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, have signed a consent form, and are able to follow the study procedures
• People who have been confirmed by laboratory testing (cell or tissue samples) to have locally advanced head and neck squamous cell carcinoma (a type of cancer in the head and neck area) that is difficult to fully remove with surgery
• People who have not yet received any treatment for their head and neck cancer
• People who have never been treated with the drugs cetuximab or any PD-(L)1 inhibitor (a type of immunotherapy)
• People who have at least one tumour that can be measured using standard imaging criteria
• People aged 18 or older, of any gender
• People whose general physical condition is rated as 0 or 1 on a standard health and activity scale (meaning they are fully active or have only minor limitations in physical activity)
• People whose life expectancy is at least 3 months
• People whose blood counts meet minimum levels — including haemoglobin, neutrophils (infection-fighting cells), and platelets (clotting cells) — as confirmed by blood tests
• People whose liver and kidney function and protein levels fall within acceptable ranges on blood tests
• People whose heart pumping function is above 50%, as shown by an echocardiogram (heart ultrasound)
• Women who could become pregnant must have had a negative pregnancy test within 7 days before joining the trial and must agree to use reliable contraception during the trial and for 8 weeks after the last dose

Who may not be able to join:

• People who have previously received any anti-cancer treatment, including chemotherapy, radiotherapy, surgery, or immunotherapy
• People with a known or suspected allergy to cetuximab, PD-(L)1 immunotherapy drugs, or the chemotherapy drugs paclitaxel or cisplatin
• People with high blood pressure that cannot be brought under control with medication, or who have significant heart conditions such as moderate-to-severe coronary artery disease, certain heart rhythm problems (including a prolonged QTc interval over 470 ms), or heart failure
• People with a history of autoimmune diseases (conditions where the immune system attacks the body, such as autoimmune colitis or hepatitis), immune deficiency conditions, a positive HIV test, or a history of organ transplant or bone marrow transplant
• People with uncontrolled active hepatitis B or active hepatitis C infection
• People with active tuberculosis
• People who have had major surgery within 4 weeks before the first dose, or whose surgical wounds have not fully healed
• People who have a clear tendency to bleed easily
• People with serious conditions affecting the digestive system, such as a blocked stomach outlet, active upper gastrointestinal bleeding, a hole in the gastrointestinal tract, blocked bile ducts, or severe malnutrition
• People who have had an abdominal fistula (abnormal internal connection), gastrointestinal perforation (a hole in the gut), or an abdominal abscess (internal infection) within the 6 months before joining
• People whose tumour appears on imaging to have grown into major blood vessels, or where the treating doctor believes this is likely to happen and could cause serious bleeding
• People with a history of lung scarring (pulmonary fibrosis), non-infectious lung inflammation, or other uncontrolled lung conditions
• People with cancer that has actively spread to the brain
• People who have had another type of cancer within the past 5 years (with the exception of certain fully treated skin cancers or cervical carcinoma in situ)
• People who are pregnant or breastfeeding
• People with other serious health conditions that the trial doctor considers would put them at risk or prevent them from completing the study

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