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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025908
Receipt No. R000029772
Scientific Title Retrospective cohort study of correlation between immune check point molecular inhibitor and response factor, side effect, and post treatment
Date of disclosure of the study information 2017/01/31
Last modified on 2017/03/26

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Basic information
Public title Retrospective cohort study of correlation between immune check point molecular inhibitor and response factor, side effect, and post treatment
Acronym The rerashonship between immune check point molecular inhibitor and response factor, side effect, or post treatment
Scientific Title Retrospective cohort study of correlation between immune check point molecular inhibitor and response factor, side effect, and post treatment
Scientific Title:Acronym The rerashonship between immune check point molecular inhibitor and response factor, side effect, or post treatment
Region
Japan

Condition
Condition Patients with non-resectable advanced or recurrent NSCLC receiving treatment with nivolumab
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate of factors influencing the response rate and adverse reactions to an immune checkpoint inhibitor, as well as subsequent therapy
Basic objectives2 Others
Basic objectives -Others A: Relation between pretreatment patient characteristics and the efficacy of nivolumab and its ARs.
B: Response patterns, sites of response (anatomical regions), and ARs
C: Influence of nivolumab on subsequent treatment
D: Correlation with effect of nivolumab and IHC of PD-L1
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To investigate whether retrospective analysis of nivolumab therapy in the real clinical setting reproduces the RR shown by primary analysis of the CheckMate trial.
Key secondary outcomes A: Relation between pretreatment patient characteristics and the efficacy of nivolumab and its ARs.
B: Response patterns, sites of response (anatomical regions), and ARs
C: Influence of nivolumab on subsequent treatment
D: Correlation with effect of nivolumab and IHC of PD-L1

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with a definite diagnosis of NSCLC based on histology or cytology.
2) Patients unsuitable for curative radiation therapy who have a clinical diagnosis of either recurrent disease or stage IV NSCLC.
3) Patients who receive at least one dose of nivolumab.
Key exclusion criteria Patients who have previously received nivolumab in a clinical trial will be excluded
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imamura Fumio
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Thoracic Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL 06-6972-1181
Email imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamiya Motohiro
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Thoracic Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL 06-6972-1181
Homepage URL
Email moto19781205@yahoo.co.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular
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 National Hospital Organization Kinki Chuo Chest Medical Center
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
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
2017 Year 01 Month 31 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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 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 Primary endpoint:
To investigate whether retrospective analysis of nivolumab therapy in the real clinical setting reproduces the RR shown by primary analysis of the CheckMate trial.

Secondary endpoints:
A: Relation between pretreatment patient characteristics and the efficacy of nivolumab and its ARs.

B: Response patterns, sites of response (anatomical regions), and ARs

C: Influence of nivolumab on subsequent treatment

D: Correlation with effect of Nivolumab and IHC of PD-L1

Management information
Registered date
2017 Year 01 Month 30 Day
Last modified on
2017 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029772

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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