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 are 18 years of age or older at the time of signing the consent form
• People who have a laboratory-confirmed diagnosis of squamous cell carcinoma of the head and neck, specifically affecting the mouth, throat (oropharynx), hypopharynx, voice box (larynx), or an unknown primary site in the neck area
• People whose cancer has spread to a limited number of other sites in the body (between 1 and 5 metastatic lesions), confirmed by tissue sample or imaging, either at the same time as the original diagnosis or at a later stage
• People whose cancer is being considered for first-line systemic (whole-body) treatment for recurrent or metastatic head and neck cancer
• People with cancer of the oropharynx (throat) who have had their HPV status tested using a specific laboratory method called p16 IHC
• People whose cancer cells show a PD-L1 CPS score of at least 1, as measured by a local laboratory
• People whose cancer staging was completed within the 12 weeks before enrolling in the trial
• People whose 1 to 5 metastatic lesions are all suitable for a specialised type of targeted radiation therapy called SABR
• People whose treating doctor considers them eligible for treatment with pembrolizumab (a type of immunotherapy)
• People whose cancer can be measured using standard imaging criteria (called RECIST 1.1)
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only mild limitations in physical activity
• People who have recovered from side effects of any previous cancer treatment (such as radiation, surgery, or systemic therapy) to near-baseline levels, and who are not currently needing steroid medications to manage those side effects
• People with adequate organ function as shown by blood test results meeting specific laboratory values
• People who have given written informed consent before enrolling in the trial

Who may not be able to join:

• People whose cancer originates in the nasopharynx, the sino-nasal area, or the salivary glands
• People whose cancer progressed within the radiation field less than 6 months after receiving curative radiation treatment to the head and neck area
• People who have any individual tumour lesion (outside the brain) measuring larger than 6 cm in its widest dimension on a CT or MRI scan — though bone metastases over 6 cm may be considered on a case-by-case basis if a radiation specialist determines they can be treated safely and no internal organs are involved
• People who have cancer that has spread only to the brain, with no other metastatic sites
• People who have previously received radiation treatment to any of the 1 to 5 metastatic lesions that would otherwise be targeted with SABR in this trial, unless the investigator discusses and agrees to proceed with the trial's radiation quality assurance team
• People who are currently taking part in, or have taken part in, another clinical trial involving an investigational drug or device within the 4 weeks before the first dose of trial treatment
• People who have previously treated brain metastases that are not showing stable appearances on repeat imaging — however, people with previously treated brain metastases that have been stable on imaging for at least 4 weeks, are clinically stable, and have not needed steroid treatment for at least 14 days before starting trial treatment may still be considered
• People who have a known contraindication to imaging contrast agents or tracers, or who cannot undergo MRI scans

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