A trial looking at MK-2870 for cancer of the womb (MK-2870-005)
Cancer type:
Status:
Phase:
This trial is comparing MK-2870 with chemotherapy for womb cancer that has come back after treatment.
It is open to women who can’t have surgery or radiotherapy to treat their womb cancer.
More about this trial
Doctors are looking at ways to improve treatment for womb cancer. In this trial they are looking at a new drug called MK-2870. The researchers are comparing this with standard chemotherapy drugs used to treat womb cancer that has come back. These drugs include doxorubicin or paclitaxel chemotherapy.
MK-2870 is a type of drug called an
- a
monoclonal antibody drug - a chemotherapy drug called KL610023
MK-2870 finds a protein called TROP2 on the cancer cells. It attaches itself to the protein. It then releases the KL610023 chemotherapy into the cancer cell. This kills or damages the cancer cell.
The main aims of the trial are to find out:
- how safe it is to have MK-2870
- which treatment works better
- what the side effects are
- how treatment affects quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have womb cancer or carcinosarcoma of the womb
- have cancer that your doctor can see on a scan
- have a sample of tissue (
biopsy ) from a previous sample that the team can use to do some tests on. Or you are willing to have a new sample taken if a previous sample isn’t available. - have had chemotherapy that included a
platinum drug or you have had animmunotherapy . Or you have had these treatments together. - are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a period after if there is any chance you could become pregnant
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you have had treatment, the cancer is stable and you have stopped taking steroids.
- have neuroendocrine cancer of the womb or sarcoma of the womb. Your doctor will know this.
- are suitable to have surgery or
radiotherapy with the aim to cure - have womb cancer or carcinosarcoma of the womb that came back more than 6 months after finishing treatment with the aim to cure. And this treatment included a
platinum drug . You can’t take part if you needed more treatment that included a platinum drug for cancer that had come back or spread. - have had more than 3
courses of treatment for womb cancer. Your doctor checks which treatment you have had. - have had treatment with a drug that works in the same way as MK-2870
- have had another cancer treatment within 4 weeks of being put into a treatment group or it hasn’t cleared from your body yet
- have had radiotherapy within 2 weeks of starting trial treatment or you have side effects from radiotherapy that meant you needed to take steroids
- have moderate to severe side effects from past cancer treatments. This doesn’t apply if you have hair loss or white patches on your skin.
- have another cancer that is getting worse or needed treatment in the last 3 years. You can take part if you had successfully treated
basal cell skin cancer ,squamous cell skin cancer or early cancer of the bladder.
Medical conditions
You cannot join this trial if any of these apply. You:
- have moderate to severe numbness and tingling in your hands or feet (
peripheral neuropathy ) - have severe dry eyes, inflammation of the eyelids or a problem with the clear covering in your eye (cornea)
- have inflammatory bowel disease and you are taking medication to damp down the
immune system or you have had inflammatory bowel disease in the past - have had a heart attack in the last 6 months or a significant
heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. - have had a
stroke in the last 6 months - take medication that affects substances in the body called CYP enzymes within 2 weeks of starting trial treatment. Your doctor can tell you more about this.
- have HIV unless you are having treatment and it is under control. You can’t take part if you have had Kaposi’s sarcoma or a disease called multicentric Castleman’s disease. Your doctor will know this.
- have active hepatitis B or hepatitis C unless you have had or are having treatment and it is under control. You can’t take part if you have both hepatitis B and hepatitis C.
- have another active infection that needs treatment to the whole body
- are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 4 weeks of being put in a treatment group for this trial.
- have had major surgery and you aren’t better yet
- have any other medical condition or mental health problem that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have had a
live vaccine within 30 days of the start of treatment. Please note that the approved COVID-19 vaccines are allowed as they aren’t live. - have a problem with drugs or alcohol
- are allergic to MK-2870, similar drugs, any of the other treatments in the trial or anything they contain
- are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The team need to find 710 people to take part including 34 from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have 1 of the following:
- MK-2870
- doxorubicin or paclitaxel chemotherapy (standard treatment)
MK-2870 (new treatment)
You have MK-2870 as a drip into a vein. You have it once every 2 weeks. Each hospital visit takes about 3 hours to 6 hours. Some visits might take longer.
You have MK-2870 as long as it is working and the side effects aren’t too bad.
Doxorubicin or paclitaxel chemotherapy (standard treatment)
Your doctor will talk to you about which treatment they think will work best. You have doxorubicin or paclitaxel as a drip into a vein.
You have doxorubicin once every 3 weeks.
You have paclitaxel once a week for 3 weeks. You then have a week when you don’t have paclitaxel.
You have doxorubicin or paclitaxel for up to 6 months.
Each hospital visit takes about 3 hours. Some visits might take longer.
Both groups
You stop treatment if your cancer gets worse. The trial doctor will talk to you about other treatment options.
Samples for research
The researchers might ask to take a tissue sample (
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about womb cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - see what happens to MK-2870 in the body
Quality of life
The trial team ask you to fill out some questionnaires:
- before you start treatment
- at set times during treatment
- at set times during follow-up
You do this on a small electronic handheld device. The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor and have some tests before you can take part. These include:
- blood tests
- urine tests
- a
physical examination - heart trace (ECG)
- heart scan (echocardiogram) or
MUGA scan - CT scan or MRI scan
- bone scan (your doctor will decide if you need it)
You have all your treatment at the hospital in the outpatient department. During treatment you see the doctor regularly. This is for blood tests and to see how you are.
Trial scans
You have a CT or MRI scan:
- every 2 months for the first year
- every 3 months after that
You stop having scans as part of the trial if your cancer gets worse.
Follow up visits
When you stop treatment, you see the trial team one month later for a check up.
The team then check how you are getting on every 8 weeks. You might see them at a routine hospital appointment. Or they may call you or check your medical notes to see how you are.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
MK-2870 is a new drug so we don’t know what all the side effects are. The most common side effects we know about so far include:
- a drop in the number of blood cells causing an increased risk of infection, tiredness, breathlessness, bruising or bleeding
- liver changes
- high levels of an enzyme which may show tissue injury or that there is an infection
- sore mouth or throat
- inflammation of the lining of the mouth and
digestive system - feeling or being sick
- skin rash
- hair loss
- high levels of sugar in the blood
- loss of appetite
- tiredness (fatigue)
- some areas of skin becoming darker than others
There is a risk that MK-2870 could cause an allergic reaction needing treatment. Symptoms of an allergic reaction include difficulty breathing, a fast pulse, fainting, sweating, tiredness, swelling of the face, lips, mouth, tongue or throat.
You have medication before each MK-2870 treatment. This is to help stop an allergic reaction. Your nurse keeps a close eye on you during treatment. They will treat any symptoms straight away.
Your doctor will talk to you about all the side effects of treatment. You will have a chance to ask them any questions you may have.
We have more information about the following drugs and their side effects:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Shibani Nicum
Supported by
Merck Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040