Trial Outcomes & Findings for A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) (NCT NCT02684006)

Last Updated: 2025-07-30

Results Overview

PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter 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 relative increase of 20 %, sum must have also demonstrated an absolute more than (\>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

886 participants

Primary outcome timeframe

From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)

Results posted on

2025-07-30

Participant Flow

A total of 886 participants were enrolled and randomized in the study.

Participant milestones

Participant milestones
Measure	Avelumab + Axitinib Participants with advanced renal cell carcinoma (aRCC) received avelumab 10 milligram per kilogram (mg/kg), intravenously (IV) once every two weeks (Q2W) in a 6-week cycle plus axitinib 5 mg, orally twice daily (BID). Each treatment cycle was of 42 days.	Sunitinib Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Overall Study STARTED	442	444
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	442	444

Reasons for withdrawal

Reasons for withdrawal
Measure	Avelumab + Axitinib Participants with advanced renal cell carcinoma (aRCC) received avelumab 10 milligram per kilogram (mg/kg), intravenously (IV) once every two weeks (Q2W) in a 6-week cycle plus axitinib 5 mg, orally twice daily (BID). Each treatment cycle was of 42 days.	Sunitinib Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Overall Study Other	18	6
Overall Study Protocol Violation	2	1
Overall Study Non-compliance with study drug	1	1
Overall Study No longer met eligibility criteria	6	2
Overall Study Lost to Follow-up	0	1
Overall Study Death	25	22
Overall Study Global deterioration of health status	18	20
Overall Study Physician Decision	15	8
Overall Study Adverse Event	86	65
Overall Study Withdrawal by Subject	29	43
Overall Study Progressive disease	236	266
Overall Study Participation terminated by sponsor	6	9

Baseline Characteristics

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.	Total n=886 Participants Total of all reporting groups
Age, Continuous	60.86 Years STANDARD_DEVIATION 9.95 • n=99 Participants	60.66 Years STANDARD_DEVIATION 10.28 • n=107 Participants	60.76 Years STANDARD_DEVIATION 10.11 • n=206 Participants
Sex: Female, Male Female	126 Participants n=99 Participants	100 Participants n=107 Participants	226 Participants n=206 Participants
Sex: Female, Male Male	316 Participants n=99 Participants	344 Participants n=107 Participants	660 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=99 Participants	18 Participants n=107 Participants	37 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	388 Participants n=99 Participants	377 Participants n=107 Participants	765 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=99 Participants	49 Participants n=107 Participants	84 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) Asian	70 Participants n=99 Participants	63 Participants n=107 Participants	133 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Race (NIH/OMB) White	332 Participants n=99 Participants	334 Participants n=107 Participants	666 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=99 Participants	32 Participants n=107 Participants	58 Participants n=206 Participants

PRIMARY outcome

Timeframe: From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)

Population: FAS included all participants who were randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=270 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=290 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants	13.8 Months Interval 11.1 to The upper limit of 95% CI was not estimable due to insufficient number of participants with event.	7.2 Months Interval 5.7 to 9.7

PRIMARY outcome

Timeframe: From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)

Population: FAS included all participants who are randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive.

OS was defined as the time 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.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=270 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=290 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Overall Survival (OS) in PD-L1 Positive Participants	43.2 Months Interval 36.5 to 51.7	36.2 Months Interval 29.8 to 44.2

SECONDARY outcome

Timeframe: From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)

Population: FAS included all randomized participants.

PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter 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 relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression	13.8 Months Interval 11.1 to The upper limit of 95% CI was not estimable due to insufficient number of participants with event.	8.4 Months Interval 6.9 to 11.1

SECONDARY outcome

Timeframe: From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)

Population: FAS included all randomized participants.

OS 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.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
OS in Participants Irrespective of PD-L1 Expression	44.8 Months Interval 39.7 to 51.1	38.9 Months Interval 31.4 to 45.2

SECONDARY outcome

Timeframe: From date of randomization until PD (maximum up to approximately 26 months)

Population: FAS included all randomized participants.

OR was defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression	51.4 Percentage of participants Interval 46.6 to 56.1	25.7 Percentage of participants Interval 21.7 to 30.0

SECONDARY outcome

Timeframe: From date of randomization until PD (maximum up to approximately 89 months)

Population: FAS included all randomized participants.

OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by investigator recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression	59.7 Percentage of participants Interval 55.0 to 64.3	32.0 Percentage of participants Interval 27.7 to 36.5

SECONDARY outcome

Timeframe: From date of randomization until PD (maximum up to approximately 26 months)

Population: FAS included all randomized participants.

DC was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) according to RECIST v1.1 as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis\<10mm). 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. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression	82.8 Percentage of participants Interval 79.0 to 86.2	73.4 Percentage of participants Interval 69.1 to 77.5

SECONDARY outcome

Timeframe: From date of randomization until PD (maximum up to approximately 89 months)

Population: FAS included all randomized participants.

DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 as assessed by investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis\<10mm). 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. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression	85.1 Percentage of participants Interval 81.4 to 88.3	76.4 Percentage of participants Interval 72.1 to 80.2

SECONDARY outcome

Timeframe: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)

Population: FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by BICR (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=227 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=114 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression	2.6 Months Interval 1.2 to 13.8	3.2 Months Interval 1.2 to 11.6

SECONDARY outcome

Timeframe: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)

Population: FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by investigator (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=264 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=142 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression	2.8 Months Interval 1.1 to 34.5	2.8 Months Interval 1.2 to 65.2

SECONDARY outcome

Timeframe: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)

Population: FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BICR assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression assessed by BICR or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter 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 relative increase of 20%, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=227 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=114 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression	NA Months Median and 95% CI was not estimable due to insufficient number of participants with event.	NA Months Interval 11.2 to Median and upper limit of 95% CI was not estimable due to insufficient number of participants with event.

