UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma
Acronym	Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma
Scientific Title	Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma
Scientific Title:Acronym	Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma
Region	Japan

Condition
Condition	malignant pleural mesothelioma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess efficacy and safety of the first-line combination therapy of cisplatin, pemetrexed and nivolumab for advanced or metastatic malignant pleural mesothelioma which is untreated and unresectable
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Centrally reviewed, overall response rate based on Modified RECIST criteria: to last administration
Key secondary outcomes	Safety: adverse event, laboratory test, vital sign, body weight, 12-lead electrocardiogram, chest X-ray, ECOG Performance Status Efficacy: 1) Response rate (assessment by local institution, Modified RECIST criteria) 2) Disease control rate (central review, Modified RECIST criteria) 3) Overall survival 4) Progression-free survival (central review, Modified RECIST criteria) 5) Duration of response (central review, Modified RECIST criteria) 6) Time to response (central review, Modified RECIST criteria) 7) best overall response (central review, Modified RECIST criteria) 8) The rate of change of the sum of the target lesion length (assessment by local institution, Modified RECIST criteria) QOL: EQ-5D, LCSS-Meso

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continue to administer the combination therapy of cisplatin, pemetrexed and nivolumab and the maintenance therapy of nivolumab to a patient until the patient correspond to the withdrawal criteria for individual subject.
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) Age: more than 20 years old at the date of informed consent 2) Pathologically confirmed pleural malignant mesothelioma 3) Advanced or metastatic malignant pleural mesothelioma which is untreated and unresectable 4) Patients who have a measurable lesion designated by Modified RECIST criteira 5) Available tumor sample for testing of PD-L1 expression 6) Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1 7) Life expectancy is >= 90 days 8) SpO2 measured by pulse oximeter within 7 days is >= 94% 9) Meet the defined lab value criteria 10) Females of childbearing potential who agree to prevent pregnancy and lactating to at least 5 months after last administration of nivolumab 11) Males who agree to contraception at least 7 months after last administration of nivolumab 12) Patients who understand the study contents and give a written consent at their free will
Key exclusion criteria	1) Patients with history of anaphylaxis induced by other drugs 2) Autoimmune disease 3) Double cancer 4) Metastasis to brain or meninges 5) Interstitial lung disease or pulmonary fibrosis 6) Diverticulitis or peptic ulcer 7) Pleural effusion necessary for emission every 2 weeks or more 8) Treating pericardial effusion or ascites 9) Uncontrollable tumor pain 10) Transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism within 180 days 11) Uncontrollable severe cardiovascular disease 12) Anticoagulant therapy 13) Uncontrollable diabetes 14) Treating systemic infection 15) Transplantation therapy 16) Obviously positive to HIV infection 17) HTLV-1 antibody positive, HBs antigen positive or HCV antibody positive. Either HBs antigen positive or HBc antibody positive and HBV-DNA detection although HBs antigen is negative. 18) History of treatment for T cell regulation 19) Surgery with local or surface anesthesia within 14 days 20) Surgery with general anesthesia within 28 days 21) Pleurodesis within 14 days 22) Pleurodesis using picibanil within 28 days 23) Adhesions surgery of pericardium or peritoneum 24) Radiation therapy for pain relief within 14 days 25) Radiopharmaceutical therapy within 56 days 26) Administration of unapproved drugs within 28 days or unapproved antibody within 90 days 27) Administration of systemic adrenal cortical hormone or immunosuppressive agents 28) Females who are or may be pregnant or lactating 29) Patients who are incapable of giving consent (for example, dementia) 30) Any other inadequacy for this study
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Nobukazu Middle name Last name Fujimoto
Organization	Okayama Rosai Hospital
Division name	Department of Medical Oncology
Zip code	7028055
Address	1-10-25 Chikkomidorimachi, Minami-ku, Okayama-city, Okayama 702-8055
TEL	086-262-0131
Email	nobufujimot@gmail.com

Public contact
Name of contact person	1st name Tatsushi Middle name Last name Goto
Organization	Fiverings Co.,Ltd.
Division name	Medical team
Zip code	5300044
Address	Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka 530-0044 Japan
TEL	06-6358-7110
Homepage URL
Email	gotou@fiverings.co.jp

Sponsor
Institute	Okayama Rosai Hospital
Institute
Department

Funding Source
Organization	Ono pharmaceutical Co, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	岡山大学病院（岡山県）、独立行政法人労働者健康安全機構岡山労災病院（岡山県）、独立行政法人国立病院機構山口宇部医療センター（山口県）、独立行政法人国立病院機構四国がんセンター（愛媛県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 19 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	18
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	No longer recruiting
Date of protocol fixation	2017 Year 11 Month 28 Day
Date of IRB	2017 Year 12 Month 21 Day
Anticipated trial start date	2018 Year 01 Month 20 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 19 Day
Last modified on	2019 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034363

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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