이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

ARCC(AVION) 참여자에서 Avelumab + Axitinib 병용의 효능 및 안전성을 평가하기 위한 관찰 연구

2026년 5월 20일 업데이트: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

여러 EU 국가에서 aRCC 환자를 대상으로 한 Avelumab(BAAVENCIO®) + Axitinib(INLYTA®)의 유효성 및 안전성에 대한 실세계 평가(AVION)

이 연구의 주요 목적은 일상적인 일상적인 조건에서 안전성과 내약성 외에도 진행성 신 세포 암종 (aRCC) 참가자의 1 차 요법으로 Axitinib과 병용 된 Avelumab 정맥 주사의 효과에 대한 지식을 확장하는 것입니다. 임상 실습.

연구 개요

상태

완전한

정황

연구 유형

관찰

등록 (실제)

105

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

진행된 RCC 진단이 확인된 참가자는 이 연구에서 관찰됩니다.

설명

포함 기준:

  • Eastern Cooperative Oncology Group(ECOG) 수행 상태가 0, 1 또는 2인 참가자
  • 조직학적 기원이 있는 RCC의 조직학적으로 확인된 진단을 받은 참가자
  • 국소 진행성/전이성 질환(즉, 미국 암 합동 위원회에 따라 새로 진단된 4기 RCC) 또는 재발성 질환이 있는 참가자
  • 참가자는 승인된 제품 특성 요약(SmPC)에 따라 1차 요법으로 Avelumab + Axitinib 치료를 1 또는 2주기 받았습니다.
  • 이 연구에 참여하기 위해 서면 동의서(ICF)에 서명할 의향이 있는 참가자

제외 기준:

  • 승인된 SmPC에 따라 Avelumab 또는 Axitinib에 대한 금기 사항이 있는 참가자
  • Avelumab + Axitinib 시작 전 28일 이내에 약물 또는 장치의 중재적 임상 연구에 참여한 참가자

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
아벨루맙 + 악시티닙
이 연구에는 연구 관련 개입이 없을 것입니다. 현재 임상 관행에 따른 1차 요법에 대한 시판 승인 조건에 따라 2주마다 800mg의 Avelumab을 정맥 주사하고 Axitinib 5mg을 1일 2회 경구 투여하는 진행성 RCC 참가자를 관찰합니다. 이 연구에서 24개월 동안.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival Rate
기간: 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])

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival Rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

협력자

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

수사관

  • 연구 책임자: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 8월 9일

기본 완료 (실제)

2024년 8월 8일

연구 완료 (실제)

2025년 4월 30일

연구 등록 날짜

최초 제출

2021년 6월 23일

QC 기준을 충족하는 최초 제출

2021년 6월 23일

처음 게시됨 (실제)

2021년 6월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MS100070_0110

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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