SOGUG-AVELUMAB_RWD

Study Overview
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Brief Summary
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The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first line maintenance therapy in patients with locally advanced or metastatic Urothelial Carcinoma, who have not progressed after first line platinum-based treatment. Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients. Patients understanding the nature of the study by providing their informed consent prior to participation. Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease before first line with carboplatin/cisplatin-based chemotherapy. No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor with a treatment free interval of 4-10 weeks before Avelumab initiation date. Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).

Detailed Description
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Multicentre, observational, ambispective (retrospective and prospective) study to evaluate the real-world evidence of Avelumab as maintenance therapy in patients diagnosed with Urothelial Carcinoma (WHO classification) and previously treated with platinum-based treatment in first line. Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients. Patients are selected based on the existing medical record of have been treated with Avelumab as maintenance therapy in first line before initiating the study (retrospective data); patients who continues receiving Avelumab after inclusion will also contribute to data collection until the end of treatment or end of study (prospective data). According to mUC incidence and the selective inclusion criteria from this study of having initiated Avelumab as maintenance therapy in 1L between EMA approval date (Jan. 2021) and date of national reimbursement prize (Apr.2022), which is a narrow period of time to recruit the necessary number of candidates, therefore, prospective data from each participant patient will be a key to ensure the assessment of the study objective eventually. Investigators will review the medical history of patients treated or under treatment of Avelumab and select chronologically those who matches the inclusion criteria. Patients will be informed during a regular follow up visit about the nature of the study and requested to sign the patient consent form once the decision of participating is made. At this point, the retrospective data from patients is collected (such as demographics, toxicity, anthropometrics, vital signs, comorbidities, hemogram, dosage modification etc.) previous adverse reactions (ARs) and serious adverse reaction (SARs) related to Avelumab. Included patients, that continues under Avelumab treatment will be monitored by investigators and prospective data from them will be collected during follow up visits and/or from electronic medical records (eMR). Deceased patient who fulfils the inclusion criteria can be also included, being able to access to its clinical data at the beginning of the study according to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) and the Spanish Organic Law 3/2018 of 5th December, on the protection of personal data and digital rights. Additionally, the investigator team will consult in the eMR of deceased patients to ensure that they did not express in life opposition to the use of their data for investigational purposes.

Official Title
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Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study

Conditions
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Metastatic Urothelial Carcinoma

Intervention / Treatment
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* Drug: Avelumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients understanding the nature of the study by providing their informed consent prior to participation. Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease (AJCC ed. 8th, 2017) before first line with carboplatin/cisplatin-based chemotherapy (ChT). No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor (RECIST 1.1) with a treatment free interval of 4-10 weeks before Avelumab initiation date. Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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

| Intervention/Treatment |
| --- |
|Drug: Avelumab|Single Group Assignment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression free survival (mPFS) | median time for patients from treatment initiation with Bavencio® to the date of real world progression event or death due to any cause. Patients without a real-world progression event or date of death will be censored at the most recent visit with the treating oncologist or end of follow up. | Throughout the study period. Approximately 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall survival (mOS) | median length of the time from the date patient initiates treatment with Bavencio® to the date of death. Patients not dead will be censored at the most recent visit with the treating oncologist or end of follow up. | Throughout the study period. Approximately 8 months | 
| Progression free survival rate at 12 months (PFS12) | percentage of alive patients and progression free 12 month after treatment initiation with Bavencio®. Patients without a real-world progression event or date of death will be censored at month 12th. | Throughout the study period. Approximately 8 months | 
| Collection of any adverse reaction (AR) or serious adverse reaction (SAR) | Collection of any adverse reaction (AR) or serious adverse reaction (SAR) occurring during treatment period (retrospective and prospective). | Throughout the study period. Approximately 8 months | 
| Collection of any adverse event (AE) or serious adverse event (SAE) | Collection of any adverse event (AE) or serious adverse event (SAE) during prospective data collection. Immune check points inhibitors have unique side effects known as immune-related adverse event (irAE) that along with the treatment related AE (TRAE) are of interest to the study (3, 4). | Throughout the study period. Approximately 8 months |