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:

Ovarian cancer

Status:

Closed

Phase:

Phase 2

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 (placebo Open a glossary item) 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:

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 Open a glossary item 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 Open a glossary item 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. 

Diagram for PankoMab-GEX trial design

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 genes Open a glossary item 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 Open a glossary item)
  • 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:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Jonathan Ledermann

Supported by

Glycotope

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13406

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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