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 HPV-positive squamous cell cancer of the throat/mouth area (specifically the oropharynx), confirmed by a laboratory test.
• People whose cancer has been confirmed as specifically caused by the HPV16 strain of the virus (other HPV types are not eligible).
• People whose HPV status has been confirmed through specific laboratory testing methods, including a protein marker test (p16) and at least one additional HPV genetic test.
• People who have enough stored tissue samples from their biopsy available for testing (at least 8 tissue slides); if not enough tissue is available, a new biopsy may be required before joining.
• People aged 18 or older.
• People whose cancer is at a specific stage — not too early and not too advanced — with tumours that are not excessively large (confirm with trial site for exact staging details).
• People whose cancer can be measured on scans according to standard medical measurement guidelines.
• People who have not previously received radiation therapy or chemotherapy for a head and neck cancer.
• People who have not had complete surgical removal of their head and neck cancer within the 8 weeks before joining (minor surgical biopsies with remaining detectable cancer are acceptable).
• People who are reasonably well and able to carry out daily activities (a standard medical fitness scale score of 0–1 is required).
• People whose blood test results show that their organs — including liver, kidneys, and bone marrow — are functioning within acceptable ranges.
• People who are willing and able to read and sign a consent form agreeing to take part in the study.
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting treatment.
• Women who could become pregnant must agree to use contraception during treatment and for up to 5 months after treatment ends.
• Men who are sexually active with women who could become pregnant must agree to use contraception during treatment and for up to 7 months after treatment ends.

Who may not be able to join:

• People whose cancer has spread to distant parts of the body (metastatic disease).
• People where the original site of the cancer cannot be identified through scans, physical examination, or biopsy.
• People with other serious ongoing medical conditions that could interfere with tolerating treatment, including active infections, heart problems, breathing problems, immune system disorders, or significant mental health conditions that would make it difficult to follow the treatment programme (although people who become clinically stable may become eligible — confirm with trial site).
• Women who are pregnant or breastfeeding.
• People who have had significant prior surgery to the affected area, beyond a simple biopsy or a procedure to clear a blocked airway — and where no measurable cancer remains.
• People currently taking part in another clinical trial involving an experimental treatment.
• People who have significant nerve damage in their hands or feet (peripheral neuropathy above a mild level).
• People who have a diagnosed immune system deficiency, or who have been taking high-dose steroid medications or other immune-suppressing drugs within 7 days before starting treatment.
• People with a known history of active tuberculosis (TB).
• People who have had a serious allergic reaction to cemiplimab or any other drug used in this trial.
• People who have received any cancer treatment in the 8 weeks before joining the trial.
• People with another active cancer that is growing or currently being treated (some exceptions apply, such as certain skin cancers or slow-growing cancers not expected to affect life expectancy within 3 years — confirm with trial site).
• People with an active autoimmune disease that has required treatment with steroids or immune-suppressing medications in the past year (note: routine hormone replacement therapies such as thyroid medication or insulin are not considered disqualifying).
• People with a known history of, or current evidence of, non-infectious lung inflammation (pneumonitis).
• People with a known diagnosis of HIV.
• People with active Hepatitis B or Hepatitis C infection (people whose Hepatitis C has been fully cleared may still be eligible — confirm with trial site).
• People who have received a live vaccine within 28 days before starting treatment (standard injected flu vaccines are generally acceptable, but nasal spray flu vaccines are not).

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