Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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 able and willing to sign a written consent form agreeing to take part.
• People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (this is measured on a standard scale called ECOG, scores 0 or 1).
• People with a life expectancy of at least 3 months.
• People who have a confirmed diagnosis of recurring or spreading squamous cell cancer of the head and neck, located in the oropharynx, oral cavity, hypopharynx, or larynx, where local treatments such as surgery or radiation are not expected to cure the cancer.
• People with oropharyngeal cancer must have existing test results showing their HPV (human papillomavirus) status.
• People who have not previously had systemic (whole-body) treatment for their recurring or spreading head and neck cancer.
• People who have at least one measurable tumour outside the brain, as assessed using standard imaging guidelines (RECIST 1.1).
• People whose tumour tests positive for a protein called PD-L1 (with a combined positive score of 1 or higher).
• People whose organs (such as liver, kidneys, and bone marrow) are functioning at an adequate level as determined by the trial team.
• People of reproductive potential who agree to use an effective form of contraception during the trial and for 120 days after the last dose of the study treatment.
• People who are able to follow all study requirements and attend all required study visits and procedures.

Who may not be able to join:

• People whose squamous cell cancer originates in the nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid glands, skin, or from an unknown primary site.
• People who have had another cancer in the 5 years before enrolling in the trial.
• People assessed by the investigating doctor as having a significant risk of bleeding based on imaging results.
• People whose imaging shows major blood vessel involvement, tumour growing into nearby organs, risk of an abnormal connection forming between the oesophagus and airways or chest cavity, or blood vessels surrounded by tumour in a way the investigator considers to pose a significantly increased bleeding risk.
• People with known active cancer that has spread to the brain or central nervous system.
• People with fluid build-up around the lungs, heart, or abdomen that is causing symptoms or requires repeated draining.
• People who have previously received any form of immunotherapy, including immune checkpoint inhibitors, immune checkpoint activators, immune cell therapies, or any other treatment targeting the immune system's response to tumours.
• People who have received radiation therapy to the head or neck within 8 weeks before enrolment, or radiation therapy to any other part of the body for palliative purposes within 3 weeks before enrolment.
• People with a history of serious bleeding problems or disorders affecting blood clotting.
• People with a history of inflammation of the heart muscle, disease of the heart muscle, or serious abnormal heart rhythms.
• People who have experienced a blood clot in an artery or vein, a mini-stroke, a stroke, a hypertensive crisis, or hypertensive encephalopathy (a severe complication of high blood pressure affecting the brain) within 6 months before enrolment.
• People who are pregnant or currently breastfeeding.

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