Clinical trial NCT05699135: A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer
Official title: Treatment Effectiveness of Avelumab First-Line Maintenance Among Canadian Patients With Advanced Urothelial Carcinoma (TRAVELER)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urinary Bladder Neoplasms
Bladder Cancer
Bladder Tumors
Urothelial Carcinoma
Keywords: Bladder Cancer
Bladder Neoplasms
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
avelumab maintenance
Canada bladder cancer
Non-interventional study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian patients histologically diagnosed with stage IV LA/mUC and having participated in the avelumab patient-support program (PSP).

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events explicitly attributed to avelumab
timeFrame: 12 months
measure: Response rate
timeFrame: 12 months
measure: Description of patient characteristics
timeFrame: 12 months
measure: Overall survival from the date of chemotherapy initiation to the date of death from any cause
timeFrame: 12 months
measure: Progression-free survival from the date of chemotherapy initiation to the date of progression or death from any cause
timeFrame: 12 months
measure: First-Line therapy description
timeFrame: 12 months
measure: Time to post-diagnostic imaging
timeFrame: 12 months
measure: Time to treatment discontinuation
timeFrame: 12 months
measure: Time to initiation of AVE 1LM following last dose of chemotherapy
timeFrame: 12 months
measure: Treatment duration of AVE 1LM
timeFrame: 12 months
measure: Time to next treatment
timeFrame: 12 months
measure: Reasons for treatment discontinuation
timeFrame: 12 months
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Bayshore Specialty Rx
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: