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 are 18 years of age or older at the time of signing the consent form.
• People whose general health and ability to carry out daily activities meets a specific standard (a score of 0 or 1 on a medical scale used to measure how cancer affects daily living — confirm with trial site).
• People who have previously been treated with platinum-based chemotherapy and a type of immunotherapy drug called a PD-1 inhibitor, either together or at separate times.
• People who have received no more than 2 previous treatment courses for endometrial cancer (note: chemotherapy completed more than 12 months before joining, given after initial surgery, may not count toward this limit — confirm with trial site).
• People who have received no more than 1 previous hormonal therapy for endometrial cancer.
• People who have never been treated with a type of drug called a CDK4/6 inhibitor.
• People whose cancer can be measured on scans according to standard medical criteria.
• People with advanced or returning endometrial cancer that has not responded to treatments aimed at curing the disease.
• People whose cancer is one of several specific cell types, including endometrioid, serous, clear cell, mucinous, squamous, undifferentiated, and several others (confirm with trial site if unsure of cancer type).
• People whose tumour tests positive for oestrogen receptors (ER-positive), meaning at least 1% of tumour cells show this marker on a laboratory test, confirmed from either a recent or stored tissue sample.
• People whose tumour has a normal (non-mutated) version of a gene called TP53, confirmed by laboratory testing of a recent or stored tissue sample.
• People whose cancer does not have specific genetic changes known as dMMR or POLE mutations.
• People who have had, or can have, a specific type of genetic tumour profiling test performed on their tissue (confirm with trial site).
• People who are postmenopausal, premenopausal, or perimenopausal — with specific hormonal or surgical criteria used to define menopausal status (confirm with trial site for details).
• People who are pre- or perimenopausal must be receiving a specific hormone-suppressing injection (LHRH agonist) starting at least 4 weeks before beginning the trial.
• People of childbearing potential who agree to use effective non-hormonal contraception starting 28 days before the first dose, throughout the trial, and for 120 days after the last dose.
• People who have finished any prior radiotherapy and fully recovered from its effects, with at least 14 days passed since the end of radiation before starting the trial.
• People whose blood test results meet specific minimum levels for blood cell counts, kidney function, liver function, blood clotting, and protein levels (confirm with trial site for exact values).

Who may not be able to join:

• People who have taken part in another clinical trial or received an experimental treatment within the past 30 days (or longer, depending on the drug used), or who are currently enrolled in another research study.
• People experiencing a serious crisis involving organ failure caused by the cancer spreading to internal organs, cancer spreading through the lymph vessels of the lungs, or cancer spreading to the membranes surrounding the brain and spinal cord.
• People who have previously been treated with elacestrant, certain other experimental hormonal drugs, or drugs that target a cell growth pathway called mTOR (such as everolimus or temsirolimus), or any CDK4/6 inhibitor.
• People with high cholesterol or high triglycerides that are not adequately controlled with treatment.
• People with a history of, or current signs of, a lung condition called interstitial lung disease or pneumonitis.
• People with significant active infections that are not under control (note: people living with HIV who are on effective treatment with an undetectable viral load may still be eligible — confirm with trial site).
• People with hepatitis B who do not have an undetectable viral load while on appropriate treatment.
• People with hepatitis C who have not been successfully treated and cured, unless they are currently on treatment and their viral load is undetectable.
• People who are pregnant or currently breastfeeding; people of childbearing potential must have a negative pregnancy test at the screening stage.
• People with another current or previous cancer whose history or treatment could interfere with the safety or results of this trial.
• People who have had major surgery within 4 weeks before joining the trial.
• People who are unable to swallow tablets or capsules, or who have a condition affecting how the body absorbs medication through the digestive system.
• People with a known allergy or intolerance to either of the study drugs or their ingredients.
• People with a serious medical or psychiatric condition that, in the medical team's judgement, would prevent safe participation in the trial.
• People with uncontrolled low levels of magnesium or potassium in the blood that cannot be corrected with supplements.
• People with untreated or currently active cancer spread to the brain or spinal cord (note: people with previously treated brain metastases may be eligible if they meet several specific conditions — confirm with trial site).
• People who are unable to attend follow-up visits or comply with the trial requirements.
• People currently taking, or who have recently taken, certain medications that strongly affect how the body processes the study drugs, including some herbal supplements such as St. John's Wort, ginkgo biloba, ginseng, and others (confirm with trial site for the full list and timing requirements).
• People with any other significant medical condition, laboratory finding, or physical finding that, in the medical team's judgement, would make participation unsafe or affect the reliability of the trial results.

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