CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous
(IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have
not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody.
The primary objective of the study is to determine the Investigator-assessed confirmed
objective response with CMP-001 in combination with pembrolizumab in subjects with head and
neck squamous cell carcinoma (HNSCC)
The secondary objectives are to:
- To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT)
injection in combination with pembrolizumab in subjects with HNSCC
- To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with
HNSCC
- To evaluate the effect of human papillomavirus (HPV) infection and programmed
death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with
pembrolizumab
Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the
treatment schedule until a reason for treatment discontinuation is reached.