UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033411
Receipt number 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 17:19:10

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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 or person

Institute

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



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

Value
https://center6.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