HER2 and LA/mUC: A Multi-country Chart Review Cohort Study

Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902494
• Other study ID #: SGNDV-003
• Status: Recruiting
• Start date: June 29, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Locations

Country	Name	City	State
France	Hospital Center University De Rouen	Rouen
United States	University of Colorado	Aurora	Colorado
United States	University of California Irvine	Orange	California
United States	University of California San Francisco	San Francisco	California
United States	Avera	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Secondary	Percentages of IHC0, 1+, 2+, and 3+ participants		Up to 5 years
Secondary	Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants		Up to 5 years
Secondary	Characteristics of LA/mUC participants		Up to 5 years
Secondary	Real-world Overall Survival (rwOS)	Time from the index date to date of death from any cause.	Up to 5 years
Secondary	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	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years