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A study of tirzepatide and levonorgestrel in women with endometrial cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on the treatment of endometrial adenocarcinoma, which is a type of cancer that begins in the lining of the uterus. The research aims to evaluate the effects of the medication tirzepatide, also known by the brand name Mounjaro, in people living with this condition. Additionally, the study involves the use of levonorgestrel through a Mirena intrauterine delivery system, which is a small device placed inside the uterus to release medicine.

The purpose of the study is to determine how well patients respond to these treatments over a specific period. Participants may receive different doses of Mounjaro administered via subcutaneous injection, which is a method of delivering medication just under the skin. The study will monitor several factors, including the pathologic complete response, which refers to the total disappearance of cancer cells in a tissue sample, and changes in weight. The course of the study involves regular follow-up assessments to track the progress of the disease and the safety of the medications used.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of treatment
The treatment begins after being assigned to a specific group. you will receive an injection under the skin once a week using a mounjaro kwikpen.
The amount of the mounjaro medication will be determined by the assigned group and may be 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per dose.
You may also use the mirena intrauterine delivery system, which is a device placed inside the uterus to release levonorgestrel.
Step 2
Ongoing monitoring and assessments
Your quality of life will be assessed at 12 weeks and 24 weeks during the trial.
The progress of the endometrial cancer and your weight loss will be monitored throughout the study period.
Step 3
Final assessment
At 12 months (approximately 52 weeks) after being assigned to a group, a final assessment is conducted.
This includes a biopsy, which is a procedure to take a small sample of tissue from the lining of the uterus, to check for the absence of cancer or abnormal cell growth.
A quality of life assessment is also completed at this 12-month mark.

Who can join the trial?

15 criteria

You must have a confirmed diagnosis of endometrioid adenocarcinoma, which is a specific type of cancer starting in the lining of the uterus, that is grade 1 or 2 (meaning the cancer cells look somewhat like normal cells and are not growing very aggressively).
Your cancer cells must show p53 WT (meaning the p53 gene is normal and not mutated) and be MMR proficient (meaning your body's natural system for fixing DNA errors is working correctly).
Your level of CA125, which is a protein in the blood that can sometimes be a marker for cancer, must be 30 U/mL or less.
You must not have any hypersensitivity (an allergic reaction) or reasons why you cannot use an LNG-IUS (a small device placed in the uterus that releases hormones) or GLP-1 agonists (a type of medication used for blood sugar or weight management).
You must not have severe liver disease, a history of breast cancer, an active pelvic inflammatory disease (an infection in the reproductive organs), or a congenital uterine abnormality (a uterus that formed differently from birth).
You must be able to undergo endometrial biopsies, which are small samples taken from the lining of the uterus, every three months as required.
A team of gynaecological specialists must agree that you are not a suitable candidate for radiotherapy (using radiation to treat cancer).
If you have not yet reached menopause, or if you reached menopause less than two years ago, you must have a negative pregnancy test.
You must not have an LNG-IUS device currently in place, or if you do, it must have been inserted more than 6 weeks before joining the study.
You must be able to provide written informed consent, which means signing a document that shows you understand and agree to take part in the study.
You must have a BMI (Body Mass Index, a measure of body fat based on height and weight) greater than 27 if you have other health issues like diabetes, hypertension (high blood pressure), cardiovascular disease (heart disease), or obstructive sleep apnoea (breathing stops during sleep), or a BMI greater than 30 if you have no other health issues but are at risk of complications from surgery or have chosen not to have immediate surgery.
You must be at least 18 years old at the time you are assigned to a study group.
Imaging tests, such as a CT scan (a detailed X-ray) or a chest X-Ray, must show that the cancer has not spread outside the uterus.
An MRI scan must show that the cancer has invaded the myometrium (the muscle layer of the uterus) by 50% or less.
Your biopsy must show no lymph vascular invasion, which means the cancer cells have not been found inside the blood or lymph vessels.

Who cannot join the trial?

