (0.00%) 
Erectile dysfunction * 1  1/16 (6.25%)  0/39 (0.00%) 
Testicular swelling * 1  1/16 (6.25%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  7/16 (43.75%)  10/39 (25.64%) 
Dysphonia * 1  7/16 (43.75%)  20/39 (51.28%) 
Dyspnoea * 1  6/16 (37.50%)  12/39 (30.77%) 
Epistaxis * 1  0/16 (0.00%)  2/39 (5.13%) 
Hypoxia * 1  1/16 (6.25%)  1/39 (2.56%) 
Nasal congestion * 1  1/16 (6.25%)  4/39 (10.26%) 
Oropharyngeal pain * 1  2/16 (12.50%)  5/39 (12.82%) 
Productive cough * 1  1/16 (6.25%)  3/39 (7.69%) 
Pulmonary embolism * 1  0/16 (0.00%)  3/39 (7.69%) 
Rhinitis allergic * 1  1/16 (6.25%)  1/39 (2.56%) 
Sinus congestion * 1  0/16 (0.00%)  2/39 (5.13%) 
Upper-airway cough syndrome * 1  1/16 (6.25%)  1/39 (2.56%) 
Wheezing * 1  3/16 (18.75%)  0/39 (0.00%) 
Dyspnoea exertional * 2  1/16 (6.25%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform * 1  0/16 (0.00%)  2/39 (5.13%) 
Dry skin * 1  2/16 (12.50%)  4/39 (10.26%) 
Eczema * 1  1/16 (6.25%)  0/39 (0.00%) 
Hyperkeratosis * 1  1/16 (6.25%)  0/39 (0.00%) 
Ingrowing nail * 1  1/16 (6.25%)  0/39 (0.00%) 
Night sweats * 1  1/16 (6.25%)  1/39 (2.56%) 
Pain of skin * 1  0/16 (0.00%)  2/39 (5.13%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  7/16 (43.75%)  12/39 (30.77%) 
Pruritus * 1  4/16 (25.00%)  10/39 (25.64%) 
Rash * 1  6/16 (37.50%)  15/39 (38.46%) 
Rash erythematous * 1  1/16 (6.25%)  0/39 (0.00%) 
Rash macular * 1  1/16 (6.25%)  1/39 (2.56%) 
Rash papular * 1  2/16 (12.50%)  1/39 (2.56%) 
Rash pruritic * 1  1/16 (6.25%)  0/39 (0.00%) 
Skin exfoliation * 1  1/16 (6.25%)  0/39 (0.00%) 
Skin hyperpigmentation * 1  1/16 (6.25%)  0/39 (0.00%) 
Skin lesion * 1  1/16 (6.25%)  0/39 (0.00%) 
Skin ulcer * 1  0/16 (0.00%)  6/39 (15.38%) 
Urticaria * 1  0/16 (0.00%)  2/39 (5.13%) 
Actinic keratosis * 2  1/16 (6.25%)  0/39 (0.00%) 
Hyperhidrosis * 2  0/16 (0.00%)  2/39 (5.13%) 
Rash maculo-papular * 2  0/16 (0.00%)  3/39 (7.69%) 
Scar pain * 2  1/16 (6.25%)  0/39 (0.00%) 
Vascular disorders     
Haematoma * 1  1/16 (6.25%)  0/39 (0.00%) 
Hypertension * 1  8/16 (50.00%)  19/39 (48.72%) 
Hypotension * 1  1/16 (6.25%)  5/39 (12.82%) 
1
Term from vocabulary, MedDRA v21.0
2
Term from vocabulary, MedDRA v23.1
*
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: 1-800-718-1021
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: NCT02493751    
Other Study ID Numbers: B9991002
2015-001137-25 ( EudraCT Number )
Javelin Renal 100 ( Other Identifier: Alias Study Number )
First Submitted: July 7, 2015
First Posted: July 9, 2015
Results First Submitted: March 27, 2019
Results First Posted: June 21, 2019
Last Update Posted: February 18, 2022