UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000036772
Receipt number	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	2022/11/16 16:57:58

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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

Scientific Title:Acronym

J-ENCORE

Region

Japan

Condition

ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

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 HIROAKI

Middle name

Last name ITO

Organization

Bristol-Myers Squibb K.K.

Division name

Japan Medical, Immuno-Oncology Medical

Zip code

1000004

Address

1-2-1, Otemachi, Chiyoda-ku, Tokyo, Japan

TEL

03-6705-7000

Email

hiroaki.ito@bms.com

Public contact

Name of contact person

1st name Keisuke

Middle name

Last name Hirota

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 or person

Institute

Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.,LTD.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Partially published

Result

URL related to results and publications

Number of participants that the trial has enrolled

286

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

No longer recruiting

Date of protocol fixation

2019 Year 04 Month 24 Day

Date of IRB

2019 Year 08 Month 06 Day

Anticipated trial start date

2019 Year 08 Month 15 Day

Last follow-up date

2024 Year 08 Month 23 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

2022 Year 11 Month 16 Day

Link to view the page

Value
https://center6.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