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

Study Overview
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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.

Official Title
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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

Conditions
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Urothelial Carcinoma

Intervention / Treatment
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* Drug: Avelumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Locally advanced or metastatic urothelial carcinoma patients treated with avelumab<br> | Drug: Avelumab<br>* As provided in real world practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time between the first injection of avelumab and the date of death from any cause | Avelumab initiation up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| overall response rate | Complete Response or Partial Response as a best response during the avelumab treatment. | Avelumab initiation up to 4 years | 
| duration of response | time between the beginning of the response and progression or death from any cause. | Beginning of response up to 4 years | 
| duration of treatment | time between the first and last dose of avelumab. | Avelumab initiation up to 4 years | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Duration of subsequent treatments | time between the first and last dose of subsequent treatment | Discontinuation of avelumab up to 4 years | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avelumab, Non-interventional study, Effectiveness, France, Maintenance, Immunotherapy, Bladder cancer