V11.2 (1/9/20 ) Page 1 of 50 WINDOW -OF OPPORTUNITY TRIAL OF NEOADJUVANT ADXS11- 001 VACCINATION PRIOR TO TRANSORAL RESECTION OF HPV -POSITIVE OROPHARYNGEAL SQUAMOUS CELL CARCINOMA CLINICAL TRIAL PROTOCOL Version 11.2 ( January 9, 2020) IND# 15688 Study Chairperson Andrew Sikora, M.D., Ph.D1 Study Institutions : (1) Baylor College of Medicine One Baylor Plaza, Houston, Texas 77030 Center for Cell and Gene Therapy Dan L Duncan Comprehensive Cancer Center (2) ISMMS - Icahn School of Medicine at Mount Sinai One Gustave L Levy Place, New York, NY 10029 (3) Arizona State University Tempe, AZ 85281 V11.2 (1/9/20 ) Page 2 of 50 BCM Site Principal Investigator Anita Sabichi , M.D.1 ISMMS Site Principal Investigator Brett Miles, MD2 Protocol Team Clinical Collaborators: At ISMMS: Marshall Posner, M.D. 2 Eric Genden, M.D.