A Real-world Study of the First Treatment and Outcomes of Patients With Advanced or Metastatic Bladder Cancer

May 25, 2026 updated by: Pfizer

Real-world Treatment Patterns and Effectiveness Among Patients With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

Bladder cancer (urothelial carcinoma) is a disease where cells in the bladder grow out of control. The bladder is an organ in the lower part of the body that stores urine. When someone has bladder cancer, abnormal cells form in the bladder and can spread to other parts of the body if not treated. Bladder cancer that has spread outside the bladder is called advanced or metastatic bladder cancer.

The purpose of this study is to examine how long it takes for adults with advanced or metastatic bladder cancer to experience worsening of their disease following their first treatment . The researchers will also describe which medicines these patients use as their first treatment for the disease.

This is a real-world study, not a clinical study. This means that researchers will look at what happens when patients receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from cancer clinics (Flatiron Health electronic health records). The study will include patients' information from the database who:

  • Were identified to have advanced or metastatic bladder cancer.
  • Started their first treatment after 01 Apr 2023.
  • Were 18 years of age or older when they were diagnosed with advanced disease.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Pfizer Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients in the United States diagnosed with locally advanced or metastatic urothelial carcinoma (la/mUC) who initiated first line systemic treatment in the Flatiron Health database after 04/01/2023.

Description

Inclusion Criteria:

  • Adults (18 years or older) diagnosed with locally advanced or metastatic urothelial carcinoma (la/mUC) in the Flatiron Health database.
  • Started first line systemic treatment for la/mUC during the study period.
  • Received care in the United States, as the study is U.S.-based.
  • Has sufficient available real-world data to assess treatment patterns and outcomes (e.g., treatment dates, follow-up, response/survival information).

Exclusion Criteria:

  • Histology other than transitional cell (urothelial) carcinoma.
  • Primary site of disease other than bladder, renal pelvis, ureter, or urethra
  • Clinical trial participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
la/mUC
Patients with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who received first line treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real world Progression Free Survival (rwPFS)
Time Frame: Up to 2 Years
Time from initiation of first line treatment for la/mUC to the earliest of disease progression or death, based on real-world data sources.
Up to 2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real world Overall Tumor Response (rwOTR)
Time Frame: Up to 2 Years
Proportion of patients achieving tumor response (e.g., complete or partial response) based on real-world oncology data.
Up to 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5701010

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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