Vaccine + Durvalumab in Human Papilloma Virus (HPV) Cancers
Status:
Not yet recruiting
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
Objectives:
Primary:
To evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab.
Secondary:
To determine the safety profile of MEDI0457 in combination with durvalumab in patients with
recurrent/metastatic human papilloma virus (HPV) 16- or 18- associated cancer.
To evaluate the progression-free survival (PFS) and overall survival (OS) of patients with
recurrent/metastatic incurable HPV-16/18 positive solid malignancies receiving the
combination of MEDI0457and durvalumab.
To evaluate objective response rate (ORR) by immune-related criteria of the combination of
MEDI0457 and durvalumab in patients with recurrent/metastatic incurable HPV-16/18 positive
solid malignancies.
To evaluate the disease control rate at 24 weeks.