Phase 3 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 fully understood and voluntarily signed the consent form for the trial
• People aged 18 to 75 years (inclusive) with a body mass index (BMI) of 18.5 or above
• People with advanced or returning endometrial (uterine) cancer that has been confirmed by a tissue or cell sample, and who have at least one measurable area of cancer
• People whose cancer did not respond to, or came back after, a first round of treatment involving platinum-based chemotherapy
• People with a performance status score of 0 or 1 on a standard scale used to measure how well a person can carry out daily activities (confirm with trial site)
• People who are able to provide a tumour sample for laboratory testing of certain cancer markers, including a test called MSI (microsatellite instability) status
• People whose tumour test results show they do not have a specific genetic marker known as MSI-H (microsatellite instability-high), or whose results show what is called pMMR (proficient mismatch repair)
• People whose major organs (such as liver, kidneys, and bone marrow) are working adequately
• People with an expected survival of at least 12 weeks
• Women who could potentially become pregnant must have had a negative blood pregnancy test within 7 days before being randomly assigned to a treatment group

Who may not be able to join:

• People whose endometrial cancer is specifically a carcinosarcoma or sarcoma type
• People whose tumour is confirmed as having dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high) status
• People who still have significant side effects from previous cancer treatment that have not settled to a mild level, with some exceptions for hair loss and certain nerve-related side effects
• People who have received systemic (whole-body) anti-cancer treatment within 4 weeks before joining the trial
• People who have had another type of cancer within the past 5 years
• People who have, or have had, cancer that has spread to the brain or spinal cord area
• People who received intensive radiotherapy within 4 weeks before joining the trial
• People who have previously been treated with certain immune checkpoint or immune-stimulating drugs (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies), or with certain targeted medicines that work on blood vessel growth (VEGFR tyrosine kinase inhibitors)
• People who have thyroid problems causing symptoms or requiring treatment at the time of screening
• People who have used immune-suppressing medicines within 4 weeks before joining the trial
• People with an active autoimmune disease currently needing treatment, or a history of autoimmune disease within the past 2 years
• People who have used immune-stimulating medicines within 4 weeks before joining the trial
• People who have received a live vaccine within 4 weeks before joining the trial, or who plan to receive one during the study
• People who have had major surgery within 4 weeks before joining the trial
• People with uncontrolled build-up of fluid around the lungs, in the abdomen, or around the heart
• People with high blood pressure that cannot be controlled with medication
• People who have a condition that affects how the body absorbs medicines, or who are unable to take medicines by mouth
• People currently taking strong medications that significantly affect the way the body processes a specific liver enzyme (CYP3A4) (confirm with trial site)
• People with certain bowel or stomach conditions, unhealed tumours with active bleeding, a history of bowel perforation or fistula that has not healed after surgery, or other conditions the doctor judges to carry a risk of gastrointestinal bleeding or perforation
• People who have had active bleeding, black or tarry stools, or bleeding from a tumour within the 2 to 3 weeks before joining the trial
• People whose tumour is growing into major blood vessels and is judged by the doctor to carry a high risk of serious bleeding
• People who have had a blood clot in an artery or deep vein within the past 6 months, a stroke or mini-stroke within the past 12 months, or clotting caused by an implanted IV device that has not been stabilised with standard treatment
• People with clinically significant heart or blood vessel disease
• People with significant abnormalities in their blood electrolyte (salt and mineral) levels, as assessed by the doctor
• People with an active infection or unexplained fever at the time of joining the trial
• People with active tuberculosis (TB) currently being treated, or who received TB treatment within the past year
• People with a history of, or current, lung conditions such as pulmonary fibrosis, interstitial lung disease, radiation-related lung damage, or drug-related lung inflammation — or those who have previously needed steroid treatment for non-infectious lung inflammation
• People who test positive for HIV (human immunodeficiency virus)
• People with a known history of significant liver disease
• People who have a known allergy or serious reaction to any of the study drugs or similar medicines
• People who have taken part in another clinical trial involving an unapproved drug within 4 weeks before joining
• People who are pregnant or breastfeeding
• People who have received an organ or tissue transplant
• People with known psychiatric conditions or substance use disorders that could affect their ability to follow the trial requirements
• People who the doctor judges to be unsuitable for the trial for any other reason

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