An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
- Conditions
- Carcinoma, Renal Cell
- Registration Number
- NCT04941768
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 108
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Rate at Month 12 Time from first dose of study drug up to Month 12
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Rate at 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 from first dose of study drug 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 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) Baseline, 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 from first dose of study drug up to Month 24 Overall Survival (OS) 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 from first dose of study drug up to Month 24 Disease Control Rate (DCR) Assessed by Investigator at 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 from first dose of study drug to the date of disease progression or death from any cause, assessed up to 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 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 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 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 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 from first dose of study drug up to Month 24 Time to Onset of All-cause Adverse Events (AEs) Time from first dose of study drug up to Month 24 Duration of All-cause Adverse Events (AEs) 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 from first dose of study drug up to Month 24 Time to Second-line Therapy Initiation Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24 Percentage of Participants Receiving Later-line therapy Time from first dose of study drug up to Month 24 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
Trial Locations
- Locations (61)
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
🇬🇷Attika, Greece
Attikon
🇬🇷Chaidari, Greece
General Hospital "Venizelio"
🇬🇷Heraclion, 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"
🇬🇷Patras, 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, Russian Federation
SRH Kliniken Landkreis Sigmaringen (DEU)
🇩🇪Sigmaringen, 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
University of Munster
🇩🇪Münster, Germany
Klinikum Osnabrück GmbH
🇩🇪Osnabrück, Germany
GPR Klinikum Rüsselsheimg GmbH
🇩🇪Ruesselsheim, Germany
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
AZ KLINA
🇧🇪Brasschaat, Belgium
AZ Sint-Jan
🇧🇪Brugge, 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
🇩🇪Hannover, Germany
Vinzenzkrankenhaus Hannover
🇩🇪Hannover, 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