Urothelial Cancer Prevail D419BR00008 (GU)

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

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.

Eligibility 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).

Available at: Hartford Hospital, Hospital of Central Connecticut and MidState Medical Center

Cancer Clinical Research Office