Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma

Completed

Conditions studied: Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT03788746

Run by

AstraZeneca

People needed

181

Starts

2019-01-17

Expected to finish

2023-05-25

Last updated by the study team

2024-02-22

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Monterey, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Englewood, Colorado, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Roswell, Georgia, United States
• Research Site — Geneva, Illinois, United States
• Research Site — Harvey, Illinois, United States
• Research Site — Lake Barrington, Illinois, United States
• Research Site — Naperville, Illinois, United States
• Research Site — Greenwood, Indiana, United States
• Research Site — Lafayette, Indiana, United States
• Research Site — Muncie, Indiana, United States
• Research Site — Cedar Rapids, Iowa, United States
• Research Site — Waterloo, Iowa, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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