A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer

Study Overview
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Brief Summary
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The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer. This study is including participants who: Participated in the Canadian avelumab patient support program Have been diagnosed with advanced bladder cancer Have been treated with platinum-based chemotherapy without their disease progressing All participants in this study have previously received avelumab first-line maintenance for the treatment of their advanced bladder cancer. Pfizer will examine the experiences of people receiving the study medicine. This will help determine the efficacy and safety of the study medicine for the treatment of bladder cancer.

Detailed Description
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Avelumab was approved by Health Canada in December 2020 for the maintenance treatment of patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) whose disease has not progressed following first-line (1L) platinum-based chemotherapy. As the urothelial carcinoma treatment landscape evolves with novel indications for previously existing medicines and novel agents entering the market, additional insights are needed to assist in guiding treatment decision making. No observational studies of treatment patterns and outcomes for patients in Canada treated with avelumab first-line maintenance (1LM) have been conducted. The purpose of the current study is to conduct an analysis of patient and disease characteristics and treatment patterns to further elucidate the clinical effectiveness and impact of avelumab 1LM therapy for patients with LA/mUC in Canada. The primary research objective is to assess effectiveness outcomes in a clinical setting for Canadian patients with LA/mUC treated with avelumab 1LM therapy, specifically overall survival (OS) from the date of avelumab 1LM initiation to the date of death from any cause and progression-free survival (PFS) from the date of avelumab 1LM initiation to the date of progression or death from any cause. Selected secondary objectives include describing treatment patterns, describe AEs explicitly attributed to avelumab among patients with LA/mUC treated with avelumab 1LM and response rates from date of avelumab 1LM initiation, and separately, from the date of chemotherapy initiation, and duration of response (DOR) from date of best overall response in each line of therapy.

Official Title
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Treatment Effectiveness of Avelumab First-Line Maintenance Among Canadian Patients With Advanced Urothelial Carcinoma (TRAVELER)

Conditions
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Urinary Bladder Neoplasms, Bladder Cancer, Bladder Tumors, Urothelial Carcinoma

Intervention / Treatment
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* Drug: Avelumab first-line maintenance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the Canadian avelumab1LM Patient support program (PSP) Histologically confirmed diagnosis of stage IV LA/mUC No evidence of disease progression following first-line platinum-based chemotherapy Receipt of avelumab1LM following 1L platinum-based chemotherapy Received the last dose of chemotherapy no more than 10 weeks before entering the PSP Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 ≥6 months of follow-up from initiation of AVE 1LM therapy until study end date, unless the patient has died, with known date of death. Exclusion Criteria: Diagnosed with LA/mUC and enrolled in the PSP, but did not receive avelumab Pregnancy at index date Participation in an interventional clinical trial at any point during the study period The index date will be considered as the initiation of index therapy. The index therapy will be considered as the avelumab 1LM treatment after 1L platinum-based chemotherapy.

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 |
| --- | --- |
| Canadian Patients with Advanced Urothelial Carcinoma<br>Patients with LA/mUC who following 4-6 cycles of platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight intravenously administered over 60 minutes every 2 weeks | Drug: Avelumab first-line maintenance<br>* Patients with LA/mUC who following 4-6 cycles platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight, intravenously administered over 60 minutes every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS from the date of avelumab initiation to the date of death from any cause | 12 months | 
| Progression-free survival | Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events explicitly attributed to avelumab | Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM | 12 months | 
| Response rate | Response rate from date of AVE 1LM initiation, and separately, from the date of chemotherapy initiation, and DOR from date of best overall response in each line of therapy | 12 months | 
| Description of patient characteristics |  | 12 months | 
| Overall survival from the date of chemotherapy initiation to the date of death from any cause | OS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of death from any cause | 12 months | 
| Progression-free survival from the date of chemotherapy initiation to the date of progression or death from any cause | PFS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of progression or death from any cause | 12 months | 
| First-Line therapy description | First-line therapy type, dose, number of cycles, switching and discontinuations | 12 months | 
| Time to post-diagnostic imaging | Time to post-diagnostic imaging | 12 months | 
| Time to treatment discontinuation | Time to treatment discontinuation | 12 months | 
| Time to initiation of AVE 1LM following last dose of chemotherapy | Time to initiation of AVE 1LM following last dose of chemotherapy | 12 months | 
| Treatment duration of AVE 1LM | Treatment duration of AVE 1LM | 12 months | 
| Time to next treatment | Time to next treatment | 12 months | 
| Reasons for treatment discontinuation | Reasons for treatment discontinuation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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avelumab, Bladder Tumors, Cancer of Bladder, Cancer of the Bladder, Malignant Tumor of Urinary Bladder, Neoplasms, Bladder, Urinary Bladder Cancer, Metastatic bladder cancer, Locally advanced bladder cancer, Urothelial carcinoma, Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma, avelumab maintenance, Canada bladder cancer, Non-interventional study, Bladder Cancer, Bladder Neoplasms