Safety and Efficacy of MEDI0457 and Durvalumab in Patients With HPV Associated Recurrent/Metastatic Head and Neck Cancer
Status:
Completed
Trial end date:
2021-03-19
Target enrollment:
Participant gender:
Summary
This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and
tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a
HPV DNA vaccine in combination with durvalumab (also known as MEDI4736) which is a human
monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1
and CD80.
An initial three to 12 patients (Safety Analysis Run-in patients) will be enrolled and
assessed for safety before additional patients are enrolled.
The initial safety analysis run-in patients along with an approximate total of 50 patients
with human papilloma virus associated recurrent or metastatic head and neck squamous cell
cancer will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457
in combination with durvalumab.