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 aged 18 or older at the time of screening (or the legal age of consent in their country).
• People who are willing and able to give written consent before any trial-related procedures begin, including any locally required privacy authorizations.
• People with a general health status rated as fully active or restricted only in physically strenuous activity (ECOG performance status 0 or 1).
• People who weigh at least 35 kg.
• People with a life expectancy of at least 12 weeks.
• People with a confirmed diagnosis of locally advanced head and neck squamous cell cancer (LA-HNSCC) in the oral cavity, throat, voicebox, or surrounding areas — or a head and neck cancer of unknown primary site that tests positive for p16.
• People whose cancer is either HPV-negative at stage III–IVB, or HPV-positive at stage III (based on standard cancer staging guidelines).
• People for whom stored tumor tissue samples (preserved in a specific way called FFPE) are available for laboratory testing.
• People who are planned to receive a definitive treatment — either surgery followed by radiation or chemoradiation, radiation alone, or chemoradiation alone.

Additional criteria for Part C of the trial (a specific treatment phase):

• People whose imaging (CT or MRI scan) at 8–12 weeks after definitive treatment shows a measurable response in their tumor.
• People with an ECOG performance status of 0 or 1 at the time of being assigned to a treatment group.
• People whose tumor shows a certain protein marker called PD-L1 (with a combined positive score of 1 or higher), as tested by a specific laboratory method.
• People in whom a type of tumor DNA in the blood (called ctDNA) was detected either at both the week 5 and week 10 blood draws, or only at the week 10 blood draw, during an earlier part of the trial.
• People with adequate blood, liver, and kidney function meeting specific laboratory value thresholds (confirm exact values with the trial site).
• People with a body mass index (BMI) of 17 or higher.
• Women of childbearing potential who are sexually active with a male partner who has not had a sterilisation procedure must agree to use at least one highly effective form of contraception from screening until 4 months after the last dose of trial treatment (periodic abstinence, the rhythm method, and withdrawal are not considered acceptable methods).
• Men who have not had a sterilisation procedure and are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from screening until 4 months after the last dose of trial treatment, and must not donate sperm during this period.

Additional criteria for Part E of the trial (a different treatment phase):

• People whose imaging (CT or MRI scan) at 8–12 weeks after definitive treatment shows a measurable response in their tumor.
• People in whom ctDNA was NOT detected in the blood sample taken at approximately week 10 during an earlier part of the trial.

Who may not be able to join:

• People whose head and neck cancer is located in a site not listed in the inclusion criteria (such as the nasopharynx, paranasal sinuses, or salivary glands), or whose cancer is a non-squamous cell type, or who have p16-negative squamous cell cancer of unknown primary site.
• People who still have significant side effects (grade 2 or higher) from a previous cancer treatment, with some exceptions such as hair loss or skin pigmentation changes (confirm exceptions with the trial site).
• People whose cancer has already spread to distant parts of the body (distant metastases).
• People who have previously received an organ transplant from another person.
• People with a known history of allergic reactions to substances chemically or biologically similar to the trial drug AZD2936 or its ingredients.
• People with a history of a primary immune system deficiency condition.
• People with active or previously documented autoimmune or inflammatory conditions (such as inflammatory bowel disease, lupus, rheumatoid arthritis, Graves' disease, or similar disorders), with certain exceptions such as controlled hypothyroidism, vitiligo, or skin conditions not requiring systemic treatment (confirm exceptions with the trial site).
• People with an active infection such as tuberculosis, active hepatitis B (with a positive surface antigen result), active hepatitis C, or acute hepatitis A — though some people with past or well-controlled hepatitis B or hepatitis C may still be eligible (confirm with trial site).
• People with a known HIV-positive diagnosis.
• People with serious uncontrolled illnesses, including active infections, heart failure, uncontrolled high blood pressure, significant heart disease or recent heart attack (within the last 12 months), active lung disease affecting the tissue, serious bowel conditions causing diarrhea, or significant mental health or social situations that may affect their ability to follow the trial protocol.
• People who have had another cancer in the past, with some exceptions — for example, cancers treated with curative intent with no known active disease for 2 or more years, adequately treated skin cancers, or early-stage prostate cancer without progression (confirm exceptions with trial site).
• People currently receiving any other cancer treatment (hormonal therapy for non-cancer reasons such as menopause is allowed).
• People who have previously received the trial drug AZD2936, or any anti-PD-1, anti-PD-L1, or anti-TIGIT therapy.
• People who have taken immune-suppressing medications within the 14 days before the first trial dose, with certain exceptions such as low-dose inhaled or topical steroids or low-dose systemic steroids (confirm exceptions with trial site).
• People who have received a live vaccine within 30 days before the first trial dose (live vaccines are also not permitted during treatment and for 30 days after the last dose; COVID-19 vaccination should not be given within 72 hours before the first dose of AZD2936).
• People who have taken part in another clinical trial using an investigational treatment within 28 days before joining this trial, or are currently enrolled in another interventional trial (observational studies or follow-up phases of other trials may be exceptions — confirm with trial site).
• People who, in the treating doctor's judgment, are unlikely to follow the trial's procedures and requirements.
• Women who are currently pregnant or breastfeeding, or who plan to become pregnant during the trial.
• People who are involuntarily imprisoned or who are unable to give consent freely, or who are unable to follow the trial procedures.

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