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:

• People aged 18 to 75 years, of any sex
• People diagnosed with a specific type of mouth cancer (squamous cell carcinoma of the oral cavity) that is at stage III or IVa and can be removed with surgery, confirmed by a tissue test, with tumours large enough to measure on a CT scan
• People who are generally well enough to carry out light activity and care for themselves (a standard health score of 0 or 1, as assessed by a doctor)
• People with an expected survival of at least 12 weeks
• People for whom a tumour tissue sample is available (either preserved in paraffin or a fresh sample taken within the last 2 years) for a specific laboratory test
• People whose bone marrow is working well enough, shown by blood test results within an acceptable range for neutrophils, platelets, and haemoglobin (without a recent blood transfusion in the 14 days before testing)
• People whose liver function blood test results are within an acceptable range
• People whose kidney function blood test results are within an acceptable range
• People whose thyroid hormone levels are within an acceptable range, or whose additional thyroid tests come back normal if the first result is slightly outside range
• People whose urine protein level is low enough, or whose 24-hour urine collection result is within an acceptable limit if the initial result is higher
• People with normal or near-normal heart function, confirmed by heart tests
• Women who could become pregnant must have a negative pregnancy blood test before the first dose of the study drug
• People who are willing and able to use highly effective contraception throughout the trial and for 90 days after treatment ends (this applies to both men and women who could potentially conceive)
• People who are willing to take part, have signed a consent form, and are able to attend follow-up visits

Who may not be able to join:

• People whose cancer has spread to distant parts of the body, or whose cancer cannot be surgically removed (stage IVb or IVc)
• People who have previously had nasopharyngeal carcinoma (a type of cancer at the back of the nose and throat)
• People who have taken part in another clinical drug or therapy trial within the 4 weeks before the first dose
• People who have had a major surgical procedure within the 4 weeks before the first dose, or who have not yet recovered from such a procedure
• People who have received a live vaccine, immunotherapy, or radiotherapy within the 2 weeks before the first dose
• People who are currently receiving any other cancer treatment
• People who have an active autoimmune disease or a history of autoimmune disease (such as autoimmune liver disease, certain types of lung inflammation, eye inflammation, bowel inflammation, pituitary inflammation, blood vessel inflammation, or kidney inflammation — some mild conditions such as vitiligo not requiring treatment, or childhood asthma now fully resolved, may still be eligible; confirm with trial site)
• People who are currently taking immune-suppressing medications or steroid medicines above a certain dose, or who have been doing so within the 2 weeks before joining
• People who have had another type of cancer in the past 5 years, except for certain treated skin cancers, early-stage prostate cancer, or cervical carcinoma in situ that have been fully cured
• People who have received blood cell-stimulating injections (such as G-CSF or erythropoietin) within the week before the first dose
• People who have previously been treated with certain immune checkpoint drugs or similar therapies targeting immune system proteins (such as PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137)
• People who test positive for HIV or syphilis
• People with active Hepatitis B or Hepatitis C, determined by specific blood test results above normal limits
• People with a known allergic reaction to the type of drug being studied (a recombinant humanised PD-1 monoclonal antibody) or its ingredients
• People with active lung disease such as interstitial lung disease, pneumonia, obstructive lung disease, or asthma, or a history of active tuberculosis
• People with uncontrolled medical problems, including ongoing serious infections, high blood pressure that cannot be controlled with medication, poorly controlled diabetes, or significant heart failure or heart block
• People who, in the 6 months before the first dose, experienced blood clots in the legs or lungs, a heart attack, severe irregular heartbeat or chest pain, a heart procedure or bypass surgery, a stroke, or a mini-stroke
• People who have previously had a stem cell transplant or organ transplant
• People with a history of substance misuse they are unable to stop, or a history of serious psychiatric disorders
• People with other severe medical conditions or abnormal test results that, in the doctor's judgement, could increase risks or affect the study results
• People who, in the doctor's judgement, are unlikely to follow the study requirements or are otherwise not suitable for the trial

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