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 who are willing to voluntarily sign a consent form agreeing to take part in the study
• People who have been newly diagnosed (not yet treated) with a type of head and neck cancer called squamous cell carcinoma — affecting the mouth, throat, voice box, or lower throat — confirmed by a tissue sample, with specific protein markers present (EGFR-positive and CPS ≥ 1), and at a particular stage of disease depending on the location and type of tumour (confirm with trial site)
• People whose surgeon has determined that an operation with the aim of curing the cancer is a suitable option
• People aged between 18 and 75 years
• People who are generally well enough to carry out normal daily activities, with only minor limitations at most (based on a standard medical fitness scale called ECOG 0–1)
• People expected to live for more than 6 months
• People who have at least one tumour that can be measured on a scan, using standard criteria called RECIST 1.1
• People whose blood counts, liver function, kidney function, and other organ tests meet specific minimum levels — tests must be done without having received blood transfusions or certain growth factor medicines in the 14 days beforehand (confirm specific values with trial site)
• People whose heart pumping function, measured by a scan, is at least 50%
• Women who could become pregnant and who agree to use contraception during treatment and for 3 months after the last dose
• People who are likely to follow the study requirements reliably

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People who have had an allergic reaction to medicines that work similarly to PD-1 inhibitors
• People who have had another cancer in the past 5 years or currently have another cancer, except for certain types that have been fully cured (such as a specific type of skin cancer, early-stage cervical changes, or a type of thyroid tumour)
• People who still have significant side effects from a previous cancer treatment (such as immunotherapy, targeted therapy, chemotherapy, or radiotherapy), other than hair loss, tiredness, or mild thyroid changes
• People with serious heart conditions that are not well controlled, such as moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or a serious irregular heartbeat requiring treatment
• People with moderate or severe nerve damage in their hands or feet
• People who have had a blood clot in the lungs or legs within the past 3 months (not including clots related to certain medical lines or ports)
• People who have active bleeding, a condition that affects blood clotting, or who are taking a type of blood-thinning medicine called coumarin
• People who are known to be allergic to any ingredient in the study drug vibecotamab, or who have had a severe allergic reaction to similar types of medicines in the past
• People who have recently taken another experimental medicine, are currently participating in another treatment-based clinical study, have taken high-dose steroid or immune-suppressing medicines within 2 weeks before the study starts (with some exceptions), received a live vaccine within 4 weeks, or had major surgery or serious injury within 4 weeks
• People who have had a serious infection within 4 weeks before the study starts, or who have signs of an active infection or active lung inflammation around the time of joining
• People with a serious long-term lung condition such as severe chronic obstructive pulmonary disease with breathing failure, or significant breathing problems
• People with a history of active autoimmune diseases (conditions where the immune system attacks the body), such as lung inflammation, bowel inflammation, liver inflammation, or thyroid problems — though people with certain mild conditions that needed no treatment may still be considered
• People with a weakened immune system, including those who are HIV-positive, or who have had an organ or bone marrow transplant
• People with active tuberculosis (TB), or a history of TB within the past year, or an older TB history that was never properly treated
• People with active hepatitis B or hepatitis C infection at levels above certain thresholds
• People with fluid build-up around the lungs, abdomen, pelvis, or heart that needs to be drained more than once a month
• People with a known history of substance abuse or alcohol dependence
• People whom the trial investigator considers unsuitable for inclusion for any other reason

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