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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035974
Receipt No. R000040882
Scientific Title RETROSPECTIVE JAPANESE REAL WORLD STUDY OF METASTATIC RENAL CELL CARCINOMA TREATED WITH NIVOLUMAB PLUS IPILIMUMAB (J-cardinal study)
Date of disclosure of the study information 2019/02/22
Last modified on 2019/03/01

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Basic information
Public title RETROSPECTIVE JAPANESE REAL WORLD STUDY OF METASTATIC RENAL CELL CARCINOMA TREATED WITH NIVOLUMAB PLUS IPILIMUMAB (J-cardinal study)
Acronym J-cardinal study
Scientific Title RETROSPECTIVE JAPANESE REAL WORLD STUDY OF METASTATIC RENAL CELL CARCINOMA TREATED WITH NIVOLUMAB PLUS IPILIMUMAB (J-cardinal study)
Scientific Title:Acronym J-cardinal study
Region
Japan

Condition
Condition metastatic renal cell carcinoma (mRCC)
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 (mRCC), who started treatment with nivolumab plus ipilimumab in clinical practice in Japan, is to collect data on the use of nivolumab plus ipilimumab under actual clinical conditions and clarifies the following at early timing after approval.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ORR
Key secondary outcomes Safety, BOR, PFS, OS, Tumor reduction rate, Status for use of nivolumab plus ipilimumab, Efficacy after discontinuation of nivolumab plus ipilimumab

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 plus ipilimumab between 21 Aug 2018 and 31 Jan 2019

Intermediate and poor on the IMDC risk definition
Key exclusion criteria Patients who are applied for post marketing study of nivolumab plus ipilimumab

Favorable on the IMDC risk definition
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenya Ochi
Organization Ono Pharmaceutical CO., LTD
Division name Medical Affairs, Medical Planning 1
Zip code
Address 8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL 0662632992
Email k.ochi@ono.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chizuko Kamada
Organization CMIC Co., Ltd.
Division name Academia Clinical Research Div.
Zip code
Address Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan
TEL 0367798172
Homepage URL
Email J-cardinal_cta@cmic.co.jp

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

Funding Source
Organization Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
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
Address
Tel
Email

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
2019 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
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
2019 Year 02 Month 22 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040882

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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