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:

• Adults aged 18 or older
• People with a performance status rating of 0–2 on the ECOG scale, meaning they are fully active or able to carry out light activity (confirm with trial site)
• People diagnosed with HPV-16 related squamous cell cancer of the throat/tonsil area (oropharynx), or HPV-16 related head and neck squamous cell cancer where the original tumour location is unknown — confirmed by a specific lab test called in-situ hybridisation
• People who had a detectable level of HPV DNA in their blood (at least 50 copies per millilitre) before surgery, measured by a specific test called the Naveris digital PCR assay
• People who have had surgery that removed all visible cancer, with no visible remaining disease on scans taken after surgery
• People whose post-surgery blood tests show HPV DNA has dropped to undetectable levels (less than 1 copy per millilitre), measured on two separate occasions within 2–6 weeks after surgery, ideally at least one week apart
• People whose cancer tissue analysis after surgery meets at least one specific pathology finding required for either Arm A or Arm B of the trial (see below)
• Arm A — people whose surgical pathology shows at least one of: certain cancer stage combinations under AJCC 7th edition staging, lymphovascular invasion, perineural invasion, or a close surgical margin of 3mm or less
• Arm B — people whose surgical pathology shows a microscopically positive surgical margin or extracapsular extension (cancer spreading beyond the lymph node capsule)
• Arm B only — people with adequate blood counts, kidney function, and liver function within 30 days before joining the trial, meeting specific minimum levels (confirm exact values with trial site)
• Arm B only — women who could potentially become pregnant must have a negative pregnancy blood test within 14 days before joining the trial
• People who are able to understand the study and willing to sign a consent form (or have a legally authorised representative sign on their behalf)

Who may not be able to join:

• People whose cancer has spread to distant parts of the body (metastatic disease)
• People whose HPV type is not HPV-16 (for example, HPV-18, -31, -33, or -35)
• People who had their surgery performed at an outside hospital or surgical centre, unless that centre is considered high-volume and an exception is approved by the trial's principal investigators
• People who have previously had radiation therapy to the head or neck area
• People who did not have an HPV DNA blood test before surgery, or whose pre-surgery HPV DNA level was 50 copies per millilitre or below
• People with another active primary cancer outside the oropharynx, unless an exception is approved by the principal investigators
• People with a history of another invasive cancer (other than certain non-melanoma skin cancers), unless they have been cancer-free for at least 3 years, or unless their previous cancer has a 5-year cure rate of 90% or higher — exceptions may be considered by the principal investigators
• People who have previously received chemotherapy specifically for the cancer being studied in this trial (prior chemotherapy for a different cancer is permitted)
• People with serious active health conditions, including: unstable chest pain or heart failure requiring hospitalisation in the past 6 months, a full-thickness heart attack in the past 6 months, an active bacterial or fungal infection requiring intravenous antibiotics at the time of joining, a lung disease flare-up or other breathing illness requiring hospitalisation within the past 30 days, or significant liver failure causing jaundice or blood clotting problems
• People who are unable or unwilling to sign an informed consent form or complete study questionnaires

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