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 18 to 70 years old, any gender
• People whose cancer has been confirmed by a tissue sample (biopsy) to be squamous cell carcinoma in the mouth — specifically in the front two-thirds of the tongue, floor of the mouth, gums, inner cheeks, hard palate, or the area behind the back teeth
• People whose mouth cancer has been assessed as early stage (Stage I or II, meaning the tumour is small and has not spread to lymph nodes or other parts of the body), based on a widely used cancer staging system
• People who are fully active or have only minor limitations in daily physical activity (this is measured on a standard medical scale — confirm with trial site)
• People whose bone marrow, liver, kidney, and other organ functions are within acceptable ranges based on blood tests and other checks before the trial starts (confirm specific thresholds with trial site)
• People whose thyroid, heart, blood clotting, and other routine health checks come back as normal before joining
• Women of childbearing age (18–49 years) whose pregnancy test (blood or urine) is negative within 7 days before treatment starts, and who agree to use medically approved contraception during treatment and for 120 days after treatment ends
• People who are willing and able to sign a consent form, take part in the study voluntarily, and follow all study requirements including appointments, treatments, and tests

Who may not be able to join:

• People who have fluid build-up in the chest, around the heart, or in the abdomen that cannot be controlled and needs repeated draining
• People who have had an allergic reaction to the drug adbelimab in the past
• People who have taken another experimental drug within 4 weeks before the trial starts, or within 5 half-lives of that drug (confirm with trial site)
• People who are currently enrolled in another clinical trial that involves a treatment intervention (observational studies or follow-up from a previous trial may be acceptable — confirm with trial site)
• People who have received any anti-cancer treatment — including radiotherapy, chemotherapy, immunotherapy, hormone therapy, targeted therapy, biological therapy, or tumour embolisation — within 2 weeks before the trial starts
• People who have needed steroid medications (above a low daily dose equivalent) within 2 weeks before starting the trial, with some exceptions for certain uses such as inhaled or topical steroids at low doses (confirm with trial site)
• People who have received an anti-cancer vaccine, or any live vaccine, within 4 weeks before the trial starts
• People who have had major surgery or a serious injury within 4 weeks before the trial starts
• People who have previously been treated with a type of chemotherapy drug called taxanes
• People whose side effects from previous cancer treatments have not sufficiently settled down before joining (except hair loss)
• People who have active autoimmune diseases, or a history of certain autoimmune conditions such as lung inflammation, bowel inflammation, liver inflammation, or others — though some stable, well-managed conditions such as thyroid disease on a steady dose of medication or Type 1 diabetes on a steady insulin dose may be considered (confirm with trial site)
• People with a weakened immune system, a positive HIV test, other immune deficiency conditions, a history of organ transplant or bone marrow transplant, or active hepatitis B or C infection
• People with poorly controlled heart conditions, including significant heart failure, unstable chest pain (angina), a heart attack within the past year, or certain uncontrolled heart rhythm problems
• People who have had a serious infection within 4 weeks before the trial starts, or who have signs of an active infection or need oral or intravenous antibiotics within 2 weeks before starting (preventive antibiotic use may be an exception — confirm with trial site)
• People who have a history of a lung condition called interstitial lung disease (with some exceptions — confirm with trial site)
• People who have active tuberculosis, had active tuberculosis within the past year, or had tuberculosis more than a year ago that was not properly treated
• People who have been diagnosed with another cancer within the past 5 years, except for certain very low-risk skin cancers or early-stage cervical conditions that have been fully treated
• Women who are pregnant or breastfeeding
• People who, in the view of the trial doctors, have other serious medical, psychological, family, or social circumstances that could affect their safety or the reliability of the study data

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