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:

• People who have signed and dated a consent form after being fully informed about the trial.
• People who are female.
• People who are 20 years of age or older at the time of signing the consent form.
• People who have been diagnosed with endometrial cancer or carcinosarcoma (also called Mixed Mullerian Tumor), confirmed through a tissue or cell sample.
• People whose cancer is at Stage I through IIIC2 and can be completely removed by surgery.
• People who have no signs of cancer that has spread to distant parts of the body.
• People whose cancer has a specific genetic feature called MMR-deficient (MMRd) or microsatellite instability-high (MSI-H), as confirmed by laboratory testing (confirm with trial site).
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (ECOG score of 0 or 1).
• People who are expected to live for at least 3 months.
• People whose recent blood and organ function test results fall within the required ranges, tested within 7 days before the first dose (confirm specific values with trial site).
• People who are able to become pregnant must agree to use an approved form of contraception from the time of signing the consent form until at least 5 months after the last dose, and must agree not to breastfeed during this same period.

Who may not be able to join:

• People who have had more than one type of cancer, unless the second cancer was a minor skin cancer, a very early-stage cancer, or a cancer that has not returned for at least 5 years.
• People who still have side effects from a previous treatment or surgery that could affect the safety assessment in this trial, in the opinion of the trial doctor.
• People who have had a severe allergic reaction to any antibody-based medicine in the past.
• People who have a current or past history of an autoimmune disease (where the immune system attacks the body), whether ongoing, long-term, or recurring.
• People who have a current or past history of scarring or inflammation of the lungs (interstitial lung disease or pulmonary fibrosis), based on scans or clinical findings (people with stable, past radiation-related lung inflammation may be considered — confirm with trial site).
• People who currently have diverticulitis (inflammation of pouches in the bowel) or symptomatic stomach or intestinal ulcers.
• People who have fluid around the heart, lungs, or in the abdomen that requires medical treatment.
• People who have cancer-related pain that cannot be controlled.
• People who have had a mini-stroke, stroke, blood clot in the lungs, or deep vein blood clot within the 180 days before joining the trial.
• People who have had a heart attack or uncontrolled chest pain within 180 days before joining, or who have severe heart failure, uncontrolled high blood pressure despite treatment, or a heart rhythm problem requiring treatment.
• People who are currently taking or need to take blood-thinning medication (people on low-dose aspirin or similar antiplatelet medicines may still be considered — confirm with trial site).
• People who have uncontrolled diabetes.
• People who have a serious infection currently requiring treatment.
• People who have taken steroid medicines (used throughout the body) or immune-suppressing medicines within 28 days before joining, except for short-term use such as for allergy prevention.
• People who have received cancer treatments such as chemotherapy, targeted therapy, or immunotherapy within 28 days before joining.
• People who have had a surgical procedure to seal the lining around the lungs or heart within 28 days before joining.
• People who have had surgery under general anaesthetic within 28 days before joining.
• People who have had a procedure under local anaesthetic within 14 days before joining.
• People who have received radiation therapy within 28 days before joining, or radiation to bone spread within 14 days before joining.
• People who have received radioactive treatment (not including radioactive scans for diagnosis) within 56 days before joining.
• People who test positive for HIV, HTLV-1, hepatitis B surface antigen, or hepatitis C antibody.
• People who test negative for hepatitis B surface antigen but have other hepatitis B markers present along with a detectable level of hepatitis B virus in the blood.
• People who are pregnant, possibly pregnant, or currently breastfeeding.
• People who have taken part in another trial or received an unapproved medicine within 28 days before joining.
• People who have previously been treated with Nivolumab or similar immune checkpoint medicines (including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or other T-cell regulating therapies).
• People who are not able to give informed consent, for example due to dementia.
• People who have had an allergic reaction to Nivolumab in the past.
• People who are able to become pregnant and return a positive pregnancy test within 72 hours before being assigned to the trial.
• People considered unsuitable for any other reason, at the judgement of the trial doctor.

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