Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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 a suspected squamous cell cancer of the head and neck that doctors believe can be surgically removed with the goal of curing or treating the disease.
• People who are willing and able to sign a written consent form agreeing to take part in the trial.
• People who are 18 years of age or older at the time of signing the consent form.
• People who either have a tissue sample (biopsy) taken within the past 90 days that is available for research, or who are willing to have a new biopsy taken during the screening period (needle biopsies must be a certain minimum size — confirm with trial site).
• People whose general health and ability to carry out daily activities is rated as good on a standard medical scale (ECOG score of 0 or 1, meaning fully active or restricted in physically strenuous activity but able to carry out light work).
• People whose blood tests, taken within 14 days before treatment starts, show that the blood, kidneys, and liver are working well enough to meet specific levels set by the trial (confirm exact values with trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose of study treatment.
• Women who could become pregnant must agree to use reliable contraception throughout the trial and for 5 months after the last dose of study treatment.
• Men must agree to use reliable contraception and not donate sperm from the first dose of study treatment through 5 months after the last dose.

Who may not be able to join:

• People who are currently taking part in another clinical trial or who have received an experimental treatment or used an experimental device within the past 4 weeks.
• People who have been diagnosed with an immune system deficiency, or who have been taking steroid medications or other immune-suppressing treatments within 7 days before the first dose (some exceptions may apply for low-dose or short-term use — confirm with trial site).
• People with a known history of active tuberculosis (TB).
• People with a current active or reactivated Epstein-Barr virus (EBV) infection.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have received a cancer-fighting antibody treatment within 4 weeks before the trial starts, or who have not yet recovered from side effects of such a treatment.
• People who have had targeted drug therapy or radiation therapy within 2 weeks before the trial starts, or who have not yet recovered from side effects of those treatments.
• People who have another cancer that is currently active or requires ongoing treatment (some exceptions apply for certain low-risk or resolved cancers — confirm with trial site).
• People who have an autoimmune disease that has needed systemic medical treatment within the past 2 years (hormone or other straightforward replacement therapies are not included in this).
• People with a known history of, or currently active, lung inflammation (pneumonitis) that has required steroid treatment.
• People with a known history of moderate or severe chronic obstructive pulmonary disease (COPD, stage 2 or higher).
• People with asthma that requires systemic (oral or injected) steroid treatment at the time of screening (inhaled steroids for asthma are allowed).
• People who have a medical condition, mental health condition, or substance use disorder that, in the treating doctor's opinion, would interfere with safely completing the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 120 days after the last dose of treatment.
• People who have previously been treated with certain types of immune checkpoint drugs (anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies).
• People with known active hepatitis B or hepatitis C infection (some exceptions may apply for hepatitis B — confirm with trial site).
• People with currently severe heart failure (New York Heart Association class III or higher), though people with a history of heart failure that has improved to a lower class may be considered.
• People who have received a live vaccine within 4 weeks before starting the study, or who are expected to need one during the study or within 5 months after the last dose.
• People living with HIV may be considered, but only if they meet specific conditions related to their HIV treatment and test results — confirm with trial site.
• People who have had major surgery within 8 weeks before screening, or who have major surgery planned within 6 months of being assigned to a treatment group (needle biopsies are not considered major surgery).
• People who have previously received certain immune cell-depleting treatments, intravenous immunoglobulin, or plasma exchange therapies within specific time periods — confirm details with trial site.
• People who have previously been treated with certain chemotherapy agents that affect immune cells, or with total lymphoid irradiation.
• People with a history of severe allergic reactions, including anaphylaxis, to monoclonal antibody treatments.
• People with serious, uncontrolled conditions affecting the heart, nervous system, lungs, kidneys, liver, hormone systems (including uncontrolled diabetes), or digestive system.
• People who have had a serious infection requiring hospital admission or intravenous antibiotics within 4 weeks before screening, or oral antibiotics within 2 weeks before screening (people who receive antibiotics just for a biopsy procedure may still be eligible).
• People who are able to have children but are not willing to use effective contraception.
• People who do not have usable veins for intravenous access.
• For one specific treatment group (Arm B): People with a history of severe allergic reactions to specific antibody components used in that arm — confirm with trial site.
• For another specific treatment group (Arm C): People with a known active infection of any kind (bacterial, viral, fungal, or other), pre-existing nerve or brain conditions such as demyelinating disorders or seizure disorders, a history of certain bowel conditions that could increase the risk of bowel perforation, current liver disease unrelated to the cancer diagnosis, or a history of or currently active immune deficiency.

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