Safety and efficacy of MEDI0457 and Durvalumab in participants with Human Papilloma Virus (HPV) associated recurrent/metastatic head and neck cancer

Study identifier:D8860C00005

ClinicalTrials.gov identifier:NCT03162224

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1b/2a, Multi-Center Open-Label Study to Evaluate the Safety and Efficacy of Combination Treatment with MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients with Recurrent/Metastatic HPV Associated Head and Neck Squamous Cancer

Medical condition

head and neck cancer

Phase

Phase 1/2

Healthy volunteers

No

Study drug

MEDI0457, Durvalumab

Sex

All

Actual Enrollment

35

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 26 Jun 2017
Primary Completion Date: 19 Mar 2021
Study Completion Date: 19 Mar 2021

Study design

Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2022 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria