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
2 other identifiers
observational
596
1 country
81
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 30, 2021
CompletedStudy Start
First participant enrolled
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2024
CompletedResults Posted
Study results publicly available
April 2, 2026
CompletedApril 2, 2026
March 1, 2026
2.8 years
March 22, 2021
December 22, 2025
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (40)
OS From Initiation of First-Line Chemotherapy: Overall
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
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
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
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
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)
- +35 more secondary outcomes
Study Arms (1)
Locally advanced or metastatic urothelial carcinoma patients treated with avelumab
Interventions
As provided in real world practice
Eligibility Criteria
Patients with advanced or metastatic Urothelial Carcinoma treated with avelumab as a maintenance treatment
You may qualify if:
- Patient ≥ 18 years of age
- 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.
- Patient benefiting from a social security scheme according to local regulations
You may not qualify if:
- Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Merck KGaA, Darmstadt, Germanycollaborator
Study Sites (81)
CHU Charles Nicolle
Rouen, Haute-normandie, 76031, France
CHU Nantes
Nantes, Pays de la Loire Region, 44093, France
Centre Hospitalier du Pays d AIX
Aix-en-Provence, 13100, France
CHU Amiens-Picardie
Amiens, 80054, France
Centre Hospitalier Victor Dupouy
Argenteuil, 95107, France
Centre Hospitalier Auxerre
Auxerre, 89000, France
Institut Sainte Catherine
Avignon, 84918, France
Centre Hospitalier de la cote Basque
Bayonne, 64100, France
Chru Besancon
Besançon, 25030, France
Clinique Tivoli-Ducos
Bordeaux, 33000, France
CHU de Bordeaux - Hopital Saint Andre
Bordeaux, 33075, France
Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier de Boulogne Sur Mer
Boulogne-sur-Mer, 62321, France
Centre Hospitalier Regional Universitaire de Brest
Brest, 29200, France
Clinique Pasteur - Lanroze
Brest, 29200, France
Hopital Louis Pradel
Bron, 69677, France
CENTRE HOSPITALIER Dr Jean-Eric TECHER
Calais, 62107, France
Medipole de Savoie
Challes-les-Eaux, 73190, France
Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin
Clermont-Ferrand, 63011, France
Centre Hospitalier Universitaire Gabriel Montpied
Clermont-Ferrand, 63011, France
Pole Sante Republique
Clermont-Ferrand, 63050, France
Polyclinique Saint Come
Compiègne, 60200, France
Clinique de Flandre
Coudekerque-Branche, 59210, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010, France
Centre Leonard de Vinci
Dechy, 59187, France
Clinique Clement Drevon
Dijon, 21000, France
Centre Hospitalier Intercommunal Louviers
Elbeuf, 76503, France
Centre Hospitalier Annecy Genevois
Epargny METZ Tessy, 74370, France
Clinique Du Mousseau
Évry, 91035, France
Chi Frejus - Saint Raphael
Fréjus, 83608, France
Chi Alpes Du Sud
Gap, 5000, France
Centre Hospitalier de Grenoble
Greboble, 38043, France
Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard
Grenoble, 38000, France
Centre Hospitalier Haguenau
Haguenau, 67500, France
Polyclinique de Blois
La Chaussée-Saint-Victor, 41260, France
La Roche Sur Yon - Centre Hospitalier Departemetal Vendee
La Roche-sur-Yon, 85960, France
Groupe Hospitalier La Rochelle - Re - Aunis
La Rochelle, 17019, France
Clinique Victor Hugo
Le Mans, 72015, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
Polyclinique Du Bois
Lille, 59004, France
Clinique de la Louvière
Lille, 59042, France
Chu Dupuytren Service Oncologie
Limoges, 87000, France
Polyclinique de LIMOGE-Clinique François CHENIEUX
Limoges, 87039, France
Centre Hospitalier Jura Sud
Lons-le-Saunier, 39000, France
Centre Hospitalier Bretagne Sud
Lorient, 56322, France
Clinique de la Sauvegarde
Lyon, 69337, France
Centre Leon Berard
Lyon, 69373, France
Hopital Europeen
Marseille, 13003, France
Hopital de La Timone
Marseille, 13385, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295, France
Hopital prive Arnault Tzanck
Mougins, 06254, France
Centre D'Oncologie de Gentilly
Nancy, 54100, France
Hopital prive du Confluent S.A.S
Nantes, 44277, France
Clinique Saint Georges
Nice, 06105, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut de Cancerologie Du Gard
Nîmes, 30900, France
ONCOGARD
Nîmes, 30900, France
Hopital Prive Sainte Marie
Osny, 95520, France
Hopital Saint-Louis
Paris, 75010, France
Hopital Pitie Salpetriere
Paris, 75013, France
Hopital Cochin/Unité de Cancerologie
Paris, 75014, France
Groupe Hospitalier Diaconesse La Croix Saint Simon
Paris, 75020, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Polyclinique Marzet
Pau, 64001, France
Centre Hospitalier de Cornouaille
Quimper, 29107, France
Institut Jean Godinot
Reims, 51056, France
Centre Hopistalier Roanne
Roanne, 42300, France
Ch Roubais
Roubaix, 59100, France
Clinique Mathilde
Rouen, 76100, France
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, 35768, France
Hia Begin
Saint-Mandé, 94160, France
Clinique mutualiste de l Estuaire
Saint-Nazaire, 44606, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Centre Hospitalier de Soissons
Soissons, 02200, France
Clinique Sainte Anne
Strasbourg, 67000, France
ICANS - Institut de cancerologie Strasbourg Europe
Strasbourg, 67200, France
Hopital Foch
Suresnes, 92151, France
Hia Sainte Anne
Toulon, 83041, France
IUCT - Oncopole
Toulouse, 31059, France
Centre Alexis VAUTRIN
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 30, 2021
Study Start
July 13, 2021
Primary Completion
April 25, 2024
Study Completion
April 25, 2024
Last Updated
April 2, 2026
Results First Posted
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.