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 with a specific type of head and neck cancer called squamous cell carcinoma of the oropharynx (the middle part of the throat, including the base of the tongue and tonsils), confirmed by a lab test, that has not spread to distant parts of the body.
• People whose cancer a head and neck surgeon has determined cannot be surgically removed — either because clean removal is not possible, because surgery would cause major loss of function, or because of the position or features of the tumor.
• People who had a partial surgical removal of their head and neck cancer but still have visible remaining cancer that requires further treatment.
• People whose tumor tests positive for a specific virus called HPV-16, and also shows a protein called p16INK4A — confirmed through tissue samples available from a biopsy or surgery.
• People whose tumor tissue is available for an additional test called PD-L1 staining.
• People who carry a specific genetic marker called HLA-A*0201, confirmed by a genetic test.
• People who have at least one area of cancer that can be measured by imaging or physical examination, meeting specific size requirements as defined by the trial.
• People aged 18 or older.
• People with a good general health and activity level, as rated on a standard medical scale (ECOG score of 0 or 1, meaning fully active or able to carry out light activity).
• People with adequate functioning of organs such as the liver, kidneys, and bone marrow, as assessed by blood tests defined in the trial protocol.
• People living with HIV who are on effective treatment and have had an undetectable amount of the virus in their blood within the past 6 months.
• People with a history of hepatitis B who have an undetectable level of the virus while on appropriate treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable level of the virus.
• People who have had or currently have another cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial.
• People with a history of heart disease or prior treatment with heart-affecting medicines, provided a heart function assessment places them at a certain level of heart health (New York Heart Association Class 2B or better).
• Male participants who agree to use highly effective contraception during treatment and for at least 120 days after the last dose, and who agree not to donate sperm during this period.
• Female participants who are not pregnant and not breastfeeding, and who either are not of childbearing potential or agree to use highly effective contraception during treatment and for at least 120 days after the last dose. Accepted contraception methods include hormonal options (pill, patch, ring, injection, or implant), copper intrauterine device, intrauterine hormone-releasing system, tubal ligation, complete abstinence from sex (confirm with trial site), or a vasectomised partner (where that person is the only sexual partner).
• People who are able to understand the study and are willing to sign a consent form.

Who may not be able to join:

• People whose cancer has spread to distant parts of the body, or where imaging shows spread to the brain or membranes surrounding the brain.
• Female participants of childbearing potential who have a positive pregnancy test within 72 hours before the first dose of the study drug.
• People who have already received radiation therapy or any systemic cancer treatment (including other clinical trial treatments) for the head and neck cancer being studied.
• People who are currently taking part in, or who have taken part in, another clinical trial involving an experimental treatment or device within the past 4 weeks.
• People with a history of allergic reactions to proteins similar to the study drugs, or to certain ingredients used in the study drug formulations.
• People with a history of autoimmune disease (where the immune system attacks the body), with some exceptions: vitiligo, resolved childhood eczema, certain cases of mild psoriasis not needing systemic treatment, or a history of Graves' disease where thyroid function has returned to normal.
• People who have had a bone marrow, stem cell, or organ transplant from another person.
• People who have been taking steroid medicines above a low threshold dose (more than 10 mg per day of prednisone or equivalent) or other immune-suppressing medicines within 7 days before the first dose. Low-dose, topical, inhaled, or nasal steroids are generally allowed.
• People with a significant history of heart problems, including: a heart attack or unstable chest pain within the past 16 weeks; serious irregular heart rhythms; very high blood pressure that is not controlled; a blood clot, stroke, or mini-stroke within the past 16 weeks; a specific abnormality in heart electrical activity; severe heart failure; inflammation of the lining around the heart; or heart muscle inflammation.
• People with significant breathing difficulties (for example, those who require extra oxygen).
• People with significant digestive tract conditions, including: a hole in the gut wall within the past year (or more recently if the trial team considers the area still at risk); significant bleeding from the digestive tract within the past 3 months; a recent episode of serious pancreas inflammation within the past 3 months; or a significant flare of a bowel condition called diverticulitis within the past 4 weeks.
• People who have an active serious infection (viral, bacterial, or fungal) that requires treatment given into a vein, within 7 days before the first dose, or who have not finished a course of infection treatment at least 1 week before the first dose.
• People with a second cancer that has not been in remission for more than 2 years — though certain less serious cancers (such as some skin cancers, early-stage cervical changes, early-stage prostate cancer, or removed melanoma in situ) may be exceptions.
• People who have had a significant injury or major surgery within 4 weeks before the first dose.
• People who have received a live vaccine within 30 days before the first dose. This includes vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and the nasal spray form of the flu vaccine. Standard injected flu vaccines are generally allowed.
• People with significant hearing loss (Grade 2 or higher on a clinical grading scale, with symptoms).
• People with significant nerve damage (Grade 2 or higher neuropathy).
• People with significant bleeding related to their cancer (Grade 2 or higher).
• People who have had lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with active alcohol or substance misuse, or a history of this within the past year.
• People with other serious uncontrolled illnesses.
• People with mental health conditions or personal circumstances that, in the treating doctor's view, would make it difficult to follow the trial requirements.
• People with any condition, treatment history, or test result that the treating doctor believes could affect the trial results, interfere with full participation, or would not be in the person's best interest.
• Trial site staff who are directly involved in running the study.
• People who are imprisoned or otherwise involuntarily detained.
• People who are pregnant or breastfeeding, as the safety of the study drugs in pregnancy or for nursing infants is not yet known.

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