Advaxis initiates Phase 1/2 trial of ADXS-HPV in head and neck cancer

Advaxis announced that the Icahn School of Medicine at Mount Sinai will initiate a Phase 1/2 study of ADXS-HPV in 25 patients with Human Papilloma Virus-positive head and neck cancer, a type of cancer which is increasing at an epidemic rate. This clinical trial will be the first study to evaluate the effects of ADXS-HPV in patients when they are initially diagnosed with HPV-associated head and neck cancer, prior to receiving any chemotherapy or radiation. This study will be an important first step toward understanding ADXS-HPV's potential to treat this type of cancer before chemotherapy and/or radiation and its potential to reduce the need for these treatments. This non-randomized investigator-initiated study has been designed to evaluate the safety and immunogenicity of ADXS-HPV in patients with HPV-positive stage II-IV squamous cell carcinoma of the oropharynx. In this study, 15 patients will receive ADXS-HPV treatment followed by ablative transoral robotic surgery, and 10 patients will serve as the control group and receive only TORS.

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