PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 830

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-city, Aichi, Japan, 480-1103
      • Aichi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Full analysis set; 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?

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

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2018
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: CMA-Ate004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (ClinicalStudyDataRequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No