UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer.
Title of the study (Brief title)	Nivolumab PET imaging
Region	Japan

Condition
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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kenji Tamura
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Breast and Medical Oncology
Address	5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan
TEL	03-3542-2511
Email	ketamura@ncc.go.jp

Public contact
Name of contact person	Asuka Kawachi/ Akihiko Shimomura
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Breast and Medical Oncology
Address	5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	akawachi@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Tokyo, Japan
Institute
Department

Funding Source
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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 24 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 23 Day
Last modified on	2017 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030609