A Clinical Trial: Adjuvant Low-dose Ipilimumab + Nivolumab After Resection of Melanoma Macrometastases
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
Nivolumab (OpdivoTM, BMS), a human IgG-4 anti-PD-1 monoclonal antibody has demonstrated
anti-tumor activity in patients with advanced melanoma.
The investigators postulate that patients with melanoma nivolumab have a comparable tumor
response rate at a dose range of 0.1 to 10 mg/kg q2wks.
Ipilimumab (YervoyTM, BMS), a human IgG-1 anti-CTLA-4 monoclonal antibody improves the
survival of patients with advanced melanoma. Adjuvant therapy with ipilimumab improves the
relapse-free survival after complete resection of high-risk stage III melanoma (EORTC 18071).
Combined treatment with ipilimumab plus nivolumab improves the tumor response rate and
overall survival of patients with advanced melanoma but is associated with a higher incidence
of immune related adverse events (CheckMate 067).Nivolumab and ipilimumab have distinct
immunological mechanisms that can be revealed by analyzing TCR usage in blood lymphocytes.