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

NCT05699135 | Terminated FDA Drug

• 2 other identifiers: B9991053TRAVELER
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Adverse events explicitly attributed to avelumab

  12 months

• Response rate

  12 months

• Description of patient characteristics

  12 months

• Overall survival from the date of chemotherapy initiation 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

  12 months

Study Arms (1)

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

Interventions

Avelumab first-line maintenance DRUG

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

Canadian Patients with Advanced Urothelial Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Bayshore Specialty Rx

Mississauga, Ontario, L5K2L3, Canada

Location

Related Links

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

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 26, 2023
• Study Start: March 9, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)