Brief Title
A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
Official 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
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.
Study Type
Observational
Primary Outcome
overall survival
Secondary Outcome
overall Survival from the start of the chemotherapy used in 1st line
Condition
Urothelial Carcinoma
Intervention
Avelumab
Study Arms / Comparison Groups
Locally advanced or metastatic urothelial carcinoma patients treated with avelumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
600
Start Date
July 13, 2021
Completion Date
June 30, 2024
Primary Completion Date
June 30, 2024
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04822350
Organization ID
B9991045
Responsible Party
Sponsor
Study Sponsor
Pfizer
Collaborators
Merck KGaA, Darmstadt, Germany
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
January 2023