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 endometrial cancer with a specific genetic change called an ARID1A loss-of-function mutation, confirmed by an approved genetic test and verified by the lead doctor before joining.
• People who have at least one tumour that can be measured using scans or physical examination, meeting specific size requirements set by the trial.
• People who have previously received at least one chemotherapy treatment for their endometrial cancer (prior hormone therapy is also allowed, with no waiting period required after stopping it).
• People who have previously received an immunotherapy drug that targets the PD-1 or PD-L1 pathway at any stage of their treatment (up to 12 participants who have not had this type of immunotherapy may also be considered).
• People aged 18 or older.
• People whose general physical functioning falls within an acceptable range, as assessed using a standard scale called the ECOG performance status (scores of 0, 1, or 2).
• People who can provide a stored tissue sample from their cancer — either a tissue block or 15 prepared slides from a previous surgery or biopsy.
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning within the levels required by the trial.
• People who are not pregnant at the time of screening, and who agree to use effective contraception during the trial and for a defined period after their last dose (at least 30 days after the last avelumab dose and at least 6 months after the last M1774 dose); this applies to people who could become pregnant and have not had surgery to prevent pregnancy or reached menopause.
• People who are able to understand and willing to sign a written consent form agreeing to take part.

Who may not be able to join:

• People who have received chemotherapy, immunotherapy, another experimental treatment, or radiation therapy within the 4 weeks before starting the trial (or within 6 weeks for certain specific chemotherapy drugs).
• People who still have side effects from previous cancer treatments that have not improved to a mild level (Grade 1 or lower), unless the trial doctors consider those effects stable and not a safety concern.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord (a condition called meningeal carcinomatosis); people with treated and stable brain metastases who have been off corticosteroids for more than 14 days, or are on a stable or decreasing steroid dose, may be considered (confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or higher) to avelumab, M1774, or similar antibody-based medicines, or who have a history of anaphylaxis or uncontrolled asthma.
• People who have an active or uncontrolled infection, with some exceptions for people with well-controlled HIV, hepatitis B, or treated and cured hepatitis C (confirm with trial site).
• People currently taking immune-suppressing medications within 7 days before joining, with some exceptions for low-dose or locally applied steroids (confirm with trial site).
• People with an active autoimmune disease that may worsen when stimulated by immunotherapy; people with Type 1 diabetes, vitiligo, psoriasis, or thyroid conditions that do not require immune-suppressing treatment may still be considered.
• People who have had an organ transplant or bone marrow transplant using donor cells.
• People with serious bowel problems, such as a bowel blockage within the last 4 weeks, uncontrolled diarrhoea in the last 4 weeks, or a history of inflammatory bowel disease.
• People with psychiatric or personal circumstances that the trial doctors believe would make participation unsafe or unsuitable, including active or recent (within the past year) thoughts of self-harm or suicide.
• People with serious heart or blood vessel problems, including poorly controlled high blood pressure, significant heart failure, uncontrolled heart rhythm problems, unstable chest pain, a heart attack, a stroke, or a related procedure within the 180 days before starting treatment.
• People with a known problem with alcohol or drug misuse.
• People with a history of another cancer, unless they have been free of that cancer for at least 5 years, or the trial doctors consider the risk of it returning to be low; certain early-stage skin and cervical cancers diagnosed and treated within the past 5 years may still be eligible (confirm with trial site).
• People with other serious ongoing medical conditions or abnormal lab results that, in the opinion of the trial doctors, would make participation unsafe.
• People who have received a live vaccine within 4 weeks before starting treatment, or who plan to receive one during the trial; inactivated (non-live) vaccines are permitted.
• People who are currently using herbal or natural remedy products, including St. John's Wort, ginkgo biloba, ginseng, and others listed by the trial.
• People who are taking certain medications that strongly affect how the trial drugs are processed by the body (specific enzyme inhibitors or inducers, or proton pump inhibitors) within 7 days before starting treatment.
• People who are pregnant or breastfeeding; breastfeeding would need to be stopped if a participant is treated, and should not resume for at least 1 month after the last treatment.
• People whose heart electrical reading (QTc interval) is above a certain level on an ECG that does not improve after correcting any related issues.

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