UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023873
Receipt number R000027498
Scientific Title A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.
Date of disclosure of the study information 2016/08/31
Last modified on 2022/03/07 08:27:10

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Basic information

Public title

A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.

Acronym

A biomarker study of of Nivolumab in blood and pleural effusion.

Scientific Title

A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.

Scientific Title:Acronym

A biomarker study of of Nivolumab in blood and pleural effusion.

Region

Japan


Condition

Condition

previously treated patients with advanced non-small-cell lung cancer

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal predictive biomarker for nivolmab

Basic objectives2

Others

Basic objectives -Others

response rate, progression free survival, overall survival

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

We study biomarkers in peripheral blood and pleural effusion between before and 2-4 week after Nivolumab treatment start.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Collecting pleural effusion and blood before and after Nivolumab treatment

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

1)Histologically or cytologically comfarmed non-small-cell lung cancer
2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with pleural effusion that can be taken
3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria.
4)Twenty or more years old at tnetime of imformed consent
5)Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS)0-1
6)Have adequate organ function within 14 days before entry
7)Estimate life expectancy of at least 12 weeks
8)Have signed an informed consent document

Key exclusion criteria

1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray
2)Clinically significant drug allergy
3)Presencee of other active malignancy
4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage
5)Positive serum HBs antigen
6)With severe infection, cardiac diseases, diabates, hypertention, other severe complication
7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks.
8)Pregnancy or lactating patients

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Kumanogoh

Organization

Osaka University Medical School

Division name

Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Gradu ate School of Medicine

Zip code


Address

2-2 Yamada-oka, Suita, Osaka

TEL

06-6879-3831

Email

kumanogo@imed3.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hidekazu Suzuki

Organization

Osaka Habikino Medical Center

Division name

Department of Thoracic oncology

Zip code


Address

3-7-1 Habikino, Habikino-shi, Osaka

TEL

+81-72-957-2121

Homepage URL


Email

suzukih@opho.jp


Sponsor or person

Institute

Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb.

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 08 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

Completed

Date of protocol fixation

2016 Year 07 Month 01 Day

Date of IRB

2016 Year 07 Month 19 Day

Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 31 Day

Last modified on

2022 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name