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:

• Adults aged 18 to 85 years old
• People with a laboratory-confirmed diagnosis of squamous cell carcinoma (a type of cancer) in the head and neck area, specifically at stage III or IVA, with no spread to distant parts of the body, and located in the oropharynx (HPV-negative only), mouth, hypopharynx, or larynx (voice box)
• People whose cancer has at least one measurable tumour, as assessed using standard imaging guidelines
• People who have not yet received any treatment for this cancer (other than a biopsy to diagnose it)
• People who are in generally good physical condition, able to carry out daily activities with little or no limitation (confirm with trial site)
• People whose doctors consider them suitable for standard surgery followed by standard chemotherapy and/or radiation therapy
• People without an active autoimmune disease (a condition where the immune system attacks the body)
• People who do not currently have another cancer at the same time
• People whose life expectancy is estimated to be more than 3 months
• People who have enough tumour tissue available for a specific protein test called PD-L1 testing
• People with blood counts within acceptable ranges, with no blood transfusions or signs of bleeding in the 7 days before joining (confirm with trial site for specific values)
• People with liver function test results within acceptable ranges (confirm with trial site for specific values)
• People with kidney function within acceptable limits (confirm with trial site for specific values)
• People whose HPV status has been tested and confirmed through an approved laboratory method
• People who are able to understand the study and who, along with their legal representative if applicable, have voluntarily agreed to take part and signed a consent form

Who may not be able to join:

• People with failure of multiple organs
• People with HPV-positive oropharyngeal cancer (a type of throat cancer linked to HPV)
• People with a more advanced stage of head and neck cancer classified as T4B and/or N3 (confirm with trial site)
• People whose cancer has spread to distant parts of the body
• People with serious uncontrolled medical conditions such as severe heart disease, stroke-related conditions, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infections, or active stomach ulcers
• People with dementia, significant changes in mental state, or a mental health condition that would prevent them from understanding the study, giving consent, or completing questionnaires
• People with moderate or severe nerve damage causing symptoms such as numbness or pain (Grade 2 or higher peripheral neuropathy)
• People with moderate or severe hearing loss (Grade 2 or higher hearing impairment)
• People with a known allergy or sensitivity to any of the study medications
• People diagnosed with another cancer within the past 5 years, unless that cancer was fully treated with no signs of return — some exceptions may apply for certain early-stage cancers that were completely treated (confirm with trial site)
• People with a known history of HIV or AIDS
• People diagnosed with nasopharyngeal carcinoma, or with squamous cell carcinoma located in areas such as the sinuses or at an unknown primary site
• People who have taken part in another clinical trial or received an experimental treatment within 30 days before screening
• People who have taken high-dose steroid medications or other immune-suppressing drugs within 14 days before joining (some exceptions may apply — confirm with trial site)
• People who are pregnant or breastfeeding, or people of childbearing age who are not willing to use contraception during the study
• People considered unsuitable for the study by the treating doctor
• People who have taken antibiotics in the week before starting the study, or who have an active infection requiring treatment
• People with a known history of hepatitis B or active hepatitis C infection
• People who have received a live vaccine within 30 days before starting the study, or during the study

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