SECONDARY outcome

Timeframe: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months)

Population: FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Investigator assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression (PD) assessed by investigator or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter 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 relative increase of 20%, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=264 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=142 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression	19.4 Months Interval 16.4 to 22.3	14.5 Months Interval 8.7 to 16.6

SECONDARY outcome

Timeframe: From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)

Population: FAS included all randomized participants.

Investigator assessed PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter 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 relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression	13.9 Months Interval 11.1 to 16.6	8.5 Months Interval 8.2 to 9.7

SECONDARY outcome

Timeframe: From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)

Population: FAS included all randomized participants.

PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter 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 relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression	30.4 Months Interval 25.8 to 34.6	19.4 Months Interval 17.0 to 22.4

SECONDARY outcome

Timeframe: From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

Population: Safety analysis set included all participants who received at least one dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period (time from the first dose of study treatment through 90 days after last dose of study treatment or start day of new anti-cancer drug therapy-1 day). As per NCI-CTCAE v4.03, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=434 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=439 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 Grade 3	271 Participants	268 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 Grade 4	64 Participants	54 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 Grade 5	30 Participants	24 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 Grade 1	5 Participants	17 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 Grade 2	64 Participants	73 Participants

SECONDARY outcome

Timeframe: From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

Following hematology parameters were assessed: hemoglobin decreased (anemia), hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell (WBC) decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 4.03 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Baseline was defined as last assessment prior to first dose of study treatment. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=428 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=434 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Number of Participants According to Grade Shift in Hematology Parameters Anemia (Baseline G0 to post-baseline G3-4)	3 Participants	9 Participants
Number of Participants According to Grade Shift in Hematology Parameters Anemia (Baseline G1 to post-baseline G3-4)	6 Participants	21 Participants
Number of Participants According to Grade Shift in Hematology Parameters Anemia (Baseline G2 to post-baseline G3-4)	4 Participants	14 Participants
Number of Participants According to Grade Shift in Hematology Parameters Anemia (Baseline G3 to post-baseline G3-4)	0 Participants	2 Participants
Number of Participants According to Grade Shift in Hematology Parameters Lymphocytes count decreased (Baseline G0 to post-baseline G3-4)	21 Participants	53 Participants
Number of Participants According to Grade Shift in Hematology Parameters Lymphocytes count decreased (Baseline G1 to post-baseline G3-4)	11 Participants	18 Participants
Number of Participants According to Grade Shift in Hematology Parameters Lymphocytes count decreased (Baseline G2 to post-baseline G3-4)	7 Participants	15 Participants
Number of Participants According to Grade Shift in Hematology Parameters Lymphocytes count decreased (Baseline G3 to post-baseline G3-4)	2 Participants	6 Participants
Number of Participants According to Grade Shift in Hematology Parameters Neutrophils count decreased (Baseline G0 to post-baseline G3-4)	7 Participants	108 Participants
Number of Participants According to Grade Shift in Hematology Parameters Neutrophils count decreased (Baseline G1 to post-baseline G3-4)	0 Participants	2 Participants
Number of Participants According to Grade Shift in Hematology Parameters Neutrophils count decreased (Baseline G2 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Hematology Parameters Platelets count decreased (Baseline G0 to post-baseline G3-4)	3 Participants	61 Participants
Number of Participants According to Grade Shift in Hematology Parameters Platelets count decreased (Baseline G1 to post-baseline G3-4)	1 Participants	6 Participants
Number of Participants According to Grade Shift in Hematology Parameters WBC decreased (Baseline G0 to post-baseline G3-4)	1 Participants	35 Participants
Number of Participants According to Grade Shift in Hematology Parameters WBC decreased (Baseline G1 to post-baseline G3-4)	0 Participants	7 Participants
Number of Participants According to Grade Shift in Hematology Parameters WBC decreased (Baseline G2 to post-baseline G3-4)	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

Population: Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows.

Following chemistry parameters were assessed: alanine aminotransferase(ALT) increased, alkaline phosphatase(ALP) increased, aspartate aminotransferase(AST) increased, blood bilirubin increased, cholesterol high, creatinine phosphokinase(CPK) increased, creatinine increased, gamma glutamyl transferase(GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesmia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased and serum amylase increased. Laboratory abnormality graded as per NCI CTCAE v4.03; G0=non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported. Only non-zero categories for any reporting arm are reported.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=428 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=433 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Number of Participants According to Grade Shift in Chemistry Parameters ALT increased (Baseline G0 to post-baseline G3-4)	42 Participants	19 Participants
Number of Participants According to Grade Shift in Chemistry Parameters ALT increased (Baseline G1 to post-baseline G3-4)	3 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters ALP increased (Baseline G0 to post-baseline G3-4)	9 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters ALP increased (Baseline G1 to post-baseline G3-4)	5 Participants	6 Participants
Number of Participants According to Grade Shift in Chemistry Parameters ALP increased (Baseline G2 to post-baseline G3-4)	1 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters ALP increased (Baseline G3 to post-baseline G3-4)	4 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters AST increased (Baseline G1 to post-baseline G3-4)	6 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters AST increased (Baseline G3 to post-baseline G3-4)	1 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Blood bilirubin increased (Baseline G0 to post-baseline G3-4)	3 Participants	6 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Blood bilirubin increased (Baseline G1 to post-baseline G3-4)	2 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Cholesterol high (Baseline G0 to post-baseline G3-4)	8 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Cholesterol high (Baseline G2 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters CPK increased (Baseline G0 to post-baseline G3-4)	7 Participants	7 Participants
Number of Participants According to Grade Shift in Chemistry Parameters CPK increased (Baseline G2 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters CPK increased (Baseline G1 to post-baseline G3-4)	0 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters CPK increased (Baseline G3 to post-baseline G3-4)	1 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Creatinine increased (Baseline G0 to post-baseline G3-4)	7 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Creatinine increased (Baseline G1 to post-baseline G3-4)	4 Participants	5 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Creatinine increased (Baseline G2 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Creatinine increased (Baseline G3 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters GGT increased (Baseline G0 to post-baseline G3-4)	15 Participants	16 Participants
Number of Participants According to Grade Shift in Chemistry Parameters GGT increased (Baseline G1 to post-baseline G3-4)	20 Participants	7 Participants
Number of Participants According to Grade Shift in Chemistry Parameters GGT increased (Baseline G2 to post-baseline G3-4)	12 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters GGT increased (Baseline G3 to post-baseline G3-4)	7 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters GGT increased (Baseline G4 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypercalcemia (Baseline G0 to post-baseline G3-4)	4 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypercalcemia (Baseline G1 to post-baseline G3-4)	1 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypercalcemia (Baseline G2 to post-baseline G3-4)	1 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypercalcemia (Baseline G3 to post-baseline G3-4)	0 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypercalcemia (Baseline G4 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperglycemia (Baseline G0 to post-baseline G3-4)	37 Participants	20 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperglycemia (Baseline G1 to post-baseline G3-4)	4 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperglycemia (Baseline G2 to post-baseline G3-4)	5 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperglycemia (Baseline G3 to post-baseline G3-4)	6 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperkalemia (Baseline G0 to post-baseline G3-4)	19 Participants	16 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperkalemia (Baseline G1 to post-baseline G3-4)	1 Participants	5 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperkalemia (Baseline G3 to post-baseline G3-4)	1 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperkalemia (Baseline G4 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypermagnesemia (Baseline G0 to post-baseline G3-4)	13 Participants	20 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypermagnesemia (Baseline G1 to post-baseline G3-4)	1 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypernatremia (Baseline G0 to post-baseline G3-4)	7 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypertriglyceridemia (Baseline G0 to post-baseline G3-4)	18 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypertriglyceridemia (Baseline G2 to post-baseline G3-4)	15 Participants	6 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypertriglyceridemia (Baseline G3 to post-baseline G3-4)	4 Participants	5 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypertriglyceridemia (Baseline G4 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypoalbunemia (Baseline G0 to post-baseline G3-4)	3 Participants	6 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypoalbunemia (Baseline G1 to post-baseline G3-4)	1 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypoalbunemia (Baseline G3 to post-baseline G3-4)	1 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypocalcemia (Baseline G0 to post-baseline G3-4)	4 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypocalcemia (Baseline G1 to post-baseline G3-4)	0 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypoglycemia (Baseline G0 to post-baseline G3-4)	2 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypokalemia (Baseline G2 to post-baseline G3-4)	2 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypomagnesemia (Baseline G0 to post-baseline G3-4)	3 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypomagnesemia (Baseline G1 to post-baseline G3-4)	2 Participants	1 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypomagnesemia (Baseline G2 to post-baseline G3-4)	1 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyponatremia (Baseline G0 to post-baseline G3-4)	42 Participants	35 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyponatremia (Baseline G1 to post-baseline G3-4)	19 Participants	14 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyponatremia (Baseline G3 to post-baseline G3-4)	1 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Lipase increased (Baseline G0 to post-baseline G3-4)	63 Participants	27 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Lipase increased (Baseline G1 to post-baseline G3-4)	19 Participants	8 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Lipase increased (Baseline G2 to post-baseline G3-4)	7 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Lipase increased (Baseline G3 to post-baseline G3-4)	2 Participants	7 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Lipase increased (Baseline G4 to post-baseline G3-4)	1 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Serum amylase increased (Baseline G0 to post-baseline G3-4)	21 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Serum amylase increased (Baseline G1 to post-baseline G3-4)	12 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Serum amylase increased (Baseline G2 to post-baseline G3-4)	4 Participants	4 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Serum amylase increased (Baseline G3 to post-baseline G3-4)	1 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters AST increased (Baseline G0 to post-baseline G3-4)	26 Participants	16 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Cholesterol high (Baseline G1 to post-baseline G3-4)	4 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hyperkalemia (Baseline G2 to post-baseline G3-4)	3 Participants	3 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypertriglyceridemia (Baseline G1 to post-baseline G3-4)	31 Participants	23 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypoalbunemia (Baseline G2 to post-baseline G3-4)	2 Participants	2 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypocalcemia (Baseline G2 to post-baseline G3-4)	1 Participants	0 Participants
Number of Participants According to Grade Shift in Chemistry Parameters Hypokalemia (Baseline G0 to post-baseline G3-4)	17 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days)

Population: Safety analysis set included all participants who received at least one dose of study drug. "Number Analyzed" signifies number of participants evaluable for the specified time points.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days)

Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=433 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=439 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Baseline	75.4 beats per minute Standard Deviation 12.49	75.6 beats per minute Standard Deviation 12.63
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at Cycle 2, Day 1	0.4 beats per minute Standard Deviation 12.77	3.1 beats per minute Standard Deviation 10.69
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at Cycle 3, Day 1	0.8 beats per minute Standard Deviation 12.58	3.1 beats per minute Standard Deviation 11.34
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at Cycle 4, Day 1	-0.6 beats per minute Standard Deviation 12.79	2.8 beats per minute Standard Deviation 10.34
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at Cycle 5, Day 1	-0.5 beats per minute Standard Deviation 12.00	2.5 beats per minute Standard Deviation 10.82
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at Cycle 6, Day 1	-1.9 beats per minute Standard Deviation 12.37	1.6 beats per minute Standard Deviation 10.75
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at Cycle 7, Day 1	-1.9 beats per minute Standard Deviation 11.69	2.1 beats per minute Standard Deviation 10.13
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit Change at End of Treatment	2.9 beats per minute Standard Deviation 15.29	3.5 beats per minute Standard Deviation 12.27

SECONDARY outcome

Timeframe: From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)

Population: Safety analysis set included all participants who received at least one dose of study drug.

