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 between 18 and 75 years old
• People who have been confirmed by tissue or cell testing to have squamous cell carcinoma of the head and neck, including cancers of the mouth, throat (oropharynx or hypopharynx), or voice box (larynx)
• People who have at least one tumour that can be measured on a scan, according to standard measurement rules (RECIST 1.1)
• People whose cancer is at clinical stage III–IVb (if P16-negative) or stage II–III (if P16-positive) (confirm with trial site if unsure which applies)
• People who have tumour tissue available that can be tested for gene expression
• People with a good general activity level, rated 0 or 1 on a standard scale called the ECOG score, meaning they are fully active or have only minor limitations in physical activity
• People who have not previously received radiotherapy, chemotherapy, or any other anti-cancer treatment
• People whose blood test results meet specific thresholds for white blood cell count, red blood cell levels, and platelet count
• People whose liver and kidney function blood tests fall within acceptable ranges, including normal levels of bilirubin, liver enzymes (AST and ALT), kidney filtration rate, and blood clotting measures
• People of childbearing potential who agree to use appropriate contraception before and during the trial
• People who have signed an informed consent form agreeing to take part
• People who are able to follow the study plan and attend required follow-up visits

Who may not be able to join:

• People who have received any anti-cancer treatment in the past 6 months, including radiotherapy, chemotherapy, surgery, or immunotherapy
• People who currently have, or have previously had, another cancer — except for certain cancers that were fully treated more than 5 years ago with no recurrence, such as some skin cancers, early-stage cervical cancer, superficial bladder cancer, or papillary thyroid cancer
• People whose cancer has spread to distant parts of the body (metastasis)
• People with active autoimmune diseases or a history of autoimmune conditions such as lung inflammation, colitis, hepatitis, or thyroid problems — though people with well-controlled hypothyroidism on a stable thyroid hormone dose, type 1 diabetes on stable insulin, vitiligo, or childhood asthma or allergies that no longer require treatment may still be considered eligible (confirm with trial site)
• People with a known history of a primary immune system deficiency, a positive HIV test, other immune deficiency conditions, or a history of organ or bone marrow transplant
• People who have had a serious infection within the 4 weeks before starting the study drug, or who show signs of active lung inflammation or an active infection requiring antibiotic treatment at the time of enrolment
• People with severe liver or kidney disease, uncontrolled heart conditions (such as moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or significant heart rhythm problems), uncontrolled diabetes, or uncontrolled high blood pressure
• People with untreated chronic hepatitis B, or hepatitis B with viral levels above a certain threshold, or active hepatitis C infection — though people with stable, treated hepatitis B or fully cleared hepatitis C may be considered eligible (confirm with trial site)
• People with a history of interstitial lung disease or non-infectious lung inflammation
• People with active tuberculosis, or a history of active tuberculosis within the past year, or a history of tuberculosis more than one year ago that was not properly treated
• People who have needed regular steroid medications (above a low daily dose) or other immune-suppressing medicines in the 2 weeks before starting the study drug, or who have received a tumour vaccine, a live vaccine within 4 weeks before starting the study drug, major surgery or serious trauma within 4 weeks before starting the study drug, or who are already enrolled in another clinical trial
• Women who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 7 days before joining
• People with substance use issues, or psychological or social factors that would make it difficult to give informed consent or take part in the study
• People who may be allergic to the study drug
• People who are unable to attend radiotherapy and chemotherapy due to geographic or social reasons
• People who have lost 10% or more of their body weight in the 6 weeks before enrolment
• People with any other uncertain factor that the study team considers may affect their safety or ability to participate
• People for whom steroid (hormone) use is medically contraindicated

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