An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.

Urinary Bladder Cancer Clinical Trial

— POLARIS  

Official title:

An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation of Initial Treatment Pattern and Overall Survival in the Chinese Muscle Invasive Urothelial Bladder Carcinoma Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433924
• Other study ID #: D9012R00001
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

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

External Links

•   CSR synopsis_redacted and confirmd by GSD