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 throat/mouth cancer (head and neck squamous cell carcinoma of the oropharynx) that has tested positive for a virus called HPV16, confirmed through specific laboratory tests.
• People who are at least 18 years old.
• People whose cancer has spread to nearby lymph nodes in a way that meets specific size and staging requirements, or whose main tumour is classified as a larger/more advanced stage (T3 or T4), as determined by a doctor using standard cancer staging guidelines.
• People whose cancer can be measured on scans using standard criteria (called RECIST 1.1).
• People who have not previously had radiation therapy or chemotherapy for head and neck cancer.
• People who have not had their head and neck cancer fully removed by surgery within 8 weeks before joining (some limited surgical biopsies or removal of a single lymph node with remaining cancer still present may be acceptable — confirm with trial site).
• People who are considered generally well enough to carry out daily activities with little to no limitation, based on a standard fitness scale (ECOG score of 0 or 1).
• People whose organ function (such as kidney, liver, and blood) meets specific health thresholds set out in the trial protocol.
• People who a treating doctor considers medically suitable to receive a chemotherapy drug called cisplatin.
• People who are able to understand and willing to sign a written consent form before joining the trial.
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting the study treatment.
• Women who could become pregnant must agree to use contraception for the full duration of treatment.
• Men who are sexually active with women who could become pregnant must agree to use contraception for the full duration of treatment.

Who may not be able to join:

• People whose cancer has clearly spread to distant parts of the body (known as stage M1 or metastatic disease).
• People whose cancer tests positive for a type of HPV other than HPV16.
• People where the original location of the cancer cannot be identified.
• People with other serious ongoing health conditions that could affect their ability to tolerate the treatment or that could limit their survival, such as active infections, heart problems, lung problems, immune deficiency, or significant mental health or social challenges (stable, well-managed conditions may still be reviewed by the lead doctor on a case-by-case basis).
• People with low-risk lymph node involvement, specifically a single lymph node smaller than 3 cm.
• People with active, known, or suspected autoimmune or inflammatory conditions that require immune-suppressing medication, with some exceptions (such as vitiligo, hair loss, stable underactive thyroid managed with hormone replacement, or mild skin conditions not requiring systemic treatment — confirm with trial site).
• People who have taken high-dose steroid or immune-suppressing medications within 14 days before starting treatment, or any long-term immune-suppressing medication within 6 months before starting (some exceptions may apply — confirm with trial site).
• People who have had an autoimmune disease requiring systemic treatment within the past 2 years (note: hormone or gland replacement therapies are generally not considered systemic treatment in this context — confirm with trial site).
• People who have previously had a severe allergic reaction (such as anaphylaxis) to a human immunoglobulin or antibody-based medicine.
• People who have taken herbal remedies known to stimulate the immune system or affect organ function within 28 days before starting treatment (unless agreed with the lead investigator).
• People who have had prior surgery beyond a limited biopsy or emergency airway procedure, and where no measurable remaining tumour is present.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have received any systemic cancer treatment within the past 8 weeks.
• People with another cancer that is currently growing or requiring active treatment (some skin cancers or early-stage cancers that have been successfully treated may be exceptions — confirm with trial site).
• People with a known history of, or current evidence of, non-infectious lung inflammation (pneumonitis).
• People with active Hepatitis B or Hepatitis C infection (people whose infection has been fully cleared may still be eligible — confirm with trial site).
• People who have received a live vaccine within 28 days before the planned start of treatment.

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