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 female and at least 18 years old at the time of signing the consent form
• People who have been diagnosed with a specific type of early-stage uterine cancer (Stage 1, low-to-moderate grade endometrioid endometrial adenocarcinoma) that has a particular genetic feature called MMR deficiency, confirmed through lab testing of tumour tissue
• People who either want to keep their uterus or who are not suitable for surgery to remove it
• People who are well enough to carry out basic daily activities (a general health scale used by doctors would rate them at a level of 2 or below, confirm with trial site)
• People whose cancer does not appear to have spread beyond the uterus, based on physical examination and medical imaging
• People whose blood tests show that their bone marrow, liver, kidneys, and blood clotting are working adequately (specific lab value thresholds apply — confirm with trial site)
• People who are post-menopausal, confirmed through a hormone blood test at screening, or people of childbearing potential who test negative for pregnancy before each treatment cycle and agree to use a reliable form of contraception (such as the oral contraceptive pill or a hormonal IUD) from screening until at least 4 months after the last dose of study treatment — people who do not have heterosexual intercourse as part of their usual lifestyle do not need to use contraception
• People with Type 1 or Type 2 diabetes who have their condition well managed through medication and/or diet, with a specific blood sugar marker (HbA1c) below 8.5% at screening, and who are willing to monitor their blood sugar levels at home during the study
• People with normal blood pressure, or those whose high blood pressure is well managed and controlled
• People who are willing and able to give written consent and take part for the full duration of the study

Who may not be able to join:

• People whose uterine cancer is a type other than endometrioid adenocarcinoma — for example, sarcoma, papillary serous, or clear cell types
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial period
• People who have previously received an organ or tissue transplant from another person
• People with uncontrolled high blood pressure, a history of hypertensive crisis or hypertensive brain condition, a specific heart rhythm abnormality at baseline (QTc above 450), or serious heart or blood vessel conditions such as stroke, mini-stroke, heart attack, unstable angina, severe heart failure, or uncontrolled irregular heartbeat within the past 6 months (rate-controlled arrhythmia may be considered at the investigator's discretion)
• People who are considered at high medical risk due to an uncontrolled medical condition, serious non-cancer illness, or an active infection requiring intravenous antibiotics in the past 2 weeks — this includes conditions such as active lung inflammation (non-infectious), uncontrolled seizures, unstable spinal cord compression, a major vein blockage in the chest, or a psychiatric or substance use condition that would prevent participation
• People who have an immune system deficiency, or who have been taking high-dose steroid medication or other immune-suppressing treatments within 7 days before the study starts
• People with an active autoimmune disease that has required systemic medical treatment in the past 2 years (note: standard hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment for this purpose; inhaled steroids, steroid eye drops, and local steroid injections are also permitted)
• People who have had COVID-19 or influenza A or B within 3 months before screening
• People who have received a blood product transfusion (including red blood cells or platelets) within 21 days before the first dose of study treatment
• People who have had major surgery within 4 weeks before signing the consent form
• People who have previously had serious side effects from immunotherapy treatment, including severe immune-related reactions, serious neurological events of any severity, serious skin reactions, or heart muscle inflammation of any severity
• People who have taken part in another clinical trial involving an investigational medicine or device within 30 days or 5 half-lives before the study starts (whichever is later) — a hormonal IUD is excepted
• People who currently have another cancer, or who have had a previous non-uterine invasive cancer and have not been cancer-free for more than 5 years since finishing treatment (non-melanoma skin cancers and fully treated in-situ carcinomas are generally permitted)
• People with a known history of HIV, or who test positive for HIV at screening
• People with known active Hepatitis B or C (people who have been fully and curatively treated with no detectable virus remaining may be considered)
• People who are known to be allergic to the study drug or any of its ingredients
• People with a history or current diagnosis of a lung condition called interstitial lung disease
• People who have received or are scheduled to receive a live vaccine within 30 days before the first dose of study treatment, during treatment, or within 180 days after the last dose
• People who are unwilling or unable to follow the study requirements, including attending follow-up appointments
• People with any condition that would make tumour or blood sampling procedures unsafe or not possible

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