Phase 2 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 between 18 and 60 years old who have been diagnosed with high-grade cervical cell changes (called CIN2 or CIN3), confirmed by a biopsy and reviewed by the trial's central team
• People whose cervical swab sample tests positive for a specific strain of HPV called HPV16 (other HPV types present at the same time are allowed)
• People who have tested negative for HIV
• People who are able and willing to attend all study visits and be available for follow-up appointments over one year
• People who are capable of becoming pregnant and agree to avoid pregnancy by remaining sexually abstinent, using contraception (such as the pill, barrier methods, spermicide, or an IUD), or having a partner who has had a vasectomy — for at least 6 months during the study
• People whose blood test results show that their organs (including liver, kidneys, and blood cells) are functioning within acceptable levels at the time of joining the trial

Who may not be able to join:

• People who are trying to become pregnant within 6 months, are currently pregnant, or are breastfeeding
• People who have a weakened immune system or are taking medications that suppress the immune system
• People who have received a blood product transfusion within the 3 months before joining
• People who have received a standard vaccine within 2 weeks before joining (or within 4 weeks for a live vaccine)
• People who have taken part in another trial involving an experimental drug or device within 30 days of signing the consent form
• People with a history of seizures, unless they have been seizure-free for at least 5 years
• People who have had a cancer diagnosis in the past 5 years, except for certain localised skin cancers
• People who have had chemotherapy, radiation, biological cancer treatment, or other experimental treatments within 28 days before the first dose of the study drug
• People who have had surgery within 28 days before joining, not including minor procedures such as dental work or a small skin biopsy
• People who have an uncontrolled ongoing illness, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or a mental health or personal situation that would make it difficult to follow the study requirements
• People who have an active autoimmune disease, such as rheumatoid arthritis, lupus, ulcerative colitis, Crohn's disease, multiple sclerosis, or ankylosing spondylitis
• People who have previously had a cervical cone biopsy, a LEEP procedure, or a full hysterectomy due to cervical disease
• People whose cervical cell changes cover more than half the circumference of the cervix (more than 180 degrees)
• People who test positive for active Hepatitis B virus (if the Hepatitis B surface antigen test is also positive)
• People who test positive for active Hepatitis C virus (if the anti-HCV test is also positive)
• People whose cervical cell changes cannot be fully seen during a colposcopy examination, or where a tissue sample taken from inside the cervical canal shows high-grade disease
• People whose cervical biopsy or internal cervical sample shows a type of abnormal cell change called adenocarcinoma in situ (AIS)
• People whose pre-biopsy cervical smear showed certain high-risk abnormal glandular cells, squamous cell carcinoma, or who had CIN2/3 alongside bleeding after menopause
• People who do not have at least two suitable muscle sites on the body where the injection and a specialised electrical device (used to help deliver the treatment) can be safely used — sites may be ruled out if there is not enough muscle depth, the skin fold is too thick, or the skin has tattoos, raised patches, keloid scarring, or other conditions in that area (confirm with trial site)
• People who cannot receive injections into the muscle or have blood drawn
• People who have a metal implant or medical device in the area of more than two of the potential injection sites
• People who have a non-removable electronic device in their body, such as a pacemaker, implantable heart defibrillator, nerve stimulator, or deep brain stimulator
• People who are employed at the trial site and directly involved in this or related studies, or who are a family member of such an employee or of the investigator
• People considered vulnerable in a legal or institutional sense, such as people who are incarcerated or under a legal protection order

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