Phase 1b Trial of Pre-surgery MEDI6469 for Head and Neck Cancer

Title: Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI6469) Administered Prior to Definitive Surgical Resection Patients With Locoregionally Advanced, Oral Head and Neck Squamous Cell Carcinoma¹

Principal Investigators: Richard B. Bell, MD, Providence Cancer Center

Description: For this phase 1b, non-randomized study, researchers are evaluating whether pre-surgery MEDI6469, an anti-OX40 antibody, will improve outcomes among patients with head and neck cancer.

All enrolled patients will have loco-regionally advanced oral head and neck squamous cell carcinoma.

There are 3 study arms: in the first, patients will receive MEDI6469 3 weeks prior to surgery, in the second, patients will receive MEDI6469 2 weeks before surgery, and in the third, patients will receive MEDI6469 1 weeks prior to surgery.

The primary outcome measure is safety and feasibility of surgery post–MEDI6469 administration. The secondary outcome measure is immunologic phenotypes of lymphocyte subsets.

The estimated enrollment is 55 patients.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02274155.

Status: This study is open and recruiting patients as of July 13, 2017.

This study is sponsored by Providence Health & Services in collaboration with MedImmune LLC.

Reference

1. Clinicaltrials.gov. Anti-OX40 antibody in head and neck cancer patients.  NCT02274155.  https://clinicaltrials.gov/ct2/show/NCT02274155. Accessed July 13, 2017.