Number of participants who discontinued treatment due to toxicity are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=434 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=439 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Number of Participants Who Discontinued Treatment Due to Toxicity	136 Participants Interval 17.41 to	65 Participants Interval 12.82 to

SECONDARY outcome

Timeframe: From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)

Time to treatment discontinuation/ failure due to toxicity was defined as the time from first dose of study treatment to discontinuation of study treatment due to an adverse event or death due to study treatment toxicity.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=136 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=65 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Time to Treatment Discontinuation/Failure Due to Toxicity	13.5 Months Standard Deviation 17.41	10.5 Months Standard Deviation 12.82

SECONDARY outcome

Timeframe: Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6

Population: Avelumab PK concentration analysis set: all participants who had at least one post-dose concentration above lower limit of quantitation (LLQ) for avelumab. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.

Predose concentration during multiple dosing.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=389 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 2 (day 1)	24.87 Micrograms per milliliter Geometric Coefficient of Variation 92	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 2 (day 29)	22.62 Micrograms per milliliter Geometric Coefficient of Variation 113	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 1 (day 1)	4.218 Micrograms per milliliter Geometric Coefficient of Variation 1232	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 1 (day 15)	18.69 Micrograms per milliliter Geometric Coefficient of Variation 102	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 1 (day 29)	21.99 Micrograms per milliliter Geometric Coefficient of Variation 96	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 3 (day 1)	26.04 Micrograms per milliliter Geometric Coefficient of Variation 98	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 3 (day 29)	30.13 Micrograms per milliliter Geometric Coefficient of Variation 82	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 4 (day 1)	29.15 Micrograms per milliliter Geometric Coefficient of Variation 98	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 4 (day 29)	31.38 Micrograms per milliliter Geometric Coefficient of Variation 86	—
Trough Plasma Concentration (Ctrough) of Avelumab Cycle 6 (day 1)	39.11 Micrograms per milliliter Geometric Coefficient of Variation 58	—

SECONDARY outcome

Timeframe: Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)

Population: Axitinib PK concentration analysis set: all participants who received at least one dose of study drug and have at least one post-dose concentration above lower limit of quantitation (LLQ) for axitinib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.

Predose concentration during multiple dosing.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=312 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Ctrough of Axitinib Cycle1 (day 15)	4.904 Nanograms per milliliter Geometric Coefficient of Variation 172	—
Ctrough of Axitinib Cycle1 (day 29)	6.272 Nanograms per milliliter Geometric Coefficient of Variation 174	—

SECONDARY outcome

Timeframe: 2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1

Population: Axitinib PK concentration analysis: all participants who received at least one dose of study drug and have at least one post-dose concentration above lower limit of quantitation (LLQ) for axitinib. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=316 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Maximum Plasma Concentration (Cmax) of Axitinib Cycle1 (day 1); Post Dose	17.93 Nanogram per milliliter Geometric Coefficient of Variation 182	—
Maximum Plasma Concentration (Cmax) of Axitinib Cycle1 (day 15); Pre-Dose	4.904 Nanogram per milliliter Geometric Coefficient of Variation 172	—
Maximum Plasma Concentration (Cmax) of Axitinib Cycle1 (day 15); Post Dose	18.45 Nanogram per milliliter Geometric Coefficient of Variation 157	—
Maximum Plasma Concentration (Cmax) of Axitinib Cycle1 (day 29); Pre-Dose	6.272 Nanogram per milliliter Geometric Coefficient of Variation 174	—
Maximum Plasma Concentration (Cmax) of Axitinib Cycle1 (day 29); Post Dose	17.19 Nanogram per milliliter Geometric Coefficient of Variation 174	—

SECONDARY outcome

Timeframe: At screening

Population: Biomarker analysis set for biomarkers that are measured only at screening, included all participants who received at least one dose of study drug and who had at least one screening biomarker assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Tumor biospecimens from pre-treatment tissue samples were analyzed by immunohistochemistry for PD-L1 biomarker expression. Number of participants with positive PD-L1 biomarker expression are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=397 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=407 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue	266 Participants	288 Participants

SECONDARY outcome

Timeframe: From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)

Population: Biomarker positive/negative subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows.

PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter 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 relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=402 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=410 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups PD-L1 Positive Tumors	13.8 Months Interval 11.1 to The upper limit of 95% CI was not estimable due to insufficient number of participants with event.	7.2 Months Interval 5.7 to 9.7
PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups PD-L1 Negative Tumors	16.1 Months Interval 9.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with event.	11.1 Months Interval 6.9 to 17.3

SECONDARY outcome

Timeframe: From date of randomization until PD (maximum up to approximately 26 months)

OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=402 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=410 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups PD-L1 Positive Tumors	55.2 Percentage of participants Interval 49.0 to 61.2	25.5 Percentage of participants Interval 20.6 to 30.9
Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups PD-L1 Negative Tumors	47.0 Percentage of participants Interval 38.2 to 55.8	28.3 Percentage of participants Interval 20.5 to 37.3

SECONDARY outcome

Timeframe: From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)

Population: Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment.

