Metastatic Mucosal Melanoma
Conditions
Interventions
Nivolumab+Radiotherapy
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven mucosal melanoma 2) Aged 20 years old or more 3) metastatic disease 4) No previous treatment for metastatic mucosal melanoma 5) ECOG PS of 0 or 1 6) Need for measurable lesion 7) Adequate organ functions 8) 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) The current radiation field do not overlap the previous radiation field. 3) Active infection requiring systemic therapy. 4) Patients with immune suppression. 5) Patients with central nerve system metastases. 6) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor. 7) Patients received live vaccines. 8) Pregnancy, possible pregnancy or breastfeeding. 9) Psychiatric disease. 10) Patients requiring systemic steroid medication. 11) Severe pulmonary fibrosis or emphysema. 12) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Public ContactMotoo Nomura
Kyoto university Department of Medical Oncology
Outcome results
None listed