Advaxis Clinical Trial

A leader in developing the next generation of cancer immunotherapies, Advaxis, Inc. chose the Icahn School of Medicine to implement its Phase 1/2 trial for its human papillomavirus (HPV)-related cancer vaccine. Known as ADX-HPV, this trial is the first of its kind to evaluate the efficacy of a vaccine in patients who already have the initial diagnosis of an HPV-associated head and neck cancer and have not undergone any chemotherapy or radiation.

Bench to Bedside Studies

Our Head and Neck Cancer Research Program was chosen as the only site for this trial because it is widely recognized for its groundbreaking bench-to-bedside studies on transoral robotic surgery (TORS) for the treatment of oral and tongue cancers and because the former Director of the Program, Andrew Sikora, MD, PhD, specialized in immunotherapy and head and neck cancer research. Brett Miles, MD, director of the Advaxis trial and robotic head and neck cancer surgeon, still works closely with his research colleague, as well as Marshall Posner, MD, and a team of researchers who are investigating the safety and efficacy of the vaccine. Specifically, they are seeking to know if it will induce HPV-specific cytotoxic against the tumor in order to react with the HPV cells.

How the Advaxis Vaccine Works

Much like the flu vaccine, which carries a limited amount of the virus in order to effectively deliver the vaccine to the body, the Advaxis vaccine contains a nominal amount of bioengineered attenuated listeria (bacteria) with the goal of suppressing key components in the tumor microenvironment that contribute to tumor growth.

“Advaxis is the only company offering this listeria-based technology that allows us to activate the immune system,” says Dr. Miles. “We thought it was important to partner with this company, as the team at the Head and Neck Cancer Research Program was already conducting studies on HPV-related cancers and robotic surgery, and this was a unique opportunity to apply a new treatment approach to HPV-related head and neck cancers. Additionally, Advaxis was already realizing success in other areas, such as breast cancer, cervical cancer, and veterinary medicine for dogs.”

Likewise, Advaxis leadership was thrilled to partner with the Icahn School of Medicine at Mount Sinai. “Mount Sinai was chosen as the site for this trial, as its research program was actively studying immunotherapies, transoral robotic surgery (TORS), and HPV-related head and neck cancers,” says Daniel O’Connor, President and Chief Executive Officer of Advaxis. “We sought an academic medical center in a large metropolis that was reputable for both its head and neck cancer research and clinical application of robotic surgery. Mount Sinai was carefully selected for this trial because its researchers and physicians have a keen understanding of immunotherapy and experience treating this disease at all stages with all available treatments.”

Who is Eligible for the Clinical Trial and What to Expect

Researchers are collecting data at this time and are still recruiting additional patients for the study. This clinical trial is open to patients with HPV-positive stage II-IV squamous cell carcinoma of the oropharynx. They must not have been already treated with chemotherapy or radiation prior to the study. Patients who wish to participate in the trial and who have been cleared as candidates receive the ADXS-HPV treatment, followed by robotic surgery. “This clinical trial is all about partnering with our patients at Mount Sinai,” Dr. Miles says. “If they decide they are interested, that is great, but if they’re more comfortable with traditional modalities, at least they have the opportunity to explore this option.”

For more information, call Pang Herrera, Senior Clinical Research Coordinator, at 212-241-4282 or Leslie Waters-Martin, Research Program Coordinator, at 212-241-7101, or visit