UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026658 |
|---|---|
| Receipt number | R000030609 |
| Scientific Title | 64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer. |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2017/03/25 09:35:52 |
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Basic information
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
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
| 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
ketamura@ncc.go.jp
Public contact
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
akawachi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Tokyo, Japan
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030609
