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
Not Applicable
- Conditions
- Stage IV urothelial cancer
- Registration Number
- JPRN-UMIN000037727
- Lead Sponsor
- AstraZeneca K.K.
- Brief Summary
By performing validated assay techniques on the FFPE samples, including Ventana PD-L1 (SP263) assay and NGS, PD-L1 expression, histological classification, cancer-immune phenotype, and TMB could be determined. Based on these data, prevalence of the immunogenic biomarkers including PD-L1 expression, TMB and OS, PFS from start of first-line treatment for Stage IV urothelial cancer was assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 143
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PD-L1 High or Low/ Negative
- Secondary Outcome Measures
Name Time Method Secondary Endpoints 1.TMB levels, TMB high or Low/ Negative 2.Median OS and OS rate at 12 months, 18 months and 24 months from start of 1st line treatment in stage IV. Median PFS and PFS rate at 6 months, 12 months and 18 months from start of 1st line treatment in stage IV. 3.Treatment patterns from 1st line treatment to 3rd line treatment in stage IV. Exploratory Endpoints 1.Cancer immune phenotype: immune-desert, immune-excluded or inflamed 2.Median OS and OS rate at 12 months, 18 months and 24 months from start of 1st line treatment in stage IV in patients sub populations. Median PFS and PFS rate at 6 months, 12 months and 18 months from start of 1st line treatment in stage IV in patients sub populations. [Sub populations] PD-L1 high or low/negative population PD-L1 expression; 0, 10, 25, 50, 75, 100% TMB high or low population Cancer immune phenotype; Immune-desert, immune-excluded or inflamed 3.Patients number and ratio in each gene mutations in primary tumor tissues analysed by NGS