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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032686
Receipt No. R000037240
Scientific Title A Biomarker Analysis of Nivolumab in Previously Treated Advanced Gastric Cancer(WJOG10417GTR)
Date of disclosure of the study information 2018/05/24
Last modified on 2018/08/02

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Basic information
Public title A Biomarker Analysis of Nivolumab in Previously Treated Advanced Gastric Cancer(WJOG10417GTR)
Acronym A Biomarker Analysis of Nivolumab in Previously Treated Advanced Gastric Cancer
Scientific Title A Biomarker Analysis of Nivolumab in Previously Treated Advanced Gastric Cancer(WJOG10417GTR)
Scientific Title:Acronym A Biomarker Analysis of Nivolumab in Previously Treated Advanced Gastric Cancer
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the factors and immunological conditions in patient's peripheral blood and endoscopic tumor biopsy related to the efficacy obtained before and after initiating nivolumab in clinical practice for advanced gastric cancer
Basic objectives2 Others
Basic objectives -Others To predict the efficacy of nivolumab and to develop new combination therapy with nivolumab
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To explore the factors related of efficacy of nivolumab such as response, progression free survival and overall survival
Key secondary outcomes To explore the mechanism of intrinsic and acquired resistance of nivolumab

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) Scheduled to receive nivolumab monotherapy
2) Histologically confirmed adenocarcinoma of the stomach or esophago-gastric junction
3) Available tumor specimens for biomarker analysis
4) Having evaluable lesions based on CT imaging within 28 days prior to registration
5) Patents treated with at least two or more lines of previous chemotherapy
6) No prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells
7) No systemic corticosteroids (10 mg/day or more) or immune-suppressants administered concurrently or within 14 days before registration
Key exclusion criteria 1) Synchronous or metachronous malignancies
2) A positive test result for any of the followings: Human immunodeficiency virus antibody, hepatitis B surfaces (HBs) antigen, or hepatitis C virus antibody
3) Positive test result for either HBs antibody or hepatitis B core antibody, with a detectable level of hepatitis B virus-deoxyribonucleic acid (HBV-DNA) even in case of negative HBs antigen test
4) Judged to be incapable of providing consent for certain reasons, such as concurrent dementia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narikazu Boku
Organization National Cancer Center Hospital
Division name Gastrointestinal Medical Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email nboku@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD. and 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 筑波大学附属病院(茨城県)、埼玉県立がんセンター(埼玉県)、千葉県がんセンター(千葉県)、杏林大学医学部付属病院(東京都)、慶應義塾大学病院(東京都)、虎の門病院(東京都)、東京慈恵会医科大学付属病院(東京都)、国立がん研究センター中央病院(東京都)、がん研究会有明病院(東京都)、静岡県立静岡がんセンター(静岡県)、愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 24 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To explore the factors and immunological conditions in patient's peripheral blood and endoscopic tumor biopsy related to the efficacy obtained before and after initiating nivolumab in clinical practice for advanced gastric cancer (Nivolumab is administered as clinical practice, not specified in the protocol)

Management information
Registered date
2018 Year 05 Month 23 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037240

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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