A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (AVENANCE)

AVENANCE - A Non-interventional Study to Provide Real-world Data on the Use of Avelumab as a Maintenance Treatment for Patients With Advanced or Metastatic Urothelial Carcinoma

A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.

Study Overview

• Status: Completed
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Drug: Avelumab

• Study Type: Observational
• Enrollment (Actual): 596

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Centre Hospitalier du Pays d AIX
  • Amiens, France, 80054
    • CHU Amiens-Picardie
  • Argenteuil, France, 95107
    • Centre Hospitalier Victor Dupouy
  • Auxerre, France, 89000
    • Centre Hospitalier Auxerre
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
  • Besançon, France, 25030
    • CHRU Besançon
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Bordeaux, France, 33000
    • Clinique Tivoli-Ducos
  • Bordeaux, France, 33075
    • CHU de Bordeaux - Hôpital Saint André
  • Boulogne-sur-Mer, France, 62321
    • Centre Hospitalier de Boulogne Sur Mer
  • Brest, France, 29200
    • Clinique Pasteur - Lanroze
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire de Brest
  • Bron, France, 69677
    • Hôpital Louis Pradel
  • Calais, France, 62107
    • CENTRE HOSPITALIER Dr Jean-Eric TECHER
  • Challes-les-Eaux, France, 73190
    • Medipole de Savoie
  • Clermont-Ferrand, France, 63050
    • Pôle Santé République
  • Clermont-Ferrand, France, 63011
    • Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin
  • Clermont-Ferrand, France, 63011
    • Centre Hospitalier Universitaire Gabriel Montpied
  • Compiègne, France, 60200
    • Polyclinique Saint Côme
  • Coudekerque-Branche, France, 59210
    • Clinique de Flandre
  • Créteil, France, 94010
    • Centre Hospitalier Intercommunal de Creteil
  • Dechy, France, 59187
    • Centre Leonard de Vinci
  • Dijon, France, 21000
    • Clinique Clement Drevon
  • Elbeuf, France, 76503
    • Centre Hospitalier Intercommunal Louviers
  • Epargny METZ Tessy, France, 74370
    • Centre Hospitalier Annecy Genevois
  • Fréjus, France, 83608
    • Chi Frejus - Saint Raphael
  • Gap, France, 5000
    • Chi Alpes Du Sud
  • Greboble, France, 38043
    • Centre Hospitalier de Grenoble
  • Grenoble, France, 38000
    • Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard
  • Haguenau, France, 67500
    • Centre Hospitalier Haguenau
  • La Chaussée-Saint-Victor, France, 41260
    • Polyclinique de Blois
  • La Roche-sur-Yon, France, 85960
    • La Roche Sur Yon - Centre Hospitalier Departemetal Vendee
  • La Rochelle, France, 17019
    • Groupe Hospitalier La Rochelle - Re - Aunis
  • Le Mans, France, 72015
    • Clinique Victor Hugo
  • Le Puy-en-Velay, France, 43000
    • Centre Hospitalier Emile Roux
  • Lille, France, 59042
    • Clinique de la Louvière
  • Lille, France, 59004
    • Polyclinique Du Bois
  • Limoges, France, 87000
    • Chu Dupuytren Service Oncologie
  • Limoges, France, 87039
    • Polyclinique de LIMOGE-Clinique François CHENIEUX
  • Lons-le-Saunier, France, 39000
    • Centre Hospitalier Jura Sud
  • Lorient, France, 56322
    • Centre Hospitalier Bretagne Sud
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Lyon, France, 69337
    • Clinique de la Sauvegarde
  • Marseille, France, 13385
    • Hopital de la Timone
  • Marseille, France, 13003
    • Hôpital Européen
  • Montpellier, France, 34295
    • Centre Hospitalier Universitaire de Montpellier
  • Mougins, France, 06254
    • Hopital prive Arnault Tzanck
  • Nancy, France, 54100
    • Centre d'oncologie de Gentilly
  • Nantes, France, 44277
    • Hopital prive du Confluent S.A.S
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Nice, France, 06105
    • Clinique Saint Georges
  • Nîmes, France, 30900
    • Institut de Cancérologie du Gard
  • Nîmes, France, 30900
    • ONCOGARD
  • Osny, France, 95520
    • Hôpital privé sainte Marie
  • Paris, France, 75013
    • Hopital Pitie Salpetriere
  • Paris, France, 75908
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75010
    • Hopital Saint-Louis
  • Paris, France, 75014
    • Hopital Cochin/Unité de Cancerologie
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesse La Croix Saint Simon
  • Pau, France, 64001
    • Polyclinique Marzet
  • Quimper, France, 29107
    • Centre Hospitalier de Cornouaille
  • Reims, France, 51056
    • Institut Jean Godinot
  • Roanne, France, 42300
    • Centre Hopistalier Roanne
  • Roubaix, France, 59100
    • Ch Roubais
  • Rouen, France, 76100
    • Clinique Mathilde
  • Saint-Grégoire, France, 35768
    • Centre Hospitalier Privé Saint Grégoire
  • Saint-Mandé, France, 94160
    • HIA Begin
  • Saint-Nazaire, France, 44606
    • Clinique mutualiste de l Estuaire
  • Saint-Priest-en-Jarez, France, 42271
    • Institut de Cancérologie Lucien Neuwirth
  • Soissons, France, 02200
    • Centre Hospitalier de Soissons
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Strasbourg, France, 67200
    • ICANS - Institut de cancérologie Strasbourg Europe
  • Suresnes, France, 92151
    • Hopital Foch
  • Toulon, France, 83041
    • HIA Sainte Anne
  • Toulouse, France, 31059
    • IUCT - Oncopole
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Alexis Vautrin
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Évry, France, 91035
    • Clinique Du Mousseau
  • Haute-normandie
    • Rouen, Haute-normandie, France, 76031
      • CHU Charles Nicolle
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44093
      • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with advanced or metastatic Urothelial Carcinoma treated with avelumab as a maintenance treatment

Description

Inclusion Criteria:

1. Patient ≥ 18 years of age

2. Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.

