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 are willing and able to give informed consent to take part in the trial and its procedures
• People who have been confirmed through a tissue sample (biopsy) to have head and neck squamous cell cancer (a specific type of head and neck cancer)
• People whose head and neck cancer is at an advanced stage that cannot be cured with surgery or radiation, or has spread to other parts of the body (Stage IV)
• People with throat cancer (oropharyngeal cancer) whose cancer has been tested for HPV status using standard lab methods
• People whose cancer tests positive for a protein called PD-L1, measured using a specific scoring method
• People who have a tumour that the doctor considers safe to biopsy
• People who have not previously received systemic (whole-body) treatment for their recurrent or metastatic head and neck cancer
• People whose treating doctor considers them eligible to receive the drug pembrolizumab as standard treatment
• People who are reasonably physically functional, as measured by a standard medical scale (ECOG score of 2 or below) (confirm with trial site)
• People who have measurable cancer on scans, as defined by standard medical criteria (RECIST 1.1)
• People aged 18 or older, of any gender
• People whose kidneys are working at an adequate level, based on blood test results
• People whose liver is working at an adequate level, based on blood test results
• People whose bone marrow is producing enough blood cells, based on blood test results
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study drug
• Women who could become pregnant must agree to use an appropriate form of contraception during the study and for 120 days after the last dose of study medication
• Men who could father a child must agree to use an appropriate form of contraception from the first dose until 120 days after the last dose of study medication
• People who are willing to provide blood, cheek swab, stool, and tissue samples for research purposes (where the doctor considers it safe to do so)

Who may not be able to join:

• People who have cancer that has spread to the brain and has not yet been treated, or where treated brain metastases have not been stable for at least 4 weeks, or where symptoms or steroid use related to brain metastases are still present; people with cancer spread to the lining of the brain are also excluded even if treated
• People who have previously been treated with certain immune checkpoint or T-cell targeting drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 therapies
• People with an active or recent autoimmune disease or condition that has required high-dose steroids or immune-suppressing medications (some exceptions apply, such as vitiligo, type 1 diabetes, or an underactive thyroid managed with hormone replacement alone)
• People with active or prior lung inflammation (a condition called ILD or pneumonitis) that required treatment with steroids
• People who are currently using or plan to use probiotics, yogurt, or bacteria-enriched foods during the treatment period
• People who have needed steroid tablets or immune-suppressing medications (above a certain dose) within the 14 days before starting the study drug
• People with uncontrolled adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones)
• People with a known medical condition that the doctor believes would make study participation unsafe or affect the ability to assess safety results
• People who have not yet recovered from side effects of previous treatments (recovery to a mild level or better is required before joining)
• People who are pregnant or breastfeeding
• People with a history of heart muscle inflammation, advanced heart failure, unstable chest pain, serious uncontrolled heart rhythm problems, uncontrolled infection, or a heart attack within the 6 months before joining the study
• People whose blood test results fall outside the required ranges for white blood cells, neutrophils (infection-fighting cells), platelets, liver enzymes, bilirubin, or kidney function
• People with a known history of HIV
• People with known active Hepatitis B or Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People who have previously received an organ transplant
• People who have previously received a bone marrow transplant
• People who have received a live vaccine within 30 days before the planned start of study treatment (some inactivated flu vaccines are permitted, but live nasal spray flu vaccines are not)

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