DC was defined as a best overall response of CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. SD was defined as PR that the sum increases by less than 20% from the nadir, (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=270 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=290 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Percentage of Participants With DC in Biomarker-Positive Subgroup	84.4 Percentage of participants Interval 79.6 to 88.6	71.0 Percentage of participants Interval 65.4 to 76.2

SECONDARY outcome

Timeframe: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)

Population: Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

TTR was defined as the time from randomization to the first documentation of objective tumor response (CR or PR) according to RECIST v1.1 which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=149 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=74 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
TTR in Biomarker-Positive Subgroup	1.6 Months Interval 1.2 to 10.1	3.0 Months Interval 1.2 to 11.6

SECONDARY outcome

Timeframe: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)

DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause, whichever occurred first. As per RECIST version 1.1, CR: 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%\< in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: defined as at least a 20% \> in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=211 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=108 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups PD-L1 Positive Tumors	NA Months Median and 95% CI was not estimable due to insufficient number of participants with event.	NA Months Interval 10.9 to Median and 95% CI was not estimable due to insufficient number of participants with event.
DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups PD-L1 Negative Tumors	NA Months Interval 11.1 to Median and 95% CI was not estimable due to insufficient number of participants with event.	NA Months Interval 9.0 to Median and 95% CI was not estimable due to insufficient number of participants with event.

SECONDARY outcome

Timeframe: From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)

Population: Immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA/nAb sample collected for avelumab in "Avelumab + Axitinib" arm. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed for ''Sunitinib'' reporting group.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=433 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib ADA Positive	77 Participants	—
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib nAb Positive	51 Participants	—

SECONDARY outcome

Timeframe: Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months)

Population: FAS included all randomized participants.

TTD was defined as the time from date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS. FKSI was used to assess symptoms and quality of life (QoL) for those diagnosed with advanced kidney cancer and it consisted of 19 questions. A 9-item subscale of the FKSI known as FKSI-Disease Related Symptoms subscale (FKSI-DRS). This subscale included 9 items: lack of energy, pain, losing weight, bone pain, fatigue, shortness of breath, coughing, bothered by fevers, and hematuria. Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher score indicated greater presence of symptoms.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)	4.2 Months Interval 4.2 to 5.7	6.3 Months Interval 5.5 to 8.3

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)

Population: FAS included all randomized participants. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable for the specified rows.

