UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025796
Receipt number R000029667
Scientific Title Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.
Date of disclosure of the study information 2017/01/22
Last modified on 2018/01/31 12:08:00

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Basic information

Public title

Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.

Acronym

Pharmacodynamic analysis and the mechanism of immune-related adverse events in immune-checkpoint inhibitor.

Scientific Title

Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.

Scientific Title:Acronym

Pharmacodynamic analysis and the mechanism of immune-related adverse events in immune-checkpoint inhibitor.

Region

Japan


Condition

Condition

solid cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To Investigate Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.

Basic objectives2

Others

Basic objectives -Others

Search for biomarkers on immune-related adverse events and therapeutic effects.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.

Key secondary outcomes

Identify autoantigens that cause immunological adverse events.To confirm whether thyroid autoantibodies are predictors of thyroid dysfunction. Relationship between immunological adverse event and response rate, duration of response, progression-free survival time, overall survival time, PD-L1, HLA class I, II .
The relationship between immune-related proteins (PD-L1) expression of tumor tissue and predictions of therapeutic effect and irAE.


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

(1) ECOG performance status (PS) of 0 to 2.
(2) Age of more than 20 years old.
(3) Written informed consent.

Key exclusion criteria

1) History of severe hypersensitivity to drugs used in this study.
(2) Within 14 days administer other antineoplastic agent before treatment of immune checkpoint inhibitors.
(3) Active infection.
(4) HBs antigen, HCV antibody and HIV antibody is positive.
(5) Pregnacy or patient's hope to be pregnant.
(6) An inappropriate case judged by doctor in charge.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyuki Hamada

Organization

Showa University

Division name

Department of Internal Medicine,Division of Medical Oncology

Zip code


Address

1-5-8,hatanodai,shinagawa-ku,Tokyo 142-8666,JAPAN

TEL

03-3784-8000

Email

hamadakaz@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuyuki Hamada

Organization

Showa University

Division name

Department of Internal Medicine,Division of Medical Oncology

Zip code


Address

1-5-8,hatanodai,shinagawa-ku,Tokyo 142-8666,JAPAN

TEL

03-3784-8000

Homepage URL


Email

hamadakaz@med.showa-u.ac.jp


Sponsor or person

Institute

Department of Internal Medicine,Division of Medical Oncology, Showa University School of Medicine.

Institute

Department

Personal name



Funding Source

Organization

Department of Internal Medicine,Division of Medical Oncology, Showa University School of Medicine.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Clinial Research Institute of Clinical Pharmacology and Therapeutics, Showa University.

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

昭和大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 22 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

Enrolling by invitation

Date of protocol fixation

2016 Year 10 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

An observational study of solid cancer Patients who are being treated with Anticancer drug at Showa University Hospital and meet to our inclusion criteria.
We will obtain peripheral blood mononucear cells and plasma sample from the patients.
We are going to measure plasma levels of cytokines (e.g. IFN-g , TNF-a , IL-4,5,6), PD-L1, PD-L2 and VEGF.
We are going to measure lymphocyte subset activation and PD - 1 receptor occupation rate of immune-checkpoint inhibitor on peripheral blood T lymphocyte.


Management information

Registered date

2017 Year 01 Month 22 Day

Last modified on

2018 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name