UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020222 |
|---|---|
| Receipt number | R000023357 |
| Scientific Title | A Phase I Trial of Combined immunotherapy with nivolumab and interferon-beta in Patients with advanced melanoma. |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2017/12/11 19:33:15 |
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Basic information
Public title
A Phase I Trial of Combined immunotherapy with nivolumab and interferon-beta in Patients with advanced melanoma.
Acronym
A Phase I Trial of immunotherapy with nivolumab and interferon-beta in melanoma patients.
Scientific Title
A Phase I Trial of Combined immunotherapy with nivolumab and interferon-beta in Patients with advanced melanoma.
Scientific Title:Acronym
A Phase I Trial of immunotherapy with nivolumab and interferon-beta in melanoma patients.
Region
| Japan |
Condition
Condition
advanced melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To deside the safety dose of IFN-b when co-administrate with nivolumab
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event
Maximum tolerated dose (MTD)
At 6 weeks, we assess the primary outcomes and will observe during 6 months.
Key secondary outcomes
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
A combination immunotherapy with nivolumab (2mg/ kg) and IFN-beta (1 million U, 2 million U or 3 million U).At day 0, IFNb is administered in combination with nivolumab. Then, according to the conventional recipe, nivolumab will be administered at every three weeks.
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
unresectable advanced melanoma
Key exclusion criteria
hypersensitibity against nivolumab
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Fujimura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku
TEL
022-717-7271
tfujimura1@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Fujimura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku
TEL
022-717-7271
Homepage URL
tfujimura1@mac.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD/Bristol-Myers Squibb
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 17 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023357
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/12/11 | 151217 protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/12/11 | CRF 0w.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/12/11 | data.xlsx |
