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 who are willing to take part, sign a consent form, and follow all study visits, treatments, and tests as required.
• People who have been diagnosed with nasopharyngeal carcinoma (a type of cancer at the back of the nose) confirmed by a tissue biopsy, specifically the non-keratinising type.
• People aged 18 to 70 years old.
• People who are generally well enough to carry out daily activities with little or no limitation (based on a standard medical fitness scale scored 0 or 1).
• People whose nasopharyngeal carcinoma has come back or spread, and where treatment with a platinum-based first-line and/or second-line regimen has stopped working.
• People who have previously received at least one round of systemic (whole-body) cancer treatment.
• People whose cancer has stopped responding to a type of immunotherapy called anti-PD-1 or anti-PD-L1, with at least 6 weeks of exposure to that treatment, and whose situation meets specific relapse or progression timing criteria (confirm with trial site).
• People who have at least one measurable tumour that meets specific size requirements on a CT scan.
• People whose side effects from previous cancer treatments have largely resolved to a mild level or better before joining.
• People whose blood counts, liver function, kidney function, and other key organ measurements meet the required levels set by the trial (confirm with trial site for specific values).
• People who are expected to live for at least 3 months or more.
• Women of childbearing age who have a negative pregnancy blood test and who agree to use effective contraception during the trial and for 6 months after the last dose.
• Male participants and their partners who agree to use one of the contraceptive methods specified by the trial.

Who may not be able to join:

• People whose cancer has returned in a localised area where surgery with curative intent is still possible.
• People who have had a severe allergic reaction to mitoxantrone or liposomes (such as severe rash, low blood pressure, breathing difficulties, or anaphylaxis).
• People who have previously received doxorubicin or similar chemotherapy drugs (anthracyclines) above a certain cumulative dose threshold.
• People whose expected survival is less than 3 months.
• People who have been diagnosed with or treated for another type of cancer within the past 5 years (with some exceptions such as certain skin cancers or cervical cancer that have been fully treated).
• People who have had surgery, chemotherapy, radiotherapy, immunotherapy, or any experimental treatment within the 4 weeks before starting the trial (or within 2 weeks for palliative radiotherapy).
• People with high blood pressure that cannot be controlled with medication, significant heart disease, or certain heart-related events in the 6 months before enrolment, including heart attack, severe chest pain, heart failure, certain abnormal heart rhythms, atrial fibrillation, bypass surgery, stroke, or blood clots; or people whose heart pumping function is below 50%.
• People who have had a severe infection requiring intravenous antibiotics, antifungals, or antivirals in the 4 weeks before the first dose, or an unexplained fever or elevated white blood cell count close to the start of the trial.
• People currently using immunosuppressant medications or high-dose steroid therapy within 2 weeks before the first dose.
• People with an active autoimmune disease or a history of autoimmune conditions such as lung inflammation, eye inflammation, bowel inflammation, hepatitis, or thyroid disorders (some exceptions may apply — confirm with trial site).
• People who have had a flare-up of chronic lung disease requiring hospitalisation within 1 month before joining, or who have active tuberculosis or have been treated for tuberculosis within the past year.
• People who are HIV-positive, have active hepatitis B, or have tested positive for hepatitis C antibodies.
• People who have received a live vaccine within 4 weeks before starting the trial, or who may need one during the study.
• People who are pregnant or breastfeeding.
• People of childbearing potential or sexually active men who are unwilling or unable to use an acceptable form of contraception.
• People with serious uncontrolled medical conditions, significant substance use issues, severe mental illness, or family or social circumstances that the study doctor believes could affect safe participation.
• People the study doctor considers unsuitable for any other reason.

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