Phase 2 Endometrial 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:

• Women aged 21 or older who have an active (not yet surgically removed), laboratory-confirmed diagnosis of cervical cell changes classified as CIN grade 2 or 3, or carcinoma in situ (without invasion into surrounding tissue), including cases where the affected areas appear in more than one location
• Women who are not currently pregnant, not breastfeeding, and are either unable to become pregnant, or are able to become pregnant but agree to use contraception throughout the treatment period and for at least 120 days after the last dose of the study treatment
• People who are willing and able to provide written consent to participate in the trial (or have a legal representative do so on their behalf)
• People who can provide a tissue sample from the affected area — either a previously stored sample or a newly taken biopsy from a lesion that has not been treated with radiation
• People who are willing to agree to an additional biopsy partway through treatment (after the second cycle), if the affected area is accessible and a biopsy is considered safe at that time
• People who are willing to agree to a cervical surgical procedure (either LEEP or cold-knife cone) at the end of the 24-week treatment period, unless surgery is considered unsafe at that time
• People who are generally well enough to carry out normal daily activities, with little to no physical limitation (described by doctors as an ECOG performance score of 0 or 1)
• People whose organ function is within normal ranges on blood tests taken within 10 days before starting treatment (pregnancy test must be taken within 72 hours before starting)

Who may not be able to join:

• Women of childbearing potential who have a positive pregnancy test within 72 hours before being allocated to the trial
• People who have previously been treated with certain types of immune checkpoint drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other drugs that affect specific immune system receptors (such as CTLA-4, OX-40, or CD137 targeted therapies)
• People who have received any previous systemic (whole-body) treatment for CIN, including experimental treatments, within the 4 weeks before joining the trial, or who have not yet recovered from side effects of previous treatments
• People who have had radiation therapy within 2 weeks before starting the study treatment, or who have not fully recovered from radiation-related side effects
• People who have received a live vaccine within 30 days before the first dose of the study drug — examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and some typhoid and influenza (nasal spray) vaccines
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within the 4 weeks before the first dose
• People who have a condition that weakens the immune system, or who are currently taking steroid medication at doses above 10 mg of prednisone (or equivalent) per day, or any other immune-suppressing medication within the 7 days before the first dose
• People who have a history of another cancer, unless treatment for that cancer has been completed with no signs of cancer returning for at least 2 years (some skin cancers and certain early-stage cancers that were fully removed may be exceptions — confirm with trial site)
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients
• People who have an autoimmune disease (where the immune system attacks the body) that has needed medical treatment in the past 2 years — note that hormone or gland replacement therapies are generally not considered to fall under this exclusion (confirm with trial site)
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People who have an active infection that requires treatment with systemic (whole-body) medication
• People with a known history of HIV infection
• People with a known history of active hepatitis B or currently active hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People with any medical condition, ongoing treatment, or abnormal test result that the treating doctor believes could interfere with the study results or make participation unsafe
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the requirements of the trial
• People who are pregnant, breastfeeding, or planning to become pregnant (or father a child) at any point from the screening visit through to 120 days after the last dose of treatment
• People who have received an organ or tissue transplant from another person

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