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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033411
Receipt No. R000038092
Scientific Title Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2018/07/17
Last modified on 2019/07/18

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Basic information
Public title Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer
Acronym Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes
Scientific Title Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer
Scientific Title:Acronym Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes
Region
Japan

Condition
Condition Non-small cell lung carcinoma
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the efficacy of nivolumab, evaluate treatment response with respect to immune-related gene SNPs among patients with NSCLC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival after administration of nivolumab with respect to immune-related gene SNPs.
Key secondary outcomes Immune-related adverse events after administration of nivolumab with respect to immune-related gene SNPs.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Written informed consent.
2) Age 18 or over.
3) Patients with non-small cell lung cancer diagnosed by histology or cytology.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
5) With one or more measurable disease (RECIST ver.1.1). Radiated tumor be excluded.
6) Major organs are held by the examination value within 14 days and clinical examination at the start of treatment meets the following criteria
Neut >= 2,500/mm3
Lym>= 500/ul
Plt>= 100,000/ul
Hb >= 9.0 g/dL
CRE <= 1.5 mg/dL
T-bil <= x2 facility standard
AST/ALT <= x3 facility standard
7) No previus immune-checkpoint inhibitors treatment.
Key exclusion criteria 1) Chemotherapy was used in the past 21 days. Exceptionally administration of tyrosine kinase inhibitors are not to be excluded.
2)Patients with symptomatic brain metastases and meningeal metastases. However, clinically stable brain metastasis cases can be registered.
3) Uncontrolled pleural effusion, pericardial effusion, and/or ascites.
4) Uncontrolled hyperkalemia.
5) Active double cancer within 5years of the first day of nivolumab treatment.
6) Pregnant or breast-feeding female patients.
7) Autoimmune disease.
8) Evident pulmonary fibrosis, organized pneumonia, drug-induced pneumonia or interstitial lung disease. Patients with active pneumonia at screening CT.
9) Serum albumin < 2.5g/dl
10) Patients with active infectious disease (HBV hepatitis, tuberculosis, pneumonia, sepsis etc.)
11) Ptients with serious heart disease.
12) Attenuated live vaccine within 4 weeks of the first dose of nivolumab, or suppose to be needed during the treatment.
13) Immunostimulant (INF, IL-2, etc) within 6 weeks.
14) Immunosuppressant (predonisoron, cyclophosphamide, azathioprine, methotrexate, etc) within 2 weeks.
Target sample size 112

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ozasa
Organization Kyoto University
Division name Department of Respiratory Medicine
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3830
Email ozahiro@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Nomizo
Organization Kyoto University
Division name Department of Respiratory Medicine
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3830
Homepage URL http://kukonai.com/
Email gnomizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Graduate School of Medicine, Kyoto 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 Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
Tel 075-751-3830
Email ozahiro@kuhp.kyoto-u.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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 07 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
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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective observational study to investigate the association between immune-related gene polymorphism and nivolumab treatment in patients with NSCLC.

Management information
Registered date
2018 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038092

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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