Phase 3 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 were between 18 and 65 years old when they were diagnosed
• People whose cancer has been confirmed by a laboratory test as a specific type of nasopharyngeal (back of the nose/throat) cancer called "non-keratinizing carcinoma" according to WHO guidelines
• People whose cancer has been classified as locally advanced nasopharyngeal cancer based on specific staging criteria, or who had a particular virus marker (EBV DNA) in their blood at or above a certain level before treatment
• People who have already completed the full recommended course of induction chemotherapy and chemotherapy given at the same time as radiation therapy
• People whose general physical fitness is rated at 0 or 1 on a standard activity scale, meaning they are fully active or have only minor limitations in physical activity
• People who are able to start the follow-up treatment within one month of finishing their last radiation session, and no later than six weeks after
• People whose bone marrow is working well enough, shown by blood cell counts being above required levels
• People whose liver and kidney function test results are within acceptable ranges
• People who are willing and able to attend all required appointments, follow the treatment plan, and complete all tests as set out in the study
• People of childbearing potential (both female participants and male participants whose partners could become pregnant) who agree to use reliable contraception from the screening period through to one year after treatment ends

Who may not be able to join:

• People who test positive for active hepatitis B virus above a certain level, or who test positive for hepatitis C antibodies
• People who test positive for HIV or who have been diagnosed with AIDS
• People who have difficulty swallowing, ongoing diarrhoea, or a bowel blockage that could interfere with taking medication by mouth
• People who have a serious ongoing or active infection that requires treatment with antibiotics, antifungal, or antiviral medicines before entering the trial, including tuberculosis
• People with an active autoimmune disease (where the immune system attacks the body), with some exceptions such as type 1 diabetes, thyroid conditions managed with hormone replacement, or certain skin conditions that do not need systemic treatment (confirm with trial site)
• People who have had lung inflammation requiring steroid tablets or injections at any point in the past year
• People who still have clear signs of remaining cancer or cancer that has spread after completing their chemoradiotherapy
• People who have taken immune-suppressing medications, including steroids at a daily dose above the equivalent of 10 mg of prednisone, within the 28 days before signing consent (lower doses or inhaled/topical steroids may be acceptable — confirm with trial site)
• People with serious uncontrolled heart conditions, including significant heart failure, unstable chest pain, a heart attack within the past year, or certain irregular heart rhythms requiring treatment
• People who are pregnant or breastfeeding
• People who have had, or currently have, another cancer, with limited exceptions such as certain treated skin cancers, cervical carcinoma in situ, or papillary thyroid cancer
• People who received a live vaccine within 30 days before the first dose of the study drug tislelizumab
• People who have had an organ transplant
• People with other serious conditions — including serious mental health conditions, severely abnormal test results, or significant social or family risk factors — that a study doctor determines could affect safety or the ability to follow the study requirements
• People who received surgery, biological therapy, or immunotherapy during or before their radiation treatment
• People who are currently receiving, or are expected to receive, other chemotherapy, biological therapy, or immunotherapy, or who have had a severe allergic reaction to another monoclonal antibody treatment
• People who received chemotherapy or surgery on the primary tumour or lymph nodes before standard treatment
• People who had radiation therapy to the area before standard treatment (with the exception of certain treated skin cancers)
• People who are known to be unable to tolerate or are sensitive to any of the medicines used in this trial

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