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 sign a written consent form agreeing to take part in the trial
• People who are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with a non-bulky squamous cell carcinoma (a type of cancer) of the head and neck that doctors have determined can be removed with surgery, generally at certain stages of disease (confirm specific staging eligibility with trial site)
• People whose cancer has been reviewed by a medical team and is considered appropriate for surgical removal with the goal of curing the disease
• People who are in good enough general health to carry out normal daily activities with little or no limitation, as measured by a standard medical scale (ECOG score of 0 or 1)
• People who agree to have a tissue sample (biopsy) taken from their tumour before and during treatment
• People whose liver, kidneys, and other organs are functioning well enough as shown by blood tests
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study medication
• Women who could become pregnant must agree to use two reliable forms of contraception, or to abstain from heterosexual activity, during the study and for 120 days after the last dose of study medication
• Men must agree to use a reliable method of contraception from the first dose of study medication until 120 days after the last dose (abstinence is considered acceptable)

Who may not be able to join:

• Women who could become pregnant and have a positive pregnancy test within 72 hours before starting treatment
• People who have previously been treated with certain types of immunotherapy drugs that target specific immune system pathways (such as anti-PD-1, anti-PD-L1, or anti-PD-L2 treatments)
• People who have previously received systemic (whole-body) cancer treatment for head and neck squamous cell carcinoma, including experimental treatments, within the past 4 weeks
• People who have received radiation therapy within the past 2 weeks before starting the study (a shorter 1-week gap may apply in certain limited circumstances — confirm with trial site)
• People who have received a live or live-attenuated vaccine (including live COVID-19 vaccines) within 30 days before the first dose (non-live vaccines, including mRNA vaccines such as some COVID-19 vaccines, are allowed)
• People who are currently taking part in another clinical trial or have used an experimental medical device within the past 4 weeks
• People who have an immune system disorder, or who are taking steroid medications at doses above a certain level, or any other medicines that suppress the immune system, within 7 days before the first dose
• People who have another cancer that is currently active or has required treatment within the past 2 years (some low-risk skin cancers and slow-growing cancers not expected to affect life expectancy within 3 years may be exceptions — confirm with trial site)
• People who have active cancer spread to the brain or the lining of the brain (those with previously treated and stable brain metastases may be considered — confirm with trial site)
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients
• People who have an autoimmune disease (where the immune system attacks the body) that has required systemic medical treatment within the past 2 years (hormone replacement therapies such as thyroid or insulin are not considered systemic treatment and are generally allowed)
• People who have a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition
• People who have an active infection that requires treatment through the bloodstream (systemic therapy)
• People who have a known history of HIV infection
• People who have a known history of Hepatitis B or Hepatitis C
• People who have any medical condition, ongoing treatment, or abnormal test result that, in the treating doctor's opinion, could interfere with the study or would not be in the person's best interest
• People who have a psychiatric illness or substance use disorder that the treating doctor believes would prevent them from following the trial requirements (stable, well-managed conditions may be acceptable — confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 120 days after the last dose
• People who have previously received an organ or tissue transplant from another person
• People who have congestive heart failure, unstable chest pain (angina), a serious uncontrolled irregular heartbeat, a heart attack within the past 6 months, or a history of heart muscle inflammation (myocarditis)

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