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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Brasschaat, Belgium
    • AZ Klina
  • Bruges, Belgium
    • AZ Sint-Jan
• Germany
  • Amberg, Germany
    • Klinikum St. Marien Amberg
  • Aschaffenburg, Germany
    • Klinikum Aschaffenburg Medizinische Klinik
  • Berlin, Germany
    • Zentrum für urologische Onkologie
  • Biberach an der Riss, Germany
    • Biberach
  • Bielefeld, Germany
    • Evangelisches Klinikum Bethel
  • Bielefeld, Germany
    • Evangelisches Krankenhaus Bielefeld
  • Braunschweig, Germany
    • Urologie im Schlosscarree
  • Deggendorf, Germany
    • Donauisar Klinikum Deggendorf
  • Dresden, Germany
    • Urologische Gemeinschaftspraxis
  • Eisenach, Germany
    • St. Georg Klinikum Eisenach gGmbH
  • Erlangen, Germany
    • Universitätsklinikum Erlangen
  • Essen, Germany
    • Universitaetsklinikum Essen Uroonkologie
  • Friedrichshafen, Germany
    • Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
  • Fürth, Germany
    • Onkologische GP Dres. Wilke/Wagner/Petzoldt
  • Fürth, Germany
    • Onkologische SP Praxis Fürth
  • Goslar, Germany
    • MVZ Onkologische Kooperation Harz GbR
  • Halberstadt, Germany
    • Praxis Dr. Maas
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Hanover, Germany
    • Medizinische Hochschule Hannover
  • Hanover, Germany
    • Vinzenzkrankenhaus Hannover
  • Heinsberg, Germany
    • Praxis Kretz
  • Jena, Germany
    • Universitätskinderklinik Jena
  • L.-Eisleben, Germany
    • Urologische Praxis Dr. Ralf Eckert
  • Luckenwalde, Germany
    • Urologische Praxis Dipl.-Med. Susanne Kloß
  • Lübeck, Germany
    • Universitatsklinik Schleswig-Holstein
  • Magdeburg, Germany
    • Schwerpunktpraxis für Hämatologie und Onkologie
  • Minden, Germany
    • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
  • Münster, Germany
    • University of Munster
  • Münster, Germany
    • Uniklinikum Münster
  • Osnabrück, Germany
    • Marienhospital Osnabrück - Standort Natruper Holz
  • Osnabrück, Germany
    • Paracelsus Klinik Osnabrück
  • Osnabrück, Germany
    • Klinikum Osnabrück GmbH
  • Ostfildren, Germany
    • medius Klinik Ostfildern-Ruit
  • Rostock, Germany
    • Wissenschaftskontor Nord GmbH & Co. KG
  • Rüsselsheim am Main, Germany
    • GPR Klinikum Rüsselsheimg GmbH
  • Sigmaringen, Germany
    • SRH Kliniken Landkreis Sigmaringen (DEU)
  • Stolberg, Germany
    • Hämatologie und Onkologie Stolberg
  • Troisdorf, Germany
    • Praxis Troisdorf
  • Westerstede, Germany
    • Medizinische Studiengesellschaft Nord-West GmbH
  • Wetzlar, Germany
    • Lahn Dill Kliniken GmbH
• Greece
  • Athens, Greece
    • Gen. Hos. "Alexandra"
  • Athens, Greece
    • General Hospital of Athens G.Gennimatas
  • Athens, Greece
    • Henry Dunant Hospital Center
  • Athens, Greece
    • University Hospital of Athens Sotiria
  • Attiki, Greece
    • Attikon Hospital
  • Chaïdári, Greece
    • Attikon
  • Heraklion, Greece
    • General Hospital "Venizelio"
  • Ioannina, Greece
    • University Hospital of Ioannina
  • Kavala, Greece
    • Kavala General Hospital
  • Larissa, Greece
    • University Hospital of Larissa
  • Piraeus, Greece
    • Metaxa Hospital
  • Piraeus, Greece
    • Metropolitan Hospital Greece
  • Pátrai, Greece
    • General Hospital of Patras "o Agios Andreas"
  • Thessaloniki, Greece
    • Papageorgiou Hospital
  • Thessaloniki, Greece
    • Agios Loukas Hospital
  • Thessaloniki, Greece
    • Bioclinic (GRC)
  • Thessaloniki, Greece
    • Saint Luke Hospital
• Russia
  • Irkutsk, Russia
    • Regional Oncology Dispensary - Irkutsk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a confirmed diagnosis of advanced RCC will be observed in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Avelumab + Axitinib; 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?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate	Overall survival 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.	At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate	Overall survival rate was defined as the percentage of participants who are alive at 24 months after the index date. Percentage of participants alive at the time of outcome assessment (24 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.	At 24 months after index date (baseline visit as reported in the eCRF)
Duration of Overall Survival	Duration of overall survival is defined as the time from index date to the date of death due to any cause. The overall survival was analyzed by using the 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.	From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date	Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) as best overall response up to 24 months after the index date. CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. 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.	up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date	Disease control rate is defined as the percentage of participants with objective response (complete response [CR] or partial response [PR] or stable disease [SD]) as best overall response up to 24 months after the index date. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. 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.	up to 24 months after the index date (baseline visit as reported in the eCRF)
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	DoR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. 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.	up to 24 months after the index date (baseline visit as reported in the eCRF)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator	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.	From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator	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.	From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score	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: 0-12, 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.	Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA)	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention. 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.	From the index date (baseline visit as reported in the eCRF) 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 occurred first
Number of Participants With Adverse Events Based on Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0	Severity of TEAEs were evaluated using the NCI-CTCAE version 5.0. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE. Number of participants with TEAEs grade greater than or equal to (>=) 3 were reported. 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.	From the index date (baseline visit as reported in the eCRF) 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 occurred first
Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3	Time to therapy discontinuation due to AE >= grade 3 was reported. 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.	From the index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Axitinib Due to All-Cause AEs >= Grade 3	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. Duration of Avelumab plus Axitinib therapy (days) = (Date of discontinuation of Axitinib - Date of index date + 1). Duration of avelumab plus axitinib therapy among participants who discontinued the Axitinib due to all-cause AEs >= grade 3 was reported.	Time from first dose of study drug up to 24 months
Time to Onset of Treatment - Emergent Adverse Events (TEAEs)	Time to onset of TEAE = Start date TEAE - Index date. 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.	From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Treatment-Emergent Adverse Events (TEAEs)	Duration of TEAE = (Stop date of TEAE - Start date of TEAE + 1) divided by 7. 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.	From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy	Percentage of participants with therapy modifications due to AE related to avelumab plus axitinib therapy were reported. 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.	From index date (baseline visit as reported in the eCRF) up to 24 months
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy	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. 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.	From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Percentage of Participants Receiving Later-line Therapy	Percentage of participants receiving later-line therapy were reported. 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.	From index date (baseline visit as reported in the eCRF) up to 24 months
Time to Second-line Therapy Initiation	Time to second line treatment was calculated as: (second line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375.	Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs	Number of participants with patient-reported potential signs and symptoms of immune-related AEs were reported. 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.	From index date (baseline visit as reported in the eCRF) up to 24 months

Collaborators and Investigators

• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Collaborators: Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Avelumab; Renal cell carcinoma; Axitinib; BAVENCIO®; INLYTA®
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: MS100070_0110