The purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1 expression in patients diagnosed with advanced urothelial carcinoma.
Advanced urothelial carcinoma (UC) (locally advanced/unresectable or metastatic UC) is a fatal disease with 5-year survival rate of 5%. The most frequently studied diagnostic for advanced UC is the programmed death-ligand 1 (PD-L1) protein expression in tumor tissue. A better understanding of PD-L1 expression in a "real world" setting could help understand its clinical utility in the management and decision making in advanced UC and clinical trial design
Study Type
OBSERVATIONAL
Enrollment
181
Categorization of PD-L1 results (dichotomous, high vs. low) based on pre-treatment tissue samples.
The proportion of advanced UC patients with biomarker PD-L1 high results will be calculated.
Time frame: 24 months
To assess the association of pre-treatment tumor tissue PD-L1 expression with pre-treatment tumor tissue TMB (tTMB) based on the chosen assay
Assay results for pre-treatment tTMB will be assessed by pre-treatment tumor tissue PD-L1 expression status.
Time frame: 24 months
To describe the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) as well as treatment patterns in the 1L setting of advanced UC
1L advanced UC treatment patterns (such as regimen/agents used, start (first dose) and stop (last dose) dates, reasons for cis/carboplatin ineligibility) will be collected. Objective Response: complete or partial response based on healthcare provider (HCP) assessment; Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria highly recommended Progression: evidence malignancy has become worse or spreads in the body (based on HCP assessment). Objective response and survival endpoints (overall, stratified by PD-L1 expression \[high vs. low\] including the following: ORR: The proportion of patients with a complete or partial response based on HCP assessment; PFS: The time from the start of 1L advanced UC treatment until progression or death (any cause); and OS: The time from start of 1L advanced UC treatment until death (any cause)
Time frame: 54 months
To assess the association between pre-treatment tumor tissue PD-L1 expression with objective response, PFS, and OS among treated patients (anti PD-L1/PD-1, chemotherapy, other)
Objective response, PFS, and OS (defined above) will be stratified by pre-treatment tumor tissue PD-L1 expression, and among patients treated with anti-PD-L1/PD-1 or chemotherapy or other.
Time frame: 60 months
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Research Site
Little Rock, Arkansas, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Monterey, California, United States
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Santa Rosa, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Hartford, Connecticut, United States
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Stamford, Connecticut, United States
...and 48 more locations