PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

Study Overview
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Brief Summary
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This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC. Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan. PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.

Official Title
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A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

Conditions
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Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Written informed consent for this study. In the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research. 2. Age at nephrectomy≧20 years 3.Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression Exclusion Criteria: 1. Malignancies other than RCC is co-existed from the time of nephrectomy and death. 2. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full analysis set<br>Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients. | Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3) | Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause. | Baseline | 
| Overall survival after nephrectomy (including cytoreductive nephrectomy) | Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause. | Baseline | 
| Time to recurrence after radical nephrectomy | Time to recurrence after radical nephrectomy is the duration from the day of surgery to diagnosis of recurrent. | Baseline | 
| Treatment duration (first-line and second-line therapy) | Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment. | Baseline |