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Um estudo observacional para avaliar a eficácia e a segurança da combinação avelumabe + axitinibe em participantes com aRCC (AVION)

20 de maio de 2026 atualizado por: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Avaliação no mundo real da eficácia e segurança com avelumabe (BAVENCIO®) + axitinibe (INLYTA®) em pacientes com aRCC em vários países da UE (AVION)

O principal objetivo deste estudo é ampliar o conhecimento sobre a eficácia da infusão intravenosa de Avelumabe em combinação com Axitinibe como terapia de primeira linha em participantes com carcinoma de células renais avançado (aRCC), além da segurança e tolerabilidade em condições rotineiras de uso diário prática clínica.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

105

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Amberg, Alemanha
        • Klinikum St. Marien Amberg
      • Aschaffenburg, Alemanha
        • Klinikum Aschaffenburg Medizinische Klinik
      • Berlin, Alemanha
        • Zentrum für urologische Onkologie
      • Biberach an der Riss, Alemanha
        • Biberach
      • Bielefeld, Alemanha
        • Evangelisches Klinikum Bethel
      • Bielefeld, Alemanha
        • Evangelisches Krankenhaus Bielefeld
      • Braunschweig, Alemanha
        • Urologie im Schlosscarree
      • Deggendorf, Alemanha
        • Donauisar Klinikum Deggendorf
      • Dresden, Alemanha
        • Urologische Gemeinschaftspraxis
      • Eisenach, Alemanha
        • St. Georg Klinikum Eisenach gGmbH
      • Erlangen, Alemanha
        • Universitätsklinikum Erlangen
      • Essen, Alemanha
        • Universitaetsklinikum Essen Uroonkologie
      • Friedrichshafen, Alemanha
        • Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
      • Fürth, Alemanha
        • Onkologische GP Dres. Wilke/Wagner/Petzoldt
      • Fürth, Alemanha
        • Onkologische SP Praxis Fürth
      • Goslar, Alemanha
        • MVZ Onkologische Kooperation Harz GbR
      • Halberstadt, Alemanha
        • Praxis Dr. Maas
      • Hamburg, Alemanha
        • Universitätsklinikum Hamburg-Eppendorf
      • Hanover, Alemanha
        • Medizinische Hochschule Hannover
      • Hanover, Alemanha
        • Vinzenzkrankenhaus Hannover
      • Heinsberg, Alemanha
        • Praxis Kretz
      • Jena, Alemanha
        • Universitätskinderklinik Jena
      • L.-Eisleben, Alemanha
        • Urologische Praxis Dr. Ralf Eckert
      • Luckenwalde, Alemanha
        • Urologische Praxis Dipl.-Med. Susanne Kloß
      • Lübeck, Alemanha
        • Universitatsklinik Schleswig-Holstein
      • Magdeburg, Alemanha
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Minden, Alemanha
        • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
      • Münster, Alemanha
        • University of Munster
      • Münster, Alemanha
        • Uniklinikum Münster
      • Osnabrück, Alemanha
        • Marienhospital Osnabrück - Standort Natruper Holz
      • Osnabrück, Alemanha
        • Paracelsus Klinik Osnabrück
      • Osnabrück, Alemanha
        • Klinikum Osnabrück GmbH
      • Ostfildren, Alemanha
        • medius Klinik Ostfildern-Ruit
      • Rostock, Alemanha
        • Wissenschaftskontor Nord GmbH & Co. KG
      • Rüsselsheim am Main, Alemanha
        • GPR Klinikum Rüsselsheimg GmbH
      • Sigmaringen, Alemanha
        • SRH Kliniken Landkreis Sigmaringen (DEU)
      • Stolberg, Alemanha
        • Hämatologie und Onkologie Stolberg
      • Troisdorf, Alemanha
        • Praxis Troisdorf
      • Westerstede, Alemanha
        • Medizinische Studiengesellschaft Nord-West GmbH
      • Wetzlar, Alemanha
        • Lahn Dill Kliniken GmbH
  • Bélgica
      • Bonheiden, Bélgica
        • Imelda Ziekenhuis
      • Brasschaat, Bélgica
        • AZ Klina
      • Bruges, Bélgica
        • AZ Sint-Jan
  • Grécia
      • Athens, Grécia
        • Gen. Hos. "Alexandra"
      • Athens, Grécia
        • General Hospital of Athens G.Gennimatas
      • Athens, Grécia
        • Henry Dunant Hospital Center
      • Athens, Grécia
        • University Hospital of Athens Sotiria
      • Attiki, Grécia
        • Attikon Hospital
      • Chaïdári, Grécia
        • Attikon
      • Heraklion, Grécia
        • General Hospital "Venizelio"
      • Ioannina, Grécia
        • University Hospital of Ioannina
      • Kavala, Grécia
        • Kavala General Hospital
      • Larissa, Grécia
        • University Hospital of Larissa
      • Piraeus, Grécia
        • Metaxa Hospital
      • Piraeus, Grécia
        • Metropolitan Hospital Greece
      • Pátrai, Grécia
        • General Hospital of Patras "o Agios Andreas"
      • Thessaloniki, Grécia
        • Papageorgiou Hospital
      • Thessaloniki, Grécia
        • Agios Loukas Hospital
      • Thessaloniki, Grécia
        • Bioclinic (GRC)
      • Thessaloniki, Grécia
        • Saint Luke Hospital
  • Rússia
      • Irkutsk, Rússia
        • Regional Oncology Dispensary - Irkutsk

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Os participantes com diagnóstico confirmado de CCR avançado serão observados neste estudo.

