UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030892 |
|---|---|
| Receipt number | R000034363 |
| Scientific Title | Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma |
| Date of disclosure of the study information | 2018/01/19 |
| Last modified on | 2023/02/10 14:09:20 |
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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
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
gotou@fiverings.co.jp
Sponsor or person
Institute
Okayama Rosai Hospital
Institute
Department
Personal name
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
-
-
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
Completed
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
| 2022 | Year | 03 | Month | 31 | 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
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034363
