Phase 1 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) of the head and neck, confirmed by a tissue or cell sample, where the cancer started in the mouth, throat, nasal cavity, sinuses, voice box, or the area just below the throat
• People whose cancer is at a specific stage (as determined by their medical team using standard staging guidelines) with no sign that the cancer has spread to distant parts of the body, where surgery followed by radiation and possibly chemotherapy would be the standard treatment approach
• People with returning head and neck cancer or a new second head and neck cancer that can be removed by surgery, as long as no prior radiation or systemic therapy has been received
• People whose cancer can be removed through surgery, and who are healthy enough to undergo surgery
• People with blood test results within acceptable ranges, including healthy enough levels of red blood cells, white blood cells, platelets, kidney function, and liver function (confirm specific values with the trial site)
• Adults aged 18 or older
• People who are generally healthy and able to carry out daily activities with no restriction, or only minor limitations (a score of 0 or 1 on a standard medical fitness scale)

Who may not be able to join:

• People who have previously received radiation therapy or systemic therapy (such as chemotherapy) for a head and neck cancer
• People whose mouth cancer cannot be surgically removed, or who are not well enough to have surgery
• People who have, or have previously had, an autoimmune or inflammatory condition that was treated with steroids or immune-modifying drugs in the past 5 years — though some conditions may be excepted, including vitiligo, type 1 diabetes, thyroid conditions managed only with hormone replacement, childhood asthma that has fully resolved, and psoriasis not requiring systemic treatment
• People currently needing regular high-dose steroid medications or other immune-suppressing drugs within 14 days before starting treatment
• People who have received a live vaccine within 30 days before starting treatment
• People who have previously had a stem cell transplant (either from a donor or using their own cells)
• People who had a serious infection requiring hospital admission or intravenous antibiotics within 2 weeks before starting treatment
• People with uncontrolled HIV, hepatitis B, or hepatitis C infections, or a diagnosed immune deficiency condition — though people with these infections that are well-controlled may still be eligible (confirm with trial site)
• People who have had immune-related lung inflammation (pneumonitis) within the past 5 years
• People with a history of scarring or chronic inflammation of the lung tissue, or currently active non-infectious lung inflammation that required strong immune-suppressing treatment
• People with a known allergy or sensitivity to any ingredient in the study drug, cemiplimab
• People who have had a solid organ transplant, such as a kidney or heart transplant (a corneal eye transplant is an exception)
• People with other serious medical conditions, abnormal physical findings, or laboratory results that the trial doctor considers would make participation unsafe
• People who test positive for pregnancy at the start of the trial (an ultrasound may be used to confirm, confirm with trial site)
• People who are currently breastfeeding
• Women who are able to become pregnant, are sexually active, and are not willing to use highly effective contraception before, during, and for at least 180 days after the last dose of the study drug (accepted methods include certain hormonal contraceptives, intrauterine devices, surgical sterilisation, a vasectomised partner, or abstinence)

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