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

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).

Study Overview

• Status: Recruiting
• Conditions: Urothelial Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Seagen Trial Information Support; Phone Number: 866-333-7436; Email: clinicaltrials@seagen.com

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Hospital Center University De Rouen
    • Principal Investigator: Christian Pfister
• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine
      • Principal Investigator: Nataliya Mar
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco
      • Principal Investigator: Vadim Koshkin
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Principal Investigator: Laura Graham
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera
      • Principal Investigator: Casey Williams

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Time from the index date to date of death from any cause.	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	Up to 5 years
rwORR for each subsequent LOT following the index LOT	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.	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.	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.	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.	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Seagen Inc.
• Investigators: Study Director: Nicholas Choong, MD, Seagen Inc.; Study Director: Emilie Scherrer, MSc, Seagen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Seattle Genetics; Bladder Cancer; Urothelial Cancer; HER2 Mutations; HER2 Overexpression; HER2 Amplification
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Transitional Cell
• Other Study ID Numbers: SGNDV-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO