“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of MK-1775 with chemotherapy for ovarian cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called MK-1775 alongside paclitaxel and carboplatin for ovarian cancer that has come back.
Unfortunately, ovarian cancer can come back after surgery and chemotherapy. If this happens, you may have more chemotherapy. But researchers are looking for ways to improve treatment for ovarian cancer that has come back. In this trial, they are looking at a drug called MK-1775 alongside chemotherapy.
Some cancer cells have a particular change (a
The women taking part in this trial have tumours that have a particular mutation to the p53 gene. They also have cancer that responded to treatment with
The aims of the trial are to
- See if adding MK-1775 to chemotherapy helps women who have platinum sensitive ovarian cancer with a particular change to the p53 gene
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has got worse after having chemotherapy with a
- Have cancer that didn’t start getting worse for at least 6 months after you finished platinum chemotherapy
- Have recovered from the side effects of any other treatment (apart from hair loss) unless they are very mild
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are at least 18 years old
To be able to take part in this trial, the researchers must be able to test a sample of your cancer to see if it has a particular change to the p53 gene.
You cannot enter this trial if you
- Have cancer that is a borderline tumour or is low grade and very unlikely to spread – your doctor can explain this to you
- Have cancer that has spread to your brain or spinal cord (central nervous system) unless it has been successfully treated, has not got worse in the last month, and if you took steroids, you have now stopped or have been on a stable dose for at least 2 weeks
- Have already had more than 3 different types of chemotherapy that included a platinum drug
- Have had radiotherapy or biological therapy in the last 4 weeks
- Have had another experimental drug in the last 4 weeks
- Are known to be very sensitive to any of the drugs in the trial
- Have a build up of fluid in your tummy (
ascites) or in your lungs (pleural effusion) that is causing symptoms
- Have had drugs that affect body substances called cytochrome P (CYP) enzymes in the last 2 weeks – your doctor can confirm this
- Have had problems with drugs or alcohol in the last year
- Are known to have HIV, hepatitis B or hepatitis C
- Have any other medical condition or mental health problem that the trial doctors think could affect you taking part
- May have a condition called Li Fraumeni syndrome – your doctors can tell you if they think you might have this condition
- Are pregnant or breastfeeding
This phase 2 trial will recruit 119 women. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
Half the women taking part have paclitaxel, carboplatin and MK-1775. The other half have paclitaxel, carboplatin and a dummy drug (
You have paclitaxel and carboplatin through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. MK-1775 (and the dummy drug) is a capsule that you swallow. You take them 5 times in each cycle of treatment. You keep a diary at home to note down exactly when you take the capsules.
As long as you don’t have bad side effects, you can have up to 6 cycles of treatment.
You see the trial team and have some tests before you start treatment. The tests include
The trial team will get a sample of tissue that was removed when you had surgery or a
During treatment, you go to hospital once a week. You have regular blood tests. You have a CT or MRI scan every 6 weeks.
When you finish treatment, you see the trial team a month later and have a physical examination and blood tests. You then see them and have a CT or MRI scan every 6 weeks or every 3 months, depending on how your cancer responded to treatment. Your doctor will explain this to you.
As MK-1775 is a new drug, there may be side effects we don’t know about yet. In other trials, the most common side effects have been
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Tiredness (fatigue)
- Feeling or being sick
- Loss of appetite
- High temperature (fever)
- Sore mouth
- Tummy (abdominal) pain
How to join a clinical trial
Dr Susie Banerjee
Experimental Cancer Medicine Centre (ECMC)
Merck, Sharp & Dohme
NIHR Clinical Research Network: Cancer