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

Sponsor

Seagen Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05902494

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Retrospective

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

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Outcome Measures

Primary Outcome Measures

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

Percentages of IHC0, 1+, 2+, and 3+ participants [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 [Up to 5 years]
Characteristics of LA/mUC 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.
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
rwORR for each subsequent LOT following the index LOT [Up to 5 years]
The proportion of participants who have a 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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra.
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 start 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 within 1 year prior to the index date