Status:
COMPLETED
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma
Lead Sponsor:
AstraZeneca
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18-130 years
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2023
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT03788746
Start Date
January 17 2019
End Date
May 25 2023
Last Update
February 22 2024
Active Locations (58)
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1
Research Site
Little Rock, Arkansas, United States, 72211
2
Research Site
Glendale, California, United States, 91204
3
Research Site
Los Angeles, California, United States, 90048
4
Research Site
Los Angeles, California, United States, 90067