UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036642 |
|---|---|
| Receipt number | R000041745 |
| Scientific Title | Accompanying study in a physician-initiated phase II clinical trial of anti-PD-1 antibody therapy for relapsed / progressive meningioma. |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2019/11/02 11:17:58 |
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Basic information
Public title
Accompanying study in a physician-initiated phase II clinical trial of anti-PD-1 antibody therapy for relapsed / progressive meningioma.
Acronym
Accompanying study in MENIVO
Scientific Title
Accompanying study in a physician-initiated phase II clinical trial of anti-PD-1 antibody therapy for relapsed / progressive meningioma.
Scientific Title:Acronym
Accompanying study in MENIVO
Region
| Japan |
Condition
Condition
meningioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate biomarker of efficacy of anti-PD-1 antibody, Nivolumab, against relapse/progressive meningioma which were treated in MENIVO trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of methylation, aberrant in expression of mRNA or protein, expression of serum miRNA in meningioma showed effectiveness with nivolumab.
Key secondary outcomes
Genetic features in recurrent / progressive meningioma
Natural history of the tumor after the treatment of nivolumab for 1.5years.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients included in MENIVO trial.
patients who agree to be enroll in this study.
Key exclusion criteria
patients who decline to be enroll in this study.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Sasaki |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku
TEL
03-5363-3808
hsasaki@keio.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Kamamoto |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku
TEL
03-5363-3808
Homepage URL
daikamamoto@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ono-Pharmaceutical co.
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
Keio University School of Medicine
Address
35 Shinanomachi Shinjuku-ku
Tel
03-3353-1211
daikamamoto@hotmail.com
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
| 2019 | Year | 05 | Month | 07 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2019 | Year | 05 | Month | 03 | Day |
Last modified on
| 2019 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041745
