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

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 - YODO study Real world evidence of PD-L1 prevalence and efficacy of 1st line chemotherapy for stage IV urothelial cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037727

Enrollment

150

Registered

2019-09-01

Start date

2019-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV urothelial cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 20, Japanese men and women. 2. Patients who have started at least 1 cycle of chemotherapy. 3.Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable. 4.Patients who are diagnosed as stage IV (AJCC, 7th edition) UC between January 1st in 2017 and December 31st in 2018. 5. 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 preferable to also send a sample taken before neoajuvant therapy, even if it was taken before 1st Jan 2017.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
PD-L1 High or Low/ Negative	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Japan

Contacts

Public ContactMika Kanno

Linical Co.,Ltd. Contract Medical Affairs Unit, Clinical Trial Operations

kanno-mika@linical.co.jp03-6215-8005

Outcome results