Phase 3 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 diagnosed with locally advanced head and neck squamous cell carcinoma (a specific type of head and neck cancer) at certain stages, who had standard surgery after pre-surgery treatment combining immunotherapy and chemotherapy, and whose pathology results showed no remaining cancer in either the main tumour or the lymph nodes after that treatment
• People with no history of other cancers
• People aged 18 to 65 years
• People whose recent blood tests show healthy levels of white blood cells (neutrophils), platelets, and haemoglobin, without needing recent blood transfusions or certain blood-boosting medications in the past 14 days
• People whose liver function blood tests are within acceptable ranges
• People whose kidney function is within acceptable ranges
• People whose blood clotting tests are within acceptable ranges
• People whose thyroid hormone levels are within the normal range, or whose additional thyroid tests are normal even if one thyroid measure is slightly outside range (confirm with trial site)
• People whose heart enzyme blood tests are within normal limits (minor abnormalities may still be considered if the medical team judges them not to be clinically significant)
• Women of childbearing age who have a negative pregnancy test within 3 days before starting the study treatment
• People who agree to use highly effective contraception (with a failure rate of less than 1% per year) throughout the entire treatment period and for up to 120 days after the last dose of the study drug, or 180 days after the last chemotherapy dose
• People who sign an informed consent form agreeing to take part

Who may not be able to join:

• People whose head and neck cancer is not the first (original) cancer diagnosis, or who did not receive neoadjuvant (pre-surgery) therapy as described
• People who have had an active autoimmune disease requiring systemic treatment (such as disease-modifying drugs, steroids, or immune-suppressing medications) within the past 2 years — note that hormone replacement therapies such as thyroxine or insulin are not considered systemic treatment for this purpose
• People who have had an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant from another person
• People with a known HIV infection (positive HIV 1/2 antibody test)
• People with untreated, active hepatitis B — though people with hepatitis B who have a low viral load and are receiving or willing to receive antiviral treatment may still be considered (confirm with trial site)
• People with active hepatitis C infection (positive antibody test and detectable virus levels)
• Women who are pregnant or breastfeeding
• People with serious or poorly controlled heart conditions, including significant abnormal heart rhythms, unstable chest pain, heart failure classified as moderate or severe, or a heart attack, stroke, or related event within the past 6 months
• People with poorly controlled high blood pressure (above 140/90 mmHg)
• People who have had lung inflammation requiring steroid treatment, or active ongoing lung disease, within the past year
• People with active tuberculosis
• People with an active infection currently requiring treatment
• People with active bowel conditions such as diverticulitis, abdominal abscess, or bowel obstruction
• People with significant liver diseases such as cirrhosis or active hepatitis
• People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
• People with significant protein in their urine confirmed by a 24-hour urine test showing more than 1.0 g of protein
• People with a mental health condition that would prevent them from cooperating with the treatment and study requirements
• People with any other medical history, condition, or abnormal test results that the trial medical team considers unsuitable for participation

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