non-squamous cell carcinoma of the head and neck
Conditions
Interventions
Nivolumab 240 mg/body q2weeks
Sponsors
Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically proven head and neck non squamous cell carcinoma 2.No indication of the local treatment 3.Written informed consent was obtained 4.Aged 20 years or older 5.Platinum resistant/refractory 6.ECOG perfomance status 0-2 7.Life expectancy of at least 3 months 8.Offer of the tumor tissue to use for PD-L1 expression and biomarker analysis 9.One or more measurable lesions 10.Adequate bone marrow, hepatic and renal function
Exclusion criteria
Exclusion criteria: 1.Active concomitant malignancy 2.Active infection 3.Central nervous system metastases 4.Carcinomatous Meningitis 5.Infection of HIV, AIDS related disease, and HCV 6.Medical history of immune checkpoint inhibitor 7.Pregnant, breast-feeding, or unwilling to use adequate contraception 8.Treatment of systemic corticosteroid or other immune suppressor 9.Received radiation therapy within 14 days before registration 10.Histroy of interstitial pneumonia 11.History of auto-immune disease 12.hemodialysis 13.Allergy or hypersensitivity reaction for chemothery or other investigational Products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, Overall survival, Progression free survival, Adverse events | — |
Countries
Japan
Contacts
Public ContactYoshiaki Nagatani
Kobe University Hospital and Graduate School of Medicine Medical Oncology / Hematology, Department of Medicine
Outcome results
None listed