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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Categorization of PD-L1 results (dichotomous

Primary Outcome 1 - Timeframe: 24 months

Primary Outcome 2 - Measure: high vs. low) based on pre-treatment tissue samples.

Primary Outcome 2 - 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