A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
- Registration Number
- NCT04822350
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 599
-
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.
- 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.
-
Patient benefiting from a social security scheme according to local regulations
- For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
- Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Locally advanced or metastatic urothelial carcinoma patients treated with avelumab Avelumab -
- Primary Outcome Measures
Name Time Method overall survival Avelumab initiation up to 4 years time between the first injection of avelumab and the date of death from any cause
- Secondary Outcome Measures
Name Time Method Overall response rate on subsequent treatments Discontinuation of avelumab up to 4 years Complete Response or Partial Response as a best response during the subsequent treatments
Overall survival on subsequent treatments Discontinuation of avelumab up to 4 years time between the first dose of subsequent treatment and the date of death from any cause
overall Survival from the start of the chemotherapy used in 1st line 1st line Chemotherapy start up to 4 years time between the first injection of the chemotherapy used in 1st line and the date of death from any cause.
Progression free survival 1 Avelumab initiation up to 4 years time between the first injection of avelumab and the date of progression or death from any cause.
duration of treatment Avelumab initiation up to 4 years time between the first and last dose of avelumab.
Patient reported outcome Initiation of avelumab, 6 weeks, 3 months, and every three months for up to 2 years Evolution of PROs NCCN/FACT FBlSI-18 and EQ-5D-5L scores during avelumab treatment.
Duration of subsequent treatments Discontinuation of avelumab up to 4 years time between the first and last dose of subsequent treatment
Progression free survival 2 Avelumab initiation up to 4 years time between the first injection of avelumab and the date of progression or death from any cause during the 2nd line of treatment post-avelumab.
duration of response Beginning of response up to 4 years time between the beginning of the response and progression or death from any cause.
Patterns of progression under avelumab Avelumab initiation up to 4 years Metastatic sites and type of progression (new lesion(s)/progression of known lesion(s)).
Adverse events (AEs) reporting Avelumab initiation up to 4 years Adverse events (AEs) of any type, grade 3-4 AEs, AEs leading to interruption or discontinuation, AEs leading to death.
Premedications (acetaminophen and antihistamine) Avelumab initiation up to 4 years Proportion of patients who received a premedication at each injection of avelumab. Median number of cycles with premedication.
overall response rate Avelumab initiation up to 4 years Complete Response or Partial Response as a best response during the avelumab treatment.
Progression free survival on subsequent treatments Discontinuation of avelumab up to 4 years time between the first dose of subsequent treatment and the date of progression or death from any cause
Trial Locations
- Locations (81)
Centre Hospitalier de Boulogne Sur Mer
🇫🇷BOULOGNE SUR MER Cedex, France
Hopital Louis Pradel
🇫🇷Bron Cedex, France
Medipole de Savoie
🇫🇷Challes Les Eaux, France
Centre Hospitalier Universitaire Gabriel Montpied
🇫🇷Clermont Ferrand, France
Polyclinique Saint Come
🇫🇷Compiegne Cedex, France
Centre Hospitalier Auxerre
🇫🇷Auxerre, France
Pole Sante Republique
🇫🇷Clermont Ferrand Cedex 2, France
Institut Bergonie
🇫🇷Bordeaux cedex, France
Clinique Tivoli-Ducos
