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 through laboratory testing (tissue or cell sample) with squamous cell carcinoma of the head and neck (a specific type of cancer) that has come back or not fully responded to treatment, located in the mouth, throat, voice box, or lower throat area
• People whose cancer shows a certain protein marker (called PD-L1 combined positive score, or CPS) of 1 or higher, confirmed by a certified laboratory
• People whose insurance or other payment method covers the pre-surgery chemotherapy used in this trial (confirm with trial site)
• People whose cancer can be measured using standard imaging guidelines (called RECIST 1.1)
• People whose cancer has returned or persisted in specific areas of the head and neck, and who doctors have determined are suitable candidates for a surgical procedure aimed at curing the disease
• People whose cancer can be fully removed by surgery without leaving visible remaining disease
• People with mouth cancer who previously had surgery for that cancer and whose cancer has since returned or not fully responded
• People being considered for voice box removal surgery to treat returning voice box cancer, where the surgery is intended to be curative
• People whose cancer has returned only in nearby lymph nodes and where surgery to remove it is considered possible
• People whose cancer does not involve major blood vessels, certain neck structures, or muscles near the spine in a way that would prevent curative surgery
• People with no signs that the cancer has spread to distant parts of the body
• People who have had a full physical examination and the required scans (CT scan of the neck and a PET/CT scan of the neck, chest, and abdomen)
• People aged 18 or older
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning they are fully active to capable of limited self-care)
• People who can become pregnant must have a negative pregnancy test (urine or blood) within 30 days before joining the trial
• People whose blood test results meet specific minimum levels for white blood cells, platelets, and haemoglobin (red blood cell protein) — haemoglobin can be brought up to the required level with a transfusion if needed
• People whose kidneys are functioning well enough, based on a standard calculation of kidney filtering ability
• People whose liver function blood test results are within acceptable ranges
• People who previously received radiation therapy in a standard treatment or post-surgery setting (one course only), completed at least 6 months before joining, where more than half of the returning cancer area received a significant radiation dose
• People who previously received systemic therapy, including certain immunotherapy drugs, as part of their original treatment course, as long as it was completed at least 4 months before joining

Who may not be able to join:

• People who have previously received systemic therapy or immunotherapy specifically to treat cancer that had already returned or spread
• People who have received any experimental cancer treatment within 4 weeks before joining
• People with moderate to severe heart failure (rated Class III or IV on a standard heart function scale)
• People who currently have an active infection being treated with intravenous (IV) antibiotics, antiviral, or antifungal medications
• People with severe nerve damage in their hands or feet (grade 3 or 4 peripheral neuropathy)
• People with a history of a lung condition called interstitial lung disease
• People with current, non-infectious lung inflammation that requires immune-suppressing treatment
• People who have previously received a solid organ transplant (corneal transplants are an exception)
• People with an active autoimmune disease that has required ongoing systemic treatment in the past 2 years, such as strong immune-suppressing medications or daily steroid doses above a certain level — though some exceptions apply, including people with type 1 diabetes, thyroid conditions managed only with hormone replacement, or certain skin conditions not needing systemic treatment (confirm with trial site)
• People with a known allergy to the study drug, similar drugs, or immune checkpoint inhibitor medications

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