UMIN-CTR Clinical Trial

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

malignant melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Public Health Research Foundation

Institute

Department

Personal name

Organization

Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan/United States

Co-sponsor

Name of secondary funder(s)

Organization

NO

Address

NO

Tel

NO

Email

NO

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2015

Year

02

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

02

Month

23

Day

Last modified on

2020

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019276