34 criteria

You cannot participate if your ECOG performance status is 3 or higher, which is a scale used by doctors to measure how much your illness affects your ability to perform daily activities and physical tasks.
You are excluded if you have obesity (being significantly overweight) caused by other endocrine disorders, which are problems with the body's hormone-producing glands, such as Cushing syndrome.
You cannot join if you have used medications in the last 3 months that cause significant weight gain, such as systemic corticosteroids (steroid medicines), certain antidepressants, atypical antipsychotics (medicines used to treat certain mental health conditions), or mood stabilizers (medicines used to manage extreme mood swings).
You are excluded if you have a specific type of endometrioid adenocarcinoma (a type of cancer starting in the lining of the uterus) that is grade 1 or 2 and has spread deeper than 50% into the myometrium (the muscular wall of the uterus) as seen on an MRI (a medical imaging test), or if you have grade 3 endometrioid adenocarcinoma.
You cannot participate if you have been part of a clinical trial for weight control within the last 3 months.
You are excluded if you have had surgical treatment for obesity in the past, though liposuction (fat removal surgery) is allowed if it was done more than one year ago.
You cannot join if you have a history of major depressive disorder, a high score on the PHQ-9 (a standard questionnaire used to screen for depression severity), other severe psychiatric disorders like schizophrenia or bipolar disorder, or an eating disorder such as bulimia or binge eating.
You are excluded if you have a history of a suicide attempt or any suicidal behavior within the past month.
You cannot participate if you have a major surgery scheduled during the time of the study.
You are excluded if you have impaired liver function, which is measured by high levels of aspartate aminotransferase or alanine aminotransferase (enzymes that indicate liver health) in your blood.
You cannot join if you have impaired renal function, which means your kidneys are not filtering blood as well as they should, measured by a value called eGFR.
You are excluded if imaging shows extra-uterine extension, which means the cancer has spread outside of the uterus.
You cannot participate if you have significant cardiovascular disease, such as unstable angina (chest pain), a history of myocardial infarction (heart attack), arrhythmias (irregular heartbeats), conduction delays (problems with the heart's electrical signals), stroke, or heart failure.
You are excluded if you have uncontrolled hypertension, which is high blood pressure.
You cannot join if there is known or suspected abuse of alcohol or narcotics (strong pain medications or illegal drugs).
You are excluded if your cancer has MMR deficiency or p53 mutation, which are specific genetic changes found in certain cancer cells.
You cannot participate if there is a language barrier, if you have difficulty understanding the study, or if you are unable to complete the required mental health questionnaires.
You are excluded if you have a history of breast, thyroid, or colon cancer.
You cannot join if you have any other current cancer, except for certain types of skin cancer like basal cell or squamous cell carcinoma.
You are excluded if you are breastfeeding.
You cannot participate if your cancer is a different cell type than endometrioid adenocarcinoma, such as sarcomas or high-risk types like papillary serous or clear cell cancer.
You are excluded if you are pregnant or planning to become pregnant during the study.
You cannot join if you have a uterine anomaly, which is a physical abnormality in the shape or structure of the uterus.
You are excluded if you have had prior treatment for EAC (endometrial adenocarcinoma).
You cannot participate if you have a history of pelvic or abdominal radiotherapy (using radiation to treat cancer in the lower belly area).
You are excluded if you are unwilling to have additional endometrial biopsies (taking a small sample of the uterine lining) or cannot attend monthly check-ups.
You cannot join if you are unable to provide informed consent (legal permission to participate) or complete the necessary forms.
You are excluded if you have a history of severe gastrointestinal disease, gastroparesis (slow stomach emptying), or dysmotility (problems with how food moves through the digestive system).
You cannot participate if you have acute pelvic inflammatory disease, untreated sexually transmitted diseases, or genital infections.
You are excluded if you have genital actinomycosis (a specific type of bacterial infection).
You cannot join if you have a history of pancreatitis (inflammation of the pancreas).
You are excluded if you have been diagnosed with Type 1 diabetes.
You cannot participate if you have used GLP-1 receptor agonists (a type of medication often used for diabetes or weight loss) within the last 3 months.
You are excluded if your thyroid-stimulatory hormone (TSH) levels are outside the normal range.

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St Vincent's University Hospital
Dublin, Ireland

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Investigated drugs

Mounjaro
is an injectable medication used in this study to evaluate its effectiveness in treating endometrial cancer.
Mirena
is a small device placed inside the uterus that releases a hormone to help treat the cancer being studied.

What is already known about the treatment

Tirzepatide
This medication is a type of glucose-lowering drug that is administered through a weekly injection under the skin. It is currently used in medical practice to help manage blood sugar levels in people with type 2 diabetes and to assist with weight management. The substance works by mimicking two natural hormones in the body that regulate appetite and insulin production, effectively signaling the brain to feel full and helping the pancreas release insulin.
Levonorgestrel
This medication is a synthetic version of a natural female hormone and is delivered through a small device placed inside the uterus. It is widely used in medicine as a form of long-term hormonal contraception to prevent pregnancy. It works by preventing the ovaries from releasing an egg and by thickening the mucus in the cervix to block sperm from reaching an egg.

Investigated diseases

Endometrial adenocarcinoma - This is a type of cancer that originates in the lining of the uterus. It typically develops when cells in the uterine lining grow and multiply uncontrollably. The disease often begins with changes in the thickness or structure of the uterine lining. As it progresses, these abnormal cells can spread within the uterus or to nearby tissues. It is the most common form of uterine cancer.