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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433924
Other study ID # D9012R00001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2020
Est. completion date March 27, 2023

Study information

Verified date March 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.


Description:

The primary objective of this observational study is: •To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High. The second objectives of this observational study are: - To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients. - To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab. - To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China. - To observe 2-year OS of the Chinese MIUBC patients. The exploratory objectives of this observational study are: - To explore the relationship between the demographic characteristics and expression of PD-L1 and other exploratory biomarkers including immune cell (IC) subset CD8+ T cells and tumor mutation burden (TMB). - To explore the relationship between OS and the demographic characteristics as well as the expression of biomarkers. - To explore the relationship between PD-L1 and TMB, PD-L1 and CD8 positive T cell respectively.


Recruitment information / eligibility

Status Completed
Enrollment 248
Est. completion date March 27, 2023
Est. primary completion date March 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years at the time of screening. - Be able and willing to sign the informed consent form (ICF). - Patients with histologically or cytologically documented, muscle invasive urothelial carcinoma (ie, T2 toT4, any N, any M) of bladder (see National Comprehensive Cancer Network [NCCN] Bladder Cancer Guidelines), who had not been previously treated with any systemic chemotherapy, radiotherapy, investigational product, or biologic therapy for cancer treatment. - For PD-L1 testing by IHC assay, all patients were able to provide a newly acquired tumor sample within 60 days before enrollment by cystectomy, transurethral resection or biopsy. Samples with limited tumor content and fine needle aspirate specimens were not acceptable. Specimens from metastatic bone lesions were typically unacceptable unless there was a significant soft tissue component. The tumor specimen submitted to establish PD-L1 status should be of sufficient quantity to allow for PD-L1 IHC analyses and was preferred in FFPE blocks. Exclusion Criteria: - Prior acquiring tumor tissue samples exposure to immune-mediated therapy (including Bacillus Calmette Guerin), including but not limited to, any anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, therapeutic anticancer vaccines. - Any concurrent chemotherapy, investigational product, or biologic therapy for cancer treatment. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent was acceptable (eg, local surgery or radiotherapy).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Research Site Beijing
China Research Site Beijing
China Research Site Changchun
China Research Site Changsha
China Research Site Chengdu
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Hangzhou
China Research Site Jinan
China Research Site Meizhou
China Research Site Nanjing
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shenyang
China Research Site Wuhan
China Research Site Xiamen
China Research Site Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other The prevalence of PD-L1 expression by subgroups The prevalence of PD-L1 expression by subgroups according to age, gender, primary tumor site, metastatic disease, at baseline, and prior tobacco use, etc enrollment visit
Other OS by subgroups OS by subgroups according to age, gender, primary tumor site, metastatic disease at baseline and the PD-L1 expression of high and low/negative as well as other biomarkers, etc. Simple correlation coefficients among biomarkers including PD-L1 with TMB, PD-L1 with CD8+ T cell, PD-L1+ IC with CD8+ T cell. from enrollment to OS, up to 2 years
Other Simple correlation coefficients among biomarkers Simple correlation coefficients among biomarkers including PD-L1 with TMB, PD-L1 with CD8+ T cell, PD-L1 positive IC with CD8+ T cell. enrollment visit
Primary the prevalence of High PD-L1 expression in the MIUBC patients Tumor tissue will be collected from all eligible patients who sign the ICF. Samples will be tested for PD-L1 expression status. Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Secondary Proportion of patients with different PD-L1 expression level Proportion of patients with different PD-L1 expression level Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Secondary PD-L1 testing concordance between central lab and hospital labs PD-L1 testing concordance between central lab and hospital labs Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Secondary Distribution percent of different treatment approaches Distribution percent of different treatment approaches enrollment visit
Secondary 2-year OS follow up for OS up to 2 years from the baseline From enrollment to OS, up to 2 years
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