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

NCT ID: NCT04822350

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

599 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-13

Study Completion Date

2024-04-25

Brief Summary

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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

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Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Locally advanced or metastatic urothelial carcinoma patients treated with avelumab

Avelumab

Intervention Type DRUG

As provided in real world practice

Interventions

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Avelumab

As provided in real world practice

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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CHU Charles Nicolle

Rouen, Haute-normandie, France

Site Status

CHU Nantes

Nantes, Pays de la Loire Region, France

Site Status

Centre Hospitalier du Pays d AIX

Aix-en-Provence, , France

Site Status

CHU Amiens-Picardie

Amiens, , France

Site Status

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Site Status

Centre Hospitalier Auxerre

Auxerre, , France

Site Status

Institut Sainte Catherine

Avignon, , France

Site Status

Centre Hospitalier de la cote Basque

Bayonne, , France

Site Status

Chru Besancon

Besançon, , France

Site Status

Clinique Tivoli-Ducos

Bordeaux, , France

Site Status

CHU de Bordeaux - Hopital Saint Andre

Bordeaux, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Centre Hospitalier de Boulogne Sur Mer

Boulogne-sur-Mer, , France

Site Status

Centre Hospitalier Regional Universitaire de Brest

Brest, , France

Site Status

Clinique Pasteur - Lanroze

Brest, , France

Site Status

Hopital Louis Pradel

Bron, , France

Site Status

CENTRE HOSPITALIER Dr Jean-Eric TECHER

Calais, , France

Site Status

Medipole de Savoie

Challes-les-Eaux, , France

Site Status

Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Universitaire Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Pole Sante Republique

Clermont-Ferrand, , France

Site Status

Polyclinique Saint Come

Compiègne, , France

Site Status

Clinique de Flandre

Coudekerque-Branche, , France

Site Status

Centre Hospitalier Intercommunal de Creteil

Créteil, , France

Site Status

Centre Leonard de Vinci

Dechy, , France

Site Status

Clinique Clement Drevon

Dijon, , France

Site Status

Centre Hospitalier Intercommunal Louviers

Elbeuf, , France

Site Status

Centre Hospitalier Annecy Genevois

Epargny METZ Tessy, , France

Site Status

Clinique Du Mousseau

Évry, , France

Site Status

Chi Frejus - Saint Raphael

Fréjus, , France

Site Status

Chi Alpes Du Sud

Gap, , France

Site Status

Centre Hospitalier de Grenoble

Greboble, , France

Site Status

Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard

Grenoble, , France

Site Status

Centre Hospitalier Haguenau

Haguenau, , France

Site Status

Polyclinique de Blois

La Chaussée-Saint-Victor, , France

Site Status

La Roche Sur Yon - Centre Hospitalier Departemetal Vendee

La Roche-sur-Yon, , France

Site Status

Groupe Hospitalier La Rochelle - Re - Aunis

La Rochelle, , France

Site Status

Clinique Victor Hugo

Le Mans, , France

Site Status

Centre Hospitalier Emile Roux

Le Puy-en-Velay, , France

Site Status

Polyclinique Du Bois

Lille, , France

Site Status

Clinique de la Louvière

Lille, , France

Site Status

Chu Dupuytren Service Oncologie

Limoges, , France

Site Status

Polyclinique de LIMOGE-Clinique François CHENIEUX

Limoges, , France

Site Status

Centre Hospitalier Jura Sud

Lons-le-Saunier, , France

Site Status

Centre Hospitalier Bretagne Sud

Lorient, , France

Site Status

Clinique de la Sauvegarde

Lyon, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Hopital Europeen

Marseille, , France

Site Status

Hopital de La Timone

Marseille, , France

Site Status

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status

Hopital prive Arnault Tzanck

Mougins, , France

Site Status

Centre D'Oncologie de Gentilly

Nancy, , France

Site Status

Hopital prive du Confluent S.A.S

Nantes, , France

Site Status

Clinique Saint Georges

Nice, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Institut de Cancerologie Du Gard

Nîmes, , France

Site Status

ONCOGARD

Nîmes, , France

Site Status

Hopital Prive Sainte Marie

Osny, , France

Site Status

Hopital Saint-Louis

Paris, , France

Site Status

Hopital Pitie Salpetriere

Paris, , France

Site Status

Hopital Cochin/Unité de Cancerologie

Paris, , France

Site Status

Groupe Hospitalier Diaconesse La Croix Saint Simon

Paris, , France

Site Status

Hopital Europeen Georges Pompidou

Paris, , France

Site Status

Polyclinique Marzet

Pau, , France

Site Status

Centre Hospitalier de Cornouaille

Quimper, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Centre Hopistalier Roanne

Roanne, , France

Site Status

Ch Roubais

Roubaix, , France

Site Status

Clinique Mathilde

Rouen, , France

Site Status

Centre Hospitalier Prive Saint Gregoire

Saint-Grégoire, , France

Site Status

Hia Begin

Saint-Mandé, , France

Site Status

Clinique mutualiste de l Estuaire

Saint-Nazaire, , France

Site Status

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status

Centre Hospitalier de Soissons

Soissons, , France

Site Status

Clinique Sainte Anne

Strasbourg, , France

Site Status

ICANS - Institut de cancerologie Strasbourg Europe

Strasbourg, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Hia Sainte Anne

Toulon, , France

Site Status

IUCT - Oncopole

Toulouse, , France

Site Status

Centre Alexis VAUTRIN

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B9991045

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

Other Identifiers

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NCT04822350

Identifier Type: REGISTRY

Identifier Source: secondary_id

B9991045

Identifier Type: -

Identifier Source: org_study_id

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