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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033312
Receipt No. R000037973
Official scientific title of the study EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Date of disclosure of the study information 2018/07/06
Last modified on 2018/07/06

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Basic information
Official scientific title of the study EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Title of the study (Brief title) 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 Hirokazu Kaneko
Organization Bristol-Myers Squibb
Division name Japan Medical & Development, Oncology Medical
Address 6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1327
TEL 03-6705-7147
Email hirokazu.kaneko@bms.com

Public contact
Name of contact person Tomoyoshi - Kaneko
Organization Mebix, Inc
Division name Oncology Group
Address Toranomon, Minato-ku, Tokyo 2-8-10 Toranomon 15 Mori Building
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)

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

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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 07 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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