Phase 2 Head and Neck Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older who have been diagnosed with squamous cell carcinoma (a type of cancer) of the mouth, or a specific type of throat cancer that has tested negative for HPV (a virus)
• People whose cancer has come back in the same area where it first started (not spread to distant parts of the body)
• People for whom surgery to remove the returned cancer is considered an option by their medical team
• People whose cancer returned at least 3 months after completing previous treatment, which must have included both surgery and radiation therapy after surgery (additional treatments such as chemotherapy were allowed but not required)
• People whose cancer can be measured on scans according to standard medical guidelines (called RECIST 1.1)
• People who are generally well enough to carry out normal daily activities, with only mild symptoms at most (rated 0 or 1 on a standard health scale used by doctors)
• People willing to have a tissue sample (biopsy) taken before and during treatment for research purposes, unless a stored tumour sample from a previous procedure is already available
• People with blood counts within acceptable ranges: haemoglobin at least 9 g/dL (blood transfusions are permitted to reach this level), neutrophil count at least 1 x 10⁹/mL, and platelet count at least 80 x 10⁹/mL
• People whose kidneys are functioning at an adequate level, based on a standard calculation using a blood test result
• People whose liver function blood test results are within acceptable limits (confirm with trial site for specific values)
• Women who could become pregnant must agree to use two forms of contraception throughout treatment and for at least 120 days after treatment ends
• Men who are sexually active with women who could become pregnant must agree to use contraception throughout treatment and for at least 90 days after treatment ends

Who may not be able to join:

• People whose cancer returned within 3 months of finishing their previous treatment
• People whose cancer has spread to distant parts of the body, such as internal organs or distant lymph nodes
• People who received an immune checkpoint inhibitor therapy (a type of cancer drug that works with the immune system) less than 1 year before enrolling in this trial
• People who have needed steroid medication (such as prednisone at more than 10 mg per day) within 14 days before starting the trial — though certain low-level replacement doses and inhaled or topical steroids may be allowed (confirm with trial site)
• People with an active autoimmune disease (a condition where the immune system attacks the body) that has needed medical treatment in the past 5 years — though some milder conditions such as vitiligo, type 1 diabetes managed with insulin, underactive thyroid managed with hormone replacement, childhood asthma that has fully resolved, or psoriasis not needing systemic treatment may be permitted
• People with a history of certain lung conditions, such as pulmonary fibrosis or a type of lung inflammation that required high-dose steroid treatment
• People who have received a solid organ transplant (such as a kidney or liver transplant; corneal transplants are an exception)
• People who have previously had a stem cell transplant (either from a donor or using their own cells)
• People with a history of another cancer that was treated less than 5 years ago — though some specific early-stage or low-risk cancers treated at least 1 year ago with no current signs of disease may be permitted (confirm with trial site)
• People with an active, uncontrolled infection requiring antibiotic, antiviral, or antifungal treatment within 10 days before starting the trial — though people with hepatitis B, hepatitis C, or HIV may be considered if the virus is undetectable at screening
• People with certain serious health conditions including a heart attack within the past 6 months, unstable chest pain (angina), uncontrolled diabetes, or severe heart failure
• Women who are pregnant or breastfeeding
• People with a known allergy or serious reaction to any of the study medications or their ingredients

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