EQ-5D-5L is a 5-item participant-completed questionnaire designed to assess health status in terms of a single utility score. 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. Overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. Published UK weights were used to create a single summary utility score. Utility scores range from -0.594 to 1, with higher scores representing better health status.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 25 (Day 1)	-0.019 Units on a scale Standard Deviation 0.1825	-0.007 Units on a scale Standard Deviation 0.1678
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 26 (Day 1)	-0.039 Units on a scale Standard Deviation 0.1927	-0.009 Units on a scale Standard Deviation 0.1471
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 2 (Day 1)	-0.034 Units on a scale Standard Deviation 0.1743	0.001 Units on a scale Standard Deviation 0.1632
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 6 (Day 1)	-0.025 Units on a scale Standard Deviation 0.1787	-0.003 Units on a scale Standard Deviation 0.1967
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 7 (Day 1)	-0.018 Units on a scale Standard Deviation 0.1651	0.008 Units on a scale Standard Deviation 0.1618
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 8 (Day 1)	-0.029 Units on a scale Standard Deviation 0.1848	0.002 Units on a scale Standard Deviation 0.1731
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 9 (Day 1)	-0.029 Units on a scale Standard Deviation 0.2021	-0.011 Units on a scale Standard Deviation 0.1662
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 10 (Day 1)	-0.025 Units on a scale Standard Deviation 0.1935	-0.018 Units on a scale Standard Deviation 0.1617
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 12 (Day 1)	-0.026 Units on a scale Standard Deviation 0.1875	-0.016 Units on a scale Standard Deviation 0.1712
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 13 (Day 1)	-0.026 Units on a scale Standard Deviation 0.1777	-0.017 Units on a scale Standard Deviation 0.1549
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 15 (Day 1)	-0.036 Units on a scale Standard Deviation 0.1892	0.018 Units on a scale Standard Deviation 0.1487
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 16 (Day 1)	-0.044 Units on a scale Standard Deviation 0.1757	0.020 Units on a scale Standard Deviation 0.1663
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 17 (Day 1)	-0.050 Units on a scale Standard Deviation 0.1950	-0.000 Units on a scale Standard Deviation 0.1675
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 18 (Day 1)	-0.040 Units on a scale Standard Deviation 0.1667	-0.027 Units on a scale Standard Deviation 0.1765
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 19 (Day 1)	-0.059 Units on a scale Standard Deviation 0.1959	0.003 Units on a scale Standard Deviation 0.1665
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 20 (Day 1)	-0.050 Units on a scale Standard Deviation 0.1942	0.001 Units on a scale Standard Deviation 0.1538
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 21 (Day 1)	-0.048 Units on a scale Standard Deviation 0.1902	-0.004 Units on a scale Standard Deviation 0.1904
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 23 (Day 1)	-0.033 Units on a scale Standard Deviation 0.2021	-0.028 Units on a scale Standard Deviation 0.1729
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 24 (Day 1)	-0.036 Units on a scale Standard Deviation 0.1982	0.004 Units on a scale Standard Deviation 0.1618
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 28 (Day 1)	-0.039 Units on a scale Standard Deviation 0.2060	-0.007 Units on a scale Standard Deviation 0.1639
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 30 (Day 1)	-0.032 Units on a scale Standard Deviation 0.2244	-0.003 Units on a scale Standard Deviation 0.1557
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 31 (Day 1)	-0.042 Units on a scale Standard Deviation 0.2246	-0.009 Units on a scale Standard Deviation 0.1508
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 34 (Day 1)	-0.029 Units on a scale Standard Deviation 0.1776	0.038 Units on a scale Standard Deviation 0.1558
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 35 (Day 1)	-0.010 Units on a scale Standard Deviation 0.1442	-0.002 Units on a scale Standard Deviation 0.1610
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 36 (Day 1)	-0.016 Units on a scale Standard Deviation 0.1599	0.030 Units on a scale Standard Deviation 0.1551
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 39 (Day 1)	-0.042 Units on a scale Standard Deviation 0.1569	0.052 Units on a scale Standard Deviation 0.1386
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 42 (Day 1)	-0.021 Units on a scale Standard Deviation 0.1634	0.034 Units on a scale Standard Deviation 0.1585
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 44 (Day 1)	-0.028 Units on a scale Standard Deviation 0.1300	0.016 Units on a scale Standard Deviation 0.2114
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 45 (Day 1)	-0.050 Units on a scale Standard Deviation 0.1442	0.007 Units on a scale Standard Deviation 0.2191
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 47 (Day 1)	-0.019 Units on a scale Standard Deviation 0.1240	-0.015 Units on a scale Standard Deviation 0.2335
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 49 (Day 1)	-0.028 Units on a scale Standard Deviation 0.1356	0.010 Units on a scale Standard Deviation 0.1873
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 50 (Day 1)	-0.028 Units on a scale Standard Deviation 0.1359	0.028 Units on a scale Standard Deviation 0.2507
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 53 (Day 1)	-0.084 Units on a scale Standard Deviation 0.1437	0.048 Units on a scale Standard Deviation 0.1308
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 54 (Day 1)	-0.040 Units on a scale Standard Deviation 0.1425	0.078 Units on a scale Standard Deviation 0.1157
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 55 (Day 1)	-0.046 Units on a scale Standard Deviation 0.1121	0.051 Units on a scale Standard Deviation 0.1060
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 58 (Day 1)	-0.078 Units on a scale Standard Deviation 0.1408	0.031 Units on a scale Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score End of Treatment	-0.111 Units on a scale Standard Deviation 0.2464	-0.069 Units on a scale Standard Deviation 0.2375
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 3 (Day 1)	-0.023 Units on a scale Standard Deviation 0.1826	-0.017 Units on a scale Standard Deviation 0.1804
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 4 (Day 1)	-0.029 Units on a scale Standard Deviation 0.1829	-0.022 Units on a scale Standard Deviation 0.1667
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 5 (Day 1)	-0.019 Units on a scale Standard Deviation 0.1622	-0.016 Units on a scale Standard Deviation 0.1826
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 11 (Day 1)	-0.020 Units on a scale Standard Deviation 0.1854	0.004 Units on a scale Standard Deviation 0.1642
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 14 (Day 1)	-0.036 Units on a scale Standard Deviation 0.1938	-0.006 Units on a scale Standard Deviation 0.1600
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 22 (Day 1)	0.037 Units on a scale Standard Deviation 0.1919	0.002 Units on a scale Standard Deviation 0.1561
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 27 (Day 1)	-0.046 Units on a scale Standard Deviation 0.2233	0.014 Units on a scale Standard Deviation 0.1492
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 29 (Day 1)	-0.019 Units on a scale Standard Deviation 0.2095	0.017 Units on a scale Standard Deviation 0.1601
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 32 (Day 1)	-0.044 Units on a scale Standard Deviation 0.2095	0.032 Units on a scale Standard Deviation 0.1255
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 33 (Day 1)	-0.051 Units on a scale Standard Deviation 0.2294	-0.060 Units on a scale Standard Deviation 0.3550
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 37 (Day 1)	-0.027 Units on a scale Standard Deviation 0.1507	0.052 Units on a scale Standard Deviation 0.1601
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 38 (Day 1)	-0.016 Units on a scale Standard Deviation 0.1459	0.057 Units on a scale Standard Deviation 0.1666
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 40 (Day 1)	-0.021 Units on a scale Standard Deviation 0.1484	0.060 Units on a scale Standard Deviation 0.1232
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 41 (Day 1)	-0.030 Units on a scale Standard Deviation 0.1492	0.056 Units on a scale Standard Deviation 0.1853
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 43 (Day 1)	-0.031 Units on a scale Standard Deviation 0.1334	0.011 Units on a scale Standard Deviation 0.2062
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 46 (Day 1)	-0.042 Units on a scale Standard Deviation 0.1380	-0.007 Units on a scale Standard Deviation 0.2495
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 48 (Day 1)	-0.025 Units on a scale Standard Deviation 0.1566	0.009 Units on a scale Standard Deviation 0.2833
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 51 (Day 1)	-0.011 Units on a scale Standard Deviation 0.1304	-0.010 Units on a scale Standard Deviation 0.2594
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 52 (Day 1)	-0.036 Units on a scale Standard Deviation 0.1265	-0.035 Units on a scale Standard Deviation 0.2524
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 56 (Day 1)	-0.083 Units on a scale Standard Deviation 0.1081	0.025 Units on a scale Standard Deviation 0.1796
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 57 (Day 1)	-0.104 Units on a scale Standard Deviation 0.1347	0.031 Units on a scale Standard Deviation NA Standard deviation (SD) could not be calculated as only 1 participant was analyzed.
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 59 (Day 1)	-0.106 Units on a scale Standard Deviation 0.1053	—
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score Cycle 60 (Day 1)	-0.040 Units on a scale Standard Deviation 0.1167	—

