UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031736 |
|---|---|
| Receipt number | R000036236 |
| Scientific Title | Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/09/13 11:47:38 |
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Basic information
Public title
Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab
Acronym
Nivo/Ipi Combi-POS
Scientific Title
Prospective observational study of Japanese melanoma patients treated with combination therapy using nivolumab and ipilimiumab
Scientific Title:Acronym
Nivo/Ipi Combi-POS
Region
| Japan |
Condition
Condition
Melanoma, advanced
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate safety and efficacy of combination therapy using nivolumab and ipilimumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best overall response, overall surviva, adverse events
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Advanced melanoma patients who have never treated with immune checkpoint inhibitors and planning to treat with nivolumab+ipilimumab combination therapy
Key exclusion criteria
Prior treatment with immune checkpoint inhibitors
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1 Tennodai, Tsukuba City
TEL
0298533128
fujisan@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1 Tennodai, Tsukuba City
TEL
0298533128
Homepage URL
fujisan@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036236
