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 already been diagnosed with a confirmed type of head and neck cancer called squamous cell carcinoma (HNSCC), where the cancer has come back, spread to other parts of the body, or cannot be removed by surgery or cured. This includes cancers starting in the mouth, throat, voice box, lower throat, nasal cavity, or sinuses.
• People who have at least one area of cancer that can be measured on a CT or MRI scan (at least 1 cm in size).
• People who have received at least 1, but no more than 2, previous treatments for their returned or spread cancer, and at least one of those treatments must have included a type of immunotherapy called an anti-PD-1 or anti-PD-L1 drug.
• People aged 18 or older at the time of signing the consent form.
• People who have records available showing the results of two tumour marker tests — one for a protein called PD-L1 and, for throat (oropharyngeal) cancers, one for HPV status — if those results exist in their medical file.
• People who are reasonably active and able to care for themselves, as measured by a standard health scale called the ECOG Performance Scale (score of 0 or 1).
• People whose blood test results, taken within 14 days before joining the trial, show that their bone marrow, liver, and kidneys are functioning at a minimum acceptable level (confirm specific values with trial site).
• People who have had tumour measurements recorded from a scan taken within 28 days before joining the trial.
• Women who could become pregnant must have a negative pregnancy test within 7 days of joining the trial, and must be willing to use 2 methods of contraception throughout the trial and for 120 days after the last dose.
• Men must be willing to use a condom throughout the trial and for 120 days after the last dose, and are discouraged from donating sperm for up to 6 months after the last dose.
• People who are willing and able to sign a written consent form for the trial.

Who may not be able to join:

• People who have already received 3 or more previous treatment courses for their returned or spread head and neck cancer.
• People who have received radiation therapy within 10 days before starting the trial treatment.
• People who have received a solid organ transplant (such as a kidney, liver, or heart transplant).
• People who currently have active cancer that has spread to the brain or the lining around the brain. People with previously treated brain metastases may still be considered, provided the cancer has been stable on scans, they have been off steroid medications for at least 3 weeks, and there are no signs of new or growing brain tumours.
• People with a significant history of autoimmune disease (where the immune system attacks the body) who are currently being treated for it, including those taking steroid medications at a dose equivalent to 10 mg or more of prednisone per day.
• People with serious uncontrolled illnesses, such as an active infection, heart failure, unstable chest pain (angina), recent stroke, or a serious heart rhythm problem within the past 6 months.
• People who have another cancer that is currently growing or requires active treatment (some skin cancers or early-stage cervical cancer that has been treated may be exceptions — confirm with trial site).
• People who test positive for active hepatitis B or hepatitis C virus infection. People living with HIV may still be considered if their HIV viral load is undetectable and they are on HIV treatment.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period or within 120 days after the last treatment dose.

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