   • For a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data
   • For a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data.

3. Patient benefiting from a social security scheme according to local regulations

   Exclusion Criteria:

4. For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
5. Patient enrolled in a prospective interventional clinical trial assessing an investigational product.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Locally advanced or metastatic urothelial carcinoma patients treated with avelumab	Drug: Avelumab; As provided in real world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS): Overall	OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method.	From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)
OS: by Histology Group	OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.	From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS From Initiation of First-Line Chemotherapy: Overall	OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to consider the participant 'immortality' time before avelumab initiation.	From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months)
OS From Initiation of First-Line Chemotherapy: by Histology Group	OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. OS from initiation of first line chemotherapy according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to take into account the participant 'immortality' time before avelumab initiation.	From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Overall	PFS: time between first injection of avelumab and the date of disease progression (PD) or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method.	From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)
PFS 1 According to RECIST 1.1: by Histology Group	PFS:time between first injection of avelumab and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group:pure urothelial carcinoma,pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used.	From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)
PFS During the Second Line of Treatment Post-Avelumab (PFS 2) According to RECIST 1.1: Overall	PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of second line of post-avelumab treatment during the study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. Analysis was performed using Kaplan-Meier method.	From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up)
PFS 2 According to RECIST 1.1: by Histology Group	PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of 2nd line of post-avelumab treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used.	From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up)
Overall Response Rate (ORR) According to RECIST 1.1: Overall	ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up)
ORR According to RECIST 1.1: by Histology Group	ORR was defined as the percentage of participants with a CR or PR as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up)
Duration of Response (DOR): Overall	DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier.	From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
DOR: by Histology Group	DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. DOR according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used.	From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Duration of Treatment (DOT): Overall	DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method.	From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up)
DOT: by Histology Group	DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. DOT according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.	From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up)
Number of Participants Classified Per Progression Type: Overall	The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure.	From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months)
Number of Participants Classified Per Progression Type: by Histology Group	The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. Number of participants classified per progression type according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months)
Duration of Subsequent Treatment: Overall	Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method.	From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months)
Duration of Subsequent Treatment: by Histology Group	Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Duration of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.	From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months)
PFS of Subsequent Treatment: Overall	PFS of subsequent treatment was defined as time between first injection of subsequent treatment and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method.	From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months)
PFS of Subsequent Treatment: by Histology Group	PFS: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used.	From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months)
ORR of Subsequent Treatment: Overall	ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months)
ORR of Subsequent Treatment: by Histology Group	ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR of subsequent therapy according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months)
OS of Subsequent Treatment: Overall	OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method.	From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months)
OS of Subsequent Treatment by Histology Group	OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.	From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months)
Number of Participants With Adverse Events (AEs): Overall	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both serious AEs (SAEs) and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With AEs: by Histology Group	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With Grade 3, 4 or 5 AEs: Overall	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE, Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 were reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With Grade 3, 4 or 5 AEs: by Histology Group	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE and Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab: Overall	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab were reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab by Histology Group	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With AEs Leading to Death: Overall	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death are reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants With AEs Leading to Death: by Histology Group	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: Overall	Number of participants who received at least one premedication with paracetamol among all avelumab injections were reported in this outcome measure.	From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months)
Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: by Histology Group	Number of participants who received at least one premedication with paracetamol among all avelumab injections according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months)
Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: Overall	Number of participants who received at least one premedication with antihistamines among all avelumab injections were reported in this outcome measure.	From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months)
Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: by Histology Group	Number of participants who received at least one premedication with antihistamines among all avelumab injections according to histology group: pure urothelial carcinoma (UC), pure variant, urothelial carcinoma variant and missing were reported in this outcome measure.	From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months)
Change From Baseline in National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy -Bladder Symptom Index-18 (FACT FBlSI-18) at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall	The NCCN/FACT FBlSI-18 was a self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. The response to each of the 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline was defined as the time of avelumab initiation.	Baseline; at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in NCCN/FACT FBlSI-18 at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group	NCCN/FACT FBlSI-18: self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Response to each of 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline=time of avelumab initiation. Change from Baseline in NCCN/FACT FBlSI-18 according to histology group: pure UC, pure variant and UC variant were reported.	Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall	The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the visual analogue scale (VAS). The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation.	Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in EQ-5D-5L Index Score at Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group	The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L Index Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure.	Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in EQ-5D-5L-VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall	The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation.	Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in EQ-5D-5L- VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group	The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L- VAS Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure.	Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Bladder cancer; Immunotherapy; Avelumab; France; Effectiveness; Maintenance; Non-interventional study
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; avelumab
• Other Study ID Numbers: B9991045; NCT04822350 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No