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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 599
-
Patient โฅ 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 Victor Dupouy
๐ซ๐ทArgenteuil Cedex, France
CHU Amiens-Picardie
๐ซ๐ทAmiens Cedex 1, France
Centre Hospitalier de la cote Basque
๐ซ๐ทBayonne, France
Institut Bergonie
๐ซ๐ทBordeaux cedex, France
CHU de Bordeaux - Hopital Saint Andre
๐ซ๐ทBordeaux cedex, France
Clinique Du Mousseau
๐ซ๐ทEvry Cedex, France
Centre Hospitalier de Grenoble
๐ซ๐ทGreboble, France
Hopital prive du Confluent S.A.S
๐ซ๐ทNantes cedex 2, France
Centre Hospitalier Prive Saint Gregoire
๐ซ๐ทSaint Gregoire Cedex, France
Centre Hospitalier de Cornouaille
๐ซ๐ทQuimper, France
Hopital Pitie Salpetriere
๐ซ๐ทParis, France
Ch Roubais
๐ซ๐ทRoubaix, France
Hia Begin
๐ซ๐ทSaint Mande, France
Centre Hospitalier de Soissons
๐ซ๐ทSoissons, France
Clinique Sainte Anne
๐ซ๐ทStrasbourg, France
Hopital Foch
๐ซ๐ทSuresnes, France
Institut Gustave Roussy
๐ซ๐ทVillejuif Cedex, France
ICANS - Institut de cancerologie Strasbourg Europe
๐ซ๐ทStrasbourg, France
CHU Charles Nicolle
๐ซ๐ทRouen, Haute-normandie, France
Centre Hospitalier de Boulogne Sur Mer
๐ซ๐ทBOULOGNE SUR MER Cedex, France
CHU Nantes
๐ซ๐ทNantes, PAYS DE LA Loire, France
Centre Hospitalier du Pays d AIX
๐ซ๐ทAix-en-provence, France
Centre Hospitalier Auxerre
๐ซ๐ทAuxerre, France
Clinique Tivoli-Ducos
๐ซ๐ทBordeaux, France
Hopital Louis Pradel
๐ซ๐ทBron Cedex, France
Institut Sainte Catherine
๐ซ๐ทAvignon, Cedex 9, France
Clinique Pasteur - Lanroze
๐ซ๐ทBrest, France
Centre Hospitalier Regional Universitaire de Brest
๐ซ๐ทBrest, France
Chru Besancon
๐ซ๐ทBesancon Cedex, France
Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin
๐ซ๐ทLille, France
Polyclinique Saint Come
๐ซ๐ทCompiegne Cedex, France
Clinique de Flandre
๐ซ๐ทCOUDEKERQUE-BRANCHE cedex, France
Centre Hospitalier Intercommunal de Creteil
๐ซ๐ทCrรฉteil Cedex, France
Centre Leonard de Vinci
๐ซ๐ทDechy, France
CENTRE HOSPITALIER Dr Jean-Eric TECHER
๐ซ๐ทCalais, France
Medipole de Savoie
๐ซ๐ทChalles Les Eaux, France
Centre Hospitalier Universitaire Gabriel Montpied
๐ซ๐ทClermont Ferrand, France
Clinique Clement Drevon
๐ซ๐ทDijon, France
Centre Hospitalier Intercommunal Louviers
๐ซ๐ทElbeuf, France
Centre Hospitalier Annecy Genevois
๐ซ๐ทEpargny METZ Tessy, France
Chi Frejus - Saint Raphael
๐ซ๐ทFrejus Cedex, France
Chi Alpes Du Sud
๐ซ๐ทGAP, France
Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard
๐ซ๐ทGrenoble, France
Centre Hospitalier Haguenau
๐ซ๐ทHaguenau, France
Polyclinique de Blois
๐ซ๐ทLa Chaussee St Victor, France
La Roche Sur Yon - Centre Hospitalier Departemetal Vendee
๐ซ๐ทLa Roche Sur Yon, France
Clinique Victor Hugo
๐ซ๐ทLe Mans, France
Polyclinique Du Bois
๐ซ๐ทLille, France
Clinique de la Louviรจre
๐ซ๐ทLille, France
Chu Dupuytren Service Oncologie
๐ซ๐ทLimoges, France
Polyclinique de LIMOGE-Clinique Franรงois CHENIEUX
๐ซ๐ทLimoges, France
Centre Hospitalier Jura Sud
๐ซ๐ทLons le Saunier, France
Centre Hospitalier Bretagne Sud
๐ซ๐ทLorient, France
Centre Leon Berard
๐ซ๐ทLyon cedex 08, France
Clinique de la Sauvegarde
๐ซ๐ทLyon Cedex 09, France
Hopital Europeen
๐ซ๐ทMarseille, France
Hopital de La Timone
๐ซ๐ทMarseille, France
Centre Hospitalier Universitaire de Montpellier
๐ซ๐ทMontpellier, France
Centre D'Oncologie de Gentilly
๐ซ๐ทNancy, France
Centre Antoine Lacassagne
๐ซ๐ทNice cedex 2, France
Hopital Prive Sainte Marie
๐ซ๐ทOsny, France
Polyclinique Marzet
๐ซ๐ทPAU, France
Centre Hopistalier Roanne
๐ซ๐ทRoanne, France
Clinique mutualiste de l Estuaire
๐ซ๐ทSaint Nazaire Cedex, France
Institut de Cancรฉrologie Lucien Neuwirth
๐ซ๐ทSaint Priest en Jarez Cedex, France
Hia Sainte Anne
๐ซ๐ทToulon, France
Centre Alexis VAUTRIN
๐ซ๐ทVandoeuvre Les Nancy, France
IUCT - Oncopole
๐ซ๐ทToulouse, France
Pole Sante Republique
๐ซ๐ทClermont Ferrand Cedex 2, France
Groupe Hospitalier La Rochelle - Re - Aunis
๐ซ๐ทLa Rochelle Cedex, France
Centre Hospitalier Emile Roux
๐ซ๐ทLe Puy En Velay, France
Clinique Saint Georges
๐ซ๐ทNice, France
Hopital prive Arnault Tzanck
๐ซ๐ทMougins, France
Institut de Cancerologie Du Gard
๐ซ๐ทNimes, France
ONCOGARD
๐ซ๐ทNimes, France
Hopital Europeen Georges Pompidou
๐ซ๐ทParis Cedex 15, France
Hopital Cochin/Unitรฉ de Cancerologie
๐ซ๐ทParis, France
Hopital Saint-Louis
๐ซ๐ทParis Cedex 10, France
Groupe Hospitalier Diaconesse La Croix Saint Simon
๐ซ๐ทParis, France
Institut Jean Godinot
๐ซ๐ทReims, France
Clinique Mathilde
๐ซ๐ทRouen, France