A trial looking at MK-2870 for oesophageal, stomach or gastro oesophageal junction cancer
Cancer type:
Status:
Phase:
This trial is comparing a new drug called MK-2870 with standard chemotherapy for cancer that has spread into surrounding tissues or to another part of the body.
It is for people whose cancer is getting worse despite treatment and who have one of the following:
- cancer of the food pipe (oesophagus)
- stomach cancer
- cancer where the food pipe meets the stomach (gastro oesophageal junction cancer)
More about this trial
Cancer that has spread into the surrounding tissues is
You might have
Doctors are looking for ways to improve treatment for people who have these types of cancers. In this trial they are looking at a new drug called MK-2870.
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. The KL610023 kills or damages the cancer cell.
In this trial some people have MK-2870 and some people have
The main aims of the trial are to find out:
- how safe MK-2870 is
- 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
adenocarcinoma of the stomach, oesophagus or cancer that started at the point where your food pipe (oesophagus) joins your stomach (gastro oesophageal junction cancer) - have cancer that has spread into the surrounding tissue and you can’t have surgery to remove it. Or you have cancer that has spread to another part of the body.
- have cancer that your doctor can measure on a scan
- have cancer that got worse after at least 2
courses of treatment with chemotherapy,immunotherapy or a combination of both. Your doctor will check the type of treatment you have had in the past. - have had a
targeted cancer drug called trastuzumab if you have cancer that has a large number of receptors forHER2 . This is HER2 positive cancer. - 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 satisfactory blood test results
- are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- can swallow tablets if you are in the trifluridine and tipiracil chemotherapy group
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner 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 had cancer treatment to the whole body (
systemic treatment ) within a few weeks of starting trial treatment - have had
radiotherapy within a few weeks of starting trial treatment. Or you have side effects from radiotherapy that needed steroids or you have inflammation of the lungs caused by radiotherapy. - are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of being put in a treatment group for this trial.
- have moderate to severe side effects from past treatment. You can take part if you have developed white patches on your skin (vitiligo) or hair loss.
- have had another cancer that has got worse or needed treatment in the past 3 years. You can join if it was successfully treated
non melanoma skin cancer ,early prostate cancer orcarcinoma in situ . You can’t join if it was carcinoma in situ of the bladder.
Medical conditions
You cannot join this trial if any of these apply. You:
- have severe dry eyes, inflammation of the eyelids or a problem with the clear covering in your eye (cornea)
- moderate to severe numbness or tingling in your hands or feet (peripheral neuropathy)
- have inflammatory bowel disease and you are taking medication to damp down the
immune system or you have had an 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 - have fluid on the lung, around the heart or tummy (abdomen) that needed to be drained in the last 2 weeks or you are having medication to treat this
- take medication that affects substances in the body called
CYP enzymes within a few weeks of starting trial treatment. Your doctor can tell you more about this. - have HIV, hepatitis B or hepatitis C unless they are well controlled with medication. Your doctor will know about this. You can’t take part if you have, or have had, both hepatitis B and hepatitis C.
- have any other severe infection that needs treatment
- have had major surgery or a significant injury in the month before starting trial treatment. Or you might need to have surgery during the trial.
- have another medical condition that could affect you taking part in the trial
Other
You cannot join this trial if any of these apply. You:
- have had MK-2870 or similar drugs in the past
- are allergic to MK-2870 or anything it contains. Or you are allergic to another
targeted cancer drug. - have had a
live vaccination within 30 days of starting trial treatment. This does not apply to the approved COVID-19 vaccinations as these aren’t live. - are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The team need 450 people to take part including 12 from the UK.
It is a randomised trial. A computer puts you into a group. 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 (group 1)
- standard chemotherapy (group 2)
MK-2870 group
You have MK-2870 as a drip into a vein. You have it once every 2 weeks.
You have MK-2870 as long as it’s working and the side effects aren’t too bad.
Chemotherapy group
Your doctor will talk to you about which chemotherapy they think will work best. You have one of the following:
You have paclitaxel, irinotecan and docetaxel as a drip into a vein. Trifluridine and tipiracil is a tablet you take by mouth.
You have chemotherapy in
You have irinotecan once every 2 weeks. This is a cycle of treatment.
You have paclitaxel once a week for 3 weeks. You then have a week when you don’t have treatment. This is a cycle of treatment.
You have docetaxel once every 3 weeks. This is a cycle of treatment.
You take trifluridine and tipiracil in a 4 week cycle of treatment as follows:
- days 1 to 5, you take the tablets twice a day
- days 8 to 12, you take the tablets twice a day
- you don’t take the tablets on the other days
How long you have chemotherapy for depends on the drugs you are having. The team can tell you more about this.
Samples for research
The researchers will 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 your type of cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - look for
circulating tumour DNA (ctDNA) in the bloodstream
The team may ask to store any remaining samples away for future research. You do not have to agree to your samples being stored. You can still take part in the trial.
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 after treatment
You complete the questionnaires on a hand held device (tablet) at the hospital. The team will show you how to do this if you need help. 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 tests before you can take part. These include:
- blood tests
- a
physical examination - heart trace (ECG)
- heart scan (echocardiogram) or
MUGA scan - CT scan or MRI scan
You might also need to have a bone scan.
Most people have treatment at the hospital in the outpatient department. If you are in the trifluridine and tipiracil group, you take your tablets at home.
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
Trial scans
You have a CT scan or MRI:
- once every 6 weeks in the first year of the trial and then
- every 9 weeks
You stop having the 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 6 to 12 weeks. You might see them at a routine hospital appointment. Or they may call you or look at your medical notes.
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 of MK-2870 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
- weight loss
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 possible side effects of treatment. You’ll have a chance to ask 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
Professor Was Mansoor
Supported by
Merck Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040