JPRN-UMIN000015845CompletedPhase 2
A phase II trial of nivolumab in advanced mucosal melanoma - A phase II trial of nivolumab in advanced mucosal melanoma
Aichi Cancer Center Hospital0 sites20 target enrollmentStarted: December 4, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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.
Investigators
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