
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people with cancer of the food pipe (oesophageal cancer) who are going to have chemotherapy for the 1st time.
Treatment for oesophageal cancer depends on where the cancer is and whether it has spread. You might have:
In this trial, doctors are looking at 2 new drugs called durvalumab (MEDI4736) and tremelimumab. Both drugs seek out cancer cells by looking for proteins on the surface of the cancer cells and blocking them so that the immune system recognises them and kills them. Durvalumab and tremelimumab seek out 2 different proteins.
Researchers think that durvalumab and tremelimumab may help your immune system attack the cancer and stop them from growing.
There are 6 groups in this trial:
Your doctor can tell you which group (cohort) you are suitable for before you join this trial. The treatment you have depends on the cohort you join.
The main aim of this trial is to find out whether it is safe to have durvalumab, tremelimumab and chemotherapy or radiotherapy.
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.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is a phase 1/2 trial. Researchers hope that around 75 people from the UK will take part.
There are 6 groups (cohorts) in this trial:
Your doctor can tell you which cohort you are in before you join this trial.
Cohort A
This group is divided into 2 groups: cohort A1 and cohort A2.
People taking part in A1 have 2 treatments with durvalumab alone. You have it as a drip into a vein. You have it in the first week of treatment and then after 2 weeks. This cohort is now complete.
People taking part in A2 have durvalumab and tremelimumab as a drip into a vein on the 1st day of treatment. And have a second dose of durvalumab alone after 2 weeks. This cohort is now complete.
Then everyone has durvalumab and the chemotherapy drugs oxaliplatin and capecitabine. You have durvalumab, oxaliplatin and capecitabine as cycles of treatment. Each cycle takes 3 weeks. You have up to 6 treatment cycles in total.
You have each treatment cycle in the following way. You:
Cohort B
The treatment you have if you are in this group depends on what the researchers find in the first 2 groups (Cohorts A1 and A2). You can have durvalumab and the chemotherapy drugs oxaliplatin and capecitabine. Or durvalumab, tremelimumab, oxaliplatin and capecitabine. This cohort is now complete.
Cohort C
You have 2 treatments with durvalumab alone. Then you have 2 cycles of treatment with durvalumab, oxaliplatin and capecitabine. You:
You have surgery after you finish the 2 treatment cycles of durvalumab, oxaliplatin and capecitabine. You have surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this and what to expect.
After you recover from surgery, you might have more durvalumab. You can have it for up to 6 months.
Cohort C-FLOT
You have 2 treatments with durvalumab alone. Then you have 4 treatments with FLOT (5-fluorouracil, leucovorin, oxaliplatin and docetaxel) and durvalumab. You:
About 6 to 8 weeks after you finish treatment, you have surgery. You have surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this and what to expect.
About 3 months after surgery, you might have more treatment with durvalumab alone, FLOT alone, or durvalumab in combination with FLOT. Your study doctor will decide which treatment you will get. You can have the additional treatment for up to 6 months.
Cohort D
You have durvalumab as a drip into a vein every 2 weeks for a month. you then have chemotherapy with paclitaxel and carboplatin as a drip into a vein once a week, together with radiotherapy (chemoradiotherapy) for 5 weeks. After chemoradiotherapy, you have another durvalumab treatment.
About 6 to 8 weeks after you finish chemoradiotherapy and durvalumab, you have surgery. You have surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this.
About 3 months after surgery, you might have more treatment with durvalumab. You can have it for up to 6 months.
Cohort D2
You have durvalumab as a drip into a vein every 2 weeks for a month. You will then have chemotherapy with paclitaxel and carboplatin as a drip into a vein once a week, together with radiotherapy (chemoradiotherapy), for 5 weeks. You continue to have durvalumab every 2 weeks together with chemotherapy and radiotherapy.
About 6 to 8 weeks after you finish chemoradiotherapy and durvalumab, you have surgery. You have surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this.
About 3 months after surgery, you might have more treatment with durvalumab. You can have it for up to 6 months.
Blood tests
You have extra blood tests as part of this trial. Researchers want to look at the effect durvalumab and tremelimumab has in your body.
You have the extra blood tests before the start of treatment and at set times during the trial.
Tissue sample
The trial team ask to take tissue samples (biopsy) of your cancer before the start of treatment and then:
Doctors want to look at the genes and at how the cancer changes during treatment.
Saliva sample and photographs
If you are in group C, C-FLOT, D, or D2, the trial team will ask to take saliva samples and photographs of your cancer before the start of treatment and then:
Doctors want to look at how the cancer changes during treatment. If you agree to this, the photographs will be taken at the same time as your tumour biopsy.
You see a doctor and have some tests before taking part. These tests might include:
During treatment, you see the trial doctor regularly. How often you see them depends on the group (cohort) you are in. You have blood tests, urine tests and a physical examination each time you see them.
You have a CT scan or PET-CT scan at set times during the trial. You continue to have treatment for as long as it works and the side effects aren’t too bad.
When you finish treatment, you see the doctor after 2 weeks. You then see them after:
After 4 months, the trial team will phone you every 6 months for 3 years.
The trial team monitor you during the time you have treatment and afterwards. Durvalumab and tremelimumab are new drugs so there might be side effects we don’t know about yet. You have a phone number to call them if you are worried about anything.
The team will tell you about all the possible side effects before you start the trial. The most common side effects of durvalumab and tremelimumab are:
We have information about the possible side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Middleton
AstraZeneca
Ludwig Institute for Cancer Research
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”