A phase II trial of nivolumab in advanced mucosal melanoma
- Conditions
- mucosal melanoma
- Registration Number
- JPRN-UMIN000015845
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method 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