Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer

Urologic Neoplasms Clinical Trial

— YODO  

Official title:

Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052113
• Other study ID #: D419BR00014
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: February 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).

Description:

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB). Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free survival (PFS) from start of 1st line treatment in stage IV will be assessed.

In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The patients should have received at least 1 cycle of chemotherapy and never receive immune oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age > 20, Japanese men and women.

• Patients who have started at least 1 cycle of chemotherapy.

• Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.

• Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in 2018.

• Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block.

Exclusion Criteria:

-Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.

Related Conditions & MeSH terms

• Urologic Neoplasms

Locations

Country	Name	City	State
Japan	Research Site	Kyoto-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of PD-L1 in stage IV UC patients in real world setting.	Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.	Baseline
Secondary	Prevalence of TMB in stage IV UC patients in real world setting.	Calculate median and average of TMB levels. Summarize number and calculate ratio of TMB high or low/negative patients, respectively.	Baseline
Secondary	OS from start of 1st line treatment in stage IV	Median OS and OS rate at 12 months, 18 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.	2 years
Secondary	PFS from start of 1st line treatment in stage IV	Median PFS and PFS rate at 6months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.	18 months

External Links

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