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:

This trial has two groups (Cohort A and Cohort B). The criteria are listed separately for each.

Cohort A — People with HPV16-related precancerous cell changes (LSIL or HSIL):

• Women between 18 and 60 years of age
• People who tested positive for the HPV16 strain during the screening period
• People with tissue-confirmed (biopsy-proven) HPV16-related precancerous changes in the cervix, vagina, or vulva — either low-grade (LSIL, present for more than 6 months) or high-grade (HSIL, with specific examination findings confirmed at screening) (confirm with trial site)
• People who are able to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) throughout the trial and for at least 6 months after the last dose, and whose pregnancy blood test is negative within 7 days before starting the study treatment
• People who have fully understood the study, signed the consent form willingly, and are able to attend all required visits and complete all required procedures

Cohort B — People with advanced or returning HPV16-related cervical cancer:

• Women aged 18 years or older
• People with HPV16-related cervical cancer (confirmed by biopsy as squamous cell, adenocarcinoma, or adenosquamous type) that has come back or spread, and where at least one previous standard treatment has not worked, caused serious side effects the person could not tolerate, or where no standard treatment currently exists
• People with at least one tumour that can be measured on scans, as defined by standard imaging guidelines (RECIST 1.1)
• People with a general health/activity score of 0 or 1 on the standard scale used by oncology researchers (meaning fully active or able to carry out light work) (confirm with trial site)
• People who have recovered from side effects of previous cancer treatments to a mild or baseline level, with some exceptions as assessed by the treating doctor
• People whose blood counts, liver function, kidney function, and blood clotting results fall within the ranges required by the trial (confirm with trial site for exact values)
• People who, in the treating doctor's judgement, are expected to live for at least 3 more months
• People who are able to use reliable contraception throughout the trial and for at least 6 months after the last dose, and whose pregnancy blood test is negative within 7 days before starting the study treatment
• People who have fully understood the study, signed the consent form willingly, and are able to attend all required visits and complete all required procedures

Who may not be able to join:

Cohort A exclusions:

• People with biopsy-confirmed glandular-type precancerous changes (adenocarcinoma in situ) or any invasive cancer
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who received a non-live vaccine within 2 weeks before the first dose of study treatment
• People who received a live vaccine within 4 weeks before the first dose of study treatment
• People who received treatment for their precancerous lesion within 4 weeks before the first dose of study treatment
• People who took part in another clinical trial, or are still in a follow-up period for one, within 30 days before screening
• People who used corticosteroids continuously for more than one week (at a dose equivalent to more than 10 mg per day of prednisone) within 30 days before screening, not counting hormone replacement therapy or locally applied treatments such as inhalers or eye drops
• People with a history of immune system deficiency or autoimmune diseases such as rheumatoid arthritis, lupus, or multiple sclerosis
• People currently using or expected to use certain immune-modifying medications (such as methotrexate, cyclosporine, or biologics like infliximab or adalimumab)
• People who used immune-suppressing medications continuously for more than one week within 30 days before screening
• People who have had a solid organ or bone marrow transplant
• People with a past or current cancer diagnosis, except for certain fully treated and cured cancers (such as some skin cancers, early breast lesions, or any cancer cured more than 5 years before joining)
• People with severe, uncontrolled infections
• People with a history of HIV infection or who carry syphilis
• People with active infections including active hepatitis B, hepatitis C, tuberculosis, shingles (active herpes zoster), or active syphilis (confirm with trial site for definitions)
• People with a history of severe allergies, allergy-prone conditions (atopic diseases), or a generally allergic constitution
• People with a history of severe or repeated serious allergic reactions to medicines or pharmaceutical products
• People with a history of severe reactions to vaccines, including extensive arm swelling lasting more than 72 hours, or serious whole-body reactions such as high fever, breathing difficulties, throat swelling, fainting, seizures, or brain effects
• People with severe heart, lung, or other major organ problems
• People with a confirmed history of significant neurological or psychiatric conditions, including epilepsy or dementia
• People with a history of drug abuse or alcoholism
• People whom the treating doctor considers unsuitable for this trial for any reason

Cohort B exclusions:

• People with cervical cancer that is non-HPV-related, or that is at a stage that can be cured with local treatment alone
• People who have not recovered from side effects of previous surgery, radiotherapy, chemotherapy, or immunotherapy
• People who took part in another clinical trial, or are still in a follow-up period for one, within 30 days before screening
• People who received a non-live vaccine within 2 weeks before the first dose of study treatment
• People who received a live vaccine within 4 weeks before the first dose of study treatment
• People who used corticosteroids continuously for more than one week (at a dose equivalent to more than 10 mg per day of prednisone) within 30 days before screening, not counting hormone replacement therapy or locally applied treatments
• People with a history of immune system deficiency or autoimmune diseases such as rheumatoid arthritis, lupus, or multiple sclerosis
• People currently using or expected to use certain immune-modifying medications (such as methotrexate, cyclosporine, or biologics like infliximab or adalimumab)
• People who used immune-suppressing medications continuously for more than one week within 30 days before screening
• People who have had a solid organ or bone marrow transplant
• People with a past or current cancer diagnosis, except for certain fully treated and cured cancers (such as some skin cancers, early breast lesions, or any cancer cured more than 5 years before joining)
• People whose cancer has spread to the brain or the lining of the brain
• People with significant or recurring fluid build-up around the lungs, abdomen, or heart that requires frequent draining
• People with severe, uncontrolled infections
• People with a history of HIV infection or who carry syphilis
• People with active infections including active hepatitis B, hepatitis C, tuberculosis, shingles, or active syphilis (confirm with trial site for definitions)
• People with a history of severe allergies, allergy-prone conditions, or a generally allergic constitution
• People with a history of severe or repeated serious allergic reactions to medicines or pharmaceutical products
• People with a history of severe reactions to vaccines, including extensive arm swelling lasting more than 72 hours, or serious whole-body reactions such as high fever, breathing difficulties, throat swelling, fainting, seizures, or brain effects
• People with severe heart, lung, or other major organ problems
• People with a confirmed history of significant neurological or psychiatric conditions, including epilepsy or dementia
• People with a history of drug abuse or alcoholism
• People who are pregnant, breastfeeding, or have a positive pregnancy blood test, or those unwilling to use effective contraception during the study and for 6 months after the last dose
• People whom the treating doctor considers unsuitable for this trial for any reason

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