Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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 between 18 and 79 years of age
• People who have head and neck squamous cell cancer (in the mouth, throat, voice box, or lower throat area) that has come back or is a new primary cancer in an area that was previously treated with radiation
• People who have had surgery to remove the visible tumour and are enrolled within 8 weeks of that surgery
• People whose cancer is considered high risk, meaning the surgeon found cancer cells at or very close to the edge of the removed tissue (positive margins), and/or cancer that has spread outside the lymph nodes (extranodal extension)
• People whose tumour tested positive for a protein marker called PD-L1, with a Combined Positive Score of 1 or higher, tested in a certified laboratory on tissue from their most recent surgery
• People who previously received radiation to the area where the cancer returned, where more than half of the tumour had received a substantial radiation dose, and that radiation was completed at least 6 months before joining the trial
• People who show no signs of cancer that has spread to distant parts of the body, based on scans done within 28 days before joining
• People who are generally well enough to carry out normal daily activities with no or minimal limitations (confirm with trial site regarding the specific fitness scale used)
• People who are willing and able to sign a consent form agreeing to take part; people who cannot make this decision themselves may still be considered if a legally authorised representative or caregiver is available
• People who are not pregnant or breastfeeding, and who have had a pregnancy test within 14 days before joining (and again within 72 hours before receiving the first dose of study treatment if the earlier test falls outside that window)
• People who agree to use reliable contraception or abstain from sex during the study treatment and for 120 days after the last dose
• People whose recent blood tests (taken within 28 days before joining) show:
  • Adequate white blood cell levels (specifically neutrophils)
  • Adequate platelet counts
  • Liver function within acceptable ranges
  • Kidney function above a minimum threshold
• People living with HIV who are on effective treatment and have had an undetectable level of the virus within the past 6 months, provided they have no history of certain HIV-related conditions (Kaposi sarcoma or multicentric Castleman disease)

Who may not be able to join:

• People who have previously received certain immunotherapy drugs (called anti-PD-1 or PD-L1 treatments) for their recurrent cancer; people who received these drugs as part of their original treatment may still be considered if the last dose was given more than one year before joining
• People who have a current active infection that requires treatment with medications at the time of joining
• People who have had a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment within the past 3 years
• People who have previously had a solid organ transplant or stem cell transplant
• People who are currently taking immune-suppressing medications, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm specific exceptions with trial site)
• People with moderate to severe heart failure (classified as New York Heart Association class III or IV)
• People who have received a live vaccine within 30 days before starting the study drug (examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, and some flu nasal sprays; standard injected flu vaccines are generally allowed)
• People who have had a severe allergic reaction (grade 3 or higher) to the study drug pembrolizumab or any of its ingredients
• People who have an active autoimmune disease that has required systemic treatment (such as immune-modifying or steroid medications) within the past 2 years; hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not considered systemic treatment and are generally permitted
• People with a known psychiatric condition or substance use disorder that could affect their ability to participate in the study
• People with a known active hepatitis B or hepatitis C infection

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