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

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

INTRODUCTION

  • Org Study ID: D419BR00008
  • Secondary ID: N/A
  • NCT ID: NCT03788746
  • Sponsor: AstraZeneca

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

  • Overall Status
    Completed
  • Start Date
    January 17, 2019
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Petros Grivas, MD, Joshua Meeks

Role: Study Chair, Study Chair

Affiliation: University of Washington, Northwestern University

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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