Trial Outcomes & Findings for An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION) (NCT NCT04941768)

Last Updated: 2025-11-28

Results Overview

OS rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.

Recruitment status

COMPLETED

Target enrollment

105 participants

Primary outcome timeframe

At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])

Results posted on

2025-11-28

Participant Flow

The results reported are based on the primary analyses at the 12-months cut-off.

Participant milestones

Participant milestones
Measure	Avelumab + Axitinib Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Overall Study STARTED	105
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Avelumab + Axitinib Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Overall Study Lost to Follow-up	10
Overall Study Death	24
Overall Study Progressive Disease	4
Overall Study Withdrawal by Subject	4
Overall Study Other	3
Overall Study Treatment ongoing	21
Overall Study Off treatment and in follow-up	21

Baseline Characteristics

An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avelumab + Axitinib n=104 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Age, Continuous	68 years STANDARD_DEVIATION 10.3 • n=30 Participants
Sex: Female, Male Female	31 Participants n=30 Participants
Sex: Female, Male Male	73 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants
Race (NIH/OMB) White	0 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	104 Participants n=30 Participants

PRIMARY outcome

Timeframe: At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=104 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Overall Survival (OS) Rate	82.7 Percentage of Participants

SECONDARY outcome

Timeframe: At 24 months after index date (baseline visit as reported in the eCRF)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 24 months after index date

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months after the index date

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months after the index date

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months after the index date

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the index date to the date of disease progression or death from any cause, whichever occurred first (assessed up to 12 months after index date)

PFS time was defined as the time from index date to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered PD. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. PFS was calculated based on KM method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=104 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator	11.3 months Interval 8.1 to Here "NA" means the upper limit of 95% confidence interval could not be estimated due to small number of death events resulting large variability and therefore the upper 95% confidence limits of KM survival estimate remaining above 50%.

SECONDARY outcome

Timeframe: From the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 12 months after index date)

PFS2 was defined as time interval from the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The tumor response will be determined according to RECIST version 1.1 and assessed by the investigator. PFS2 was calculated based on Kaplan Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=104 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator	NA months Interval 11.8 to Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to small number of death events resulting large variability and therefore the upper 95% confidence limits of KM survival estimate remaining above 50%.

SECONDARY outcome

Timeframe: Index date (Baseline), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 weeks

Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

NCCN-FACT FKSI-19, a validated, disease-specific questionnaire for RCC. It includes 19 items across four domains,Disease-Related Symptoms-Physical (DRS-P), Disease-Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Functional Wellbeing (FWB), based on symptoms experienced over past 7 days. Responses were recorded on 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score from 0 to 76, higher scores reflecting better quality of life. A negative mean change in score indicated worsening condition. Domain score ranges and directionality: DRS-P: 0-48, higher scores = fewer physical symptoms; DRS-E: 0-4, higher = fewer emotional symptoms; TSE: 0-32, higher = more severe side effects; FWB: 0-12, higher = better functional wellbeing. As per NCCN-FACT FKSI-19 scoring guidelines, the total Health-related quality of life (HRQoL) score (range 0-76) was calculated as sum of single items scores multiplied by 19 and divided by the number of items completed.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=95 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score Baseline	58.3 scores on a scale Standard Deviation 9.64
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 6 Weeks	-0.2 scores on a scale Standard Deviation 8.38
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 12 Weeks	-1.1 scores on a scale Standard Deviation 10.36
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 18 Weeks	-0.6 scores on a scale Standard Deviation 9.42
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 24 Weeks	-0.3 scores on a scale Standard Deviation 10.04
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 30 Weeks	-1.4 scores on a scale Standard Deviation 10.08
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 36 Weeks	-0.4 scores on a scale Standard Deviation 7.89
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 42 Weeks	-0.8 scores on a scale Standard Deviation 8.58
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 48 Weeks	-0.8 scores on a scale Standard Deviation 10.06
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 54 Weeks	-0.7 scores on a scale Standard Deviation 10.29
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 60 Weeks	-0.4 scores on a scale Standard Deviation 10.47
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 66 Weeks	-0.6 scores on a scale Standard Deviation 11.21
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 72 Weeks	-1.1 scores on a scale Standard Deviation 8.94
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 78 Weeks	-1.3 scores on a scale Standard Deviation 8.86
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 84 Weeks	-1.0 scores on a scale Standard Deviation 9.87
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 90 Weeks	-1.3 scores on a scale Standard Deviation 9.67
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score 96 Weeks	1.4 scores on a scale Standard Deviation 9.42

