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

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04941768
Collaborator
Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany (Other)
400
77
46.2
5.2
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real-world Evaluation of Efficacy and Safety With Avelumab (BAVENCIO®) + Axitinib (INLYTA®) in Patients With aRCC in Multiple EU Countries (AVION)
    Actual Study Start Date :
    Aug 9, 2021
    Anticipated Primary Completion Date :
    Dec 15, 2024
    Anticipated Study Completion Date :
    Jun 15, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) Rate at Month 12 [Time from first dose of study drug up to Month 12]

    Secondary Outcome Measures

    1. Overall Survival (OS) Rate at Month 24 [Time from first dose of study drug up to Month 24]

    2. Overall Survival (OS) [Time from first dose of study drug to the date of death from any cause, assessed up to Month 24]

    3. Overall Response (OR) Rate Assessed by Investigator at Month 24 [Time from first dose of study drug up to Month 24]

    4. Disease Control Rate (DCR) Assessed by Investigator at Month 24 [Time from first dose of study drug up to Month 24]

    5. 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]

    6. 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]

    7. 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]

    8. 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]

    9. 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]

    10. 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]

    11. 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]

    12. 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]

    13. Time to Onset of All-cause Adverse Events (AEs) [Time from first dose of study drug up to Month 24]

    14. Duration of All-cause Adverse Events (AEs) [Time from first dose of study drug up to Month 24]

    15. 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]

    16. 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]

    17. 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]

    18. Percentage of Participants Receiving Later-line therapy [Time from first dose of study drug up to Month 24]

    19. Time to Second-line Therapy Initiation [Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24]

    20. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imelda Ziekenhuis Bonheiden Belgium
    2 AZ KLINA Brasschaat Belgium
    3 AZ Sint-Jan Brugge Belgium
    4 Z.O.L. Campus Sint Jan Genk Belgium
    5 Klinikum St. Marien Amberg Amberg Germany
    6 Klinikum Aschaffenburg Medizinische Klinik Aschaffenburg Germany
    7 GFO Kliniken Rhein Berg Bergisch Gladbach Germany
    8 Zentrum für urologische Onkologie Berlin Germany
    9 Evangelisches Klinikum Bethel Bielefeld Germany
    10 Evangelisches Krankenhaus Bielefeld Bielefeld Germany
    11 Urologie im Schlosscarree Braunschweig Germany
    12 Urologische Praxis Dr. U. Kube Chemnitz Germany
    13 Donauisar Klinikum Deggendorf Deggendorf Germany
    14 Städtisches Klinikum Dessau Dessau-Rosslau Germany
    15 Urologische Gemeinschaftspraxis Dresden Germany
    16 Uniklinik Duesseldorf Poliklinik fuer Urologie Düsseldorf Germany
    17 St. Georg Klinikum Eisenach gGmbH Eisenach Germany
    18 Universitatsklinikum Erlangen Erlangen Germany
    19 Universitaetsklinikum Essen Uroonkologie Essen Germany
    20 Universitätsklinik Frankfurt Frankfurt Germany
    21 Onkologische GP Dres. Wilke/Wagner/Petzoldt Fürth Germany
    22 Onkologische SP Praxis Fürth Fürth Germany
    23 MVZ Onkologische Kooperation Harz GbR Goslar Germany
    24 Praxis Dr. Maas Halberstadt Germany
    25 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany
    26 Medizinische Hochschule Hannover Hannover Germany
    27 Vinzenzkrankenhaus Hannover Hannover Germany
    28 Praxis Kretz Heinsberg Germany
    29 Universitätskinderklinik Jena Jena Germany
    30 Städt. Klinikum Karlsruhe Karlsruhe Germany
    31 Uniklinik Koeln, Klinikum für Urologie Köln Germany
    32 Urologische Praxis Dr. Ralf Eckert L.-Eisleben Germany
    33 Bonifatius Hospital Lingen Lingen Germany
    34 Urologische Praxis Dipl. Med. Susanne Kloss Luckenwalde Germany
    35 Universitatsklinik Schleswig-Holstein Lübeck Germany
    36 Medizinische Akademie Magdeburg Magdeburg Germany
    37 Schwerpunktpraxis für Hämatologie und Onkologie Magdeburg Germany
    38 Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR) Minden Germany
    39 Klinikum der Universität München A.ö.R. München Germany
    40 Uniklinikum Münster Münster Germany
    41 University of Munster Münster Germany
    42 Lukaskrankenhaus GmbH Neuss Germany
    43 Marienhospital Osnabrück - Standort Natruper Holz Osnabrück Germany
    44 Paracelsus Klinik Osnabrück Osnabrück Germany
    45 Wissenschaftskontor Nord GmbH & Co. KG Rostock Germany
    46 GPR Klinikum Rüsselsheimg GmbH Ruesselsheim Germany
    47 Clinical Research Stolberg GmbH Stolberg Germany
    48 Hämatologie und Onkologie Stolberg Stolberg Germany
    49 Diakonie Krankenhaus Stuttgart Stuttgart Germany
    50 Praxis Troisdorf Troisdorf Germany
    51 Klinikum Tuebingen Tübingen Germany
    52 Medizinische Studiengesellschaft Nord-West GmbH Westerstede Germany
    53 Lahn Dill Kliniken GmbH Wetzlar Germany
    54 Athens Medical Centre (IATRIKO) Athens Greece
    55 Attikon University Hospital of Athens Athens Greece
    56 Gen. Hos. "Alexandra" Athens Greece
    57 General Hospital of Athens G.Gennimatas Athens Greece
    58 Henry Dunant Hospital Center Athens Greece
    59 Theageneio Hospital Athens Greece
    60 Attikon Hospital Attika Greece
    61 Attikon Chaidari Greece
    62 General Hospital "Venizelio" Heraclion Greece
    63 University Hospital of Ioannina Ioannina Greece
    64 University Hospital of Crete Iraklio Greece
    65 Hospital of Agioi Anargyroi Kifisia Greece
    66 University Hospital of Larissa Larissa Greece
    67 General Hospital of Patras "o Agios Andreas" Patras Greece
    68 Metaxa Hospital Piraeus Greece
    69 Metropolitan Hospital Greece Piraeus Greece
    70 Agios Loukas Hospital Thessaloniki Greece
    71 Papageorgiou Hospital Thessaloniki Greece
    72 Saint Luke Hospital Thessaloniki Greece
    73 Regional Oncology Dispensary - Irkutsk Irkutsk Russian Federation
    74 Mälarsjukhuset Eskilstuna Sweden
    75 Lasarettsvägen Halmstad Sweden
    76 Kalmar (Sös / Huddinge) Kalmar Sweden
    77 Sundsvall Sundsvall Sweden

    Sponsors and Collaborators

    • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT04941768
    Other Study ID Numbers:
    • MS100070_0110
    First Posted:
    Jun 28, 2021
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2022