Unresectable or metastatic malignant melanoma,unresectable or metastatic non small cell lung cancer
Conditions
Interventions
Drug: 64Cu-DOTA-nivolumab Device: 64Cu-DOTA-nivolumab PET
Sponsors
National Cancer Center Hospital, Tokyo, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of 64Cu-DOTA-nivolumab PET imaging Positive predive predictive value and negative predictive value of 64Cu-DOTA-nivolumab PET imaging | — |
Countries
Japan
Contacts
Public ContactAsuka Kawachi/ Akihiko Shimomura
National Cancer Center Hospital, Tokyo, Japan Breast and Medical Oncology
Outcome results
None listed