An Open Label Phase II Study on the efficacy of Nivolumab(ONO-4538) in Japanese Subjects with cancer of unknown primary (CUP) (NivoCUP)
- Conditions
- Cancer of unknown primary
- Registration Number
- JPRN-UMIN000030649
- 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
- 55
Not provided
1.Indication for curative surgery or radiotherapy 2.Favorable subsets under treatable condition 3.Proven primary site before enrollment 4.History of allergy or hypersensitivity to drug components 5.Judged that the adverse events from the previous treatment influence on the study evaluation 6.Subjects with untreated CNS metastases 7.Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 8.Prior therapy with drug targeting immune-checkpoint pathways 9.Subjects treated with any investigational drug within 28 days before initiation of the study treatment 10.Anti-cancer therapy within 14 days before enrollment 11.Subjects who were treated with radiotherapy within 28 days (palliative radiotherapy within 14 days) before enrollment 12.Subjects with diseases listed as below -An active, chronic or recurrent autoimmune disease -Interstitial lung disease -Diverticulitis or symptomatic gastrointestinal ulcer disease -Uncontrollable diabetes -Uncontrollable pleural , ascites or pericardial effusion requiring treatment -Stroke, cerebrovascular accident, thrombosis, or thromboembolism within 180 days before the enrollment -Known history of HIV or AIDS -Positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection -Systemic infection requiring treatment -Uncontrolled or severe cardiovascular disease, congestive heart failure, arrhythmias, pericardial disease or cardiac amyloidosis -Uncontrolled intercurrent illness 13.Surgery requiring local or surface anesthesia within 14 days or general anesthesia within 28 days before the enrollment 14.Subjects with other active malignancy 15.History of organ transplantation or hematopoietic stem cell transplantation 16.Women who are pregnant or breast feeding 17.Subjects be in a state lacking consent ability 18.Subjects with unsuitable condition judged by principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (Blinded independent central review) for previously treated subjects.
- Secondary Outcome Measures
Name Time Method Overall response rate (Investigator's review) for previously treated subjects. Overall response rate (Blinded independent central review) for whole subjects. Disease control rate, overall survival, overall survival rate and progression free survival rate at 6, 12, 18, and 24 months, progression free survival, duration of response, time to response, best response, and change of tumor burden (Blinded independent central review and investigator's review). Safety and feasibility of nivolumab for cancer of unknown primary. Evaluation the association between efficacy of nivolumab and PD-L1 expression (cut off; 1%, 10%, 50%) or tumor infiltrated T lymphocytes (CD4,CD8,FOXP3).