Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma (NCT03788746) | Clinical Trial Compass
CompletedNot Applicable
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma
United States181 participantsStarted 2019-01-17
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
Categorization of PD-L1 results (dichotomous, high vs. low) based on pre-treatment tissue samples.