Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
A Multicenter, Open-label, Phase 2 Study of Imprime PGG & Pembrolizumab in Subjects With Adv Squamous Cell Carcinoma of H&N (SCCHN) Who Failed Pembro Monotherapy or Experiencing SD Following Completion of 4 to 8 Cycles of Pembro Monotherapy
Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in
subjects with advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Safety: To
characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis:
Restore (for subjects who have failed pembrolizumab mono therapy) or enhance (for subjects
who actively experiencing SD) sensitivity to checkpoint inhibitors (CPI) by appropriate and
effective stimulation of the subject's innate and adaptive immune systems by combining
Imprime PGG with pembrolizumab.
The study will require documenting at least 5 objective responses among the 38 subjects
enrolled who have failed prior pembrolizumab monotherapy and at least 17 objective responses
among the 49 subjects enrolled who are actively experiencing stable disease following at
least 4 cycles (but no more than 8 cycles) of pembrolizumab monotherapy.
n/a
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