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)

EQ-VAS records the participant's self-rated health status from 0 (worst imaginable health status) to 100 (best imaginable health status), where higher scores indicated better health status.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=442 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=444 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 23 (Day 1)	3.7 Units on a scale Standard Deviation 16.90	1.3 Units on a scale Standard Deviation 15.16
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 25 (Day 1)	4.6 Units on a scale Standard Deviation 15.28	4.2 Units on a scale Standard Deviation 14.42
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 26 (Day 1)	4.4 Units on a scale Standard Deviation 17.10	3.4 Units on a scale Standard Deviation 13.00
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 27 (Day 1)	4.7 Units on a scale Standard Deviation 16.59	5.4 Units on a scale Standard Deviation 13.43
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 28 (Day 1)	6.3 Units on a scale Standard Deviation 16.08	5.0 Units on a scale Standard Deviation 13.84
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 29 (Day 1)	4.8 Units on a scale Standard Deviation 15.44	5.4 Units on a scale Standard Deviation 14.24
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 30 (Day 1)	6.0 Units on a scale Standard Deviation 15.78	5.3 Units on a scale Standard Deviation 14.61
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 33 (Day 1)	5.5 Units on a scale Standard Deviation 16.07	3.6 Units on a scale Standard Deviation 20.61
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 2 (Day 1)	-0.9 Units on a scale Standard Deviation 16.12	-0.2 Units on a scale Standard Deviation 15.85
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 6 (Day 1)	1.3 Units on a scale Standard Deviation 16.05	2.6 Units on a scale Standard Deviation 15.35
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 7 (Day 1)	1.2 Units on a scale Standard Deviation 16.34	3.3 Units on a scale Standard Deviation 14.91
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 12 (Day 1)	2.1 Units on a scale Standard Deviation 14.72	2.6 Units on a scale Standard Deviation 14.59
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 13 (Day 1)	3.0 Units on a scale Standard Deviation 14.39	2.7 Units on a scale Standard Deviation 14.29
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 14 (Day 1)	2.7 Units on a scale Standard Deviation 15.07	3.0 Units on a scale Standard Deviation 13.98
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 15 (Day 1)	3.1 Units on a scale Standard Deviation 14.97	4.7 Units on a scale Standard Deviation 13.63
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 16 (Day 1)	2.9 Units on a scale Standard Deviation 15.08	3.6 Units on a scale Standard Deviation 14.02
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 17 (Day 1)	3.0 Units on a scale Standard Deviation 15.44	3.2 Units on a scale Standard Deviation 12.88
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 18 (Day 1)	3.2 Units on a scale Standard Deviation 15.31	2.0 Units on a scale Standard Deviation 13.69
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 19 (Day 1)	4.5 Units on a scale Standard Deviation 15.61	3.0 Units on a scale Standard Deviation 13.10
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 24 (Day 1)	3.3 Units on a scale Standard Deviation 18.70	4.5 Units on a scale Standard Deviation 13.45
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 31 (Day 1)	5.7 Units on a scale Standard Deviation 15.42	5.2 Units on a scale Standard Deviation 14.88
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 32 (Day 1)	5.4 Units on a scale Standard Deviation 16.35	6.0 Units on a scale Standard Deviation 13.57
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 34 (Day 1)	4.8 Units on a scale Standard Deviation 15.25	6.1 Units on a scale Standard Deviation 15.91
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 36 (Day 1)	6.0 Units on a scale Standard Deviation 15.63	5.2 Units on a scale Standard Deviation 17.11
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 37 (Day 1)	5.8 Units on a scale Standard Deviation 14.63	4.5 Units on a scale Standard Deviation 15.86
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 43 (Day 1)	6.6 Units on a scale Standard Deviation 11.64	5.4 Units on a scale Standard Deviation 20.14
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 44 (Day 1)	4.9 Units on a scale Standard Deviation 13.38	5.1 Units on a scale Standard Deviation 19.77
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 45 (Day 1)	6.3 Units on a scale Standard Deviation 12.55	1.5 Units on a scale Standard Deviation 17.97
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 51 (Day 1)	5.8 Units on a scale Standard Deviation 12.36	2.1 Units on a scale Standard Deviation 22.93
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 52 (Day 1)	4.2 Units on a scale Standard Deviation 11.37	1.5 Units on a scale Standard Deviation 19.94
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score End of treatment	-5.0 Units on a scale Standard Deviation 19.92	-4.3 Units on a scale Standard Deviation 19.63
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 35 (Day 1)	6.0 Units on a scale Standard Deviation 14.53	6.4 Units on a scale Standard Deviation 15.61
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 3 (Day 1)	-0.4 Units on a scale Standard Deviation 16.39	0.4 Units on a scale Standard Deviation 16.44
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 4 (Day 1)	-0.1 Units on a scale Standard Deviation 17.23	0.7 Units on a scale Standard Deviation 17.26
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 5 (Day 1)	0.4 Units on a scale Standard Deviation 16.66	1.8 Units on a scale Standard Deviation 16.16
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 8 (Day 1)	1.4 Units on a scale Standard Deviation 16.54	2.9 Units on a scale Standard Deviation 13.84
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 9 (Day 1)	2.0 Units on a scale Standard Deviation 16.06	3.3 Units on a scale Standard Deviation 13.77
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 10 (Day 1)	1.6 Units on a scale Standard Deviation 15.12	2.4 Units on a scale Standard Deviation 14.46
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 11 (Day 1)	2.5 Units on a scale Standard Deviation 15.70	4.1 Units on a scale Standard Deviation 12.91
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 20 (Day 1)	3.9 Units on a scale Standard Deviation 15.15	3.1 Units on a scale Standard Deviation 12.58
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 21 (Day 1)	3.7 Units on a scale Standard Deviation 16.30	2.1 Units on a scale Standard Deviation 13.00
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 22 (Day 1)	4.3 Units on a scale Standard Deviation 16.43	2.6 Units on a scale Standard Deviation 12.82
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 38 (Day 1)	5.3 Units on a scale Standard Deviation 14.58	4.3 Units on a scale Standard Deviation 17.58
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 39 (Day 1)	5.3 Units on a scale Standard Deviation 14.04	5.9 Units on a scale Standard Deviation 15.75
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 40 (Day 1)	6.0 Units on a scale Standard Deviation 15.00	4.7 Units on a scale Standard Deviation 18.17
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 41 (Day 1)	5.6 Units on a scale Standard Deviation 13.69	6.2 Units on a scale Standard Deviation 18.37
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 42 (Day 1)	5.3 Units on a scale Standard Deviation 13.68	5.4 Units on a scale Standard Deviation 18.19
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 46 (Day 1)	6.7 Units on a scale Standard Deviation 13.25	0.3 Units on a scale Standard Deviation 19.31
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 47 (Day 1)	5.4 Units on a scale Standard Deviation 11.10	2.5 Units on a scale Standard Deviation 18.07
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 48 (Day 1)	4.4 Units on a scale Standard Deviation 11.73	3.5 Units on a scale Standard Deviation 21.77
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 49 (Day 1)	4.2 Units on a scale Standard Deviation 12.21	1.9 Units on a scale Standard Deviation 21.42
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 50 (Day 1)	4.8 Units on a scale Standard Deviation 13.07	2.9 Units on a scale Standard Deviation 20.53
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 53 (Day 1)	3.2 Units on a scale Standard Deviation 11.43	7.7 Units on a scale Standard Deviation 16.22
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 54 (Day 1)	4.6 Units on a scale Standard Deviation 11.54	7.5 Units on a scale Standard Deviation 13.34
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 55 (Day 1)	4.6 Units on a scale Standard Deviation 11.65	7.8 Units on a scale Standard Deviation 17.89
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 56 (Day 1)	-0.6 Units on a scale Standard Deviation 8.08	-6.0 Units on a scale Standard Deviation 5.66
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 57 (Day 1)	-1.9 Units on a scale Standard Deviation 10.67	-2.0 Units on a scale Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 58 (Day 1)	-2.1 Units on a scale Standard Deviation 8.59	-2.0 Units on a scale Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 59 (Day 1)	0.0 Units on a scale Standard Deviation 9.35	—
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score Cycle 60 (Day 1)	-1.7 Units on a scale Standard Deviation 16.07	—

