This trial is looking at a drug called MK-2870 for cancer of the digestive system
Cancer type:
Status:
Phase:
This trial is looking at MK-2870 by itself or in combination with other drugs for some cancers of the .
It is open for people with the following cancers that have spread to another part of the body or cannot be removed by surgery:
- bowel cancer
- pancreatic cancer
- bile duct cancer. The team have enough people in this group. It is now closed to recruitment.
- gallbladder cancer. The team have enough people in this group. It is now closed to recruitment.
Bile duct cancer and gallbladder cancer are also called biliary tree cancers.
More about this trial
Your doctor will consider a number of factors when discussing treatment options for advanced cancer of the:
Researchers think that a drug called MK-2870 might help people with these .
MK-2870 is an . It is made up of a
and a
. The monoclonal antibody finds the cancer cells and attaches to them. The chemotherapy is then delivered into the cancer cells and kills or damages them.
In this trial, people with bowel cancer will have MK-2870 with fluorouracil (5FU) and leucovorin. People with pancreatic cancer, bile duct cancer and gallbladder cancer will have MK-2870 on its own.
The main aims of the trial are to find out:
- how well the combination of 5FU, leucovorin and MK-2870 works for bowel cancer
- how well MK-2870 works for pancreatic cancer, bile duct cancer and gallbladder cancer
- more about the side effects of MK-2870 by itself and in combination with 5FU and leucovorin
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 you have an of one of the following cancers:
- bowel cancer that has spread to another part of the body (stage 4) or cannot be removed by surgery. Your doctor has tested the cancer cells and the results show that it is not
MMRd or
MSI high . You have had treatment with 5FU and oxaliplatin.
- pancreatic duct cancer that has spread to another part of the body or cannot be removed by surgery. You have had 1
course of treatment that included the chemotherapy drug gemcitabine.
- bile duct cancer that has spread to another part of the body or cannot be removed by surgery. You have had 1 course of treatment that included the chemotherapy drug gemcitabine or 2 courses of treatment that included gemcitabine with a
targeted drug or an
immunotherapy .
- gallbladder cancer that has spread to another part of the body or cannot be removed by surgery. You have had 1 course of treatment that included the chemotherapy drug gemcitabine or 2 courses of treatment that included gemcitabine with a targeted drug or an immunotherapy.
And all of the following apply. You:
- have an area of cancer that the doctor can measure
- have a sample of tissue (
biopsy ) that the trial team can access and use
- have satisfactory blood test results
- are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during treatment and for a period of time after treatment 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 where the bile duct and duct of the pancreas join and empty into the intestine (ampullary cancer)
- have cancer spread to the brain, spinal cord or the tissue surrounding the brain. You can join if you had treatment for the cancer spread, if it is now stable and you have not had steroids for at least 2 weeks before starting the trial treatment.
- have ongoing side effects from previous treatment. This is apart from mild side effects and mild to moderate side effects that affect the nerves.
- have had another cancer in the past 3 years that needed treatment or was getting worse. This is apart from successfully treated
non melanoma skin cancer and any
carcinoma in situ except for carcinoma in situ of the bladder.
- have fluid around the abdomen (ascites), lung (pleural effusion) or heart (pericardial effusion) that needs treatment by draining or medication within 2 weeks of joining the trial
- have cancer treatment, including as part of another clinical trial, within 4 weeks of starting trial treatment
- have had treatment with another
antibody drug conjugate that works in a similar way to MK-2870. Your doctor will know about this.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had eye problems such as severe dry eye syndrome, severe Meibomian gland disease or swollen, itchy eyelids. Or you have problems with the outer layer of your eye (cornea) healing.
- have an active inflammatory bowel disease that needs treatment with medication, such as
steroids , that damps down the
immune system . Or you have a history of inflammatory bowel disease such as Crohn’s disease, ulcerative colitis or ongoing (chronic) diarrhoea.
- had a heart attack, congestive heart disease, unstable chest pain (angina) or any other major
heart problem in the past 6 months
- have HIV that is not well controlled by medication. You cannot join the trial if you have, or have had, Kaposi’s sarcoma or Multicentric Castleman’s Disease due to your HIV.
