mucosal melanoma
Conditions
Interventions
nivolumab 2mg/kg, triweekly
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven mucosal melanoma 2) Aged 20 years old or more 3) metastatic or advanced disease 4) ECOG PS of 0 or 1 5) No need for previous treatment 6) Need for measurable lesion 7) No previous chest radiotherapy 8) Adequate organ functions 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Patients with immune suppression. 4) Patients with central nerve system metastases. 5) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor. 6) Patients received live vaccines. 7) Patients who received anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CD137 antibody, or anti CTLA-4 antibody. 8) Positive HBs antigen, or positive HCV antibody. 9) Pregnancy, possible pregnancy or breastfeeding. 10) Psychiatric disease. 11) Patients requiring systemic steroid medication. 12) Poorly controlled diabetes mellitus. 13) Severe pulmonary fibrosis or emphysema. 14) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression free survival, disease control rate, response duration, time to response, best overall response, rate of change in tumor size, immuno-related disease control rate, immuno-related progression free survival, immuno-related response, toxicity | — |
Countries
Japan
Contacts
Public ContactMotoo Nomura
Kyoto University Department of Therapeutic Oncology
Outcome results
None listed