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NCT05699135
A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer
Conditions: Urinary Bladder Neoplasms, Bladder Cancer, Bladder Tumors, Urothelial Carcinoma
Sex: All
Ages: 18 Years – N/A
Enrollment: 125
Sponsor: Pfizer
Location: Canada
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 programHave been diagnosed with advanced bladder cancerHave 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.
Eligibility Criteria
Inclusion Criteria:Enrolled in the Canadian avelumab1LM Patient support program (PSP)Histologically confirmed diagnosis of stage IV LA/mUCNo evidence of disease progression following first-line platinum-based chemotherapyReceipt of avelumab1LM following 1L platinum-based chemotherapyReceived the last dose of chemotherapy no more than 10 weeks before entering the PSPEastern 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 avelumabPregnancy at index dateParticipation in an interventional clinical trial at any point during the study periodThe 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.
Source: ClinicalTrials.gov (NCT05699135). StuddyBuddy aggregates publicly available trial information.