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)
1 other identifier
observational
105
4 countries
61
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Typical duration for all trials
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedResults Posted
Study results publicly available
November 28, 2025
CompletedNovember 28, 2025
November 1, 2025
3 years
June 23, 2021
August 7, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) Rate
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.
At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])
Secondary Outcomes (19)
OS Rate
At 24 months after index date (baseline visit as reported in the eCRF)
Duration of OS
At 24 months after index date
Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date
up to 24 months after the index date
Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date
up to 24 months after the index date
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
up to 24 months after the index date
- +14 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Participants with a confirmed diagnosis of advanced RCC will be observed in this study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Imelda Ziekenhuis
Bonheiden, Belgium
AZ KLINA
Brasschaat, Belgium
AZ Sint-Jan
Bruges, Belgium
Klinikum St. Marien Amberg
Amberg, Germany
Klinikum Aschaffenburg Medizinische Klinik
Aschaffenburg, Germany
Zentrum für urologische Onkologie
Berlin, Germany
Biberach
Biberach an der Riss, Germany
Evangelisches Klinikum Bethel
Bielefeld, Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, Germany
Urologie im Schlosscarree
Braunschweig, Germany
Donauisar Klinikum Deggendorf
Deggendorf, Germany
Urologische Gemeinschaftspraxis
Dresden, Germany
St. Georg Klinikum Eisenach gGmbH
Eisenach, Germany
Universitatsklinikum Erlangen
Erlangen, Germany
Universitaetsklinikum Essen Uroonkologie
Essen, Germany
Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
Friedrichshafen, Germany
Onkologische GP Dres. Wilke/Wagner/Petzoldt
Fürth, Germany
Onkologische SP Praxis Fürth
Fürth, Germany
MVZ Onkologische Kooperation Harz GbR
Goslar, Germany
Praxis Dr. Maas
Halberstadt, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Vinzenzkrankenhaus Hannover
Hanover, Germany
Praxis Kretz
Heinsberg, Germany
Universitätskinderklinik Jena
Jena, Germany
Urologische Praxis Dr. Ralf Eckert
L.-Eisleben, Germany
Urologische Praxis Dipl.-Med. Susanne Kloß
Luckenwalde, Germany
Universitatsklinik Schleswig-Holstein
Lübeck, Germany
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, Germany
Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
Minden, Germany
Uniklinikum Münster
Münster, Germany
University of Munster
Münster, Germany
Klinikum Osnabrück GmbH
Osnabrück, Germany
Marienhospital Osnabrück - Standort Natruper Holz
Osnabrück, Germany
Paracelsus Klinik Osnabrück
Osnabrück, Germany
medius Klinik Ostfildern-Ruit
Ostfildren, Germany
Wissenschaftskontor Nord GmbH & Co. KG
Rostock, Germany
GPR Klinikum Rüsselsheimg GmbH
Rüsselsheim am Main, Germany
SRH Kliniken Landkreis Sigmaringen (DEU)
Sigmaringen, Germany
Hämatologie und Onkologie Stolberg
Stolberg, Germany
Praxis Troisdorf
Troisdorf, Germany
Medizinische Studiengesellschaft Nord-West GmbH
Westerstede, Germany
Lahn Dill Kliniken GmbH
Wetzlar, Germany
Gen. Hos. "Alexandra"
Athens, Greece
General Hospital of Athens G.Gennimatas
Athens, Greece
Henry Dunant Hospital Center
Athens, Greece
University Hospital of Athens Sotiria
Athens, Greece
Attikon Hospital
Attiki, Greece
Attikon
Chaïdári, Greece
General Hospital "Venizelio"
Heraklion, Greece
University Hospital of Ioannina
Ioannina, Greece
Kavala General Hospital
Kavala, Greece
University Hospital of Larissa
Larissa, Greece
General Hospital of Patras "o Agios Andreas"
Pátrai, Greece
Metaxa Hospital
Piraeus, Greece
Metropolitan Hospital Greece
Piraeus, Greece
Agios Loukas Hospital
Thessaloniki, Greece
Bioclinic (GRC)
Thessaloniki, Greece
Papageorgiou Hospital
Thessaloniki, Greece
Saint Luke Hospital
Thessaloniki, Greece
Regional Oncology Dispensary - Irkutsk
Irkutsk, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
June 28, 2021
Study Start
August 9, 2021
Primary Completion
August 8, 2024
Study Completion
April 30, 2025
Last Updated
November 28, 2025
Results First Posted
November 28, 2025
Record last verified: 2025-11