Adverse Events

Avelumab + Axitinib

Serious events: 231 serious events

Other events: 429 other events

Deaths: 284 deaths

Sunitinib

Serious events: 166 serious events

Other events: 433 other events

Deaths: 296 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Avelumab + Axitinib n=434 Participants Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.	Sunitinib n=439 Participants Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Baseline: Sitting SBP	126.5 Millimeters of mercury Standard Deviation 13.52	126.3 Millimeters of mercury Standard Deviation 12.00
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 2, Day 1: Sitting SBP	4.7 Millimeters of mercury Standard Deviation 16.08	0.8 Millimeters of mercury Standard Deviation 12.49
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 3, Day 1: Sitting SBP	3.8 Millimeters of mercury Standard Deviation 16.43	1.2 Millimeters of mercury Standard Deviation 12.81
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 4, Day 1: Sitting SBP	3.0 Millimeters of mercury Standard Deviation 15.95	0.1 Millimeters of mercury Standard Deviation 13.01
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 5, Day 1: Sitting SBP	2.5 Millimeters of mercury Standard Deviation 15.42	-0.1 Millimeters of mercury Standard Deviation 12.26
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 6, Day 1: Sitting SBP	1.6 Millimeters of mercury Standard Deviation 15.39	-0.1 Millimeters of mercury Standard Deviation 12.97
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 7, Day 1: Sitting SBP	1.9 Millimeters of mercury Standard Deviation 15.39	0.4 Millimeters of mercury Standard Deviation 13.56
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at End of Treatment: Sitting SBP	0.9 Millimeters of mercury Standard Deviation 17.40	1.7 Millimeters of mercury Standard Deviation 15.67
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Baseline: Sitting DBP	75.7 Millimeters of mercury Standard Deviation 9.32	75.9 Millimeters of mercury Standard Deviation 9.41
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 2, Day 1: Sitting DBP	5.8 Millimeters of mercury Standard Deviation 10.92	-0.1 Millimeters of mercury Standard Deviation 8.60
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 3, Day 1: Sitting DBP	4.9 Millimeters of mercury Standard Deviation 10.98	0.0 Millimeters of mercury Standard Deviation 9.64
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 4, Day 1: Sitting DBP	4.8 Millimeters of mercury Standard Deviation 11.61	-1.9 Millimeters of mercury Standard Deviation 9.30
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 5, Day 1: Sitting DBP	4.5 Millimeters of mercury Standard Deviation 11.17	-1.9 Millimeters of mercury Standard Deviation 9.71
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 6, Day 1: Sitting DBP	3.8 Millimeters of mercury Standard Deviation 10.18	-1.3 Millimeters of mercury Standard Deviation 9.89
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at Cycle 7, Day 1: Sitting DBP	3.8 Millimeters of mercury Standard Deviation 11.04	-1.1 Millimeters of mercury Standard Deviation 9.90
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit Change at End of Treatment: Sitting DBP	1.5 Millimeters of mercury Standard Deviation 12.70	-0.9 Millimeters of mercury Standard Deviation 10.92