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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020823
Receipt No. R000024033
Scientific Title Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Date of disclosure of the study information 2016/02/01
Last modified on 2016/09/05

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Basic information
Public title Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Acronym Exploration of biomarker after Nivolumab in lung cancer
Scientific Title Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Scientific Title:Acronym Exploration of biomarker after Nivolumab in lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Nivolumab is active for treatment of previously treated NSCLC. However, there have been no established biomarker to predict the efficcy and outcome after administration of Nivolumab. In this study, we explored the promising markers as a prediction of Nivolumab using blood samples.
Basic objectives2 Others
Basic objectives -Others We analyze the expression of PD-L1 within circulating cancer cells by CTC methods.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To explore the pretictive biomarkers after and before Nivolumab using blood samples.
Key secondary outcomes Potential of monitoring Nivolumab by any biomarkers

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 Candidate for administration of nivolumab

with written informed consent
Key exclusion criteria Judgement as exclusion by chief mdical physians

having auto-immune diseases
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University
Division name Oncology Clinical Development
Zip code
Address showa-machi. Maebashi, Gunma
TEL 027-220-8136
Email kkaira1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University
Division name Oncology Clinical Development
Zip code
Address showa-machi. Maebashi, Gunma
TEL 027-220-8136
Homepage URL
Email kkaira1970@yahoo.co.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co.,Ltd., 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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 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
2016 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design; Cohort study

Registration: Feb. 2016 to Jan. 2019, compatible with inclusion criteria



Using blood sample, any biomarkers before and after nivolumab administration and measured. In the first 5 patients, several points after 1,2,3,4w, 3m,6m and PD are assessed to find an appropriate point after nivolumab. Where we idenfy an optimal point, two points before and afternivolumab are evaluated. Any blood samples are used to do CTC and exosome analysis, examining immune enviromental biomarkers such as PD-L1, PD-L2, CD4 and CD8. We explored the relationship between the efficacy of nivolumab and the expression level of these markers.

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2016 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024033

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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