UMIN-CTR Clinical Trial

Basic information
Public title	EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Acronym	EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Scientific Title	EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Scientific Title:Acronym	EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Region	Japan

Condition
Condition	Patients with RCC with distant metastasis treated with nivolumab under real clinical practice.
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study on patients with metastatic renal cell carcinoma (RCC), who started treatment with nivolumab in clinical practice in Japan, is to collect data on the use of nivolumab under actual clinical conditions and clarifies the following.
Basic objectives2	Others
Basic objectives -Others	To describe actual usage and pattern of nivolumab in advanced/metastatic RCC patients in clinical practice; such as treatment frequency, treatment-history before and after nivolumab use, treatment period, treatment line, changes related to management of adverse events (AEs), etc To assess overall effectiveness (overall survival [OS], progression-free survival [PFS], objective response rate [ORR], duration of response [DOR]) and safety of nivolumab in advanced/metastatic RCC patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To describe actual usage and pattern of nivolumab in advanced/metastatic RCC patients in clinical practice; such as treatment frequency, treatment-history before and after nivolumab use, treatment period, treatment line, changes related to management of adverse events (AEs), etc To assess overall effectiveness (overall survival [OS], progression-free survival [PFS], objective response rate [ORR], duration of response [DOR]) and safety of nivolumab in advanced/metastatic RCC patients
Key secondary outcomes	Effectiveness and safety by special subgroup; brain metastasis and non-clear cell RCC etc Effectiveness and safety in post-nivolumab treatment; treatment-history, regimen/response/AE etc

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A patient with RCC with distant metastasis treated for the first time with nivolumab between 01 Feb 2017 and 31 Oct 2017.
Key exclusion criteria	Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Ito
Organization	Bristol-Myers Squibb
Division name	Japan Medical & Development, Oncology Medical
Zip code	1000004
Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo 100-0004
TEL	03-6705-7000
Email	hiroaki.ito@bms.com

Public contact
Name of contact person	1st name Mayu Middle name Last name Kakiuchi
Organization	Mebix, Inc
Division name	Oncology Group
Zip code	1050001
Address	Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon33 Mori Building 10F
TEL	03-4362-4504
Homepage URL
Email	rcc-outcome@mebix.co.jp

Sponsor
Institute	Bristol-Myers Squibb Ono Pharmaceutical CO.,LTD.
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb Ono Pharmaceutical CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mebix, Inc
Address	Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon33 Mori Building 10F
Tel	03-4362-4504
Email	rcc-outcome@mebix.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	200
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 26 Day
Date of IRB	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.

Management information
Registered date	2018 Year 07 Month 06 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037973