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 cancer (oropharyngeal squamous cell carcinoma) that can be surgically removed, and whose tumour has tested positive for a protein called p16 through laboratory testing at an approved central lab.
• People whose cancer has been confirmed as linked to high-risk HPV (human papillomavirus), with this testing completed before treatment is assigned.
• People who have a detectable level of HPV-related DNA in their blood before surgery, measured at 10 or more fragments per millilitre using a specific test called NavDX.
• People whose blood shows no detectable HPV-related DNA after surgery (less than 5 fragments per millilitre), tested within 1 to 5 weeks after the operation.
• People whose cancer is at an early or intermediate stage according to a specific staging system (AJCC 7th edition: T1N0–2B or T2N0–2B), with no sign of cancer spread to distant parts of the body and no major spread outside the lymph nodes.
• People aged 18 or older at the time of screening.
• People who have not previously had surgery, radiation, or chemotherapy for head and neck cancer, apart from limited biopsy procedures or tonsil removal.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People who have not smoked at least one cigarette (or equivalent) per day in the last 5 years, and whose total lifetime smoking history is no more than 20 pack years.
• People who are willing and able to give written informed consent.
• People whose blood tests show adequate bone marrow, liver, and kidney function, specifically: platelet count of at least 90 × 10⁹/L, haemoglobin of at least 10 g/dL (which may be achieved through transfusion), and kidney function (eGFR) of at least 50 mL/min.

Who may not be able to join:

• People under 18 years of age at the time of screening.
• People who are pregnant or breastfeeding.
• People who have had, or currently have, cancer in another part of the body, unless it was a limited set of specific, previously treated cancers with no current sign of disease for at least 3 years (confirm with trial site for the full list of exceptions).
• People with serious heart conditions, including unstable heart disease or a heart attack within the 6 months before joining the trial.
• People with a significant history of neurological or psychiatric conditions, such as severe dementia or poorly controlled seizures.
• People with an active, serious infection that is not under control.
• People with an active, unhealed peptic ulcer.
• People with active drug or alcohol dependency within the 6 months before diagnosis.
• People with severe chronic lung disease who have been hospitalised for pneumonia within the 12 months before diagnosis.
• People who have previously had an organ transplant.
• People with a lung condition called interstitial lung disease.
• People currently receiving any other cancer treatment.
• People who have taken part in a clinical drug trial within 30 days of joining this trial, or who are participating in another investigational radiation study.
• People with a history of active hepatitis C.
• People whose cancer has spread extensively to lymph nodes, cannot be fully removed by surgery, or shows clear signs of spread beyond the lymph nodes or to areas above the collarbone.
• People whose cancer is not linked to high-risk HPV, as confirmed by laboratory testing.
• People found to have 5 or more lymph nodes containing cancer after surgery, regardless of size.
• People whose cancer tests negative for p16 or HPV on laboratory testing.
• People whose blood shows no detectable HPV-related DNA before surgery, or a level below 10 fragments per millilitre.
• People who have been treated for an autoimmune disease with chemotherapy or anti-TNF medications within the last 2 years.
• People whose post-surgery blood test still shows detectable HPV-related DNA above 5 fragments per millilitre, tested 1 to 5 weeks after the operation.

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