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:

• Adults aged 18 or older who have been confirmed through a tissue test to have squamous cell carcinoma (a type of cancer) of the larynx (voice box) or hypopharynx (lower throat), and whose medical team has decided that full surgical removal of the larynx is appropriate.
• People with Stage III, IVA, or IVB cancer where surgeons expect to be able to remove the cancer with clear margins (a safe border of healthy tissue greater than 5mm around the tumour), and where scans show no signs of cancer spreading beyond the lymph nodes in the neck.
• People who are able to provide a freshly taken tissue sample from the tumour from an area that has not previously been treated with radiation — tissue preserved in a wax block is preferred over slides.
• People whose tumour tissue shows a protein called PD-L1 at a level known as CPS of 1 or higher (this is measured from the biopsy sample).
• Male participants who agree to use contraception throughout treatment and for at least 120 days after the last dose, and who agree not to donate sperm during this period.
• Female participants who are not pregnant and not breastfeeding, and who either cannot become pregnant or who agree to use contraception throughout treatment and for at least 120 days after the last dose.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity), assessed within 7 days before joining the trial.
• People whose liver, kidneys, blood, and other organ functions fall within the levels required by the trial, based on blood tests taken within 10 days before starting treatment.

Who may not be able to join:

• Women who could become pregnant and return a positive pregnancy test within 72 hours before the first dose of the study medicine.
• People who have previously received certain types of immunotherapy treatments, including drugs that target PD-1, PD-L1, PD-L2, CTLA-4, OX-40, CD137, or similar immune system pathways.
• People who have previously received any systemic (whole-body) cancer treatment, including experimental treatments.
• People who have previously received radiation therapy.
• People who have received a live or live-weakened vaccine within 30 days before the first dose (non-live/killed vaccines are allowed).
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within the past 4 weeks.
• People who have an immune system deficiency, or who are currently taking high-dose steroid medicines (above the equivalent of 10mg of prednisone daily) or other medicines that suppress the immune system, within 7 days before the first dose.
• People with a history of another cancer, unless they completed treatment for it and have had no signs of that cancer for at least 2 years.
• People with cancer that has spread to distant parts of the body, including the brain or the membranes surrounding the brain and spinal cord.
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
• People with an active autoimmune disease (where the immune system attacks the body) that has needed systemic medical treatment in the past 2 years. Note: hormone or gland replacement therapies (such as thyroid hormone or insulin) are not considered in this category and are allowed.
• People who have had inflammation of the lungs (pneumonitis or interstitial lung disease) that required steroid treatment in the past, or who currently have this condition.
• People with an active infection that requires systemic (whole-body) treatment.
• People with a known history of HIV infection (note: HIV testing is not required by this trial unless local health authorities require it).
• People with a known history of active Hepatitis B or active Hepatitis C infection (note: testing is not required unless local health authorities require it).
• People with a known history of active tuberculosis (TB).
• People with any medical condition, ongoing treatment, or abnormal test result that the treating doctor believes could affect the trial results or make participation unsafe or not in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the trial period and for 120 days after the last dose.
• People who have received a transplanted organ or donor tissue.
• People with a known intolerance or allergy to any of the medicines or supporting medications used during the trial (such as antibiotics or anti-nausea medicines).

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