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 who are able to give written consent and are willing to follow the study schedule and requirements
• People who are 21 years of age or older at the time of signing the consent form
• People diagnosed with locally advanced nasopharyngeal cancer (a type of cancer at the back of the nose/throat) classified as Stage III or Stage IVA according to standard cancer staging guidelines
• People who still have a detectable level of a virus marker in their blood (called EBV DNA) after completing 3 cycles of initial chemotherapy
• People who are generally well enough to carry out light activity and care for themselves (a standard fitness measure of 0 or 1 on a medical scale)
• Women who could become pregnant must be willing to use a highly effective form of contraception throughout the study and for at least 120 days after the last dose of the study drug, and must have a negative pregnancy test within 7 days of starting the trial
• Men who have not had a sterilisation procedure must be willing to use a highly effective form of contraception throughout the study and for at least 120 days after the last dose of the study drug

Who may not be able to join:

• People who have previously been treated with certain types of immune checkpoint therapy drugs (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar treatments that affect immune system signals)
• People who have previously received radiotherapy or other cancer treatments for this type of cancer, except for those who completed a specific initial chemotherapy combination (cisplatin and gemcitabine) within the last 22 days, or those who have already started combined chemotherapy and radiotherapy after finishing that initial chemotherapy
• People who have cancer that has spread to the brain or the lining around the brain
• People with currently active autoimmune diseases, or a history of autoimmune disease that may come back — though some conditions such as well-controlled Type 1 diabetes, an underactive thyroid managed with hormone replacement, controlled coeliac disease, or skin conditions not needing systemic treatment may still be eligible (confirm with trial site)
• People who have had another type of cancer within the past 2 years, with some exceptions for certain low-risk or fully treated cancers (confirm with trial site)
• People who have needed to take high-dose steroid tablets or other immune-suppressing medications within the 14 days before starting the study — though low-dose, topical, inhaled, or short-course steroids for specific reasons may be acceptable (confirm with trial site)
• People with uncontrolled diabetes, significantly abnormal blood levels of potassium, sodium, or calcium that have not responded to standard treatment, or severely low blood protein levels in the 14 days before starting the study
• People with a history of certain lung conditions, such as scarring of the lung tissue, inflammation of the lungs not caused by infection, or other uncontrolled lung diseases
• People with serious ongoing infections requiring antibiotic, antifungal, or antiviral treatment, including tuberculosis; or those who were hospitalised for a serious infection within the past 4 weeks; or those who received antibiotic treatment by mouth or through a drip within the past 2 weeks
• People with a known history of HIV infection
• People with untreated chronic hepatitis B, or hepatitis B carriers with high virus levels in their blood, or people with active hepatitis C — though those with stable, treated hepatitis B or cured hepatitis C may be eligible (confirm with trial site)
• People who have had a major operation requiring general anaesthesia within the 28 days before starting the study
• People who have previously had a bone marrow or organ transplant from another person
• People with certain recent heart or circulation problems, including recent chest pain from the heart, blood clot in the lungs, heart attack, severe heart failure, serious abnormal heart rhythms, stroke, uncontrolled high blood pressure, or episodes of fainting or seizures within specified time periods before the study (confirm with trial site for exact timeframes)
• People with a known history of severe allergic reactions to any of the study drugs or their ingredients
• People who have used herbal medicines intended to treat cancer within 14 days of starting the study
• People who still have significant side effects from previous cancer treatments that have not returned to their normal baseline levels
• People who received a live vaccine within 4 weeks before starting the study — noting that most flu vaccines are not live vaccines and are generally allowed, but nasal spray flu vaccines are live and are not allowed
• People with other significant medical conditions, or issues with alcohol or drug use, that could interfere with the safety or interpretation of the study
• People who are currently taking part in another clinical trial involving a treatment

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