None listed
Conditions
Interventions
Drug : Nivolumab 3mg/kg will be administered as a 60 minute IV infusion every 2 weeks. Nivolumab will be mixed with normal saline solution 100mL or institutional guide. Sites should make every effo
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed nasopharyngeal carcinoma 2. Patients who had heard all the explanations before signing the clinical trial and signed the consent form autonomously and understood that there was no disadvantage when withdrawing consent 3. 20 years or older 4. ECOG performance status 0, 1 5. Recurred after local treatment or metastatic disease. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent 6. Received at least one line of palliative chemotherapy 7. Presence of at least one measurable target lesion for further evaluation according to RECIST 1.1 criteria. Progressive lesions after radiation therapy can also be a target lesion. However, patients who were refractory to initial CCRT with platinum therapy (recurred within 6 months) were excluded. 8. Patients with last previous treatment or with newly obtained tumor tissue. 9. Adequate organ function ? ANC = 1500/ µL ? Platelets =100,000/ µL ? Hemoglobin = 9.0 g/dL ? Serum creatinine =1.5 x ULN ? Serum bilirubin =1.5 x ULN ? AST, ALT, =3.0 x ULN (regardless of liver metastasis) Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) =1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants =1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard. 10. Women who are pregnant should be negative by urine or serum pregnancy test within 72 hours of administration of the test drug. If the stool is positive, a serum pregnancy test should be performed to confirm that it is negative. 11. For women of childbearing age, two or more contraceptive methods should be used for the treatment period of niburlohag drug and 5 half-life + 30 days (ovulation cycle period), ie, 5 months after the end of treatment. (Postmenopausal women with amenorrhea more than 12 months are considered not fertile). 12. Male subjects should use appropriate contraceptive methods for the duration of nibolumach treatment after the last dose starting from the study treatment and for the test period of 5 half-lives + 90 days (sperm transition period), ie, 7 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who participated in other clinical trials within the first 4 weeks of study drug use, or who used test drug or used test equipment. 2. Patients who have been diagnosed with immunodeficiency within 7 days prior to study study drug administration, or have received systemic steroid therapy or other forms of immunosuppressive therapy. 3. Patients who received anti-cancer monoclonal antibody within 4 weeks before the study drug administration, or who did not recover to baseline or below grade 1 due to previous drug administration. 4. Patients who received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study drug administration, or who did not recover baseline or grade 1 or lower adverse events from previous treatment. 5. Note: Except for persons with neuropathy less than grade 2, they may qualify for the exam. Note: If the subject has undergone major surgery, the toxicity and complications should be adequately restored prior to initiation of treatment. 6. A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin, early gastric cancer, and cervical carcinoma in situ. 7. Patients with central nervous system metastasis or meningioma. Previously treated brain metastases are stable (neurological symptoms return to baseline without progressing to images taken within 4 weeks prior to administration of the test drug) and patients who have not used systemic steroids for at least 7 days prior to treatment are eligible for testing Yes. 8. Patients with active autoimmune disease who needed treatment with systemic steroids or immunosuppressive agents within 2 years prior to administration of the test drug. Supplemental therapies for functional glue (eg, thyroxine, insulin or corticosteroid hormone replacement therapy) are not considered a form of systemic treatment. 9. Patients with interstitial pneumonia or active non-infectious pneumonia. 10. Patients with severe active infection requiring systemic treatment. 11. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications. 12. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months. 13. Ongoing cardiac arrhythmia of grade =2, atrial fibrillation of any grade, or QTc interval>450msec for males or >470msec for female. 14. Patients who are expected to receive pregnancy or breastfeeding from screening until 5 months after the last dose of the test drug. 15. Previously treated patients. (CTLA-4) antibody (including ipilimumab or any other) or anti-CD137 or anti-Cytotoxic T-lymphocyte-associated antigen-4 Antibody or drug specifically targeting T-cell therapy with co-stimulation or checkpoint pathways 16. Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) infection. 17. Active HBV (HBV DNA is positive) or HCV (HCV RNA is detected) infection. (inactive HBsAg carrier with prophylactic antiviral treatment can be enrolled) 18. Patients who received live vaccine within 30 days of clinical study. 19. Patients with active tuberculosis. 20 .Patients with hypersensitivity reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival: [death to date or tumor progression (PD)] | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response (6-month progression-free survival, 12-month progression-free survival, 6-month overall survival, 12-month overall survival,);toxicity (CTCAE ver 4.03),;QOLQ-C30 core question | — |
Countries
Korea, Republic of
Contacts
Public Contactbhum Keam
Seoul National University Hospital
Outcome results
None listed