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

• ClinicalTrials.gov Identifier: NCT05699135
• Recruitment Status: Terminated
• First Posted: January 26, 2023
• Last Update Posted: April 24, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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
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
• Actual Enrollment: 150 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)
• Actual Study Start Date: March 9, 2023
• Actual Primary Completion Date: June 30, 2023
• Actual Study Completion Date: June 30, 2023

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Overall survival [ Time Frame: 12 months ]
   OS from the date of avelumab initiation to the date of death from any cause
2. Progression-free survival [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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).

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.

Contacts and Locations

Locations

Canada, Ontario

Bayshore Specialty Rx

Mississauga, Ontario, Canada, L5K2L3

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05699135
• Other Study ID Numbers: B9991053; TRAVELER ( Other Identifier: Alias Study Number )
• First Posted: January 26, 2023
• Last Update Posted: April 24, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• 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

Keywords provided by Pfizer:

Urothelial carcinoma; Locally advanced urothelial carcinoma; Metastatic urothelial carcinoma; 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; avelumab; avelumab maintenance; Canada bladder cancer; Non-interventional study

Additional relevant MeSH terms:

Carcinoma; Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Avelumab; Antineoplastic Agents, Immunological; Antineoplastic Agents