Clinical trial studies three immunotherapies given before surgery in newly diagnosed head and neck cancers not caused by HPV

TILs in culture

Tumor-infiltrating lymphocytes (TILs) in culture.
Image courtesy of Jason Redman

Newly diagnosed head and neck cancer not caused by HPV infection often uses surgery as the first treatment. People with this type of cancer may be eligible to participate in this trial at the NIH Clinical Center.

After surgery, about half of patients with head and neck squamous cell carcinoma (HNSCC) that was not caused by the human papillomavirus (HPV) will have disease relapse within two years. Research suggests that immunotherapy before surgery can shrink some HNSCC tumors and possibly reduce the risk of relapse. Jason Redman, M.D., Assistant Research Physician in the Genitourinary Malignancies Branch, is leading a trial of three proposed treatments given before surgery for HNSCC. M7824 is an experimental drug that blocks two pathways that some cancer cells use to evade attack by the immune system. Patients will receive M7824 alone, M7824 in combination with anti-tumor vaccines or M7824 in combination with anti-tumor vaccines plus an immunokine (N-803) that can super charge cancer-fighting parts of the immune system (natural killer cells and T cells). The goal of this trial is to learn whether these combinations can shrink previously untreated, non-HPV HNSCC cancer before surgery and/or decrease the number of patients who later experience return of the cancer after surgery. 

Clinicaltrials.gov identifier: NCT04247282
NCI Protocol ID: NCI-20-C-0024 
Official Title: A Sequential Window of Opportunity Trial of Anti-PD-L1/TGF-ß trap (M7824 ) Alone and in Combination with TriAd Vaccine, and N-803 for Resectable Head and Neck Squamous Cell Carcinoma not associated with Human Papillomavirus Infection.

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: Thu, 08/20/2020