- have active hepatitis B and active hepatitis C
- have another active infection that needs treatment that reaches your whole body such as an antibiotic infusion or antibiotic tablets
- have taken medication that affects the
CYP enzymes within 2 weeks of starting treatment. Your doctor will know about this.
- have radiotherapy within 2 weeks of starting treatment. If you have radiotherapy to relieve symptoms (palliative radiotherapy) it is within a week of starting treatment.
- have ongoing side effects from radiotherapy
- have an
immune system that is not working well. Or you are taking medication that damps down the immune system, apart from a small dose of steroids, within a week of starting treatment.
- have had a stem cell or bone marrow transplant from a donor (
allogeneic transplant )
- have had an
organ transplant - have not recovered from previous surgery or you have ongoing complications from surgery
- have any other medical condition, mental health condition or other circumstances that could affect you taking part in the trial
Other
You cannot join this trial if any of these apply. You:
- are allergic or very sensitive to MK-2870, any of its ingredients or similar drugs
- have a
live vaccine within 30 days of starting trial treatment. You can have the seasonal flu and COVID-19 vaccines as they are not live vaccines.
- are pregnant or breastfeeding
Trial design
This is a phase 1 and phase 2 trial. It is an international trial. The team need 130 people worldwide to take part, including 7 people from the UK.
There are 3 groups in this trial. People with:
- bowel cancer
- pancreatic cancer
- biliary tree cancers. This is people with bile duct cancer or gallbladder cancer. The team have enough people in this group. It is now closed to recruitment.
People with bowel cancer
You have fluorouracil (5FU), leucovorin and MK-2870.
The first few people to take part have a low dose of MK-2870 with 5FU and leucovorin. If they don’t have any bad side effects, the next few have a higher dose of MK-2870 with 5FU and leucovorin. And so on until they find the best dose. The best dose is the one that has the fewest side effects. This is a dose escalation study.
When the team find the best dose of MK-2870 to give with 5FU and leucovorin, everyone will have that dose of MK-2870.
You have 5FU, leucovorin and MK-2870 as a drip into a vein every 2 weeks.
You continue treatment as long as it is working and the side effects aren’t too bad.
People with pancreatic cancer
You have the best dose of MK-2870 by itself. You have it every 2 weeks as a drip into a vein. You continue having MK-2870 as long as it is helping you and the side effects aren’t too bad.
Samples for research
The trial team take blood samples. Where possible they will take these samples when you have blood taken as part of your routine care. The team will use these blood samples to find out:
• what happens to MK-2870 in the body
• how MK-2870 affects the body
The team ask for a piece of a previous sample of tissue (). If this is not available, they will take a fresh biopsy. They will use this sample to find out more about these cancers and how to treat them.
Hospital visits
You see the doctor to have tests before taking part. The tests include:
- a
physical examination - blood tests
- urine test
- CT scan or MRI scan
- heart trace (ECG)
- heart scan (ECHO or
MUGA )
During treatment you see the doctor regularly. This is for blood tests and to see how you are. You then see the doctor:
- at the end of treatment
- a month later
- at 8 weeks after treatment
- at 12 weeks after treatment
You have a CT scan or MRI scan:
- every 8 weeks up to 48 weeks and then
- every 12 weeks
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.
You might have an allergic reaction while having MK-2870. The signs include:
- a skin rash, itching, flushing or hives
- wheezing and difficulty breathing
- feeling dizzy and fainting
- swelling of the mouth, tongue, throat, face or eyes
- a fast pulse
- sweating
- chills
Tell your nurse straight away if you have any of above. The team will also be monitoring you closely during treatment.
MK-2870 is a new drug and there might be side effects we don’t know about. The most common side effects we do know about include:
- a drop in the number of blood cells causing an increased risk of infection, bleeding, bruising, breathlessness and tiredness
- changes to how the liver works which might mean there are liver problems such as inflammation
- an increase of enzymes in the blood that might mean an infection or damage to tissue
- inflammation of the mouth and
digestive system - feeling or being sick
- skin rash
- hair loss
- an increase of sugar in the blood
- loss of appetite, weight loss or both
- sore throat
We have information about fluorouracil (5FU) and its possible side effects.
Your doctor will talk to you about the possible side effects of the treatments and answer any questions you may have before you agree to take part in the trial.
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 Marco Gerlinger
Supported by
Merck Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040