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

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

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Bladder Neoplasms; Bladder Cancer; Urothelial Carcinoma; Bladder Tumors
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5K2L3
      • Bayshore Specialty Rx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	OS from the date of avelumab initiation to the date of death from any cause	12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events explicitly attributed to avelumab	Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM	12 months
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
Description of patient characteristics		12 months
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
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
First-Line therapy description	First-line therapy type, dose, number of cycles, switching and discontinuations	12 months
Time to post-diagnostic imaging	Time to post-diagnostic imaging	12 months
Time to treatment discontinuation	Time to treatment discontinuation	12 months
Time to initiation of AVE 1LM following last dose of chemotherapy	Time to initiation of AVE 1LM following last dose of chemotherapy	12 months
Treatment duration of AVE 1LM	Treatment duration of AVE 1LM	12 months
Time to next treatment	Time to next treatment	12 months
Reasons for treatment discontinuation	Reasons for treatment discontinuation	12 months

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bladder Cancer; Urinary Bladder Cancer; Non-interventional study; Urothelial carcinoma; Metastatic urothelial carcinoma; Bladder Neoplasms; avelumab; Bladder Tumors; Cancer of Bladder; Cancer of the Bladder; Malignant Tumor of Urinary Bladder; Neoplasms, Bladder; Metastatic bladder cancer; Locally advanced bladder cancer; Locally advanced urothelial carcinoma; avelumab maintenance; Canada bladder cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Avelumab
• Other Study ID Numbers: B9991053; TRAVELER (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No