Cancer of unknown primary
Conditions
Interventions
biweekly 240mg nivolumab treatment
Sponsors
Kindai university, Faculty of Medicine, Department of Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with histologically confirmed cancer of unknown primary site based on adequate investigation of primary sites (excludes subjects who were pathologically diagnosed with malignant melanoma, malignant lymphoma or sarcoma) 2.Treatment naive or previously treated with chemotherapy including platinum agents 3.Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or tumor tissue sections obtained within 1 year must be submitted for biomarker evaluation 4. Men and women above 20-years of age 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 6. Expected more than 90 days survival 7. Measurable disease by CT or MRI per RECIST 1.1 criteria 8. SpO2 at room air is higher than 94% by pulse oximeter 9.Adequate laboratory data ANC above; 1.5 X 109/L Hemoglobin above; 8.0 mg/dL Platelets above; 100 x 109/L without the use of hematopoietic growth factors Serum creatinine below; 1.5 X ULN Creatinine clearance (Cockcroft/Gault assumption) above 45ml/min Total bilirubin below; 1.5 X ULN AST and ALT below; 3.0 X ULN 10. Women of childbearing potential must agree to follow instructions for methods of contraception from the time of enrollment for the duration of treatment with nivolumab plus 5 months post-treatment completion. Women must not be breastfeeding 11. Men who must agree to follow instructions for methods of contraception for the duration of treatment with nivolumab plus 7 months post-treatment completion 12. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (Blinded independent central review) for previously treated subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactJunko Tanizaki, Hidetoshi Hayashi Junko Tanizaki, Hidetoshi Hayashi
Kindai University, Faculty of Medicine Department of Medical Oncology
Outcome results
None listed