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

NCT ID: NCT05699135

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2023-06-30

Brief Summary

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

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.

Conditions

Urinary Bladder Neoplasms; Bladder Cancer; Bladder Tumors; Urothelial Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Canadian Patients with Advanced Urothelial Carcinoma

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

Avelumab first-line maintenance

Intervention Type: DRUG

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

Interventions

Avelumab first-line maintenance

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Bayshore Specialty Rx

Mississauga, Ontario, Canada

Countries

Canada

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B9991053

To obtain contact information for a study center near you, click here.

Other Identifiers

TRAVELER

Identifier Type: OTHER

Identifier Source: secondary_id

B9991053

Identifier Type: -

Identifier Source: org_study_id