Phase 1 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 who have been diagnosed with head and neck cancer that has come back or spread, is not linked to HPV, and has a specific protein marker score above 1 (confirmed by lab testing).
• People whose cancer has at least one tumour that can be seen and measured by ultrasound, and that can be safely biopsied.
• People aged 18 or older, of any gender.
• People who are generally well enough to carry out basic daily activities, rated on a standard medical scale from 0 (fully active) to 2 (up and about more than half of waking hours) (confirm with trial site).
• People whose treating doctor estimates they have a life expectancy of at least 6 months.
• People whose blood test results show that their bone marrow, liver, and other organs are functioning well enough to meet specific thresholds set by the trial (confirm with trial site for exact values).
• Women who could become pregnant must have a negative pregnancy test before starting the trial, confirmed again within 28 days of starting the study drugs.
• Women who could become pregnant must use highly effective contraception for 90 days after the last dose of study drugs.
• Men who could father a child and are sexually active with women who could become pregnant must use contraception with a failure rate of less than 1% per year, continuing for 90 days after the last dose of study drugs.
• All participants must be able to understand and sign a written consent form.

Who may not be able to join:

• People whose head and neck cancer is linked to HPV or tests positive for a marker called p16.
• People who have previously been treated with certain immunotherapy drugs that target specific immune checkpoint proteins (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies).
• People who have a known allergy to any components of the study drugs, including polyethylene glycol.
• People with certain heart conditions, including: a known history of abnormal connections between the right and left sides of the heart; severe heart failure or active chest pain; very high or very low blood pressure outside specified ranges; a heart attack within the last 6 months; an abnormal heart rhythm reading on an ECG above a specific threshold; or a history of dangerous heart rhythm problems not corrected by a pacemaker or implanted device.
• People who currently have another active cancer, with some specific exceptions such as certain treated skin cancers, early-stage bladder cancer, or cervical cancer in situ that has been treated — or people whose prior cancer has not been in remission for at least 2 years after treatment aimed at curing it.
• People who still have significant side effects (rated moderate or above on a standard scale) from previous cancer treatment, with some exceptions such as hair loss or skin colour changes.
• People who are currently taking corticosteroids at doses above a certain level, or other medicines that suppress the immune system, within 28 days before starting the trial — or people who have previously received an organ transplant from another person.
• People who have an active autoimmune disease that has needed systemic medical treatment within the past 2 years (simple hormone or supplement replacement therapy is not counted as systemic treatment).
• People who are currently taking part in another clinical trial or have used an experimental drug or device within 4 weeks before the first dose of the study drugs.
• People who have received a live attenuated vaccine within 30 days before starting the trial.
• People with serious uncontrolled illnesses, active infections, certain lung or gut conditions, or mental health or social circumstances that could make it difficult to follow the trial requirements safely.
• People who are pregnant or breastfeeding.
• People with active tuberculosis, active hepatitis B, active hepatitis C (unless a specific RNA blood test is negative), or HIV infection.
• People who have untreated or active cancer spread to the brain.
• People who have had a history of lung inflammation (pneumonitis) within the past 5 years.

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