Phase 3 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 diagnosed with a specific type of nasopharyngeal cancer (a cancer at the back of the nose/throat) confirmed by a tissue sample — specifically the non-keratinizing type (WHO type II or III).
• People whose cancer has been classified as a certain advanced stage (stage IVa: T4N0-2M0 or T1-4N3M0) at the time of diagnosis, based on standard cancer staging guidelines.
• People with stage II or III nasopharyngeal cancer whose cancer did not respond well to 3 cycles of a specific chemotherapy combination (GP chemotherapy) — either showing no improvement or worsening on scans, or having a detectable virus marker (EBV DNA above 0 copies/mL) in the blood afterward.
• People aged between 18 and 70 years old.
• People who are generally able to carry out daily activities, as measured by a standard performance score (Karnofsky scale of 70 or above).
• People whose blood tests show that their bone marrow is functioning normally.
• People whose liver and kidney function tests fall within acceptable ranges — specifically, certain liver markers no more than 2.5 times the upper normal limit, and kidney function meeting a minimum threshold (confirm with trial site for exact values).
• People who are able and willing to provide written consent to participate.

Who may not be able to join:

• People whose tissue sample confirms a different type of nasopharyngeal cancer (WHO type I, keratinized squamous cell carcinoma, or basal squamous cell carcinoma).
• People whose cancer has come back after previous treatment or has spread to other parts of the body.
• People with stage II or III nasopharyngeal cancer whose cancer responded well to 3 cycles of GP chemotherapy — showing partial or complete response on scans AND having an undetectable EBV DNA level (0 copies/mL) afterward.
• People with a known allergy to large protein-based medicines or any component of the study treatment.
• People who have or have had another type of cancer.
• People who have an active autoimmune disease (where the immune system attacks the body) or a history of one.
• People with a history of psychiatric conditions, alcohol dependency, or drug addiction.
• People whose blood test results do not meet the required standards within 7 days before enrolling.
• People who have taken steroid medications (glucocorticoids) continuously for any significant period within 4 weeks before starting the study treatment.
• People with a known history of active tuberculosis (TB) within the past year, including those who received treatment for active TB within that time (confirm with trial site).
• People who have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, or CTLA-4 pathways.
• People with currently active autoimmune conditions such as eye inflammation, gut inflammation, liver inflammation, hormone gland inflammation, kidney inflammation, blood vessel inflammation, an overactive thyroid, or asthma requiring certain breathing medications. Note: skin conditions that do not need systemic (whole-body) treatment, such as vitiligo or psoriasis, may not be disqualifying (confirm with trial site).
• People with a known HIV (human immunodeficiency virus) diagnosis.
• People who test positive for hepatitis B surface antigen with a high level of hepatitis B virus in the blood, or who test positive for hepatitis C antibodies.
• People who have received a live vaccine within 4 weeks before the planned start of the study treatment.
• People who are pregnant or currently breastfeeding.

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