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 aged 18 or older who have given written consent to participate.
• People with a laboratory-confirmed diagnosis of locally advanced, diffuse, or returning skin cancer (squamous cell carcinoma) in or around the eye socket area.
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during treatment and for at least 120 days after the last dose.
• People whose cancer can be measured using standard imaging criteria (confirm with trial site).
• People who are generally able to carry out daily activities with little or no restriction (a health performance score of 0 or 1 on a standard medical scale).
• People whose blood test results meet specific levels for white blood cells, platelets, and red blood cells — without having needed a recent blood transfusion or red blood cell stimulating medication.
• People whose kidney function test results fall within acceptable ranges for this trial.
• People whose liver function test results fall within acceptable ranges for this trial.
• People whose blood clotting test results fall within acceptable ranges, or who are on blood-thinning medication with results within the intended treatment range.
• People who have fully recovered from any major surgery before the trial begins.
• People with a life expectancy of at least 12 weeks.
• People living with HIV whose condition is well managed with antiviral medication.
• People with hepatitis B who are on appropriate suppressive treatment, or people with a history of hepatitis C who have completed curative treatment with undetectable virus levels.

Who may not be able to join:

• People whose primary skin cancer diagnosis is any type other than invasive squamous cell carcinoma.
• Women of childbearing potential who return a positive pregnancy test within 72 hours before enrolling.
• People who have previously been treated with certain immune checkpoint therapies, including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or similar treatments targeting immune system receptors (confirm with trial site).
• People who have received systemic cancer treatment or taken part in another experimental drug trial within the past 4 weeks, or who have not yet recovered from side effects of prior treatment (with some exceptions for mild nerve-related side effects).
• People who have received radiation therapy within the past 2 weeks, or who have not yet recovered from radiation-related side effects (a 1-week gap may be acceptable for certain limited palliative radiation — confirm with trial site).
• People who have received a live vaccine within the past 30 days (this includes vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid; nasal flu vaccines also count, but standard injected flu vaccines are generally allowed).
• People currently taking part in, or who have taken part in, another investigational study or used an experimental medical device within the past 4 weeks.
• People who have a condition that weakens the immune system, or who are taking steroid medication above a certain dose, or other immune-suppressing drugs within the past 7 days.
• People with a history of another cancer, unless treatment was completed with no signs of cancer for at least 2 years (some exceptions apply for certain fully removed or in-situ cancers — confirm with trial site).
• People with active cancer that has spread to the brain or the lining of the brain, unless previously treated brain metastases have been stable for at least 4 weeks and no steroids have been needed for at least 14 days.
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.
• People with an active autoimmune disease that has required systemic medical treatment in the past 2 years (hormone replacement therapies for certain conditions are generally not considered systemic treatment — confirm with trial site).
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with an active infection that requires systemic treatment.
• People with a known history of active tuberculosis.
• People with a medical condition, ongoing therapy, or abnormal test result that the treating doctor believes would interfere with the trial or would not be in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period and for 120 days after the last dose.
• People who have previously received an organ transplant or a stem cell transplant from another person.
• People with certain heart or cardiovascular conditions, including: a heart attack within the past 6 months, unstable chest pain (angina), heart failure of a certain severity, a stroke within the past 6 months, or a serious irregular heartbeat requiring medication.

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