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) with different criteria.

Cohort A (for people with HPV16 infection and cervical cell changes):

• Women between 18 and 60 years of age
• People who tested positive for HPV16 during screening (other HPV types can also be present at the same time)
• People with high-grade cervical cell changes (HSIL) where the affected area is fully visible during a colposcopy examination
• People who are either not able to become pregnant, or who agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) during the trial and for at least 6 months after the last dose — and whose blood pregnancy test is negative within 7 days before the first treatment
• People who have fully understood the study, voluntarily signed the consent form, and are able to attend all required visits and complete all required treatments and tests

Cohort B (for people with advanced cervical cancer):

• Women aged 18 years or older
• People with HPV16-related cervical cancer (confirmed by tissue testing as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) that has come back or spread, and that has continued to grow after at least two prior standard treatments, or where side effects of prior treatment were not tolerable, or where no standard treatment currently exists
• People who have at least one measurable area of cancer (as assessed using standard imaging criteria called RECIST 1.1)
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (ECOG), meaning fully active or able to carry out light activity
• People who have recovered from side effects of prior cancer treatments to a mild or baseline level (with some exceptions such as hair loss or stable thyroid conditions, which the trial team will assess)
• People whose blood counts, liver function, kidney function, and blood clotting results meet specific required levels (the trial site will check these through blood tests)
• People who, in the doctor's judgement, are expected to live for at least 3 more months
• People who are either not able to become pregnant, or who agree to use reliable contraception during the trial and for at least 6 months after the last dose — and whose blood pregnancy test is negative within 7 days before the first treatment
• People who have fully understood the study, voluntarily signed the consent form, and are able to attend all required visits and complete all required treatments and tests

Who may not be able to join:

Cohort A:

• People with a confirmed diagnosis of adenocarcinoma, 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 in the 2 weeks before the first dose
• People who received a live vaccine in the 4 weeks before the first dose
• People who received treatment for cervical cell changes (LSIL or HSIL) in the 4 weeks before the first dose
• People who have participated in another clinical trial, or are still in the follow-up period of another trial, within the past 30 days
• People who have used corticosteroid medicines (at doses higher than the equivalent of 10 mg/day of prednisone) for more than one week continuously in the past 30 days (not including hormone replacement therapy or inhaled/eye 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-suppressing medicines or biological drugs (such as methotrexate, cyclosporine, infliximab, or adalimumab)
• People who have used immune-suppressing medicines continuously for more than one week in the past 30 days
• People who have had a solid organ transplant or bone marrow transplant
• People with a current or past cancer diagnosis, except for certain fully treated and cured cancers such as early-stage breast, skin, or bladder cancers, or any cancer that was fully cured more than 5 years ago
• People with severe, uncontrolled infections
• People with a history of HIV infection or who carry syphilis
• People with an active infection such as active tuberculosis, hepatitis B or C, herpes zoster, or bacterial infections (specific blood test thresholds apply — the trial site will assess these)
• People with a history of severe allergies, allergic conditions, or a generally allergy-prone constitution
• People with a history of severe or repeated allergic reactions to medicines or pharmaceutical products
• People with a history of severe reactions to vaccines — including a large painful swelling on the arm lasting more than 72 hours, or serious whole-body reactions such as high fever, breathing difficulties, throat swelling, fainting, seizures, or brain complications
• People with severe problems with other major organs, or serious heart or lung disease
• People with a confirmed history of neurological or psychiatric conditions, including epilepsy or dementia
• People with a history of drug abuse or alcoholism
• People who, in the trial doctor's judgement, are not suitable to participate

Cohort B:

• People with cervical carcinoma in situ that could be treated with local therapy alone, or with cervical cancer not related to HPV
• People who have not yet recovered from side effects of prior treatments such as surgery, radiotherapy, chemotherapy, or immunotherapy
• People who have participated in another clinical trial, or are still in the follow-up period of another trial, within the past 30 days
• People who received a non-live vaccine in the 2 weeks before the first dose
• People who received a live vaccine in the 4 weeks before the first dose
• People who have used corticosteroid medicines (at doses higher than the equivalent of 10 mg/day of prednisone) for more than one week continuously in the past 30 days (not including hormone replacement therapy or inhaled/eye 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-suppressing medicines or biological drugs (such as methotrexate, cyclosporine, infliximab, or adalimumab)
• People who have used immune-suppressing medicines continuously for more than one week in the past 30 days
• People who have had a solid organ transplant or bone marrow transplant
• People with a current or past cancer diagnosis other than the qualifying cervical cancer, except for certain fully treated and cured cancers such as early-stage breast, skin, or bladder cancers, or any cancer fully cured more than 5 years ago
• 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 an active infection such as active tuberculosis, hepatitis B or C, herpes zoster, or bacterial infections (specific blood test thresholds apply — the trial site will assess these)
• People with a history of severe allergies, allergic conditions, or a generally allergy-prone constitution
• People with a history of severe or repeated allergic reactions to medicines or pharmaceutical products
• People with a history of severe reactions to vaccines — including a large painful swelling on the arm lasting more than 72 hours, or serious whole-body reactions such as high fever, breathing difficulties, throat swelling, fainting, seizures, or brain complications
• People with severe problems with other major organs, or serious heart or lung disease
• People with a confirmed history of neurological or psychiatric conditions, including epilepsy or dementia
• People with a history of drug abuse or alcoholism
• People who, in the trial doctor's judgement, are not suitable to participate

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