UMIN-CTR Clinical Trial

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 Hiroki Middle name Last name Matsumoto
Organization	Ono Pharmaceutical CO., LTD
Division name	Oncology Medical, Medical Affairs
Zip code	541-8564
Address	8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL	662632992
Email	hi.matsumoto@ono.co.jp

Public contact
Name of contact person	1st name Chizuko Middle name Last name Kamada
Organization	CMIC Co., Ltd.
Division name	Academia Clinical Research Div.
Zip code	105-0023
Address	Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan
TEL	0367798000
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	Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
Address	8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
Tel	0662632992
Email	n.nishiwaki@ono.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	2019 Year 02 Month 22 Day

Related information
URL releasing protocol	https://academic.oup.com/jjco/advance-article/doi/10.1093/jjco/hyac124/6654520?login=true
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/jjco/advance-article/doi/10.1093/jjco/hyac124/6654520?login=true
Number of participants that the trial has enrolled	45
Results	The effectiveness of nivolumab plus ipilimumab combination therapy in a real world setting in Japan at 2-year analysis and safety at 1-year analysis were comparable with those of CheckMate 214. The analysis also demonstrated the effectiveness of second-line therapy after the combination therapy.
Results date posted	2022 Year 09 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with IMDC intermediate or poor risk previously untreated mRCC, who had initiated nivolumab plus ipilimumab combination therapy between21 August 2018 and 31 January 2019, were allowed to enroll in this study.
Participant flow	Forty-five patients were enrolled from nine hospitals in Japan and their data were retrospectively analyzed.
Adverse events	Any grade treatment-related adverse events occurred in 35 patients (77.8%), whereas grade >=3 treatment related AEs occurred in 17 patients (37.8%). No new safety signals for nivolumab plus ipilimumab combination therapy were reported.
Outcome measures	Objective response rate of nivolumab plus ipilimumab combination therapy was 41.5% (17 patients), with 6 patients (14.6%) achieving complete response. Median progression-free survival of the combination therapy was 17.8 months and 24-month overall survival rates were 59.1%. Twenty-two patients were treated with second-line therapy. Objective response rate of second-line therapy was 20% and median progression-free survival was 9.8 months.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 28 Day
Date of IRB	2019 Year 01 Month 31 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2021 Year 01 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	2019 Year 02 Month 22 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040882