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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026925
Receipt No. R000030884
Scientific Title Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanoma
Date of disclosure of the study information 2017/04/10
Last modified on 2018/10/11

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Basic information
Public title Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanoma
Acronym Immuno-radiosensitization treatment for metastatic melanoma
Scientific Title Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanoma
Scientific Title:Acronym Immuno-radiosensitization treatment for metastatic melanoma
Region
Japan

Condition
Condition metastatic melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate whether metastic lesions decrease in size or disappear by simultaneous therapy of KORTUC and immuno checkpoint therapy for metastasic melanoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The effect of tumor reduction is evaluated by diagnostic imaging at one month, two months and three months after end of treatment. Thereafter, every three months until two years later after treatment termination , and after that, once in six 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 Device,equipment
Interventions/Control_1 After intratumor injection of hydrogen peroxide 0.5ml and sodium hyaluronate 2.5ml mixture once or twice per week, radiotherapy is give to tumor during four to six weeks.
Simultaneously, intravenous drip of nivolumab (3mg/kg) everty two weeks or pembrolizumab (2mg/kg) everty two weeks or ipilimumab (3mg/kg) everty three weeks is performed. Treatment of nivolumab or pembrolizumab is continued until tumor disappearance. However, ipilimumab is administrated four times in total.
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
95 years-old >=
Gender Male and Female
Key inclusion criteria 1) Inoperable metastatic melanoma
2) Be able to lie quietly for more than thirty minutes
3) SpO2 not less than 90%
4) Body temperature no more than 37.5 degrees
5) Gaining informed consent from patients or legal representatives
Key exclusion criteria 1) Unable to secure infusion route of drugs by using ultrasound or CT
2) Determined to have high risk for bleeding by principalinvestigator or sub-investigators
3) Determined to have high risk for infection by principalinvestigator or sub-investigators
4) Determined to be inappropriate for this trial.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetoshi Sano
Organization Kochi University, Kochi Medical School
Division name dermatology
Zip code
Address Kohasu, Okohcho, Nankoku, Kochi
TEL 0888802363
Email sano.derma@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigetoshi Sano
Organization Kochi University, Kochi Medical School
Division name dermatology
Zip code
Address Kohasu, Okohcho, Nankoku, Kochi
TEL 0888802363
Homepage URL
Email sano.derma@kochi-u.ac.jp

Sponsor
Institute Kochi University, Kochi Medical School
Institute
Department

Funding Source
Organization Kochi University, Kochi Medical School
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 10 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
2017 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2017 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

Management information
Registered date
2017 Year 04 Month 10 Day
Last modified on
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030884

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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