Phase 3 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 have signed a consent form before any study procedures begin
• People aged 18 years or older at the time of signing the consent form
• People with a laboratory-confirmed diagnosis of head and neck squamous cell cancer (a specific type of head and neck cancer) that has spread to other parts of the body or come back locally and cannot be treated with the goal of a cure
• The cancer must have started in one of these areas: the oropharynx (back of the throat), oral cavity (mouth), hypopharynx (lower throat), or larynx (voice box)
• People whose tumor tests positive for a protein called PD-L1 at a level of CPS ≥1, making them candidates for a first-line treatment with a medicine called pembrolizumab as a single therapy (confirm with trial site)
• People who have not previously received systemic (whole-body) treatment for their cancer in the setting where it cannot be cured
• People who can provide either a new tumor tissue sample or an existing archived tissue sample with enough material for testing
• People whose cancer can be measured on scans using a standard measurement method called RECIST v1.1
• People with a general health and activity level rated as 0 or 1 on a standard scale (meaning fully active or able to carry out light activities)
• People whose life expectancy is estimated at 12 weeks or more by a doctor
• People whose heart pumping function (left ventricular ejection fraction) is 50% or above, confirmed by a heart scan
• People with adequate organ function as defined by the study protocol (confirm with trial site)
• People who are HIV-positive may be eligible if their CD4+ immune cell count is 300 or above per microlitre, their viral load is undetectable, and they are currently on effective HIV treatment

Who may not be able to join:

• People with cancer that has spread to the brain and is untreated, causing symptoms, or requiring radiation, surgery, or ongoing steroid medication within 21 days before joining the trial
• People with cancer that has spread to the lining around the brain and spinal cord
• People who have received any cancer treatment or experimental drug within 4 weeks (or within a shorter timeframe depending on the specific drug) before joining the trial
• People who need to take medications that suppress the immune system
• People who have had major surgery or radiotherapy within 3 weeks before joining the trial
• People who still have significant side effects from previous cancer treatments that have not improved to a mild or baseline level (with some exceptions for certain side effects such as mild muscle pain, nerve-related issues, hair loss, or hormone-related conditions from prior treatment)
• People who have previously had a serious allergic reaction to any ingredient in the study drugs petosemtamab or pembrolizumab
• People with unstable chest pain (angina), moderate-to-severe heart failure, serious heart rhythm problems requiring treatment, or a heart attack within the past 6 months
• People who have had another cancer in the last 5 years, except for a localised cancer that was fully removed
• People who currently have breathlessness at rest for any reason, or who need continuous oxygen therapy
• People with serious ongoing illnesses, including uncontrolled active infection, or significant lung, metabolic, or psychiatric conditions
• People with certain known infectious diseases as specified in the study protocol (confirm with trial site)
• People who are pregnant or breastfeeding
• People with a diagnosed immune deficiency condition, or who are taking steroid medications at a dose higher than 10 mg per day of prednisone or equivalent, or any other immune-suppressing therapy
• People who have an active autoimmune disease that required immune-suppressing treatment in the past 2 years (hormone replacement-type therapies are not considered immune-suppressing in this context)
• People who have received an organ or tissue transplant from another person
• People whose cancer started in the nasopharynx (upper throat behind the nose) or the nasal/sinus area

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