UMIN-CTR Clinical Trial

Public title

Development of prediction model for the efficacy of anti-PD-1 antibody on malignant pleural mesothelioma

Acronym

Prediction model in MPM

Scientific Title

Development of prediction model for the efficacy of anti-PD-1 antibody on malignant pleural mesothelioma

Scientific Title:Acronym

Prediction model in MPM

Region

Japan

Condition

Malignant pleural mesothelioma

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

Primary outcomes

Tumor response rate

Key secondary outcomes

Progression Free Survival
Overall survival

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 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

Name of lead principal investigator

1st name
Middle name
Last name	Seiki Hasegawa

Organization

Hyogo college of medicine

Division name

Department of Thoracic Surgery

Zip code

Address

1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.

TEL

0798-45-6111

Email

hasegawa@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Seiji Matsumoto

Organization

Hyogo college of medicine

Division name

Department of Thoracic Surgery

Zip code

Address

1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.

TEL

0798-45-6111

Homepage URL

Email

smatsumo@hyo-med.ac.jp

Institute

Hyogo college of medicine

Institute

Department

Personal name

Organization

Hyogo college of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2018

Year

10

Month

15

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

Preinitiation

Date of protocol fixation

2018

Year

09

Month

18

Day

Date of IRB

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

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

Registered date

2018

Year

09

Month

11

Day

Last modified on

2018

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038863