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BRIEF TITLE: Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic 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


  • Org Study ID: D419BR00008
  • Secondary ID:
  • NCT ID: NCT03788746
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting January 17, 2019 Observational

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 24 months

Condition:

  • Urothelial Carcinoma

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Petros Grivas, MD

Role: Study Chair

Affiliation: University of Washington

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Little Rock, Arkansas 72211
United States
Recruiting
Research Site
Glendale, California 91206
United States
Recruiting
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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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Freehold, New Jersey 07728
United States
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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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Nashville, Tennessee 37209
United States
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Houston, Texas 77005
United States
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Virginia Beach, Virginia 23462
United States
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Olympia, Washington 98506
United States
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Tacoma, Washington 98684
United States
Recruiting