Brief Title
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma
Official Title
A Prospective, Non-Interventional Study to Assess the Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic Urothelial Carcinoma
Brief Summary
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.
Detailed Description
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
Primary Outcome
Categorization of PD-L1 results (dichotomous, high vs. low) based on pre-treatment tissue samples.
Secondary Outcome
To assess the association of pre-treatment tumor tissue PD-L1 expression with pre-treatment tumor tissue TMB (tTMB) based on the chosen assay
Condition
Urothelial Carcinoma
Study Arms / Comparison Groups
Patients diagnosed with advanced urothelial carcinoma
Description: Patients with a confirmed diagnosis of advanced urothelial carcinoma, prior to or during first line therapy, who have available tumor tissue samples collected as part of standard of care
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
180
Start Date
January 17, 2019
Completion Date
June 7, 2023
Primary Completion Date
February 5, 2021
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent
- Age ≥18 years old
- Patient must have advanced UC confirmed by their HCP; histologically- confirmed
diagnosis of UC an dHCP-confirmed advanced UC.
- Patient must be either currently receiving 1L systemic treatment for their advanced UC
or will be starting 1L systemic treatment (i.e. "newly diagnosed" advanced UC; 1L
therapy is defined as the first systemic therapy given for advanced UC).
- Patient remains eligible for the study if they received neoadjuvant or adjuvant
platinum-based chemotherapy if their recurrence was more than 12 months after their
last chemotherapy dose.
- Radio-sensitizing chemotherapy as part of chemoradiation is NOT counted as neoadjuvant
or adjuvant chemotherapy; thus, the 12-month interval mention above does not apply,
and the patient would be eligible
- Patients with available tumor tissue sample (fresh or archival - up to 3 years old)
that was collected as part of SoC any time prior to 1L treatment for advanced UC with
a target of 18 slides (7 minimum) available for biomarker testing (PD-L1 and tTMB).
Already prepared slides must have been cut within 6 months prior to PD-L1 testing.
Exclusion Criteria:
- Patients concurrently enrolled in other clinical trials that prohibit their
participation in a non-interventional study
- Patient has resectable localized UC and has refused surgery
- Patients with history of non-urothelial active malignancy that completed therapy
within 2 years from study enrollment except:
- Any resected in situ carcinoma or non-melanoma skin cancer
- Localized (early stage) cancer treated with curative intent (without evidence of
recurrence and intent for further therapy) and in which no systemic therapy was
indicated
Gender
All
Ages
18 Years - 130 Years
Accepts Healthy Volunteers
No
Contacts
Petros Grivas, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03788746
Organization ID
D419BR00008
Responsible Party
Sponsor
Study Sponsor
AstraZeneca
Study Sponsor
Petros Grivas, MD, Study Chair, University of Washington
Verification Date
December 2022