UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of prediction model for the efficacy of anti-PD-1 antibody on malignant pleural mesothelioma
Title of the study (Brief title)	Prediction model in MPM
Region	Japan

Condition
Condition	Malignant pleural mesothelioma
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to develop a prediction model for the effect of anti-PD-1 antibody by analyzing immunocompetent cells in patients with malignant pleural mesothelioma undergoing nivolumab therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tumor response rate
Key secondary outcomes	Progression Free Survival Overall survival

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 Patients who have been confirmed as MPM by histology or cytology. (Epithelial type, sarcoma type and bilayer type are not limited) 2 MPM patients who received previous platinum agent and pemetrexede combination therapy and were judged as progressive disease. 3 Patients with at least one measurable lesion as defined by mRECIST using CT or MRI 4 Patients who can receive nivolumab therapy 5 Patients who received full explanation from investigators or research sharing doctors regarding contents of this research using agreement document and explanation document and who consented to participate in this research by the person himself or herself
Key exclusion criteria	1 Patients receiving pervious systemic chemotherapies (two or more regimens), including platinum agent and pemetrexede combination therapy. 2 Patients with ECOG PS 2 or more 3 Patients receiving steriod therapy (10mg per day or more) 4 Patients receiving antibiotics between 4 weeks before and after the nivolumab therapy 5 Patients who are deemed inappropriate as study participants by investigators or medical doctors.
Target sample size	50

Research contact person
Name of lead principal investigator	Seiki Hasegawa
Organization	Hyogo college of medicine
Division name	Department of Thoracic Surgery
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL	0798-45-6111
Email	hasegawa@hyo-med.ac.jp

Public contact
Name of contact person	Seiji Matsumoto
Organization	Hyogo college of medicine
Division name	Department of Thoracic Surgery
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL	0798-45-6111
Homepage URL
Email	smatsumo@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 18 Day
Anticipated trial start date	2018 Year 10 Month 15 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	Tumor immune escape mechanism has recently been elucidated. Anti-tumor immunity antibodies are attracting attention. As susceptibility predictors of antitumor immune antibodies, tumor and lymphocyte antigens and expression of surface markers can be mentioned, but little is known regarding these issues. The objectives of this study are as follows. 1 Development of prediction method for the efficacy of antitumor immune antibody by receptor analysis of lymphocytes and measurement of expression of surface markers 2 Correlation between PD-L1 expression and tumor mutation burden using tumor specimens and lymphocyte analysis results 3 Neoepitope analysis using tumor and normal tissue 4 Correlation between intestinal and oral cavity flora, lymphocyte immune cell receptor and efficacy of anti-PD1 antibody

Management information
Registered date	2018 Year 09 Month 11 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038863