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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05699135
• Other study ID #: B9991053
• Secondary ID: TRAVELER
• Status: Terminated
• Start date: March 9, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Tumors
• Carcinoma
• Carcinoma, Transitional Cell
• Neoplasms
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

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

Locations

Country	Name	City	State
Canada	Bayshore Specialty Rx	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	OS from the date of avelumab initiation to the date of death from any cause	12 months
Primary	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	Adverse events explicitly attributed to avelumab	Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM	12 months
Secondary	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
Secondary	Description of patient characteristics		12 months
Secondary	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
Secondary	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
Secondary	First-Line therapy description	First-line therapy type, dose, number of cycles, switching and discontinuations	12 months
Secondary	Time to post-diagnostic imaging	Time to post-diagnostic imaging	12 months
Secondary	Time to treatment discontinuation	Time to treatment discontinuation	12 months
Secondary	Time to initiation of AVE 1LM following last dose of chemotherapy	Time to initiation of AVE 1LM following last dose of chemotherapy	12 months
Secondary	Treatment duration of AVE 1LM	Treatment duration of AVE 1LM	12 months
Secondary	Time to next treatment	Time to next treatment	12 months
Secondary	Reasons for treatment discontinuation	Reasons for treatment discontinuation	12 months

External Links

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