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A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05366725
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy.

This study is seeking participants who:

  1. Have UC that cannot be operated on or has spread to other parts of the body
  2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
  3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
  4. Are 18 years or older on the date that they start taking Avelumab

All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.


Condition or disease Intervention/treatment
Urothelial Cancer Drug: Avelumab

Detailed Description:

The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.

The secondary objectives are:

  1. To describe the clinical and demographic characteristics of the study population
  2. To estimate real-world progression-free survival (rwPFS)
  3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy
  4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy
  5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population
  6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : May 9, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Adult patients with locally advanced or metastatic urothelial cancer Drug: Avelumab
As provided in real world practice


Outcome Measures
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Primary Outcome Measures :
  1. Real world overall survival [ Time Frame: September 2020 to April 2024 ]
    Time between avelumab initiation until date of death from any cause or end of follow-up


Secondary Outcome Measures :
  1. Real world progression free survival [ Time Frame: September 2020 to April 2024 ]

    Time between avelumab initiation until earliest of:

    • Date of first progression
    • Date of death from any cause

  2. Adverse events explicitly attributed to avelumab [ Time Frame: September 2020 to April 2024 ]

    Any AE with explicit attribution to avelumab as noted in the clinical records. Explicit attribution is not inferred by a temporal relationship between drug administration and an AE butmust be based on a definite statement of causality by a healthcare provider linking drug administration to the AE.

    • AE diagnosis
    • Outcome of AE

    • Classification as either serious or non-serious AE

      • Results in hospitalisation or prolongation of hospitalisation
      • Is life threatening
      • Resulted in death
      • Persistent or significant incapacity
      • Congenital anomaly/birth defect in any offspring
      • Other important medical event that may require medical or surgical intervention to avoid any of the above criteria
    • AEs discontinuation of avelumab
    • AEs leading to systemic steroid treatment

  3. All-cause healthcare resource burden [ Time Frame: September 2020 to April 2024 ]

    Mean and median number, per patient, of the following:

    • Accident and emergency visits
    • Hospitalisations
    • Duration of hospitalisation (days)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Adult patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed who are progression-free following completion of platinum-based chemotherapy.
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed
  2. Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
  3. Patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy
  4. Patients aged ≥18 years on the date that they commenced avelumab -

Exclusion Criteria:

  1. Patients whose hospital records are not available for review
  2. Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05366725


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United Kingdom
University Hospitals Bristol Recruiting
Bristol, United Kingdom, BS1 3NU
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
University College London Hospital Recruiting
London, United Kingdom, NW1 2PG
Guy's and St Thomas' Hospital Recruiting
London, United Kingdom, SE1 9RT
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
Lister Hospital Recruiting
Stevenage, United Kingdom, SG1 4AB
Clatterbridge Hospital Recruiting
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05366725    
Other Study ID Numbers: B9991047
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
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.
Additional relevant MeSH terms:
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Avelumab
Antineoplastic Agents, Immunological
Antineoplastic Agents