Phase 3 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 confirmed through a biopsy to have a type of head and neck cancer (HNSCC) at stage III or IVA, where the plan is to treat it with the aim of curing it, including through surgery
• People aged 18 to 79 years old at the time of joining the study
• People who are generally well enough to carry out daily activities with little to no limitation (this is measured by a standard health scale called ECOG, scores 0 or 1)
• People whose cancer can be measured on scans, according to standard guidelines called RECIST 1.1
• People who have never previously received a type of cancer treatment that works through the immune system (such as checkpoint inhibitor drugs like anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments), not counting cancer vaccines
• People whose recent blood test results show that their liver, kidneys, and blood cell counts are within acceptable ranges — these tests must be done within 14 days before joining (confirm specific values with trial site)
• Women who could become pregnant must have a negative pregnancy test within 21 days of joining the study
• Women who could become pregnant must agree to use highly effective contraception for 23 weeks after the last dose of study treatment
• Men who could father a child and are sexually active with women who could become pregnant must agree to use contraception with a failure rate of less than 1% per year, for 31 weeks after the last dose of study treatment (men who produce no sperm do not need to follow this requirement)
• People who are able to understand and are willing to sign a consent form agreeing to take part
• People who are willing and able to follow all study requirements, including attending scheduled appointments and follow-up visits
• People who agree to allow leftover tissue from their diagnosis and from any surgery to be used for research purposes

Who may not be able to join:

• People who are currently taking part in another clinical trial using an experimental treatment, or who have done so within the past 4 weeks, or who have not fully recovered from side effects of a previous experimental treatment
• People who have had another type of invasive cancer in the past 5 years, or who have received surgery, chemotherapy, targeted therapy, or radiation for any other cancer within the past 5 years
• People who have had major surgery for any reason and have not yet fully recovered from it before starting treatment
• People who have needed regular treatment with steroid tablets or other immune-suppressing medicines (above a certain dose) within 14 days before starting the study — inhaled or skin-applied steroids at lower doses may be allowed (confirm with trial site)
• People who have an active autoimmune disease (where the body's immune system attacks itself) that has needed steroid treatment within the past 3 months, or who have a documented history of a severe autoimmune condition
• People with an active, known, or suspected autoimmune disease — though some milder conditions such as vitiligo, type 1 diabetes, thyroid conditions managed with hormone replacement, or psoriasis not needing systemic treatment may still be eligible (confirm with trial site)
• People with lung inflammation (interstitial lung disease or non-infectious pneumonitis)
• People who currently have an active infection that requires treatment through the bloodstream or by tablets
• People who have previously received immune checkpoint treatments or similar drugs targeting the immune system's T-cells
• People who have had a serious allergic reaction to treatments similar to those used in this trial
• People who have any condition, treatment history, or lab result that the treating doctor believes would interfere with the trial or would not be in the person's best interest
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the trial requirements
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 23 weeks after the last dose of treatment
• People with a known history of HIV infection
• People with known active Hepatitis B or Hepatitis C
• People with a known history of active tuberculosis (TB)

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