Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 79 years old.
• People who have been diagnosed with head and neck squamous cell cancer (a type of cancer affecting the mouth, throat, or related areas) that has tested positive for the HPV virus, confirmed through a tissue or cell sample.
• People who have had surgery must be registered into the trial at least 4 weeks after that surgery.
• People who have had surgery must have what is considered "high risk" disease, meaning either: cancer cells found at or very close to the edge of the removed tissue (called positive margins), or cancer that has spread beyond the lymph nodes into surrounding tissue (called extranodal extension) — either of which can be detected under a microscope or visibly.
• People whose cancer has not spread to distant parts of the body, confirmed by scans taken within 28 days before registration (any tumour or lymph node stage is acceptable, as long as there is no distant spread).
• People who are generally well enough to carry out light activity and care for themselves, based on a standard medical fitness scale (ECOG score of 0 or 1).
• People who are able to understand and agree to sign a consent form, or who have a legally authorised representative, caregiver, or family member able to do so on their behalf.
• Women who could potentially become pregnant must have had a negative pregnancy test (blood or urine) within 14 days before registration. This applies to women who have ever had a menstrual period, have not had their uterus or both ovaries removed, or have not gone through natural menopause for at least 24 consecutive months.
• Women who could potentially become pregnant, and male participants who are sexually active, must use accepted contraception methods or abstain from sexual intercourse during the trial treatment and for 120 days after the last dose (confirm with trial site for the list of accepted methods).
• People whose blood test results, taken within 28 days before registration, show that their bone marrow, liver, and kidneys are functioning adequately (specific thresholds apply — confirm with trial site).

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People who have an active infection that requires treatment taken throughout the body (such as antibiotics or antifungals given orally or by injection) at the time of registration.
• People who have previously had a solid organ transplant (such as a kidney or liver) or a stem cell transplant.
• People who are currently taking medication that suppresses the immune system within 7 days before registration — with some exceptions, such as low-dose steroid creams, nasal sprays, inhalers, joint injections, low-dose oral steroids (10 mg per day of prednisone or equivalent or less), or steroids used before scans to prevent allergic reactions.
• People with severe heart failure classified as Class III or IV by a standard cardiac assessment scale, indicating significant limitations on physical activity.
• People who have received a live vaccine within 30 days before the first dose of the trial treatment. This includes vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid. Note: standard injectable flu vaccines are generally allowed; nasal spray flu vaccines are not. COVID-19 vaccines are allowed.
• People with a known history of active Hepatitis B or active Hepatitis C infection.
• People with a history of HIV who have had detectable levels of the virus in their blood within the past 6 months, or who have a history of Kaposi sarcoma or Multicentric Castleman Disease.
• People who have an active autoimmune disease (where the immune system attacks the body) that has required systemic medical treatment in the past 2 years. Routine hormone or replacement therapies (such as thyroid medication, insulin, or low-dose steroids for adrenal conditions) are not counted as systemic treatment and are generally allowed.
• People with a known allergy to mushrooms, mushroom products, or any ingredient in the trial formulation.
• People with a known psychiatric condition or substance use disorder that would make it difficult to complete the trial requirements or follow the study plan.

Important: Always verify eligibility with the trial site directly before applying.