Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC

Exclusion Criteria

• •Patient must not be pregnant or breast-feeding due to the unknown potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
• •Current active infection that requires systemic treatment at time of registration.
• •History of solid organ transplant or stem cell transplant.
• •Currently taking immunosuppressive medication within 7 days prior to registration, EXCEPT for the following:
• •1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
• •2. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
• •3. steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• •New York Heart Association Class III or IV heart failure. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
• •Received a live vaccine within 30 days prior to the first dose of study drug.
• •1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), or typhoid fever.
• •2. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
• •3. COVID-19 (SARS-CoV-2) vaccines (mRNA or other) are allowed.
• •Known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as positive for HCV RNA on a qualitative test).
• •History of HIV with or without antiviral treatment having
• •1. detectable viral loads within 6 months, or
• •2. history of Kaposi sarcoma and/or Multicentric Castleman Disease.
• •Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• •Known allergy to mushrooms, mushroom products, or any components of the study formulation.
• •Known psychiatric or substance abuse disorder that would interfere with the participant's ability to complete study assessments or to adhere to protocol requirements.