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 aged 18 or older, of any gender
• People who have been diagnosed with squamous cell carcinoma of the head and neck (a specific type of cancer affecting the mouth, throat, voice box, or lower throat area), confirmed by a tissue biopsy
• People whose cancer has come back or spread, and where surgery or radiotherapy is no longer considered a suitable option by the treating doctor
• People who have at least one tumour that can be measured using standard imaging methods
• People whose tumour tests positive for a protein called PD-L1, with a combined positive score (CPS) of 1 or higher
• People who are relatively well and able to carry out daily activities, as measured by a standard medical scale (ECOG performance score of 0 or 1)
• People who are expected to live for at least 3 more months
• People whose blood, liver, kidney, and heart function results fall within the ranges required by the trial (the trial site will check these through blood tests and a heart scan)
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining, must not be breastfeeding, and must agree to use reliable contraception throughout the trial; men must agree to use reliable contraception from the start of treatment until 6 months after the last dose
• People who are willing to take part voluntarily, sign a consent form, follow the trial requirements, and attend follow-up appointments

Who may not be able to join:

• People who have previously received systemic chemotherapy for their recurrent or metastatic disease (note: chemotherapy given as part of earlier treatment for locally advanced disease — such as alongside radiotherapy — does not count as an exclusion)
• People who have previously received immunotherapy treatments targeting certain immune system pathways, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 drugs, or similar treatments
• People who have previously been treated with anti-EGFR drugs, such as cetuximab, nimotuzumab, gefitinib, or afatinib
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period
• People who are currently taking part in another clinical trial or who have received an experimental treatment within 4 weeks before joining this trial
• People with active or uncontrolled cancer that has spread to the brain or spinal cord, or who have related conditions such as brain swelling or cancer affecting the membranes around the brain
• People with an active autoimmune disease (where the immune system attacks the body) or a significant history of such conditions — some exceptions apply, including vitiligo, psoriasis, hair loss conditions, well-managed type 1 diabetes, and an underactive thyroid managed with medication (confirm with trial site)
• People who have taken immune-suppressing medications in the 2 weeks before starting the trial, or who are likely to need them during the trial — some exceptions apply, such as low-dose or inhaled steroids (confirm with trial site)
• People with significant heart problems, including moderate to severe heart failure, unstable chest pain, a heart attack within the past year, a heart rhythm disorder requiring treatment, or an abnormal heart electrical reading above certain levels
• People who have an active infection currently being treated with antibiotics, antifungal, or antiviral medications, including tuberculosis, or who have an unexplained fever above 38.5°C at the time of screening or before the first dose
• People with lung conditions such as pulmonary fibrosis or other non-infectious lung disease, or with uncontrolled conditions including high blood sugar levels, high blood pressure, or kidney disease showing significant protein in the urine — with an exception for certain lung inflammation caused by radiotherapy
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires repeated draining
• People who have had another type of cancer within the past 5 years — some exceptions apply, including certain fully treated skin cancers, cervical pre-cancer, localised prostate cancer, or other cancers that were completely removed (confirm with trial site)
• People who test positive for active hepatitis B or active hepatitis C infections, based on specific virus levels in the blood
• People who have received a live virus vaccine within 4 weeks before joining, or who may need one during the study — standard flu vaccines without live virus are permitted
• People with other serious health conditions that the treating doctor believes would put them at risk or prevent them from completing the trial

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