UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 01 Month 13 Day
Date of IRB	2018 Year 05 Month 08 Day
Anticipated trial start date	2018 Year 07 Month 02 Day
Last follow-up date	2021 Year 06 Month 30 Day
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	2022 Year 05 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037240