Urothelial Carcinoma Clinical Trial
— AVENANCEOfficial 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
| Verified date | January 2024 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 584 |
| Est. completion date | June 30, 2024 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier du Pays d AIX | Aix-en-provence | |
| France | CHU Amiens-Picardie | Amiens Cedex 1 | |
| France | Centre Hospitalier Victor Dupouy | Argenteuil Cedex | |
| France | Centre Hospitalier Auxerre | Auxerre | |
| France | Institut Sainte Catherine | Avignon, Cedex 9 | |
| France | Centre Hospitalier de la cote Basque | Bayonne | |
| France | Chru Besancon | Besancon Cedex | |
| France | Clinique Tivoli-Ducos | Bordeaux | |
| France | CHU de Bordeaux - Hopital Saint Andre | Bordeaux cedex | |
| France | Institut Bergonie | Bordeaux cedex | |
| France | Centre Hospitalier de Boulogne Sur Mer | BOULOGNE SUR MER Cedex | |
| France | Centre Hospitalier Regional Universitaire de Brest | Brest | |
| France | Clinique Pasteur - Lanroze | Brest | |
| France | Hopital Louis Pradel | Bron Cedex | |
| France | CENTRE HOSPITALIER Dr Jean-Eric TECHER | Calais | |
| France | Medipole de Savoie | Challes Les Eaux | |
| France | Centre Hospitalier Universitaire Gabriel Montpied | Clermont Ferrand | |
| France | Pole Sante Republique | Clermont Ferrand Cedex 2 | |
| France | Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin | Clermont-Ferrand cedex 1 | |
| France | Polyclinique Saint Come | Compiegne Cedex | |
| France | Clinique de Flandre | COUDEKERQUE-BRANCHE cedex | |
| France | Centre Hospitalier Intercommunal de Creteil | Créteil Cedex | |
| France | Centre Leonard de Vinci | Dechy | |
| France | Clinique Clement Drevon | Dijon | |
| 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 | 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 | Clinique Victor Hugo | Le Mans | |
| France | Centre Hospitalier Emile Roux | Le Puy En Velay | |
| France | Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin | Lille | |
| France | Clinique de la Louvière | Lille | |
| France | Polyclinique Du Bois | Lille | |
| France | Chu Dupuytren Service Oncologie | Limoges | |
| 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 de La Timone | Marseille | |
| France | Hopital Europeen | Marseille | |
| France | Centre Hospitalier Universitaire de Montpellier | Montpellier | |
| France | Hopital prive Arnault Tzanck | Mougins | |
| France | Centre D'Oncologie de Gentilly | Nancy | |
| France | CHU Nantes | Nantes | PAYS DE LA Loire |
| France | Hopital prive du Confluent S.A.S | Nantes cedex 2 | |
| France | Clinique Saint Georges | Nice | |
| France | Centre Antoine Lacassagne | Nice cedex 2 | |
| France | Institut de Cancerologie Du Gard | Nimes | |
| France | ONCOGARD | Nimes | |
| France | Hopital Prive Sainte Marie | Osny | |
| France | Groupe Hospitalier Diaconesse La Croix Saint Simon | Paris | |
| France | Hopital Cochin/Unité de Cancerologie | Paris | |
| France | Hopital Pitie Salpetriere | Paris | |
| France | Hopital Saint-Louis | Paris Cedex 10 | |
| France | Hopital Europeen Georges Pompidou | Paris Cedex 15 | |
| 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 | CHU Charles Nicolle | Rouen | Haute-normandie |
| 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 | Institut Gustave Roussy | Villejuif Cedex |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Merck KGaA, Darmstadt, Germany |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival | time between the first injection of avelumab and the date of death from any cause | Avelumab initiation up to 4 years | |
| Secondary | overall Survival from the start of the chemotherapy used in 1st line | time between the first injection of the chemotherapy used in 1st line and the date of death from any cause. | 1st line Chemotherapy start up to 4 years | |
| Secondary | Progression free survival 1 | time between the first injection of avelumab and the date of progression or death from any cause. | Avelumab initiation up to 4 years | |
| Secondary | Progression free survival 2 | 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. | Avelumab initiation up to 4 years | |
| Secondary | overall response rate | Complete Response or Partial Response as a best response during the avelumab treatment. | Avelumab initiation up to 4 years | |
| Secondary | duration of response | time between the beginning of the response and progression or death from any cause. | Beginning of response up to 4 years | |
| Secondary | duration of treatment | time between the first and last dose of avelumab. | Avelumab initiation up to 4 years | |
| Secondary | Patterns of progression under avelumab | Metastatic sites and type of progression (new lesion(s)/progression of known lesion(s)). | Avelumab initiation up to 4 years | |
| Secondary | Adverse events (AEs) reporting | Adverse events (AEs) of any type, grade 3-4 AEs, AEs leading to interruption or discontinuation, AEs leading to death. | Avelumab initiation up to 4 years | |
| Secondary | Premedications (acetaminophen and antihistamine) | Proportion of patients who received a premedication at each injection of avelumab. Median number of cycles with premedication. | Avelumab initiation up to 4 years | |
| Secondary | Patient reported outcome | Evolution of PROs NCCN/FACT FBlSI-18 and EQ-5D-5L scores during avelumab treatment. | Initiation of avelumab, 6 weeks, 3 months, and every three months for up to 2 years | |
| Secondary | Overall response rate on subsequent treatments | Complete Response or Partial Response as a best response during the subsequent treatments | Discontinuation of avelumab up to 4 years | |
| Secondary | Duration of subsequent treatments | time between the first and last dose of subsequent treatment | Discontinuation of avelumab up to 4 years | |
| Secondary | Progression free survival on subsequent treatments | time between the first dose of subsequent treatment and the date of progression or death from any cause | Discontinuation of avelumab up to 4 years | |
| Secondary | Overall survival on subsequent treatments | time between the first dose of subsequent treatment and the date of death from any cause | Discontinuation of avelumab up to 4 years |
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