Urothelial CarcinomaNCT05902494
HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
An observational study of Urothelial Carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer at 23 sites in 4 countries.
Trial summary
This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 389 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 29 Jun 2023to 18 Jun 2025
- 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: Adults from US and European participating hospitals and physicians' practices with histologically confirmed LA/mUC who initiated therapy after prior progression on platinum-based therapy with or without maintenance avelumab.
Who may be able to join
- Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.
- Locally advanced unresectable or metastatic stage disease
- Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.
- At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.
- Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection
- Radiographically documented and measurable disease progression immediately before index date
Who cannot join
- Any concurrent malignant neoplasm requiring systemic therapy during the study window
- Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States11 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Levine Cancer Institute
Charlotte, North Carolina, 28204
Duke Cancer Institute - School of Medicine
Durham, North Carolina, 27710
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232
ICAHN School of Medicine at Mount Sinai,
New York, New York, 10029
University of California Irvine
Orange, California, 92868
Stanford Cancer Institute - School of Medicine
Palo Alto, California, 94394
Mayo Clinic
Phoenix, Arizona, 85054
University of California San Francisco
San Francisco, California, 94143
University of California Los Angeles
Santa Monica, California, 90404
Avera Cancer Institute Center
Sioux Falls, South Dakota, 57104
France8 sites
Chu Bordeaux Hopital Saint Andre
Bordeaux, 33075
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, 85925
Centre Léon Bérard
Lyon, 69373
Centre Antoine Lacassagne
Nice, 06189 Cedex 2
Institut Mutualiste Montsouris
Paris, 75674
CHU LYON
Pierre-Bénite, 69495
CHU de Rouen.
Rouen, 76000
Foch Hospital
Suresnes, 92150
Germany3 sites
Alexianer Krefeld GmbH
Krefeld, North Rhine-Westphalia, 47805
University Hospital Lübeck
Lübeck, Schleswig-Holstein, 23538
Stuttgart Hospital
Stuttgart, 70174
About this study
Official title: A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression
This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health.
Participants will have urothelial cancer that has grown in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Cancer, Bladder Cancer, HER2 Mutations, HER2 Overexpression, HER2 Amplification, Seattle Genetics
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
The proportion of participants who have a best overall response (BOR) based on complete response (CR) or partial response (PR). The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the lines of treatment (LOT) prior to the initiation of any subsequent LOT.
Measured: Up to 5 years
Secondary outcomes (10)
Percentages of IHC0, 1+, 2+, and 3+ participants
Measured: Up to 5 years
Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants
Measured: Up to 5 years
Characteristics of LA/mUC participants
Measured: Up to 5 years
Real-world Overall Survival (rwOS)
Time from the index date to date of death from any cause.
Measured: Up to 5 years
Characteristics of treatment patterns in LA/mUC participants
Agent, reason for change of LOT, surgery, radiotherapy, number of LOT, treatments in each LOT, mean number of LOT, median time to discontinuation of each LOT
Measured: Up to 5 years
rwORR for each subsequent LOT following the index LOT
The proportion of participants who had a real-world BOR based on CR or PR. The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the LOT prior to the initiation of any subsequent LOT.
Measured: Up to 5 years
Real-world Time on Treatment (rwTOT)
Time from the start date of the LOT to the end date of the same LOT for any reason.
Measured: Up to 5 years
Real-world Time to Next Treatment (rwTTNT)
The time from the start date of each LOT to the initiation of the next LOT for any reason.
Measured: Up to 5 years
Real-world Progression Free Survival (rwPFS)
Time from the index date to the first recorded disease progression (radiographically documented and measurable disease or physician assessed response) or death from any cause, before the start of next LOT whichever occurs first.
Measured: Up to 5 years
Real-world Duration of Response (rwDOR)
The duration of time from the first documented CR or PR in the LOT to the first recorded disease progression (radiographically documented and measurable disease or physician-assessed response) or death from any cause before the start of the next LOT, whichever occurs first.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start29 Jun 2023
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of 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
- NCT05902494
- Sponsor's protocol ID
- SGNDV-003
- Other IDs
- C5731003
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression
- ClinicalTrials.gov ID
- NCT05902494
- Acronym / sponsor ID
- SGNDV-003
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Cancer, Bladder Cancer, HER2 Mutations, HER2 Overexpression, HER2 Amplification, Seattle Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Seagen, a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 15 Jun 2023 (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.
This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health.
Participants will have urothelial cancer that has grown in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults from US and European participating hospitals and physicians' practices with histologically confirmed LA/mUC who initiated therapy after prior progression on platinum-based therapy with or without maintenance avelumab.
Key inclusion criteria (6 listed)
- Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.
- Locally advanced unresectable or metastatic stage disease
- Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.
- At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.
- Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection
Key exclusion criteria (2 listed)
- Any concurrent malignant neoplasm requiring systemic therapy during the study window
- Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy
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 Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Time frame: Up to 5 years
The proportion of participants who have a best overall response (BOR) based on complete response (CR) or partial response (PR). The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the lines of treatment (LOT) prior to the initiation of any subsequent LOT.
10 secondary outcomes
Percentages of IHC0, 1+, 2+, and 3+ participants
Time frame: Up to 5 years
Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants
Time frame: Up to 5 years
Characteristics of LA/mUC participants
Time frame: Up to 5 years
Real-world Overall Survival (rwOS)
Time frame: Up to 5 years
Characteristics of treatment patterns in LA/mUC participants
Time frame: Up to 5 years
rwORR for each subsequent LOT following the index LOT
Time frame: Up to 5 years
Real-world Time on Treatment (rwTOT)
Time frame: Up to 5 years
Real-world Time to Next Treatment (rwTTNT)
Time frame: Up to 5 years
Real-world Progression Free Survival (rwPFS)
Time frame: Up to 5 years
Real-world Duration of Response (rwDOR)
Time frame: Up to 5 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 20 Jul 2025.
- 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
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer at 23 sites in 4 countries.
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 6 inclusion and 2 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Germany, Austria. 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 Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) (time frame: Up to 5 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 20 Jul 2025.