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 aged 18 to 70 years old, of any gender
• People who have been confirmed by tissue testing to have a type of head and neck cancer called squamous cell carcinoma (not including nasopharyngeal, salivary gland, or thyroid cancers), that has not spread to distant parts of the body
• People with certain stages of this cancer depending on location and HPV status: non-throat cancers or HPV-negative throat cancers at stages III, IVA, or IVB; or HPV-positive throat cancers at stages II or III (HPV status is determined by a specific lab test called p16 immunohistochemistry)
• People whose cancer has been assessed by a head and neck surgeon as able to be removed by surgery
• People who have confirmed cancer spread to nearby lymph nodes (lymph node stage must not be N0 or Nx)
• People who are generally well enough to carry out normal daily activities, with little to no physical limitation (ECOG score of 0 or 1)
• People whose heart, liver, kidneys, and bone marrow are functioning well enough to meet the trial's laboratory requirements (confirm specific values with trial site)
• People who have freely agreed to take part, signed a consent form, and are able to attend all required visits and follow trial procedures

Who may not be able to join:

• People whose lymph node status is classified as N0 or Nx (no confirmed lymph node involvement)
• People with a history of another cancer, except for certain fully cured skin cancers, superficial bladder cancer, cervical cancer in situ, early gastrointestinal cancers, or others judged acceptable by the trial doctor
• People with an active autoimmune disease, or a history of autoimmune conditions such as lupus, multiple sclerosis, inflammatory bowel disease, autoimmune hepatitis, myasthenia gravis, or similar conditions (people with well-controlled type 1 diabetes on a stable insulin dose may still be eligible — confirm with trial site)
• People with a known history of severe allergic reactions, including known allergies to any ingredient in the trial medications (PD-1 monoclonal antibody or afatinib)
• People who have previously been treated with certain immune or targeted cancer therapies, including PD-1, PD-L1, or CTLA-4 antibodies, EGFR antibodies, or EGFR-blocking tablets
• People who have previously received an anti-cancer vaccine
• People who received a live vaccine for an infectious disease (such as flu or chickenpox) within 4 weeks before the trial starts, or who plan to receive one during the trial
• People who had major surgery or a serious injury within 4 weeks before starting the trial
• People who have needed regular steroid tablets or other immune-suppressing medicines (above a low dose threshold) within 14 days before starting the trial (confirm specific dose thresholds with trial site)
• People with significant heart problems, including poor heart pump function, heart rhythm problems, history of heart attack or angina, or abnormal heart electrical readings beyond certain limits (confirm specific values with trial site)
• People with a known history of lung scarring or inflammation not caused by infection (interstitial pneumonia), or conditions that may make it hard to detect lung side effects from the trial drugs; people with active or poorly treated tuberculosis
• People with an overactive thyroid or structural thyroid disease (people with a stable, well-controlled underactive thyroid on thyroid hormone replacement may still be eligible — confirm with trial site)
• People with an active infection, unexplained fever during the screening period, or who have used antibiotic tablets or injections within 1 week before signing the consent form
• People with active hepatitis B or hepatitis C, or a known positive HIV test or AIDS diagnosis
• People with a confirmed history of a serious neurological or psychiatric condition such as epilepsy or dementia
• People with a confirmed history of drug misuse, or alcohol misuse within the past 3 months
• People who are pregnant or breastfeeding, or people (and their partners) who are unwilling to use reliable contraception during the trial and for 3 months after it ends
• People who have taken part in another interventional clinical trial or received an experimental drug within 4 weeks before starting this trial
• People who, in the trial doctor's judgement, have other health or personal circumstances that may prevent them from completing the trial

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