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 and able to understand and sign a consent form, and agree to follow the study requirements.
• People aged 18 or older at the time of signing consent.
• People who have been diagnosed by tissue biopsy with head and neck cancer (in the oral cavity, throat, voice box, or lower throat area) that cannot be surgically removed and has spread or returned.
• People whose cancer has been confirmed to be getting worse, based on standard imaging measurements.
• People who have at least one tumour that can be measured on scans using standard criteria.
• People who are well enough to carry out basic activities, as rated on a standard scale (a score of 2 or lower out of 5) (confirm with trial site).
• People whose cancer got worse during or after treatment with certain immunotherapy drugs, such as pembrolizumab or nivolumab — including those who had side effects from those drugs but fully recovered before joining the study.
• Women who could become pregnant must have a negative pregnancy test before joining.
• People of reproductive age must use an approved form of contraception during the study and for 30 days after the last dose of the study drug.
• People whose blood counts, kidney function, and liver function fall within acceptable ranges as determined by the trial team during screening and study visits.
• People who have waited at least two weeks after stopping their previous cancer therapy and whose side effects from that treatment have reduced to a mild level or resolved.

Who may not be able to join:

• People with serious heart, liver, lung, hormonal, immune system, or psychiatric conditions that are not well controlled, or conditions that make it unsafe to use certain types of chemotherapy or targeted drugs.
• People with significant liver scarring (cirrhosis) rated at a moderate or severe level (Child-Pugh B or worse).
• People with brain metastases that are not under control — though those whose brain metastases have been previously treated and are considered stable on low or no steroid medication may still be considered.
• People with a consistently prolonged heart electrical interval (QTc greater than 480 milliseconds) on heart monitoring tests.
• People with a personal or family history of certain heart rhythm risk factors, such as heart failure or a condition called long QT syndrome.
• People who have previously received cetuximab (a targeted therapy drug) for cancer that has spread or returned — though cetuximab given alongside radiotherapy or as early-stage treatment is acceptable.
• People who have previously received any other EGFR-targeted therapy for cancer that has spread or returned.
• People who are currently taking part in another clinical trial or receiving an experimental treatment on a compassionate or expanded access basis.
• People whose cancer started in the nasopharynx (upper throat) or salivary glands.
• Women who have a positive pregnancy test.
• Women who are breastfeeding, planning to become pregnant, or men planning to father a child during the study period.
• People who test positive for HIV, active hepatitis B, or active hepatitis C — though people with well-controlled HIV, treated hepatitis B on antiviral therapy, or cured hepatitis C with no detectable virus may still be considered.
• People who have had an active infection requiring intravenous antibiotics or antifungal medication within the 7 days before the first study dose, or who have a fever from an infection.
• People who have had major surgery within 4 weeks before screening.
• People who have received a live vaccine within 4 weeks before the first study dose, or who may need one during the study.
• People with a known allergy or sensitivity to any ingredient in the study drug.
• People with other significant medical conditions or abnormal test results that, in the trial doctor's judgement, would interfere with safe participation.
• People who are unable to attend study visits as scheduled.
• People with current drug or alcohol misuse.
• People who have previously received certain chemotherapy drugs (such as paclitaxel or docetaxel, or similar drugs) for cancer that has spread or returned — though prior use of these drugs as part of curative treatment for locally advanced disease is acceptable.

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