UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035974 |
|---|---|
| Receipt number | 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 | 2022/09/01 14:20:51 |
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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 | 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
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
J-cardinal_cta@cmic.co.jp
Sponsor or person
Institute
Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040882
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