UMIN-CTR Clinical Trial

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

solid cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

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

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

昭和大学病院（東京都）

Date of disclosure of the study information

2017

Year

01

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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