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:

• People aged 18 to 65 years, either male or female (not pregnant), with a general health score showing they are fully active or have only minor restrictions in physical activity (ECOG score 0–1)
• People whose cancer has been confirmed by a laboratory test to be a specific type of nasopharyngeal carcinoma (non-keratinizing type, classified as WHO type II or III)
• People whose cancer is at a high-risk, locally advanced stage (Stage III–IVA), meaning the tumour has spread to certain lymph nodes, has specific features on imaging, or has a high level of a virus marker (EBV-DNA) in the blood before treatment — and who have not yet received any treatment for this cancer
• People who have MRI scan results of the nose/throat and neck area taken before joining, with at least one measurable tumour visible
• People who agree to provide a stored tumour tissue sample or undergo a biopsy so that a specific protein test (PD-L1) can be performed at a central laboratory
• People who agree to have virus-related blood tests (EBV antibody and EBV-DNA) done before treatment begins
• People whose blood counts fall within acceptable ranges: white blood cells, neutrophils, haemoglobin, and platelets all at or above specified levels
• People whose liver function test results (ALT, AST, and bilirubin) are within acceptable limits
• People whose kidney function (measured by a blood marker called creatinine) is within an acceptable range
• People who have signed a consent form and are willing and able to attend all required visits and follow the study procedures

Who may not be able to join:

• People whose nasopharyngeal carcinoma has come back (recurred) or has spread to distant parts of the body
• People whose cancer type is confirmed as keratinizing squamous cell carcinoma (WHO type I)
• People who have already received radiotherapy or chemotherapy
• Women who are pregnant, breastfeeding, or of childbearing age without effective contraception in place
• People who are HIV positive
• People who have had another type of cancer, unless it was a fully cured skin (basal cell) cancer or a very early-stage cervical cancer that has been cured
• People who have previously been treated with immune checkpoint inhibitor drugs (such as those targeting CTLA-4, PD-1, or PD-L1)
• People who require long-term use of immunosuppressive medications or high-dose corticosteroids (steroid medicines that suppress the immune system)
• People with immune deficiency conditions or a history of organ transplantation, or certain ongoing immune-related conditions such as interstitial lung disease, inflammation of the eye, bowel, liver, pituitary gland, kidneys, or uncontrolled thyroid conditions; people with asthma that requires medical treatment with bronchodilators (confirm with trial site for specific details)
• People who have taken high doses of corticosteroid medicines within the past 4 weeks
• People whose recent blood test results (within 7 days before joining) do not meet the required levels
• People with significantly reduced function of the heart, liver, lungs, kidneys, or bone marrow
• People with serious active infections, a heart attack within the past 6 months, symptomatic heart disease (such as unstable chest pain, heart failure, or uncontrolled irregular heartbeat), or any other condition that would make the study treatments unsafe
• People who have had a blood clot, blocked artery, or reduced blood supply to an organ (such as a heart attack, stroke, or mini-stroke) within the past 6 months
• People with severe or uncontrolled illness or infection
• People currently taking part in another clinical trial or using another experimental drug
• People who are unwilling or unable to sign the consent form
• People with a personality disorder or a mental health condition affecting their capacity to make decisions
• People who test positive for Hepatitis B surface antigen and also have a high level of Hepatitis B virus detected in the blood
• People who test positive for Hepatitis C antibodies, unless a follow-up test confirms the Hepatitis C virus is not active in the blood

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