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 signed, dated written consent to participate
• People with a cancer of the back of the throat (oropharynx) that has come back or spread, where the tumor tests positive for a protein called p16 (linked to HPV) and also tests positive for a marker called PD-L1 (with a score of 1 or higher), and who have not yet received treatment for the returned or spread disease
• People whose cancer has not been treated before for its current returned or spread stage, and whose doctor has determined that standard treatment with the immunotherapy drug pembrolizumab is the planned next step
• People who have at least one tumor that can be tracked and measured using CT scan or MRI
• People with blood test results within acceptable ranges taken within 28 days before starting treatment, including: sufficient levels of white blood cells, immune cells (CD4 T cells), platelets, and red blood cells; healthy enough kidney and liver function; and acceptable levels of calcium and blood clotting markers
• People who are not breastfeeding and agree not to breastfeed during the study and for at least 120 days after their final dose
• Women who could become pregnant must have a negative pregnancy test within 28 days before starting treatment and agree to use acceptable contraception from signing consent until at least 180 days after their final dose
• Men who could father children and are sexually active with a partner who could become pregnant must agree to use acceptable contraception from signing consent until at least 120 days after their final dose
• People who agree not to donate blood or sperm during the study and for at least 120 days after their final dose

Who may not be able to join:

• People whose cancer could potentially be treated with the aim of a cure, unless they and their doctor have decided to pursue treatment aimed at managing rather than curing the disease
• People who have more than one separate primary cancer in the oropharynx (back of the throat)
• People whose cancer did not originally start in the oropharynx
• People who have already received any treatment specifically for their returned or spread disease (treatment given earlier with the aim of a cure is allowed)
• People who are currently pregnant or breastfeeding
• People who have previously received a therapeutic or preventive HPV vaccination involving a component other than the L1 protein — note that Gardasil, Gardasil 9, and Cervarix vaccines do not disqualify someone
• People who have received a live vaccine within 30 days before the first study treatment dose (examples include vaccines for measles, mumps, rubella, chickenpox, certain shingles vaccines, yellow fever, rabies, BCG, and oral typhoid; most flu injections are allowed, but nasal spray flu vaccines are not; approved COVID-19 vaccines from Pfizer-BioNTech, Moderna, Janssen, and AstraZeneca are allowed)
• People currently taking part in another clinical trial involving an experimental drug or device, or who have done so within the past 4 weeks (confirm with trial site)
• People who have a diagnosed immune system deficiency
• People who have another cancer that is not confined to one area, is getting worse, or has required active treatment within the past 3 years — note that certain early-stage or easily treated skin cancers and non-invasive cancers that have been successfully treated do not disqualify someone
• People who have cancer that has spread to the brain or the lining around the brain, even if there are no symptoms
• People who have previously received an organ or tissue transplant from another person
• People with a known severe allergic reaction to pembrolizumab or its ingredients
• People with a history of heart inflammation (myocarditis or pericarditis) or other significant heart conditions such as heart failure, uncontrolled irregular heartbeat, unstable chest pain, or a prior heart attack
• People with an uncontrolled ongoing illness, active infection, sepsis, or a mental health or personal situation that would make it difficult to follow the study requirements
• People who test positive during screening for HIV, Hepatitis B, or Hepatitis C
• People with an active autoimmune disease that weakens the immune system, such as rheumatoid arthritis, lupus, ulcerative colitis, Crohn's disease, multiple sclerosis, or ankylosing spondylitis
• People who have received immune-suppressing medications (such as steroids, cyclosporine, or certain other drugs) within the 60 days before starting treatment
• People with a known inherited or acquired condition that weakens the immune system, including conditions affecting immune cell function or antibody levels
• People, or their close household or sexual contacts, who have unhealed wounds or active skin conditions such as eczema, impetigo, shingles, cold sores, severe acne, severe nappy rash affecting large areas of skin, psoriasis, lichen planus, or a condition called Darier disease
• People with a history of or current atopic dermatitis (a type of chronic eczema)
• People, or their close household or sexual contacts, who have conditions linked to a weakened immune system, including HIV/AIDS, leukaemia, lymphoma, widespread cancer, organ transplant, or a bone marrow transplant less than 24 months ago — or 24 months or more ago but with ongoing complications
• People found at screening to have a serious irregular heartbeat, a resting heart rate below 50 beats per minute, or a resting heart rate above 100 beats per minute — note that people with controlled irregular heartbeats managed by a heart specialist may still be considered
• People with active or previous significant lung inflammation (interstitial lung disease or pneumonitis) that required treatment with steroid medication

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