An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
NCT ID: NCT04941768
Last Updated: 2025-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
105 participants
OBSERVATIONAL
2021-08-09
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of Avelumab plus Axitinib
18 Years
ALL
No
Sponsors
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Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany
UNKNOWN
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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MS100070_0110
Identifier Type: -
Identifier Source: org_study_id
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