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 have been newly diagnosed with a specific type of head and neck cancer (squamous cell carcinoma) that started in the mouth, throat, voice box, or lower throat area, and have not yet received any treatment for it.
• People whose cancer has been confirmed by a lab test (through a tissue or cell sample).
• People whose throat cancer (oropharyngeal) has been confirmed to be HPV-negative.
• People whose cancer is considered removable by surgery, as determined by their surgical cancer specialist.
• People whose cancer is at a certain stage of advancement (stage III, IVA, or IVB based on a specific medical staging system — confirm with trial site).
• People whose cancer tests positive for a protein called PD-L1, with a score of 1 or higher on a standard test.
• People who are willing to provide blood samples and a new tissue sample from the tumour before treatment and at the time of surgery.
• People aged 18 or older at the time of signing the consent form.
• People who are generally well enough to carry out daily activities with little or no limitation (rated 0 or 1 on a standard health scale used in cancer trials).
• People whose blood test results show that their bone marrow, liver, kidneys, and blood clotting are working within acceptable ranges as required by the trial.
• People who can become pregnant and must have a negative pregnancy test within 7 days of joining the study, and again within 72 hours before the first dose of study treatment.
• People who can become pregnant and are sexually active with an unsterilised male partner must agree to use a highly effective form of contraception from the start of screening until 120 days after the last dose of study treatment.
• Unsterilised male participants who are sexually active with a partner who can become pregnant must agree to use an effective form of contraception from the start of screening until 60 days after the last dose of study treatment.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People whose head and neck cancer has come back after previous treatment, has spread to other parts of the body, is at a very early stage (stage I or II), or originated in areas such as the skin, sinuses, nasal cavity, or salivary glands.
• People with throat cancer that is linked to the HPV virus, confirmed by specific laboratory tests.
• People whose cancer is considered inoperable or unable to be removed by surgery, as determined by the treating doctor.
• People who are significantly limited in their ability to carry out daily activities due to their health condition (rated 2 or higher on the standard health scale used in cancer trials).
• People who have previously been treated with certain targeted or immunotherapy drugs that work on EGFR or PD-1 pathways.
• People who are considered by their doctor to have a significant risk of serious bleeding around the time of surgery, including those with known bleeding disorders or who have had a major bleeding episode within the past 4 weeks.
• People who have an active autoimmune disease (where the immune system attacks the body) that has required medication to control it within the past 2 years. Hormone replacement therapies for certain conditions are not included in this restriction.
• People who have an active serious infection that required hospital treatment or intravenous antibiotics within the 2 weeks before the first dose of the study treatment.
• People with known mental health, behavioural, or substance use conditions that would make it difficult to participate in the study requirements.
• People with active hepatitis B infection who require antiviral treatment but are not already on a stable antiviral therapy before joining the trial. People who test positive for hepatitis B surface antigen may still be considered if they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining (confirm with trial site).
• People with a history of hepatitis C who have not completed a full course of curative treatment, or whose hepatitis C virus is still detectable in the blood at the time of screening. Any curative treatment must have been completed at least 4 weeks before starting the study.
• People with a known history of HIV infection.
• People who have received an organ transplant, or a stem cell transplant that requires ongoing immune-suppressing medication.
• People who have been diagnosed with or treated for another cancer within the past 2 years, with some exceptions such as certain treated skin cancers, treated early-stage cervical or breast cancer confined to one area, or certain low-risk, early-stage prostate cancers meeting specific criteria (confirm with trial site for individual circumstances).
• People who have taken high-dose steroid medication or other immune-suppressing drugs within 7 days before the first dose of the study treatment, with some exceptions such as topical steroids or steroids used to prevent allergic reactions.
• People who have received a live or live-attenuated vaccine within 4 weeks before screening. Non-live vaccines are permitted.
• People who are currently pregnant or breastfeeding.
• People who are unwilling to provide tumour or blood samples for research purposes.

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