UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033560 |
|---|---|
| Receipt number | R000038274 |
| Scientific Title | 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 | 2023/02/01 09:05:56 |
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Basic information
Public title
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).
Acronym
TMB-H basket TR
Scientific Title
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).
Scientific Title:Acronym
TMB-H basket TR
Region
| Japan |
Condition
Condition
Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, and Other Solid 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. Analyze ctDNA(16S rRNA PCR) and feces of patients with advanced solid malignancies over time to profile and monitor cancer-related genomic alterations
5. 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
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan 277-8577
TEL
04-7133-1111
tmb_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan 277-8577
TEL
04-7133-1111
Homepage URL
tmb_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan 277-8577
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
国立研究開発法人 国立がん研究センター東病院（千葉県）国立大学法人北海道大学病院(北海道）、国立研究開発法人 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）、愛知県がんセンター 中央病院（愛知県）、独立行政法人国立病院機構大阪医療センター（大阪府）、独立行政法人国立病院機構 四国がんセンター（愛媛県）、独立行政法人国立病院機構九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 10 | 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
70
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
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
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
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038274
