PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748901
• Other study ID #: CMA-Ate004
• Status: Completed
• Start date: December 16, 2018
• Est. completion date: July 21, 2021

Study information

• Verified date: August 2021
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Japan	Aichi Medical University	Nagoya-city	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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