UMIN-CTR Clinical Trial

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 Naoya / Yutaka Middle name Last name Yamazaki / 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	104-0045
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 Akira Middle name Last name Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Oncology Research (CSPOR)
Zip code	169-0051
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	NO
Address	NO
Tel	NO
Email	NO

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	128
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	2015 Year 07 Month 21 Day
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	2020 Year 02 Month 27 Day

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