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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033560
Receipt No. R000038274
Official scientific title of the study TR accompanied with the study titled A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H).
Date of disclosure of the study information 2018/08/10
Last modified on 2018/07/30

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Basic information
Official scientific title of the study TR accompanied with the study titled A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H).
Title of the study (Brief title) TMB-H basket TR
Region
Japan

Condition
Condition Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, and Other gastrointestinal cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To identify biomarkers related with efficacy or resistance of immune check point inhibitors evaluate efficacy and safety of mono therapy with nivolumab in blood TMB-H patients with unresectable advanced / recurrent gastrointestinal malignancies.
Basic objectives2 Others
Basic objectives -Others Biomarker Research
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Evaluation of genome abnormality and gene expression by omics analysis of tumor etc.
2. TCR repertoire analysis and RNA expression analysis etc. of T cells in tumor tissue and peripheral blood.
3. Prediction and identification of tumor neo-antigen and evaluation of immunogenicity etc.
4. Assessment of the relationship between the analysis above and clinical pathological features or therapeutic efficacy etc.
Key secondary outcomes

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 Patients who enrolled in TMB-H basket study and provided written informed consent for this research.
Key exclusion criteria Patients who did not provide written informed consent for this research.
Target sample size 70

Research contact person
Name of lead principal investigator Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan 277-8577
TEL 04-7133-1111
Email tmb_core@east.ncc.go.jp

Public contact
Name of contact person Yoshiaki Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan 277-8577
TEL 04-7133-1111
Homepage URL
Email tmb_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 国立研究開発法人 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 24 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This study is an additional study of UMIN ID: UMIN000033182

Management information
Registered date
2018 Year 07 Month 30 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038274

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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