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

Completed

• Conditions: Urothelial Carcinoma

• Registration Number: NCT05902494
• Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Start: 2023-06-29
• Primary Completion: 2025-06-18
• Study Completion: 2025-06-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)	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.

Secondary Outcome Measures

Name	Time	Method
Characteristics of treatment patterns in LA/mUC participants	Up to 5 years	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
Real-world Time on Treatment (rwTOT)	Up to 5 years	Time from the start date of the LOT to the end date of the same LOT for any reason.
rwORR for each subsequent LOT following the index LOT	Up to 5 years	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.
Percentages of IHC0, 1+, 2+, and 3+ participants	Up to 5 years
Characteristics of LA/mUC participants	Up to 5 years
Real-world Time to Next Treatment (rwTTNT)	Up to 5 years	The time from the start date of each LOT to the initiation of the next LOT for any reason.
Real-world Progression Free Survival (rwPFS)	Up to 5 years	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.
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
Real-world Overall Survival (rwOS)	Up to 5 years	Time from the index date to date of death from any cause.
Real-world Duration of Response (rwDOR)	Up to 5 years	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.

Trial Locations

Locations (23)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

University of California Irvine; 🇺🇸 Orange, California, United States

Stanford Cancer Institute - School of Medicine; 🇺🇸 Palo Alto, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of California Los Angeles; 🇺🇸 Santa Monica, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

ICAHN School of Medicine at Mount Sinai,; 🇺🇸 New York, New York, United States

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

Duke Cancer Institute - School of Medicine; 🇺🇸 Durham, North Carolina, United States

Avera Cancer Institute Center; 🇺🇸 Sioux Falls, South Dakota, United States

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