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 are willing and able to sign a consent form and take part in all study activities for the full duration of the trial.
• People aged 18 or older (there is no upper age limit).
• People who have been diagnosed with squamous cell carcinoma (a type of cancer) confirmed by biopsy.
• People whose cancer tests positive for a protein called p16, shown at a specific level and strength under laboratory testing.
• People whose blood test (called NavDx) shows a specific type of HPV-related genetic material known as HPV16 TTMV.
• People whose cancer is at a specific early stage, as classified by a standard medical staging system (AJCC 8th edition, stage cT0-2 N1 M0) (confirm with trial site).
• People whose cancer is located in the tonsil area, clearly to one side — more than 1 cm from the centre of the throat — including the tonsil, base of tongue, or nearby areas.
• People who have no more than 2 affected lymph nodes, each no larger than 3 cm, or 1 affected lymph node larger than 3 cm but smaller than 6 cm.
• People who have smoked 10 packs of cigarettes per year or fewer across their lifetime, or who have not smoked for at least 5 years regardless of how much they previously smoked.
• People whose throat anatomy and physical condition allow for a surgical procedure called TORS (a type of robotic throat surgery), as assessed by the surgeon.
• People who have had imaging (at minimum a chest CT scan, or a PET/CT scan) within the 12 weeks before surgery confirming the cancer has not spread to other parts of the body through the bloodstream.
• People who are generally well enough to carry out daily activities with little to no limitation, based on a standard health rating scale (ECOG Performance Status 0–1).
• People whose recent blood test (within 8 weeks before surgery) shows the bone marrow is producing enough blood cells — specifically, platelets of at least 100,000 cells/mm³ and haemoglobin of at least 9.0 g/dl (a blood transfusion to reach this level is acceptable if completed 2–4 weeks before joining).
• People whose kidney and liver function blood tests (taken within 8 weeks before surgery) fall within acceptable ranges — specifically, a creatinine level below 2.0 mg/dl and a bilirubin level no more than 1.5 times the upper limit set by the testing laboratory.
• People who test negative for pregnancy within 2 weeks before surgery (applies to women who could become pregnant).
• People whose treating doctor determines they are suitable to receive platinum-based chemotherapy drugs (cisplatin is preferred; carboplatin combined with paclitaxel or abraxane are alternatives).
• Women who could become pregnant and who are using a highly effective form of contraception for at least one month before the screening period, and who agree to continue using contraception throughout the study and for up to one year after surgery as directed by their doctor. Acceptable methods include hormonal contraceptives (such as pills, patches, rings, injections, or implants), IUDs, and barrier methods (such as condoms, diaphragm, cervical cap, or sponge).

Who may not be able to join:

• People who have had previous surgery to the head or neck that the trial investigators believe could affect the meaning of future test results.
• People who have had previous radiation therapy to the head or neck, except for certain very limited treatments for skin cancer using a small area and specific beam types.
• People who have had another type of cancer within the past 5 years — exceptions include certain skin cancers (basal cell carcinoma, or stage 1–2 squamous cell carcinoma of the skin), prostate cancer that has not spread to distant parts of the body, and thyroid cancer that has not spread to distant parts of the body.
• People who have previously had squamous cell carcinoma in a moist tissue area of the head or neck that was treated with surgery alone.
• People who are currently taking medications that modify immune system activity, such as those used for rheumatoid arthritis, organ transplant, or multiple sclerosis.
• People who currently smoke or use tobacco in any form.
• People who have serious active health conditions, including any of the following: unstable chest pain or heart failure requiring a hospital stay in the past 6 months; a heart attack within the past 6 months; a serious bacterial or fungal infection currently being treated with intravenous antibiotics; a lung condition (such as COPD) that is currently causing breathing problems serious enough to require hospitalisation or prevent participation in the study; liver failure causing yellowing of the skin or eyes or problems with blood clotting; active lupus or scleroderma (immune system conditions); or psoriatic arthritis.
• People who are known to be HIV positive (HIV testing is not required to apply).
• People who could become pregnant and are unwilling or unable to use an acceptable form of contraception throughout the study and for the immediate period after surgery (1–2 weeks). Women who have had a hysterectomy or have been postmenopausal for more than 12 months are not considered to be in this category.
• People who are currently pregnant, breastfeeding, or planning to become pregnant from one month before screening through to one year after surgery, as directed by the doctor.
• People who are prisoners, involuntarily detained, or held in a facility for compulsory treatment of a psychiatric or physical condition.

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