PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

NCT03748901 | Completed

• 1 other identifier: CMA-Ate004
• Study Type: observational
• Target: 830
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3)

  Baseline

• Overall survival after nephrectomy (including cytoreductive nephrectomy)

  Baseline

• Time to recurrence after radical nephrectomy

  Baseline

• Treatment duration (first-line and second-line therapy)

  Baseline

Study Arms (1)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. 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.
• \. Age at nephrectomy≧20 years
• 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

You may not qualify if:

• \. Malignancies other than RCC is co-existed from the time of nephrectomy and death.
• \. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (1)

Aichi Medical University

Nagoya, Aichi-ken, 480-1103, Japan

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: December 16, 2018
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)