Carcinoma, Renal Cell Clinical Trial
Official title:
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.
| Status | Active, not recruiting |
| Enrollment | 108 |
| Est. completion date | May 9, 2025 |
| Est. primary completion date | August 8, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Imelda Ziekenhuis | Bonheiden | |
| Belgium | AZ KLINA | Brasschaat | |
| Belgium | AZ Sint-Jan | Brugge | |
| Germany | Klinikum St. Marien Amberg | Amberg | |
| Germany | Klinikum Aschaffenburg Medizinische Klinik | Aschaffenburg | |
| 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 | Universitätsklinik Frankfurt | Frankfurt | |
| 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 | Urologische Praxis Dr. Ralf Eckert | L.-Eisleben | |
| 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 | Paracelsus Klinik Osnabrück | Osnabrück | |
| Germany | medius Klinik Ostfildern-Ruit | Ostfildren | |
| Germany | Wissenschaftskontor Nord GmbH & Co. KG | Rostock | |
| Germany | GPR Klinikum Rüsselsheimg GmbH | Ruesselsheim | |
| Germany | SRH Kliniken Landkreis Sigmaringen (DEU) | Sigmaringen | |
| Germany | Hämatologie und Onkologie Stolberg | Stolberg | |
| Germany | Medizinische Studiengesellschaft Nord-West GmbH | Westerstede | |
| Germany | Lahn Dill Kliniken GmbH | Wetzlar | |
| 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 | Agios Loukas Hospital | Thessaloniki | |
| Greece | Papageorgiou Hospital | Thessaloniki | |
| Greece | Saint Luke Hospital | Thessaloniki | |
| Russian Federation | Regional Oncology Dispensary - Irkutsk | Irkutsk |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany |
Belgium, Germany, Greece, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) Rate at Month 12 | Time from first dose of study drug up to Month 12 | ||
| Secondary | Overall Survival (OS) Rate at Month 24 | Time from first dose of study drug up to Month 24 | ||
| Secondary | Overall Survival (OS) | Time from first dose of study drug to the date of death from any cause, assessed up to Month 24 | ||
| Secondary | Overall Response (OR) Rate Assessed by Investigator at Month 24 | Time from first dose of study drug up to Month 24 | ||
| Secondary | Disease Control Rate (DCR) Assessed by Investigator at Month 24 | Time from first dose of study drug up to Month 24 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Time to Onset of All-cause Adverse Events (AEs) | Time from first dose of study drug up to Month 24 | ||
| Secondary | Duration of All-cause Adverse Events (AEs) | Time from first dose of study drug up to Month 24 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Percentage of Participants Receiving Later-line therapy | Time from first dose of study drug up to Month 24 | ||
| Secondary | Time to Second-line Therapy Initiation | Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24 | ||
| Secondary | 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 |
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