🇫🇷Bordeaux, France
Centre Hospitalier Regional Universitaire de Brest
🇫🇷Brest, France
Clinique Pasteur - Lanroze
🇫🇷Brest, France
CHU de Bordeaux - Hopital Saint Andre
🇫🇷Bordeaux cedex, France
CHU Charles Nicolle
🇫🇷Rouen, Haute-normandie, France
Centre Hospitalier du Pays d AIX
🇫🇷Aix-en-provence, France
Chru Besancon
🇫🇷Besancon Cedex, France
CENTRE HOSPITALIER Dr Jean-Eric TECHER
🇫🇷Calais, France
Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin
🇫🇷Clermont-Ferrand cedex 1, France
Centre Hospitalier Intercommunal de Creteil
🇫🇷Créteil Cedex, France
CHU Nantes
🇫🇷Nantes, PAYS DE LA Loire, France
CHU Amiens-Picardie
🇫🇷Amiens Cedex 1, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil Cedex, France
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Hospitalier de la cote Basque
🇫🇷Bayonne, France
Clinique de Flandre
🇫🇷COUDEKERQUE-BRANCHE cedex, France
Clinique Clement Drevon
🇫🇷Dijon, France
Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard
🇫🇷Grenoble, France
Centre Hospitalier Haguenau
🇫🇷Haguenau, France
Polyclinique de Blois
🇫🇷La Chaussee St Victor, France
La Roche Sur Yon - Centre Hospitalier Departemetal Vendee
🇫🇷La Roche Sur Yon, France
Groupe Hospitalier La Rochelle - Re - Aunis
🇫🇷La Rochelle Cedex, France
Centre Hospitalier Emile Roux
🇫🇷Le Puy En Velay, France
Centre Leonard de Vinci
🇫🇷Dechy, France
Centre Hospitalier Intercommunal Louviers
🇫🇷Elbeuf, France
Centre Hospitalier Annecy Genevois
🇫🇷Epargny METZ Tessy, France
Clinique Du Mousseau
🇫🇷Evry Cedex, France
Chi Frejus - Saint Raphael
🇫🇷Frejus Cedex, France
Chi Alpes Du Sud
🇫🇷GAP, France
Centre Hospitalier de Grenoble
🇫🇷Greboble, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Clinique de la Louvière
🇫🇷Lille, France
Chu Dupuytren Service Oncologie
🇫🇷Limoges, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Polyclinique Du Bois
🇫🇷Lille, France
Polyclinique de LIMOGE-Clinique François CHENIEUX
🇫🇷Limoges, France
Centre Hospitalier Jura Sud
🇫🇷Lons le Saunier, France
Centre Hospitalier Bretagne Sud
🇫🇷Lorient, France
Centre Leon Berard
🇫🇷Lyon cedex 08, France
Clinique de la Sauvegarde
🇫🇷Lyon Cedex 09, France
Hopital Europeen
🇫🇷Marseille, France
Hopital de La Timone
🇫🇷Marseille, France
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier, France
Hopital prive Arnault Tzanck
🇫🇷Mougins, France
Centre D'Oncologie de Gentilly
🇫🇷Nancy, France
Hopital prive du Confluent S.A.S
🇫🇷Nantes cedex 2, France
Centre Antoine Lacassagne
🇫🇷Nice cedex 2, France
Clinique Saint Georges
🇫🇷Nice, France
Institut de Cancerologie Du Gard
🇫🇷Nimes, France
ONCOGARD
🇫🇷Nimes, France
Hopital Prive Sainte Marie
🇫🇷Osny, France
Hopital Saint-Louis
🇫🇷Paris Cedex 10, France
Hopital Europeen Georges Pompidou
🇫🇷Paris Cedex 15, France
Hopital Pitie Salpetriere
🇫🇷Paris, France
Hopital Cochin/Unité de Cancerologie
🇫🇷Paris, France
Groupe Hospitalier Diaconesse La Croix Saint Simon
🇫🇷Paris, France
Polyclinique Marzet
🇫🇷PAU, France
Centre Hospitalier de Cornouaille
🇫🇷Quimper, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Hopistalier Roanne
🇫🇷Roanne, France
Ch Roubais
🇫🇷Roubaix, France
Clinique Mathilde
🇫🇷Rouen, France
Centre Hospitalier Prive Saint Gregoire
🇫🇷Saint Gregoire Cedex, France
Hia Begin
🇫🇷Saint Mande, France
Clinique mutualiste de l Estuaire
🇫🇷Saint Nazaire Cedex, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint Priest en Jarez Cedex, France
Centre Hospitalier de Soissons
🇫🇷Soissons, France
Clinique Sainte Anne
🇫🇷Strasbourg, France
ICANS - Institut de cancerologie Strasbourg Europe
🇫🇷Strasbourg, France
Hopital Foch
🇫🇷Suresnes, France
Hia Sainte Anne
🇫🇷Toulon, France
IUCT - Oncopole
🇫🇷Toulouse, France
Centre Alexis VAUTRIN
🇫🇷Vandoeuvre Les Nancy, France