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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036772
Receipt No. R000041901
Scientific Title JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF NIVOLUMAB PLUS IPILIMUMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED, ADVANCED OR METASTATIC RENAL CELL CARCINOMA (ARCC) CATEGORIZED INTO IMDC INTERMEDIATE/POOR RISKS (J-ENCORE)
Date of disclosure of the study information 2019/05/16
Last modified on 2019/05/16

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Basic information
Public title JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF NIVOLUMAB PLUS IPILIMUMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED, ADVANCED OR METASTATIC RENAL CELL CARCINOMA (ARCC) CATEGORIZED INTO IMDC INTERMEDIATE/POOR RISKS (J-ENCORE)
Acronym J-ENCORE
Scientific Title JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF NIVOLUMAB PLUS IPILIMUMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED, ADVANCED OR METASTATIC RENAL CELL CARCINOMA (ARCC) CATEGORIZED INTO IMDC INTERMEDIATE/POOR RISKS (J-ENCORE)
Scientific Title:Acronym J-ENCORE
Region
Japan

Condition
Condition ADVANCED OR METASTATIC RENAL CELL CARCINOMA
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To address among previously untreated advanced or metastatic renal cell carcinoma (RCC) patients with intermediate or poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk classification, who are treated with the combination of nivolumab plus ipilimumab as first line of systematic therapy in the real world setting in Japan:
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective response rate [ORR]
Key secondary outcomes Overall survival [OS]
Progression-free survival [PFS]
Change in tumor response overtime
Duration of response
Quality of life (QOL)
Incidence/rate of adverse events
The number of doses of nivolumab plus ipilimumab therapy
The rate of subsequent therapy
ORR on subsequent therapy


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 1. Histological confirmation of RCC
2. No prior systemic therapy for RCC
3. RCC patients who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
4. IMDC risk category Intermediate and Poor
5. Over 20 years old patients for whom informed consent was obtained from the patient at the time of this study participation
Key exclusion criteria 1. combination therapy in Japan
2. Pregnant and/or lactating women
3. Patients who are judged to be inappropriate by investigator
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Hirokazu
Middle name
Last name KANEKO
Organization Bristol-Myers Squibb K.K.
Division name Japan Medical, Immuno-Oncology Medical
Zip code 1631328
Address shinjuku i-Land Tower 5-1, Nishi-Shinjuku 6-chome,Shinjuku-ku,Toko,Japan
TEL 0367057147
Email hirokazu.kaneko@bms.com

Public contact
Name of contact person
1st name Tomoyosh
Middle name
Last name Kaneko
Organization Mebix, Inc
Division name Oncology Group
Zip code 1050001
Address Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon 33 Mori Building
TEL 03-4362-4504
Homepage URL
Email j-encore@mebix.co.jp

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

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

Other related organizations
Co-sponsor The Japanese Urological Association
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mebix, Inc
Address Oncology Group
Tel 03-4362-4504
Email j-encore@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
2019 Year 05 Month 16 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 04 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 15 Day
Last follow-up date
2023 Year 07 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 prospective, non-interventional, multicenter observational, descriptive study of aRCC patients with intermediate or poor IMDC risk classification, who are treated with the combination of nivolumab plus ipilimumab as first line of systematic therapy in the real world setting in Japan.

Management information
Registered date
2019 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041901

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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