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Observační studie k vyhodnocení účinnosti a bezpečnosti kombinace avelumab + axitinib u účastníků s aRCC (AVION)

20. května 2026 aktualizováno: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Skutečné hodnocení účinnosti a bezpečnosti s avelumabem (BAVENCIO®) + axitinibem (INLYTA®) u pacientů s aRCC ve více zemích EU (AVION)

Hlavním účelem této studie je rozšířit znalosti o účinnosti intravenózní infuze avelumabu v kombinaci s Axitinibem jako terapie první volby u účastníků s pokročilým renálním karcinomem (aRCC) vedle bezpečnosti a snášenlivosti za běžných podmínek každodenního života. klinická praxe.

Přehled studie

Postavení

Dokončeno

Podmínky

Typ studie

Pozorovací

Zápis (Aktuální)

105

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

V této studii budou sledováni účastníci s potvrzenou diagnózou pokročilého RCC.

Popis

Kritéria pro zařazení:

  • Účastníci s výkonnostním stavem Eastern Cooperative Oncology Group (ECOG) 0, 1 nebo 2
  • Účastníci s histologicky potvrzenou diagnózou RCC s jakýmkoli histologickým původem
  • Účastníci s lokálně pokročilým/metastatickým onemocněním (tj. [tj.] nově diagnostikovaným RCC 4. fáze podle American Joint Committee on Cancer) nebo mají recidivující onemocnění
  • Účastníci obdrželi 1 nebo 2 cykly léčby avelumabem plus axitinibem jako léčbu první volby podle schváleného souhrnu údajů o přípravku (SmPC)
  • Účastníci, kteří jsou ochotni podepsat formulář písemného informovaného souhlasu (ICF) k účasti na této studii

Kritéria vyloučení:

  • Účastníci s kontraindikacemi pro avelumab nebo axitinib podle schváleného SmPC
  • Účastníci, kteří se zúčastnili jakékoli intervenční klinické studie léku nebo zařízení během 28 dnů před zahájením léčby avelumabem plus axitinibem

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Avelumab + axitinib
V této studii nebudou žádné intervence specifické pro studii. Účastníci s pokročilým RCC, kteří dostávají 800 miligramů (mg) avelumabu intravenózně každé 2 týdny v kombinaci s 5 mg axitinibu perorálně dvakrát denně v souladu s podmínkami registrace pro léčbu první linie podle současné klinické praxe, budou sledováni po dobu 24 měsíců v této studii.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival Rate
Časové okno: 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])

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Spolupracovníci

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

Vyšetřovatelé

  • Ředitel studie: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. srpna 2021

Primární dokončení (Aktuální)

8. srpna 2024

Dokončení studie (Aktuální)

30. dubna 2025

Termíny zápisu do studia

První předloženo

23. června 2021

První předloženo, které splnilo kritéria kontroly kvality

23. června 2021

První zveřejněno (Aktuální)

28. června 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MS100070_0110

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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