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

INTRODUCTION

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

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.

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
Recruiting
Start Date
January 17, 2019
Phase
Study Type
Observational

Primary Outcome 1 - Measure: Categorization of PD-L1 based on pre-treatment tissue samples collected at baseline

Primary Outcome 1 - Timeframe: 24 months

Urothelial Carcinoma

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Name: Petros Grivas, MD

Role: Study Chair

Affiliation: University of Washington

Name: Petros Grivas, MD

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Facility	Status	Contact
Facility: Research Site Little Rock, Arkansas 72211 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Glendale, California 91206 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Los Angeles, California 90048 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Los Angeles, California 90067 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Monterey, California 93940 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Santa Rosa, California 95405 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Denver, Colorado 80211 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Englewood, Colorado 80113 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Boca Raton, Florida 33486 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Hialeah, Florida 33016 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Augusta, Georgia 30912 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Elmhurst, Illinois 60126 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Harvey, Illinois 60426 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Lake Barrington, Illinois 60010 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Indianapolis, Indiana 46256 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Lafayette, Indiana 47905 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Muncie, Indiana 47303 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Cedar Rapids, Iowa 52403 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Waterloo, Iowa 50703 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Kansas City, Kansas 66160 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Wichita, Kansas 67226 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Baton Rouge, Louisiana 70809 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Shreveport, Louisiana 71106 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Bangor, Maine 04401 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Lewiston, Maine 04240 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Kalamazoo, Michigan 49007 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Saint Cloud, Minnesota 56303 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Bridgeton, Missouri 63044 United States	Status: Recruiting	Contact: N/A
Facility: Research Site East Brunswick, New Jersey 08816 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Englewood, New Jersey 07631 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Freehold, New Jersey 07728 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Little Silver, New Jersey 07739 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Voorhees, New Jersey 08043 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Port Jefferson Station, New York 11776 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Dayton, Ohio 45429 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Knoxville, Tennessee 37920 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Nashville, Tennessee 37209 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Houston, Texas 77005 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Virginia Beach, Virginia 23462 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Olympia, Washington 98506 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Tacoma, Washington 98684 United States	Status: Recruiting	Contact: N/A

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

BRIEF SUMMARY

DETAILED DESCRIPTION

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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