UMIN-CTR Clinical Trial

Public title

64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer.

Acronym

Nivolumab PET imaging

Scientific Title

64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer.

Scientific Title:Acronym

Nivolumab PET imaging

Region

Japan

Condition

Unresectable or metastatic malignant melanoma,unresectable or metastatic non small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This is a trial with 64Cu-DOTA-nivolumab PET imaging to evaluate sensitivity and specificity of 64Cu-DOTA-nivolumab to PD-1 expression in advanced metastatic melanoma or non-small cell lung cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Sensitivity; proportion of 64Cu-DOTA-nivolumab PET positive patients within PD-1 positive tumors.
Specificity; proportion of 64Cu-DOTA-nivolumab PET negative patients within PD-1 negative tumors.

Key secondary outcomes

Feasibility of 64Cu-DOTA-nivolumab PET imaging
Positive predive predictive value and negative predictive value of 64Cu-DOTA-nivolumab PET imaging

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

Drug: 64Cu-DOTA-nivolumab
Device: 64Cu-DOTA-nivolumab PET

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. Age more than 20 years old
2. Histologically confirmed malignant melanoma or non-small cell lung cancer.
3. Formalin fixed, paraffin embedded (FFPE) tumor sample to evaluate PD-1 expression with immunohistochemistory.
4. At least 1 site of measurable disease
5. Eastern Cooperative Oncology Group performance status of 0-2.
6. Patient must have normal organ and bone marrow function:
WBC >= 2,000/mm3
Platelet count >= 75,000/mm3
Hemoglobin concentration >= 8.0 g/dL
Aspartate aminotransferase and alanine amino
transferase <= 100 IU/L
Total bilirubin <= 1.5 mg/dL
Serum creatinine <=1.5 mg/dL
7. Getting informed concents and agreement.

Key exclusion criteria

1. Previous any drug allergies.
2. Uncontrolled any comorbidities (eg; cardiovascular disease, diabetes and psychiatric disease)
3. Active systemic infectious disease
4. Previous history of interstitial lung disease or pulmonary fibrosis disease.
5. Pregnant or lactating women.
6. Patients who recognized inappropriate candidate by physician.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Tamura

Organization

National Cancer Center Hospital, Tokyo, Japan

Division name

Breast and Medical Oncology

Zip code

Address

5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan

TEL

03-3542-2511

Email

ketamura@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Asuka Kawachi/ Akihiko Shimomura

Organization

National Cancer Center Hospital, Tokyo, Japan

Division name

Breast and Medical Oncology

Zip code

Address

5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan

TEL

03-3542-2511

Homepage URL

Email

akawachi@ncc.go.jp

Institute

National Cancer Center Hospital, Tokyo, Japan

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb Co., Ltd.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立がん研究センター中央病院

Date of disclosure of the study information

2017

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2016

Year

11

Month

10

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

23

Day

Last modified on

2017

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030609