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 diagnosed with squamous cell carcinoma (a type of cancer) in the head and neck area, including the mouth, throat, voice box, or the area connecting the throat to the oesophagus, confirmed through a tissue sample test.
• People whose cancer has one or more high-risk features, such as a large tumour (T4), spread to certain lymph nodes, incomplete surgical removal, narrow or unclear surgical margins, cancer that has spread beyond the lymph node walls, cancer growing along nerves or blood vessels, or (for HPV-negative cancers) spread to certain lymph nodes in the neck.
• People with a good general level of physical fitness and ability to carry out daily activities, rated 0 or 1 on a standard medical scale.
• People whose cancer cells show a certain level of a protein called PD-L1 (a score above 1 on a standard test).
• People who have no medical reasons preventing them from receiving immunotherapy or a combination of chemotherapy and radiation.
• People whose organs (such as liver, kidneys, and blood cells) are functioning at an adequate level.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study treatment, and must be willing to use reliable contraception during the study and for 60 days after the last dose.
• Men who are able to father children must agree to use reliable contraception during the study and for 60 days after the last dose.
• People who are able to provide informed consent to participate.

Who may not be able to join:

• People who have had or currently have another cancer, unless it was a fully cured skin cancer (basal cell type), early-stage cervical cancer that has not spread, or a superficial bladder cancer.
• People who currently have an active infection.
• People who have HIV, active Hepatitis B or C, or a known history of a positive HIV test.
• People with an active or past autoimmune disease (a condition where the immune system attacks the body), except for those with vitiligo (a skin pigmentation condition) or asthma that completely resolved in childhood and requires no ongoing treatment.
• People with significant heart or blood vessel problems, such as a stroke or heart attack within the past 6 months, unstable chest pain, certain levels of heart failure, or a serious irregular heartbeat requiring medication.
• People who are pregnant, breastfeeding, or women who could become pregnant but are unwilling or unable to use two highly effective methods of contraception as required by the study.
• People who have previously received treatment with a type of immunotherapy drug that targets the PD-1 or PD-L1 pathway.
• People who have had major surgery for a non-cancer reason and have not yet fully recovered from the effects of that surgery.
• People who have taken part in another clinical trial using an experimental cancer treatment within 28 days before the first dose of this study's treatment.
• People who the trial doctor determines should not participate for any other reason (confirm with trial site).

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