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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
  • NTC 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
    Recruiting
  • Start Date
    January 17, 2019
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 24 months

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY


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

OFFICIAL INFORMATION

Name: Petros Grivas, MD

Role: Study Chair

Affiliation: University of Washington

Overall Contact

Name: Petros Grivas, MD

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

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