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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05699135

Collaborator

(none)

125

Enrollment

Location

7.8

Anticipated Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Neoplasms Bladder Cancer Bladder Tumors Urothelial Carcinoma	Drug: Avelumab first-line maintenance

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Mar 9, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: 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

Arm

Intervention/Treatment

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

Drug: 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

Outcome Measures

Primary Outcome Measures

Overall survival [12 months]
OS from the date of avelumab initiation to the date of death from any cause
Progression-free survival [12 months]
Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.