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

Study Overview
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Brief Summary
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The main purpose of this study is to expand knowledge on the effectiveness of Avelumab intravenous infusion in combination with Axitinib as the first-line therapy in participants with advanced renal-cell carcinoma (aRCC) in addition to the safety and tolerability under routine conditions of daily clinical practice.

Official Title
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Real-world Evaluation of Efficacy and Safety With Avelumab (BAVENCIO®) + Axitinib (INLYTA®) in Patients With aRCC in Multiple EU Countries (AVION)

Conditions
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Carcinoma, Renal Cell

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 Participants with a histologically confirmed diagnosis of RCC with any histological origin Participants with a locally advanced/metastatic disease (that is [ie], newly diagnosed Stage 4 RCC per American Joint Committee on Cancer) or has recurrent disease Participants has received 1 or 2 cycles of Avelumab plus Axitinib treatment as a first-line therapy according to the approved Summary of Product Characteristics (SmPC) Participants willing to sign the written informed consent form (ICF) to participate in this study Exclusion Criteria: Participants with contraindications for Avelumab or Axitinib according to the approved SmPC Participants who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of Avelumab plus Axitinib

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Avelumab + Axitinib<br>There will not be any study-specific interventions in this study. Participants with advanced RCC receiving 800 milligrams (mg) of Avelumab intravenously every 2 weeks 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 will be observed for 24 months in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) Rate at Month 12 |  | Time from first dose of study drug up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) Rate at Month 24 |  | Time from first dose of study drug up to Month 24 | 
| Overall Survival (OS) |  | Time from first dose of study drug to the date of death from any cause, assessed up to Month 24 | 
| Overall Response (OR) Rate Assessed by Investigator at Month 24 |  | Time from first dose of study drug up to Month 24 | 
| Disease Control Rate (DCR) Assessed by Investigator at Month 24 |  | Time from first dose of study drug up to Month 24 | 
| Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |  | Time from first dose of study drug up to Month 24 | 
| Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Assessed by Investigator |  | Time from first dose of study drug to the date of disease progression or death from any cause, assessed up to Month 24 | 
| Progression-free Survival 2 (PFS2) According to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Assessed by Investigator |  | Time from first dose of study drug to the date of disease progression on second-line treatment or death from any cause, assessed up to Month 24 | 
| Health-related Quality Of Life (HRQoL) According to National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCNFACTFKSI-19) |  | Baseline, Month 24 | 
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs, AEs Leading to Permanent Treatment Discontinuation and AEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA) |  | Time from first dose of study drug up to Month 24 | 
| Number of Participants with Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 |  | Time from first dose of study drug up to Month 24 | 
| Number of Participants with Greater Than of Equal to (>=) Grade-3 Adverse Events (AEs) Leading to Discontinuation According to Medical Dictionary for Regulatory Activities (MedDRA) |  | Time from first dose of study drug up to Month 24 | 
| Duration of Avelumab plus Axitinib Therapy Among Participants Who Discontinued the Study Drugs Due to All-Cause Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3 |  | Time from first dose of study drug up to Month 24 | 
| Time to Onset of All-cause Adverse Events (AEs) |  | Time from first dose of study drug up to Month 24 | 
| Duration of All-cause Adverse Events (AEs) |  | Time from first dose of study drug up to Month 24 | 
| Number of Participants with All-cause Adverse Events (AEs) Outcomes (Resolved, Resolving, not Resolved, Resolved with Sequelae, Fatal, Unknown) |  | Time from first dose of study drug up to Month 24 | 
| Percentage of Participants with Therapy Modifications Due to Adverse Event Related to Avelumab plus Axitinib Therapy |  | Time from first dose of study drug up to Month 24 | 
| Number of Participants with Different Types of Medical Intervention or Medications Used for the Management of Adverse Events (AEs) Related to Avelumab plus Axitinib Therapy |  | Time from first dose of study drug up to Month 24 | 
| Percentage of Participants Receiving Later-line therapy |  | Time from first dose of study drug up to Month 24 | 
| Time to Second-line Therapy Initiation |  | Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24 | 
| Number of Participants with Patient-reported Potential Signs and Symptoms of Immune-related Adverse Events (AEs) |  | Time from first dose of study drug up to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axitinib, Renal cell carcinoma, Avelumab, BAVENCIO®, INLYTA®