Descrição

Critério de inclusão:

  • Participantes com status de desempenho do Eastern Cooperative Oncology Group (ECOG) 0, 1 ou 2
  • Participantes com diagnóstico confirmado histologicamente de CCR de qualquer origem histológica
  • Participantes com uma doença localmente avançada/metastática (ou seja, [ou seja], recém-diagnosticado Estágio 4 RCC por American Joint Committee on Cancer) ou tem doença recorrente
  • Os participantes receberam 1 ou 2 ciclos de tratamento com Avelumab mais Axitinib como terapia de primeira linha de acordo com o Resumo das Características do Medicamento (SmPC) aprovado
  • Participantes dispostos a assinar o termo de consentimento livre e esclarecido (TCLE) para participar deste estudo

Critério de exclusão:

  • Participantes com contraindicações para Avelumabe ou Axitinibe de acordo com o RCM aprovado
  • Participantes que participaram de qualquer estudo clínico intervencionista de um medicamento ou dispositivo dentro de 28 dias antes do início de Avelumabe mais Axitinibe

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Avelumabe + Axitinibe
Não haverá nenhuma intervenção específica do estudo neste estudo. Serão observados os participantes com CCR avançado recebendo 800 miligramas (mg) de Avelumabe por via intravenosa a cada 2 semanas em combinação com 5 mg de Axitinibe por via oral duas vezes ao dia de acordo com os termos de autorização de comercialização para a terapia de primeira linha de acordo com a prática clínica atual por 24 meses neste estudo.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Survival Rate
Prazo: At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])
Overall survival rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival Rate
Prazo: At 24 months after index date (baseline visit as reported in the eCRF)
Overall survival rate was defined as the percentage of participants who are alive at 24 months after the index date. Percentage of participants alive at the time of outcome assessment (24 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
At 24 months after index date (baseline visit as reported in the eCRF)
Duration of Overall Survival
Prazo: From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Duration of overall survival is defined as the time from index date to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date
Prazo: up to 24 months after the index date (baseline visit as reported in the eCRF)
Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) as best overall response up to 24 months after the index date. CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date
Prazo: up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease control rate is defined as the percentage of participants with objective response (complete response [CR] or partial response [PR] or stable disease [SD]) as best overall response up to 24 months after the index date. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Prazo: up to 24 months after the index date (baseline visit as reported in the eCRF)
DoR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator
Prazo: From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
PFS time was defined as the time from index date to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered PD. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. PFS was calculated based on KM method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator
Prazo: From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
PFS2 was defined as time interval from the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The tumor response will be determined according to RECIST version 1.1 and assessed by the investigator. PFS2 was calculated based on Kaplan Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score
Prazo: Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
NCCN-FACT FKSI-19, a validated, disease-specific questionnaire for RCC. It includes 19 items across four domains, Disease-Related Symptoms-Physical (DRS-P), Disease-Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Functional Wellbeing (FWB), based on symptoms experienced over past 7 days. Responses were recorded on 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score from 0 to 76, higher scores reflecting better quality of life. A negative mean change in score indicated worsening condition. Domain score ranges and directionality: DRS-P: 0-48, higher scores = fewer physical symptoms; DRS-E: 0-4, higher = fewer emotional symptoms; TSE: 0-12, higher = more severe side effects; FWB: 0-12, higher = better functional wellbeing. As per NCCN-FACT FKSI-19 scoring guidelines, the total Health-related quality of life (HRQoL) score (range 0-76) was calculated as sum of single items scores multiplied by 19 and divided by the number of items completed.
Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA)
Prazo: From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Number of Participants With Adverse Events Based on Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Prazo: From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Severity of TEAEs were evaluated using the NCI-CTCAE version 5.0. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE. Number of participants with TEAEs grade greater than or equal to (>=) 3 were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3
Prazo: From the index date (baseline visit as reported in the eCRF) up to 24 months
Time to therapy discontinuation due to AE >= grade 3 was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Axitinib Due to All-Cause AEs >= Grade 3
Prazo: Time from first dose of study drug up to 24 months
The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. Duration of Avelumab plus Axitinib therapy (days) = (Date of discontinuation of Axitinib - Date of index date + 1). Duration of avelumab plus axitinib therapy among participants who discontinued the Axitinib due to all-cause AEs >= grade 3 was reported.
Time from first dose of study drug up to 24 months
Time to Onset of Treatment - Emergent Adverse Events (TEAEs)
Prazo: From index date (baseline visit as reported in the eCRF) up to 24 months
Time to onset of TEAE = Start date TEAE - Index date. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Treatment-Emergent Adverse Events (TEAEs)
Prazo: From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of TEAE = (Stop date of TEAE - Start date of TEAE + 1) divided by 7. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy
Prazo: From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of participants with therapy modifications due to AE related to avelumab plus axitinib therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy
Prazo: From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Number of participants with different types of medical intervention or medications used for the management of TEAE related to avelumab plus axitinib therapy (e.g., use of corticosteroids, antihypertensive therapy, treatment for thyroid dysfunction, measures to decrease hemoglobin, and hematocrit) was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Percentage of Participants Receiving Later-line Therapy
Prazo: From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of participants receiving later-line therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Time to Second-line Therapy Initiation
Prazo: Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Time to second line treatment was calculated as: (second line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375.
Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs
Prazo: From index date (baseline visit as reported in the eCRF) up to 24 months
Number of participants with patient-reported potential signs and symptoms of immune-related AEs were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Colaboradores

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

Investigadores

  • Diretor de estudo: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de agosto de 2021

Conclusão Primária (Real)

8 de agosto de 2024

Conclusão do estudo (Real)

30 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2021

Primeira postagem (Real)

28 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MS100070_0110

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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