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

Condition: Urothelial Carcinoma

Purpose: 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.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03788746

Sponsor: AstraZeneca

Primary Outcome Measures:

  • Measure: Categorization of PD-L1 based on pre-treatment tissue samples collected at baseline
  • Time Frame: 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: To assess the association of pre-treatment tumor tissue PD-L1 expression with pre-treatment tumor tissue TMB (tTMB) based on the chosen assay
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: 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
  • Time Frame: 54 months
  • Safety Issue:
  • Measure: 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)
  • Time Frame: 60 months
  • Safety Issue:

Estimated Enrollment: 250

Study Start Date: January 17, 2019

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  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Provision of written informed consent
  • Age ≥18 years old
  • Patients with histologically-confirmed diagnosis of UC and healthcare provider (HCP)-confirmed advanced UC prior to or during 1L therapy (primary histology UC; mixed histologies are allowed). Where the 1L therapy setting is defined as:
  • Patients with no prior systemic therapy given for advanced UC; 1L is the first systemic therapy given for advanced UC
  • Patients who received neoadjuvant or adjuvant platinum-based chemotherapy with recurrence more than 12 months from the last chemotherapy dose
  • 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 available for biomarker testing (PD-L1 and tTMB).

Exclusion Criteria:

  • Patients concurrently enrolled in other clinical trials that prohibit their participation in a non-interventional study
  • 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


  • AstraZeneca Clinical Study Information Center
  • 1-877-240-9479


  • Research Site
  • Los Angeles California 90048 United States
  • Research Site
  • Monterey California 93940 United States
  • Research Site
  • Santa Rosa California 95405 United States
  • Research Site
  • Denver Colorado 80211 United States
  • Research Site
  • Englewood Colorado 80113 United States
  • Research Site
  • Hialeah Florida 33016 United States
  • Research Site
  • Indianapolis Indiana 46256 United States
  • Research Site
  • Cedar Rapids Iowa 52403 United States
  • Research Site
  • Waterloo Iowa 50703 United States
  • Research Site
  • Shreveport Louisiana 71106 United States
  • Research Site
  • Bangor Maine 04401 United States
  • Research Site
  • Kalamazoo Michigan 49007 United States
  • Research Site
  • Saint Cloud Minnesota 56303 United States
  • Research Site
  • Dayton Ohio 45429 United States
  • Research Site
  • Knoxville Tennessee 37920 United States
  • Research Site
  • Nashville Tennessee 37209 United States
  • Research Site
  • Virginia Beach Virginia 23462 United States
  • Research Site
  • Olympia Washington 98506 United States
  • Research Site
  • Tacoma Washington 98684 United States

View trial on ClinicalTrials.gov