SECONDARY outcome

Timeframe: From the index date up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occured first

Outcome measures

Outcome data not reported

SECONDARY outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From index date up to Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first dose of study drug up to Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From index date up to Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From index date up to Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From index date up to Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From index date upto 12 months after the index date

Number of participants with different types of medical intervention or medications used for the management of TEAE related to avelumab plus axitinib therapy (e.g., use of corticosteroids, antihypertensive therapy, treatment for thyroid dysfunction, measures to decrease hemoglobin, and hematocrit) was reported.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=104 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy Any related TEAE managed with concomitant medications	47 Participants
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy Any related TEAE managed with concomitant procedures	6 Participants
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy Any related TEAE managed with corticosteroids, immunosuppressants, or hormonal therapy	11 Participants

SECONDARY outcome

Timeframe: From index date up to Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 12

Time to 2nd line treatment was calculated as: (2nd line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375.

Outcome measures

Outcome measures
Measure	Avelumab + Axitinib n=12 Participants Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Time to Second-line Therapy Initiation	0.3 months Standard Deviation 0.40

SECONDARY outcome

Timeframe: From index date up to Month 24

Outcome measures

Outcome data not reported

Adverse Events

Avelumab + Axitinib

Serious events: 38 serious events

Other events: 80 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Avelumab + Axitinib n=104 participants at risk Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
General disorders Gait disturbance	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 5/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Infections and infestations COVID-19	1.9% 2/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Infections and infestations Gallbladder abscess	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Infections and infestations Influenza	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Gastrointestinal disorders Diarrhoea 3 ( 2.9)	2.9% 3/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Gastrointestinal disorders Diverticular perforation	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Infections and infestations Pneumonia	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Infections and infestations Post procedural infection	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Infections and infestations Subcutaneous abscess	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
General disorders Disease progression	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
General disorders Hypothermia	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
General disorders Pain	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Musculoskeletal and connective tissue disorders Back pain	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Musculoskeletal and connective tissue disorders Myositis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Musculoskeletal and connective tissue disorders Osteolysis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Nervous system disorders Haemorrhage intracranial	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Nervous system disorders Hemiparesis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Nervous system disorders Monoparesis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Cardiac disorders Myocardial infarction	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Cardiac disorders Myocarditis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Hepatobiliary disorders Autoimmune hepatitis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Hepatobiliary disorders Cholecystitis acute	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Hepatobiliary disorders Immune-mediated hepatitis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Investigations Blood creatinine increased	1.9% 2/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Investigations Eastern Cooperative Oncology Group performance status worsened	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Renal and urinary disorders Acute kidney injury	1.9% 2/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Renal and urinary disorders End stage renal disease	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Vascular disorders Hypertension	1.9% 2/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Vascular disorders Hypertensive crisis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Metabolism and nutrition disorders Hypokalaemia	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Endocrine disorders Hypothyroidism	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Eye disorders Cataract	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Immune system disorders Hypersensitivity	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Injury, poisoning and procedural complications Hip fracture	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Reproductive system and breast disorders Prostatitis	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Skin and subcutaneous tissue disorders Urticaria	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Surgical and medical procedures Ureteral stent insertion	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 4/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Cardiac disorders Cardiac failure chronic	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Metabolism and nutrition disorders Dehydration	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Nervous system disorders Cerebrovascular accident	0.96% 1/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.

Other adverse events

Other adverse events
Measure	Avelumab + Axitinib n=104 participants at risk Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study.
Gastrointestinal disorders Stomatitis	6.7% 7/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
General disorders Fatigue	16.3% 17/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 9/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Gastrointestinal disorders Diarrhoea	25.0% 26/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Gastrointestinal disorders Nausea	9.6% 10/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Musculoskeletal and connective tissue disorders Back pain	10.6% 11/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	8.7% 9/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Skin and subcutaneous tissue disorders Pruritus	7.7% 8/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Investigations Weight decreased	5.8% 6/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Vascular disorders Hypertension	10.6% 11/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Endocrine disorders Hypothyroidism	8.7% 9/104 • From index date up to 12 months after the index date AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER