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 21 or younger at the time of joining the trial.
• People newly diagnosed with stage II, III, or IV nasopharyngeal carcinoma (a type of cancer in the back of the nose and throat), confirmed by a tissue biopsy at the time of original diagnosis.
• People whose ability to carry out daily activities meets a minimum threshold, measured using age-appropriate scoring scales (a score of 60% or above on the Lansky scale for those 16 and under, or the Karnofsky scale for those over 16).
• People whose recent blood tests (taken within 7 days before starting treatment) show that white blood cell counts, platelet counts, kidney function, liver function, and heart function all meet the required levels as specified by the trial.
• People whose heart is pumping adequately, shown by specific measurements on a heart scan (shortening fraction of at least 27%, or ejection fraction of at least 50%).
• People who are not showing signs of breathing difficulty at rest, have no exercise intolerance, and have a blood oxygen level above 94% if this needs to be checked.
• People living with HIV who are on effective treatment, have had an undetectable viral load within the past 6 months, and have a normal T-cell count.
• People with a history of hepatitis B who are on suppressive therapy with an undetectable viral load, or people with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.

Who may not be able to join:

• People who have previously received radiation therapy to the head or neck area.
• People who have received chemotherapy or radiation for any cancer within the last 3 years, unless they are currently in remission.
• People who have been diagnosed with an immune deficiency condition.
• People who have an active autoimmune disease that has required systemic (whole-body) medical treatment in the past 2 years — though people with well-controlled asthma who have not needed systemic steroids in the past 12 months would not be excluded on this basis.
• People currently requiring regular doses of corticosteroids (above a specified daily threshold) within the past 14 days, or other immune-suppressing medications within the past 30 days (inhaled or topical steroids, and low-dose replacement steroids, may be permitted — confirm with trial site).
• People with a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with a detectable viral load of HIV, hepatitis B, hepatitis C, or who have active tuberculosis.
• People who have previously had a solid organ transplant or a bone marrow/stem cell transplant.
• Females who are able to become pregnant must have a negative pregnancy test before joining the trial.
• Females who are able to become pregnant and are sexually active must agree to use two highly effective forms of contraception, or abstain from heterosexual intercourse, for a specified period after the last dose of each study drug (up to 14 months after the last dose, depending on the drug).
• Males who are able to father a child and are sexually active must agree to use a highly effective form of contraception, or abstain from heterosexual intercourse, for a specified period after the last dose of each study drug (up to 11 months after the last dose, depending on the drug).
• Females who are currently breastfeeding are not eligible unless they agree to stop breastfeeding from the first dose of study treatment through at least 5 months after the last dose of nivolumab.
• People (or their parents or legal guardians, where applicable) who are unwilling or unable to sign the required written consent form.
• People whose participation would not meet all requirements set by the FDA, the National Cancer Institute, and the treating institution.

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