Clinical trial NCT04941768: An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
Official title: Real-world Evaluation of Efficacy and Safety With Avelumab (BAVENCIO®) + Axitinib (INLYTA®) in Patients With aRCC in Multiple EU Countries (AVION)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Renal Cell
Keywords: Axitinib
Renal cell carcinoma
Avelumab
BAVENCIO®
INLYTA®
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany
First posted: 2021-06-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a confirmed diagnosis of advanced RCC will be observed in this study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS) Rate at Month 12
timeFrame: Time from first dose of study drug up to Month 12
Secondary outcomes:
measure: Overall Survival (OS) Rate at Month 24
timeFrame: Time from first dose of study drug up to Month 24
measure: Overall Survival (OS)
timeFrame: Time from first dose of study drug to the date of death from any cause, assessed up to Month 24
measure: Overall Response (OR) Rate Assessed by Investigator at Month 24
timeFrame: Time from first dose of study drug up to Month 24
measure: Disease Control Rate (DCR) Assessed by Investigator at Month 24
timeFrame: Time from first dose of study drug up to Month 24
measure: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: Time from first dose of study drug up to Month 24
measure: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Assessed by Investigator
timeFrame: Time from first dose of study drug to the date of disease progression or death from any cause, assessed up to Month 24
measure: Progression-free Survival 2 (PFS2) According to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Assessed by Investigator
timeFrame: 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
measure: Health-related Quality Of Life (HRQoL) According to National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCNFACTFKSI-19)
timeFrame: Baseline, Month 24
measure: 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)
timeFrame: Time from first dose of study drug up to Month 24
measure: 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
timeFrame: Time from first dose of study drug up to Month 24
measure: 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)
timeFrame: Time from first dose of study drug up to Month 24
measure: 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
timeFrame: Time from first dose of study drug up to Month 24
measure: Time to Onset of All-cause Adverse Events (AEs)
timeFrame: Time from first dose of study drug up to Month 24
measure: Duration of All-cause Adverse Events (AEs)
timeFrame: Time from first dose of study drug up to Month 24
measure: Number of Participants with All-cause Adverse Events (AEs) Outcomes (Resolved, Resolving, not Resolved, Resolved with Sequelae, Fatal, Unknown)
timeFrame: Time from first dose of study drug up to Month 24
measure: Percentage of Participants with Therapy Modifications Due to Adverse Event Related to Avelumab plus Axitinib Therapy
timeFrame: Time from first dose of study drug up to Month 24
measure: 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
timeFrame: Time from first dose of study drug up to Month 24
measure: Percentage of Participants Receiving Later-line therapy
timeFrame: Time from first dose of study drug up to Month 24
measure: Time to Second-line Therapy Initiation
timeFrame: Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 24
measure: Number of Participants with Patient-reported Potential Signs and Symptoms of Immune-related Adverse Events (AEs)
timeFrame: Time from first dose of study drug up to Month 24
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg Medizinische Klinik
city: Berlin
country: Germany
facility: Zentrum für urologische Onkologie
city: Biberach an der Riss
country: Germany
facility: Biberach
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld
city: Braunschweig
country: Germany
facility: Urologie im Schlosscarree
city: Deggendorf
country: Germany
facility: Donauisar Klinikum Deggendorf
city: Dresden
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Eisenach
country: Germany
facility: St. Georg Klinikum Eisenach gGmbH
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen Uroonkologie
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
city: Fürth
country: Germany
facility: Onkologische GP Dres. Wilke/Wagner/Petzoldt
city: Fürth
country: Germany
facility: Onkologische SP Praxis Fürth
city: Goslar
country: Germany
facility: MVZ Onkologische Kooperation Harz GbR
city: Halberstadt
country: Germany
facility: Praxis Dr. Maas
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hannover
country: Germany
facility: Vinzenzkrankenhaus Hannover
city: Heinsberg
country: Germany
facility: Praxis Kretz
city: Jena
country: Germany
facility: Universitätskinderklinik Jena
city: L.-Eisleben
country: Germany
facility: Urologische Praxis Dr. Ralf Eckert
city: Luckenwalde
country: Germany
facility: Urologische Praxis Dipl.-Med. Susanne Kloß
city: Lübeck
country: Germany
facility: Universitatsklinik Schleswig-Holstein
city: Magdeburg
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Onkologie
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
city: Münster
country: Germany
facility: Uniklinikum Münster
city: Münster
country: Germany
facility: University of Munster
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
city: Osnabrück
country: Germany
facility: Marienhospital Osnabrück - Standort Natruper Holz
city: Osnabrück
country: Germany
facility: Paracelsus Klinik Osnabrück
city: Ostfildren
country: Germany
facility: medius Klinik Ostfildern-Ruit
city: Rostock
country: Germany
facility: Wissenschaftskontor Nord GmbH & Co. KG
city: Ruesselsheim
country: Germany
facility: GPR Klinikum Rüsselsheimg GmbH
city: Sigmaringen
country: Germany
facility: SRH Kliniken Landkreis Sigmaringen (DEU)
city: Stolberg
country: Germany
facility: Hämatologie und Onkologie Stolberg
city: Troisdorf
country: Germany
facility: Praxis Troisdorf
city: Westerstede
country: Germany
facility: Medizinische Studiengesellschaft Nord-West GmbH
city: Wetzlar
country: Germany
facility: Lahn Dill Kliniken GmbH
city: Athens
country: Greece
facility: Gen. Hos. "Alexandra"
city: Athens
country: Greece
facility: General Hospital of Athens G.Gennimatas
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Athens
country: Greece
facility: University Hospital of Athens Sotiria
city: Attika
country: Greece
facility: Attikon Hospital
city: Chaidari
country: Greece
facility: Attikon
city: Heraclion
country: Greece
facility: General Hospital "Venizelio"
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Kavala
country: Greece
facility: Kavala General Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patras
country: Greece
facility: General Hospital of Patras "o Agios Andreas"
city: Piraeus
country: Greece
facility: Metaxa Hospital
city: Piraeus
country: Greece
facility: Metropolitan Hospital Greece
city: Thessaloniki
country: Greece
facility: Agios Loukas Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic (GRC)
city: Thessaloniki
country: Greece
facility: Papageorgiou Hospital
city: Thessaloniki
country: Greece
facility: Saint Luke Hospital
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Dispensary - Irkutsk
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: