Phase 2 Study of ADXS 11-001 Vaccination in HPV-positive Oropharyngeal Squamous Cell Carcinoma

Title: Window of Opportunity Trial of Neoadjuvant ADXS 11-001 Vaccination Prior to Robot-Assisted Resection of HPV-Positive Oropharyngeal Squamous Cell Carcinoma¹

Study Chair: Andrew G Sikora, MD, PhD, Baylor College of Medicine

Description: For this phase 2, non-randomized trial, researchers are evaluating whether ADXS 11-001 vaccination prior to transoral surgery will improve outcomes for patients with HPV-positive oropharyngeal cancer.

The adverse events associated with standard treatments for HPV-positive disease can be severe, though survival rates are high. Vaccination, however, may cause tumor regression without chemotherapy or radiation, eliminating these side effects.

There are 2 arms for this study: in the first arm, patients will receive 2 ADXS 11-001 vaccination doses prior to surgery; in the second arm, patients will receive standard care.

The primary outcome is HPV E6/E7-specific CD8+ cytotoxic lymphocyte responses at different time points. Secondary outcomes include toxicity.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02002182.

Status: This study is open and enrolling patients as of April 11, 2017.

This study is sponsored by Andrew Sikora in collaboration with Advaxis, Inc.

Reference

1. Clinicaltrials.gov. ADXS 11-001 vaccination prior to robotic surgery, HPV-positive oropharyngeal cancer. NCT02002182. https://clinicaltrials.gov/ct2/show/NCT02002182. Accessed April 11, 2017.