Phase 2 Thyroid 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:

• Adults aged 18 or older who have been diagnosed with differentiated thyroid cancer (confirmed by laboratory tissue testing) and are scheduled for surgery, with no previous treatment for this cancer
• People whose cancer carries a greater than 20% chance of coming back or persisting after treatment, based on factors such as: a tumour larger than 4 cm; multiple small tumours that have grown beyond the thyroid and carry a specific genetic change (BRAF V600E); cancer that has spread to nearby lymph nodes; cancer that has visibly grown into surrounding tissues; cancer that has spread outside the lymph nodes; or a situation where the surgeon does not expect to be able to remove all of the tumour
• People diagnosed with poorly differentiated thyroid carcinoma or Hürthle cell carcinoma (specific subtypes of thyroid cancer)
• People whose cancer has already spread to distant parts of the body at the time of diagnosis
• People who have measurable areas of disease that can be tracked on scans, according to standard research criteria (RECIST 1.1)
• People who are in generally good physical condition, able to carry out normal daily activities (rated 0 or 1 on a standard scale used in cancer research), assessed within 7 days before joining the trial
• People whose liver, kidneys, blood, and other organs are functioning adequately, confirmed by blood tests taken within 10 days before starting treatment
• Male participants who agree to use contraception during treatment and for at least 6 months after the last dose, and agree not to donate sperm during this time
• Female participants who are not pregnant and not breastfeeding, and who are either not able to become pregnant, or who agree to use contraception during treatment and for at least 4 months after the last dose
• People who are able and willing to provide written consent to participate in the trial

Who may not be able to join:

• Women who could become pregnant and have a positive pregnancy test within 72 hours before joining the trial
• People who have previously been treated with certain types of immune checkpoint drugs that target PD-1, PD-L1, PD-L2, or related immune pathways (such as CTLA-4 or CD137 treatments)
• People who have received any systemic cancer treatment, including experimental treatments, within 4 weeks before joining the trial
• People who have had radiation therapy within 2 weeks before starting the trial, or who have not yet recovered from side effects of radiation, or who have developed lung inflammation from radiation
• People who have received a live vaccine within 30 days before the first dose — examples include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and some typhoid and nasal flu vaccines (standard injected flu vaccines are generally allowed)
• People who are currently in, or have recently been in, another clinical trial involving an experimental treatment or device within 4 weeks before starting
• People who have a weakened immune system, or who are taking steroid medication at doses above 10 mg of prednisone (or equivalent) daily, or who are taking other immune-suppressing medications within 7 days before starting
• People who have had another type of cancer in the past, unless treatment was completed and there has been no sign of that cancer for at least 2 years (some skin cancers, early-stage bladder cancer, and certain in-situ cancers that were fully treated may still be eligible — confirm with trial site)
• People with active cancer that has spread to the brain or the lining of the brain, unless previously treated brain metastases have been stable for at least 4 weeks and no steroid treatment has been needed for at least 14 days
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients
• People with an active autoimmune disease that has required medical treatment in the past 2 years (hormone replacement therapies such as thyroid hormone or insulin are not considered disqualifying)
• People who have a history of, or currently have, lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment
• People who have an active infection currently being treated with systemic medication
• People with a history of HIV infection
• People with active Hepatitis B or Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People with mental health conditions or substance use disorders that would make it difficult to follow the trial requirements
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the trial period and up to 120 days after the last dose
• People who have received an organ or tissue transplant from another person

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