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 who are able to sign a consent form
• People with a confirmed diagnosis of head and neck squamous cell cancer (a specific type of cancer affecting areas such as the mouth, throat, voice box, or lower throat), based on laboratory analysis of tissue or cells
• People whose cancer has come back or spread to other parts of the body, and for whom curative surgery or radiation is no longer a suitable option
• People whose tumour has a PD-L1 CPS score of 1 to 19 (a laboratory measurement of a protein on cancer cells that helps predict response to certain treatments — confirm with trial site)
• People whose cancer can be measured on scans according to a standard set of measurement rules (RECIST 1.1)
• People who have not previously received systemic (whole-body) treatment for cancer that has returned or spread
• People who received systemic treatment more than 6 months ago as part of curative treatment for locally advanced disease (this is allowed)
• People with a good general health and activity level, rated 0 or 1 on a standard scale used by doctors (ECOG Performance Status)
• People with adequate bone marrow function, shown by blood test results meeting minimum levels for white blood cells, platelets, and haemoglobin
• People with adequate liver function, shown by blood test results within acceptable ranges for liver-related markers
• People with adequate kidney function, with a kidney filtration rate of at least 30 mL/min
• People who have tumour tissue available (either stored from a previous biopsy or from a fresh sample) that can be provided before starting treatment
• People who are able to provide blood samples at set timepoints during the trial
• People who have had palliative (symptom-managing) radiotherapy or surgery within the 4 weeks before joining, as this is permitted
• People with certain nerve-related side effects, hearing problems, or reduced kidney function (filtration rate below 60 mL/min) may still be eligible but would receive a modified drug (carboplatin instead of cisplatin) — confirm with trial site

Who may not be able to join:

• People whose cancer originated in the nasopharynx, salivary glands, nasal sinuses, or as a non-melanoma skin cancer
• People whose life expectancy is estimated by the trial doctor to be less than 3 months
• People who have already received chemotherapy, cetuximab (a biological therapy), or immunotherapy for cancer that has returned or spread
• People with an immune system condition, or who are taking steroid medication above a certain dose or other immune-suppressing medicines within 30 days before starting the trial, if this cannot be stopped
• People with a known allergy or severe reaction to any of the medicines used in this trial
• People with an active autoimmune disease (where the immune system attacks the body) that has required systemic treatment in the past 2 years
• People with an active autoimmune disease that could worsen with immune-stimulating treatment (note: people with type 1 diabetes, vitiligo, psoriasis, or thyroid conditions that do not require immune-suppressing treatment may still be eligible — confirm with trial site)
• People who have had another cancer diagnosed or treated within the past 5 years, with some exceptions including certain skin cancers, prostate cancer, cervical cancer in situ, and breast cancer in situ that were all treated with curative intent
• People with any other medical condition, treatment history, or abnormal test result that the treating doctor believes would interfere with safe participation in the trial
• People with significant neurological conditions, known psychiatric disorders, or substance use disorders that would affect their ability to participate
• People with serious heart or blood vessel conditions, including stroke or heart attack within the past 6 months, unstable chest pain, significant heart failure, or serious irregular heartbeat requiring medication
• People who have previously had an organ transplant, including a bone marrow or stem cell transplant
• People with an active infection requiring intravenous (IV) antibiotic treatment
• People with a known positive HIV test result or AIDS diagnosis
• People with active hepatitis B or hepatitis C infection, confirmed by specific blood tests
• People who have received a live vaccine within 30 days before the planned start of treatment (non-live/inactivated vaccines are allowed)
• People who are pregnant or breastfeeding; women who could become pregnant must use a highly effective method of contraception throughout the trial and for 30 days after the last dose

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