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 who have been diagnosed with stage III or IVA head and neck squamous cell cancer (a specific type of head and neck cancer confirmed by lab testing), where the plan is to treat it with the aim of curing it, including surgery.
• People aged 18 to 79 years old at the time of joining the study.
• People who are fully active or have minor restrictions in physical activity but are able to carry out light work (confirmed by a doctor's assessment scale called ECOG 0 or 1).
• People whose cancer can be measured on scans according to a standard set of rules called RECIST 1.1.
• People who have never previously received a type of cancer treatment that works through the immune system (such as certain checkpoint inhibitor drugs), not counting cancer vaccines.
• People whose recent blood tests (taken within 14 days before joining) show that their liver, kidneys, and bone marrow are working well enough to meet the study's required levels (confirm with trial site for specific numbers).
• Women who could become pregnant must have a negative pregnancy test within 21 days of joining the study.
• Women who could become pregnant must use highly effective contraception for 23 weeks after the last dose of study treatment.
• Men who could father a child and are sexually active with women who could become pregnant must use contraception with a very low failure rate, and must continue using it for 31 weeks after the last dose of study treatment (men who produce no sperm are exempt from this requirement).
• People who are able to understand and willing to sign a consent form agreeing to take part.
• People who are willing and able to follow the study schedule, including attending all required visits, treatments, and follow-up appointments.
• People who agree to allow their tissue samples — both from before treatment and from surgery — to be used for research purposes.

Who may not be able to join:

• People who are currently taking part in another clinical trial of an experimental treatment, or who have done so within the past 4 weeks, or who have not yet fully recovered from side effects of a previous experimental treatment.
• People who have had another type of invasive cancer within the past 5 years, or who have had surgery, chemotherapy, targeted therapy, or radiation therapy for any cancer within the past 5 years.
• People who have had major surgery for any reason and have not yet fully recovered from the complications or side effects of that surgery.
• People who are currently taking high-dose steroid medications (above the equivalent of 10 mg of prednisone per day) or other medications that suppress the immune system, and have been doing so within the 14 days before the study start date (low-dose inhaled or skin-applied steroids may be acceptable — confirm with trial site).
• People who have an active autoimmune disease that has required steroid treatment in the past 3 months, or who have a documented history of a severe autoimmune condition, or a condition that requires ongoing steroid treatment.
• People who have an active or known autoimmune disease, except for certain mild conditions such as vitiligo, type 1 diabetes, an underactive thyroid managed only with hormone replacement, psoriasis not needing systemic treatment, or other conditions not expected to return without an external trigger.
• People who have a lung condition called interstitial lung disease, or an active non-infectious inflammation of the lungs (pneumonitis).
• People who have an active infection that requires treatment through the bloodstream or by mouth.
• People who have previously been treated with immune checkpoint drugs targeting PD-1, PD-L1, PD-L2, or CTLA-4, or any other drug specifically designed to target immune checkpoint or T-cell signalling pathways.
• People who have had an allergic reaction to medications that are chemically or biologically similar to those used in this trial.
• People who have any health condition, previous treatment, or abnormal test result that a doctor believes could interfere with the trial results or make participation unsafe or unsuitable for that person.
• People who have known mental health conditions or substance use disorders that would make it difficult to follow the requirements of the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 23 weeks after the last dose of treatment.
• People who have a known history of HIV infection.
• People who have active Hepatitis B or Hepatitis C infection.
• People who have a known history of active tuberculosis (TB).

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