ORR: percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) based on investigator's assessment as per Response Evaluation Criteria in Solid Tumours (RECIST version [v] 1.1). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after criteria for response was first met. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, Progressive Disease.

Full Analysis Set included all participants who received at least one dose of avelumab and axitinib. Participants were classified according to the study treatment received.

An Adverse Event (AE) was any untoward medical occurrence attributed to study drug in a participant who received avelumab or axitinib. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period (the time from the first dose of study treatment through minimum 30 days post last dose of study treatment or start day of new anti-cancer treatment -1 day).

Safety analysis set included all participants who received at least one dose of study drug (avelumab or axitinib). Participants were classified according to the study treatment received.

The following hematology parameters were assessed: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 3= severe and grade 4= life-threatening). Categories with non-zero values are presented.

Safety analysis set included all participants who received at least one dose of study drug (avelumab or axitinib). Participants were classified according to the study treatment received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The following chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine phosphokinase (CPK) increased, creatinine increased, gamma-glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased and serum amylase increased. Laboratory abnormalities were graded according CTCAE version 4.03 (grade 3= severe, grade 4= life-threatening and grade 5= death related). Categories with non-zero values are presented.

Safety analysis set included all participants who received at least one dose of study drug (avelumab or axitinib). Participants were classified according to the study treatment received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows.

TTR was defined as the time from the first dose of study treatment to the first documentation of objective tumor response documented in participants with confirmed objective response (CR or PR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed using Kaplan-Meier method.

Full Analysis Set included all participants who received at least one dose of avelumab and axitinib. Participants were classified according to the study treatment received. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Duration of response was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first in participants with confirmed objective response (CR or PR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed using Kaplan-Meier method.

Full Analysis Set included all participants who receive at least one dose of avelumab and axitinib. Participants were classified according to the study treatment received. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

PFS was defined as the time from first dose of study treatment (ie, start date) to the date of progression of disease (PD) by RECIST v 1.1 or death due to any cause, whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to an event, or for participants with an event after two or more missing tumor assessments. PD as per RECIST v1.1 for target lesions was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. For non-target lesions PD was defined as unequivocal progression of pre-existing lesions. Analysis was performed using Kaplan-Meier method.

Full Analysis Set included all participants who receive at least one dose of avelumab and axitinib. Participants were classified according to the study treatment received.

Overall survival was defined as the time from the date of first study treatment 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.

Full Analysis Set included all participants who received at least one dose of avelumab and axitinib. Participants were classified according to the study treatment actually received.

The Pharmacokinetic (PK) parameter analysis set is a subset of the safety analysis set and included all participants who have at least one of the PK parameters of interest for avelumab or 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.

PK parameter analysis set is a subset of the safety analysis set and included all participants who have at least one of the PK parameters of interest for avelumab or 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.

PK parameter analysis set is a subset of the safety analysis set and included all participants who have at least one of the PK parameters of interest for avelumab or 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.

PK parameter analysis set is a subset of the safety analysis set and included all participants who have at least one of the PK parameters of interest for avelumab or 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.

PD-L1 status was defined as positive when PD-L1 staining of any intensity was observed in >= 1% of the tumor cells. PD-L1 status was defined as negative when PD-L1 staining of any intensity was observed in < 1% of the tumor cells.

Biomarker analysis set is a subset of the safety analysis set and included participants who had at least one baseline biomarker assessment. Analysis sets was defined separately for blood-based and tumor tissue-based biomarkers. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis.

Biomarker analysis set is a subset of the safety analysis set and included participants who had at least one baseline biomarker assessment. Analysis sets was defined separately for blood-based and tumor tissue-based biomarkers. Here, 'Number Analyzed' signifies number of participants evaluable for this outcome measure.

The immune response was measured by total T cell receptor (TCR) sequencing in peripheral blood and determined the characterization of immune repertoires. Fraction productive of cells is defined as the number of T cells within the total nucleated cell count (T cells and non-T cells).

Biomarker analysis set is a subset of the safety analysis set and included participants who have at least one baseline biomarker assessment. Analysis sets was defined separately for blood-based and tumor tissue-based biomarkers. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The immune response was measured by TCR sequencing in peripheral blood and determined the characterization of immune repertoires. Simpson clonality is calculated for a sample as the square root of Simpson's diversity index for all productive rearrangements. Values for clonality ranged from 0 to 1. Values near 1 represented samples with one or a few predominant rearrangements (monoclonal or oligoclonal samples) dominating the observed repertoire. Clonality values near 0 represented more polyclonal samples.

Biomarker analysis set is a subset of the safety analysis set and included participants who have at least one baseline biomarker assessment. Analysis sets was defined separately for blood-based and tumor tissue-based biomarkers. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The immune response was measured by total TCR sequencing in peripheral blood and determined the characterization of immune repertoires.

Biomarker analysis set is a subset of the safety analysis set and included participants who have at least one baseline biomarker assessment. Analysis sets was defined separately for blood-based and tumor tissue-based biomarkers. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

ADA and nAb positive was defined as presence of at least one positive ADA and nAb sample, respectively. NAb analysis was planned to be conducted for ADA positive samples.

Immunogenicity analysis set is a subset of the safety analysis set and included participants who had at least one ADA assessment collected for avelumab. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. Due to the low observed rate of the treatment-induced immunogenicity responses, none of the ADA positive samples was tested for the NAb assay.