UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Kazuyuki Hamada
Organization	Showa University
Division name	Department of Internal Medicine,Division of Medical Oncology
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	Kazuyuki Hamada
Organization	Showa University
Division name	Department of Internal Medicine,Division of Medical Oncology
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
Institute	Department of Internal Medicine,Division of Medical Oncology, Showa University School of Medicine.
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029667