Clinical trial NCT04822350: A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Keywords: Avelumab
Non-interventional study
Effectiveness
France
Maintenance
Immunotherapy
Bladder cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2021-03-30
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic Urothelial Carcinoma treated with avelumab as a maintenance treatment

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.


Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: Avelumab initiation up to 4 years
Secondary outcomes:
measure: overall Survival from the start of the chemotherapy used in 1st line
timeFrame: 1st line Chemotherapy start up to 4 years
measure: Progression free survival 1
timeFrame: Avelumab initiation up to 4 years
measure: Progression free survival 2
timeFrame: Avelumab initiation up to 4 years
measure: overall response rate
timeFrame: Avelumab initiation up to 4 years
measure: duration of response
timeFrame: Beginning of response up to 4 years
measure: duration of treatment
timeFrame: Avelumab initiation up to 4 years
measure: Patterns of progression under avelumab
timeFrame: Avelumab initiation up to 4 years
measure: Adverse events (AEs) reporting
timeFrame: Avelumab initiation up to 4 years
measure: Premedications (acetaminophen and antihistamine)
timeFrame: Avelumab initiation up to 4 years
measure: Patient reported outcome
timeFrame: Initiation of avelumab, 6 weeks, 3 months, and every three months for up to 2 years
measure: Overall response rate on subsequent treatments
timeFrame: Discontinuation of avelumab up to 4 years
measure: Duration of subsequent treatments
timeFrame: Discontinuation of avelumab up to 4 years
measure: Progression free survival on subsequent treatments
timeFrame: Discontinuation of avelumab up to 4 years
measure: Overall survival on subsequent treatments
timeFrame: Discontinuation of avelumab up to 4 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Charles Nicolle
state: Haute-normandie
city: Nantes
country: France
facility: CHU Nantes
state: PAYS DE LA Loire
city: Aix-en-provence
country: France
facility: Centre Hospitalier du Pays d AIX
city: Amiens Cedex 1
country: France
facility: CHU Amiens-Picardie
city: Argenteuil Cedex
country: France
facility: Centre Hospitalier Victor Dupouy
city: Auxerre
country: France
facility: Centre Hospitalier Auxerre
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: Centre Hospitalier de la cote Basque
city: Besancon Cedex
country: France
facility: Chru Besancon
city: Bordeaux cedex
country: France
facility: CHU de Bordeaux - Hopital Saint Andre
city: Bordeaux cedex
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: BOULOGNE SUR MER Cedex
country: France
facility: Centre Hospitalier de Boulogne Sur Mer
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire de Brest
city: Brest
country: France
facility: Clinique Pasteur - Lanroze
city: Bron Cedex
country: France
facility: Hopital Louis Pradel
city: Calais
country: France
facility: CENTRE HOSPITALIER Dr Jean-Eric TECHER
city: Challes Les Eaux
country: France
facility: Medipole de Savoie
city: Clermont Ferrand Cedex 2
country: France
facility: Pole Sante Republique
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Universitaire Gabriel Montpied
city: Clermont-Ferrand cedex 1
country: France
facility: Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin
city: Compiegne Cedex
country: France
facility: Polyclinique Saint Come
city: COUDEKERQUE-BRANCHE cedex
country: France
facility: Clinique de Flandre
city: Créteil Cedex
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Dechy
country: France
facility: Centre Leonard de Vinci
city: Dijon
country: France
facility: Clinique Clement Drevon
city: Elbeuf
country: France
facility: Centre Hospitalier Intercommunal Louviers
city: Epargny METZ Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Evry Cedex
country: France
facility: Clinique Du Mousseau
city: Frejus Cedex
country: France
facility: Chi Frejus - Saint Raphael
city: GAP
country: France
facility: Chi Alpes Du Sud
city: Greboble
country: France
facility: Centre Hospitalier de Grenoble
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard
city: Haguenau
country: France
facility: Centre Hospitalier Haguenau
city: La Chaussee St Victor
country: France
facility: Polyclinique de Blois
city: La Roche Sur Yon
country: France
facility: La Roche Sur Yon - Centre Hospitalier Departemetal Vendee
city: La Rochelle Cedex
country: France
facility: Groupe Hospitalier La Rochelle - Re - Aunis
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Le Puy En Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Lille
country: France
facility: Polyclinique Du Bois
city: Lille
country: France
facility: Clinique de la Louvière
city: Limoges
country: France
facility: Chu Dupuytren Service Oncologie
city: Limoges
country: France
facility: Polyclinique de LIMOGE-Clinique François CHENIEUX
city: Lons le Saunier
country: France
facility: Centre Hospitalier Jura Sud
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Lyon cedex 08
country: France
facility: Centre Leon Berard
city: Lyon Cedex 09
country: France
facility: Clinique de la Sauvegarde
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Hopital de La Timone
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Mougins
country: France
facility: Hopital prive Arnault Tzanck
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly
city: Nantes cedex 2
country: France
facility: Hopital prive du Confluent S.A.S
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Clinique Saint Georges
city: Nimes
country: France
facility: Institut de Cancerologie Du Gard
city: Nimes
country: France
facility: ONCOGARD
city: Osny
country: France
facility: Hopital Prive Sainte Marie
city: Paris Cedex 10
country: France
facility: Hopital Saint-Louis
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Paris
country: France
facility: Hopital Cochin/Unité de Cancerologie
city: Paris
country: France
facility: Groupe Hospitalier Diaconesse La Croix Saint Simon
city: PAU
country: France
facility: Polyclinique Marzet
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Reims
country: France
facility: Institut Jean Godinot
city: Roanne
country: France
facility: Centre Hopistalier Roanne
city: Roubaix
country: France
facility: Ch Roubais
city: Rouen
country: France
facility: Clinique Mathilde
city: Saint Gregoire Cedex
country: France
facility: Centre Hospitalier Prive Saint Gregoire
city: Saint Mande
country: France
facility: Hia Begin
city: Saint Nazaire Cedex
country: France
facility: Clinique mutualiste de l Estuaire
city: Saint Priest en Jarez Cedex
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: ICANS - Institut de cancerologie Strasbourg Europe
city: Suresnes
country: France
facility: Hopital Foch
city: Toulon
country: France
facility: Hia Sainte Anne
city: Toulouse
country: France
facility: IUCT - Oncopole
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis VAUTRIN
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: