A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck
Phase 2
- Conditions
- non-squamous cell carcinoma of the head and neck
- Registration Number
- JPRN-UMIN000029636
- Lead Sponsor
- Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Disease control rate, Overall survival, Progression free survival, Adverse events