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

Pfizer

Status: Completed

Conditions: Urothelial Carcinoma

Treatments: Drug: Avelumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04822350

B9991045

NCT04822350 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 599 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

599 participants in 1 patient group

Locally advanced or metastatic urothelial carcinoma patients treated with avelumab

Treatment:

Drug: Avelumab