An Open Label Phase II Biomarker Study of Nivolumab the anti-PD-1 antibody in Japanese Subjects with pretreated non-small cell lung cancer.
- Conditions
- Pretreated Non-small cell lung cancer
- Registration Number
- JPRN-UMIN000019674
- Lead Sponsor
- Kindai university, Faculty of Medicine, Department of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 52
Not provided
Subjects with untreated symptomatic CNS metastases are excluded. 2 Symptomatic carcinomatous meningitis 3 Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism 4 Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 5 Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 6 Subjects with interstitial lung disease 7 Treatment with any investigational agent within 14 days of first administration of study treatment 8 Known history of stroke or cerebrovascular accident within 6 months prior to the enrollment 9 Subjects with known infection with HIV or AIDS 10 Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection 11 Any evidence of serious active infections. 12 Cancer directed therapy within 28 days of the first dose of nivolumab. 13 Major surgery within 28 days prior to the first dose of nivolumab.14 Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, NYHA Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.15 Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness social situations that would limit compliance with study requirements. 16 Subjects with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.17 Women who are pregnant or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the relationship between the biomarker candidate and 6 months PFS rate.
- Secondary Outcome Measures
Name Time Method