A trial of PankoMab-GEX for ovarian cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at using PankoMab-GEX after chemotherapy for ovarian cancer that has come back. It is for women who have:
These cancers are treated in a similar way. When we use the term ovarian cancer in this summary, we are referring to all 3.
More about this trial
Chemotherapy is a common treatment for ovarian cancer. If your cancer comes back you can have more chemotherapy. But it might stop working. Because of this researchers are looking for a treatment that might help to stop the cancer coming back.
PankoMab-GEX is a type of biological therapy called a monoclonal antibody. To have this drug your cancer needs to be TA-MUC1 positive. PankoMab-GEX targets a molecule called TA-MUC1 on the surface of the cancer cells. This then triggers the immune system to attack and kill the cancer cells.
Your cancer will be tested to see if it has the TA-MUC1 molecule before you can have treatment in this trial.
We know from research that PankoMab-GEX can work for other cancers. Researchers want to find out if PankoMab-GEX can help stop ovarian cancer coming back after chemotherapy.
In this trial PankoMab-GEX will be compared to a dummy drug (
) to find
- how well it works after chemotherapy for ovarian cancer
- how safe it is to give after chemotherapy for ovarian cancer
Who can enter
The following bullet points list 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.
You may be able to join this trial if you have one of the following:
- epithelial ovarian cancer
- fallopian tube cancer
- primary peritoneal cancer that is
high grade
And all of the following must apply:
- you have had between 2 and 5 different chemotherapy treatments before starting this treatment
- your cancer had stopped growing or started to go away after your last chemotherapy treatment
- you finished your chemotherapy within 6 weeks of starting treatment in this trial
- you have had treatment with
platinum chemotherapy drugs such as carboplatin and your cancer came back within a year of finishing treatment - you can do everything apart from heavy physical work (performance status 0 or 1)
- you have satisfactory blood test results
- you are willing to use reliable contraception if there is any chance you could become pregnant
- you are at least 18 years old
You cannot join this trial if any of these apply:
- you have cancer spread to the brain
- your cancer continued to grow while having platinum chemotherapy
- your cancer came back a year or more after having platinum chemotherapy
- you have had another cancer apart from successfully treated cancers, and there has been no sign of it for at least 5 years
- you are currently having any anti cancer treatment
- you have had an
monoclonal antibody in the past month - you have had an experimental drug as part of a clinical trial in the past month
- you have had radiotherapy within a month of being randomised
- you have had or planned to have major surgery within a month of being randomised
- you haven’t fully recovered from any previous surgery
- you have had a heart attack in the past 6 months
- you have had congestive heart failure that is causing symptoms or unstable angina in the past 6 months
- you have problems with your heart rhythm or have had a stroke in the past year
- you have an infection that needs treatment
- you have HIV, hepatitis B or hepatitis C
- you have any other medical condition that could affect you taking part for example unstable diabetes, vena cava syndrome or ongoing lung diseases causing symptoms
- you are taking steroids apart from inhalers, creams or nasal sprays
- you have had an severe allergic reaction to any monoclonal antibody
- you are not able to have any of the medication used in this trial
- your doctor feels you have a problem with alcohol or drugs
- you are pregnant or breastfeeding
Trial design
This is an international phase 2 trial. The team need 210 women to join.
This is a randomised trial. You are put into treatment groups by a computer. Neither you or your doctor can choose which group you are in. And neither you or your doctor will know which group you are in. This is a double blinded trial.
The groups are
- PankoMab-GEX
- dummy drug (placebo)
2 out of every 3 women will have PankoMab-GEX.
You have PankoMab-GEX or the dummy drug as an injection into a vein.
At the start you have 2 treatments a week apart. You then have treatment every 3 weeks. You continue with treatment as long as it is helping and the side effects aren’t too bad.
Quality of life
The trial team will ask you to fill in 2 questionnaires
- at the start of treatment
- every 6 weeks for 18 weeks
- every 9 weeks for 9 months
The questions will ask you about any side effects and how you have been feeling. This is a quality of life study.
Tissue and blood samples
Before you have treatment researchers will test a sample of your cancer tissue that was removed during any surgery you have had. This is to look for the TA-MUC1 molecule. If your cancer has this molecule then you can have treatment with PankoMab-GEX.
The researchers will ask if they can use this sample for additional research to look at the in the cancer to find out more about ovarian cancer and its treatment.
The team will also ask for extra blood samples to find out what happens to PankoMab-GEX in the body. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
Hospital visits
You see the doctor for some tests before taking part. These tests include:
- a physical examination
- blood tests
- urine test
- heart trace (
ECG ) - CT scan or MRI scan
During treatment you see the doctor
- when you start
- a week later
- every 3 weeks
You have the same tests you had before starting treatment apart from the heart trace. You have a CT scan or MRI scan at
- week 8
- week 14
- week 20
- then every 8 weeks for a year
- then every 12 weeks until your cancer starts to grow again
About a month after the end of treatment you see the doctor for the same tests you had at the start. Your doctor will then tell you how often they want to see you.
A member of the trial team will phone you every 3 months for a year if your cancer had started to grow again while having treatment.
Side effects
You can have a reaction to PankoMab-GEX while having it. You will have medication before having PankoMab-GEX to try and stop this happening.
The most common side effects of PankoMab-GEX include:
- feeling or being sick
- shortness of breath
- chills
- high temperature (fever)
- cough
- loss of appetite
Your doctor will talk to you about the side effects before you agree to take part.
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 Jonathan Ledermann
Supported by
Glycotope
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
