UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015845 |
|---|---|
| Receipt number | R000018439 |
| Scientific Title | A phase II trial of nivolumab in advanced mucosal melanoma |
| Date of disclosure of the study information | 2014/12/04 |
| Last modified on | 2017/12/07 00:54:59 |
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Basic information
Public title
A phase II trial of nivolumab in advanced mucosal melanoma
Acronym
A phase II trial of nivolumab in advanced mucosal melanoma
Scientific Title
A phase II trial of nivolumab in advanced mucosal melanoma
Scientific Title:Acronym
A phase II trial of nivolumab in advanced mucosal melanoma
Region
| Japan |
Condition
Condition
mucosal melanoma
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Obstetrics and Gynecology |
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival, progression free survival, disease control rate, response duration, time to response, best overall response, rate of change in tumor size, immuno-related disease control rate, immuno-related progression free survival, immuno-related response, toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nivolumab 2mg/kg, triweekly
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) Histologically proven mucosal melanoma
2) Aged 20 years old or more
3) metastatic or advanced disease
4) ECOG PS of 0 or 1
5) No need for previous treatment
6) Need for measurable lesion
7) No previous chest radiotherapy
8) Adequate organ functions
9) Written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Patients with immune suppression.
4) Patients with central nerve system metastases.
5) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor.
6) Patients received live vaccines.
7) Patients who received anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CD137 antibody, or anti CTLA-4 antibody.
8) Positive HBs antigen, or positive HCV antibody.
9) Pregnancy, possible pregnancy or breastfeeding.
10) Psychiatric disease.
11) Patients requiring systemic steroid medication.
12) Poorly controlled diabetes mellitus.
13) Severe pulmonary fibrosis or emphysema.
14) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Ando |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
052-762-6111
mandoh@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoo Nomura |
Organization
Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
TEL
075-751-3518
Homepage URL
excell@hkg.odn.ne.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
愛知県がんセンター中央病院(愛知県)、京都大学(京都府)、倉敷中央病院(岡山県)、静岡県立静岡がんセンター(静岡県)、千葉大学(千葉県)、滋賀医科大学(滋賀県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 04 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | 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
| 2014 | Year | 12 | Month | 04 | Day |
Last modified on
| 2017 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018439
