Status:
COMPLETED
A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT04822350
Start Date
July 13 2021
End Date
April 25 2024
Last Update
January 27 2025
Active Locations (81)
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1
CHU Charles Nicolle
Rouen, Haute-normandie, France, 76031
2
CHU Nantes
Nantes, Pays de la Loire Region, France, 44093
3
Centre Hospitalier du Pays d AIX
Aix-en-Provence, France, 13100
4
CHU Amiens-Picardie
Amiens, France, 80054