Metastatic Urothelial CarcinomaNCT07386847
A Real-world Study of the First Treatment and Outcomes of Patients With Advanced or Metastatic Bladder Cancer
An observational study of Metastatic Urothelial Carcinoma and Urothelial Cancer, run by Pfizer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Urothelial Carcinoma, Urothelial Cancer, Urothelial Carcinoma
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Histology other than transitional cell (urothelial) carcinoma.
- Primary site of disease other than bladder, renal pelvis, ureter, or urethra
- Clinical trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Cancer, Urothelial Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma
- Keywords
- Metastatic Urothelial Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| la/mUC | Patients with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who received first line treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real world Progression Free Survival (rwPFS)
Time from initiation of first line treatment for la/mUC to the earliest of disease progression or death, based on real-world data sources.
Measured: Up to 2 Years
Secondary outcomes (1)
Real world Overall Tumor Response (rwOTR)
Proportion of patients achieving tumor response (e.g., complete or partial response) based on real-world oncology data.
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start12 Feb 2026
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386847
- Sponsor's protocol ID
- C5701010
- Status last verified
- May 2026
- First submitted
- 28 Jan 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Treatment Patterns and Effectiveness Among Patients With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)
- ClinicalTrials.gov ID
- NCT07386847
- Acronym / sponsor ID
- C5701010
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Cancer, Urothelial Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma
- Keywords
- Metastatic Urothelial Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| la/mUC | – | –Patients with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who received first line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Histology other than transitional cell (urothelial) carcinoma.
- Primary site of disease other than bladder, renal pelvis, ureter, or urethra
- Clinical trial participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Real world Overall Tumor Response (rwOTR)
Time frame: Up to 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Urothelial Carcinoma and Urothelial Cancer, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world Progression Free Survival (rwPFS) (time frame: Up to 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.