A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
Status:
Terminated
Trial end date:
2016-10-31
Target enrollment:
Participant gender:
Summary
Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who
will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab,
motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before
surgery. The primary objective of the study is to determine the extent to which the
administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and
nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor
infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An
exploratory objective of the study is to assess whether modulation of biomarkers as described
above can predict anti-tumor response.