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

March 6, 2024 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Imelda Ziekenhuis
      • Brasschaat, Belgium
        • AZ Klina
      • Brugge, Belgium
        • AZ Sint-Jan
  • Germany
      • Amberg, Germany
        • Klinikum St. Marien Amberg
      • Aschaffenburg, Germany
        • Klinikum Aschaffenburg Medizinische Klinik
      • Bergisch Gladbach, Germany
        • GFO Kliniken Rhein Berg
      • 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
      • Frankfurt, Germany
        • Universitätsklinik Frankfurt
      • 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
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Hannover, Germany
        • Vinzenzkrankenhaus Hannover
      • Heinsberg, Germany
        • Praxis Kretz
      • Jena, Germany
        • Universitätskinderklinik Jena
      • Karlsruhe, Germany
        • Städt. Klinikum Karlsruhe
      • L.-Eisleben, Germany
        • Urologische Praxis Dr. Ralf Eckert
      • Luckenwalde, Germany
        • Urologische Praxis Dipl. Med. Susanne Kloss
      • Lübeck, Germany
        • Universitätsklinik Schleswig-Holstein
      • Magdeburg, Germany
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Minden, Germany
        • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
      • Münster, Germany
        • University of Münster
      • Münster, Germany
        • Uniklinikum Münster
      • Osnabrück, Germany
        • Paracelsus Klinik Osnabrück
      • Ostfildren, Germany
        • medius Klinik Ostfildern-Ruit
      • Rostock, Germany
        • Wissenschaftskontor Nord GmbH & Co. KG
      • Ruesselsheim, Germany
        • GPR Klinikum Rüsselsheimg GmbH
      • Sigmaringen, Germany
        • SRH Kliniken Landkreis Sigmaringen (DEU)
      • Stolberg, Germany
        • Clinical Research Stolberg GmbH
      • Stolberg, Germany
        • Hämatologie und Onkologie Stolberg
      • Stuttgart, Germany
        • Diakonie Krankenhaus Stuttgart
      • 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
      • Attika, Greece
        • Attikon Hospital
      • Chaidari, Greece
        • Attikon
      • Heraclion, Greece
        • General Hospital "Venizelio"
      • Ioannina, Greece
        • University Hospital of Ioannina
      • Kavala, Greece
        • Kavala General Hospital
      • Larissa, Greece
        • University Hospital of Larissa
      • Patras, Greece
        • General Hospital of Patras "o Agios Andreas"
      • Piraeus, Greece
        • Metaxa Hospital
      • Thessaloniki, Greece
        • Papageorgiou Hospital
      • Thessaloniki, Greece
        • Agios Loukas Hospital
      • Thessaloniki, Greece
        • Bioclinic (GRC)
      • Thessaloniki, Greece
        • Saint Luke Hospital
  • Russian Federation
      • Irkutsk, Russian Federation
        • Regional Oncology Dispensary - Irkutsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame
Overall Survival (OS) Rate at Month 12
Time Frame: Time from first dose of study drug up to Month 12
Time from first dose of study drug up to Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS) Rate at Month 24
Time Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24
Overall Survival (OS)
Time Frame: Time from first dose of study drug to the date of death from any cause, assessed up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24
Disease Control Rate (DCR) Assessed by Investigator at Month 24
Time Frame: Time from first dose of study drug up to 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 Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug to the date of disease progression or death from any cause, assessed up to Month 24
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 Frame: 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
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)
Time Frame: Baseline, Month 24
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 Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24
Time to Onset of All-cause Adverse Events (AEs)
Time Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24
Duration of All-cause Adverse Events (AEs)
Time Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24
Percentage of Participants Receiving Later-line therapy
Time Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24
Time to Second-line Therapy Initiation
Time Frame: Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24
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 Frame: Time from first dose of study drug up to Month 24
Time from first dose of study drug up to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Estimated)

May 9, 2024

Study Completion (Estimated)

May 9, 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)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS100070_0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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