Clinical trial tests immunotherapy combination for advanced HPV-associated cancers

HPV-16 E5 Oncoprotein

HPV-16 E5 Oncoprotein
Image Source: NCI Visuals Online

People 18 years and older with confirmed HPV+ cancers may be eligible to participate in a new clinical trial at the NIH Clinical Center.

Human papillomavirus (HPV) is the most common sexually transmitted infection. There are many types of HPV, some of which can cause cancers of the cervix, vulva, vagina, penis, anus, or the back of the throat. More than 30,000 cases of HPV+ cancers occur every year in the United States. Julius Strauss, M.D., Assistant Research Physician in the Laboratory of Tumor Immunology and Biology, is leading a study using a combination of 3 immunotherapy drugs to treat HPV+ cancers. In preclinical studies, this triplet combination was more effective in shrinking tumors than any of the drugs used alone or in dual combinations. Study participants will get PDS0101 - a therapeutic vaccine, M7824, which blocks signals that cancer cells use to evade the immune system, and NHS-IL12 - an antitumor drug. Investigators want to see how people with HPV+ cancers respond to this triplet of immunotherapy drugs.

Clinicaltrials.gov identifier: NCT04287868
NCI Protocol ID: NCI-20-C-0045
Official Title: Phase I/II Trial of Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

The Center for Cancer Research is NCI’s internal cancer center, a publicly funded organization working to improve the lives of cancer patients by solving important, challenging and neglected problems in cancer research and patient care. Highly trained physician-scientists develop and carry out clinical trials to create the medicines of tomorrow treating patients at the world’s largest dedicated research hospital on the campus of the National Institutes of Health in Bethesda, Maryland.   

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Summary Posted: Tue, 10/13/2020