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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016608
Receipt No. R000019276
Scientific Title Clinical Research on the efficacy evaluation and the biomarker of nivolumab to an advance malignant melanoma
Date of disclosure of the study information 2015/02/23
Last modified on 2018/01/11

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Basic information
Public title Clinical Research on the efficacy evaluation and the biomarker of nivolumab to an advance malignant melanoma
Acronym CREATIVE
(CSPOR-melanoma)
Scientific Title Clinical Research on the efficacy evaluation and the biomarker of nivolumab to an advance malignant melanoma
Scientific Title:Acronym CREATIVE
(CSPOR-melanoma)
Region
Japan

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

Objectives
Narrative objectives1 Anti-PD-1 antibody nivolumab (hereinafter referred to as nivolumab) has been approved for unresectable malignant melanoma in Japan. The sample size in a clinical study in Japan was as small as 35 patients and the patient populations were also limited. Therefore, the objective will be to obtain information on the efficacy (response rate and overall survival) of nivolumab in many patients in daily clinical practice after marketing.
In addition, selectable biomarkers in patient populations in which nivolumab (immune-checkpoint inhibitor) is expected to be effective will be exploratively studied.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)Response rate (RR) by RECIST
2)Overall Survival (OS)
Key secondary outcomes 1)Progression-free Survival (PFS)
2)Response rate by Immune-Related Response Criteria (irRECIST)
3)Information on drug therapies after discontinuation/completion of administration of nivolumab
4)Selection of the factors predictive of treatment response after administration of nivolumab

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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with unresectable malignant melanoma
2)Patients with one or more lesions which can be measured by computed tomography (CT) scan or nuclear magnetic resonance imaging (MRI) according to RECIST guideline ver. 1.1
3)Patients aged 20 years or older who gave informed consent for the study
Key exclusion criteria 1)Patients with comorbid active infection
2)Patients with interstitial lung disease or pulmonary fibrosis
3)Patients who are or may be pregnant
4)Patients who are difficult to treat due to psychosis or psychiatric symptoms
5)Patients judged to be ineligible for the study by an attending physician
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Yamazaki / Yutaka Kawakami
Organization National Cancer Center Hospital / Keio University Graduate School of Medicine
Division name Department of Dermatologic Oncology / Institute for Advanced Medical Research
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan / 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3542-2511
Email nyamazak@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamao
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Oncology Research (CSPOR)
Zip code
Address 1-1-7 Nishiwaseda, Shinjyuku-ku Tokyo 169-0051, Japan
TEL 03-5287-2636
Homepage URL
Email cspor-melanoma@csp.or.jp

Sponsor
Institute Public Health Research Foundation
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan/United States

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 1 新潟県立がんセンター新潟病院 皮膚科
2 自治医科大学附属病院 皮膚科学講座
3 埼玉医科大学病院 皮膚科
4 東京大学医学部附属病院 皮膚科・皮膚光線レーザー科
5 岩手医科大学附属病院 皮膚科
6 慶應義塾大学病院 皮膚科
7 富山県立中央病院 皮膚科
8 三重大学医学部附属病院 皮膚科
9 旭川医科大学病院 皮膚科
10 東北大学病院 皮膚科学分野
11 国家公務員共済組合連合会 虎の門病院 皮膚科
12 国立病院機構 鹿児島医療センター 皮膚腫瘍科・皮膚科
13 札幌医科大学附属病院 皮膚科
14 筑波大学附属病院 皮膚科
15 熊本大学医学部附属病院 皮膚科・形成再建科
16 国立病院機構 大阪医療センター 皮膚科
17 山梨大学医学部附属病院 皮膚科
18 群馬大学医学部附属病院 皮膚科
19 千葉大学医学部附属病院 皮膚科
20 国立がん研究センター中央病院 皮膚腫瘍科
21 久留米大学病院 皮膚科
22 信州大学医学部附属病院 皮膚科学教室
23 神戸大学医学部附属病院 腫瘍・血液内科
24 九州大学病院 皮膚科
25 埼玉医科大学国際医療センター 皮膚腫瘍科・皮膚科
26 福岡大学病院 皮膚科
27 名古屋大学医学部附属病院 皮膚科
28 広島大学病院 皮膚科
29 東北大学病院 腫瘍内科

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 23 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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study to collect information on the treatment given to eligible patients with unresectable malignant melanoma in daily clinical practice and to confirm the efficacy.

Management information
Registered date
2015 Year 02 Month 23 Day
Last modified on
2018 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019276

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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