UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044038 |
|---|---|
| Receipt number | R000050286 |
| Scientific Title | An Open-Label, Expanded Access Program with Nivolumab (ONO-4538) for cancer of unknown primary (CUP) (NivoCUP-2) Biomarker study (WJOG14620MTR) |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2022/12/26 09:38:41 |
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Basic information
Public title
An Open-Label, Expanded Access Program with Nivolumab (ONO-4538) for cancer of unknown primary (CUP) (NivoCUP-2) Biomarker study (WJOG14620MTR)
Acronym
WJOG14620MTR
Scientific Title
An Open-Label, Expanded Access Program with Nivolumab (ONO-4538) for cancer of unknown primary (CUP) (NivoCUP-2) Biomarker study (WJOG14620MTR)
Scientific Title:Acronym
WJOG14620MTR
Region
| Japan |
Condition
Condition
Cancer of unknown primary
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate exploratory biomarkers of nivolumab efficacy for unknown primary cancer.
Basic objectives2
Others
Basic objectives -Others
Biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate exploratory biomarkers of nivolumab efficacy for unknown primary cancer.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
-Subjects who were enrolled WJOG14620M
-Subjects must have a signed and dated written informed consent form for exploratory use of tissue/blood samples
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL
072-366-0221
hidet31@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
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
Kindai university institutional Review Board
Address
377-2, Ohnohigashi, Osaka-sayama, Osaka, Japan
Tel
072-366-0221
tiken-jimu@med.kindai.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 17 | 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
49
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
| 2021 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An exploratory biomarker study to evaluate the association of of nivolumab efficacy and immunological feature, clinical background/characteristics of CUP
Management information
Registered date
| 2021 | Year | 04 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050286
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
