A trial looking a lenvatinib and pembrolizumab for people with womb cancer (KEYNOTE-775)

Cancer type:

Secondary cancers
Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Phase 3
This trial is for women with womb cancer that has come back or spread to other parts of the body (advanced womb cancer). Womb cancer is also called uterine or endometrial cancer. 
 
It is for people who have had at least one type of treatment with chemotherapy that included a platinum drug. Platinum chemotherapy includes the drugs:
  • cisplatin
  • carboplatin
  • oxaliplatin

More about this trial

Treatment for advanced womb cancer is usually chemotherapy. It uses cytotoxic drugs to slow down the cancer and help with symptoms. Doxorubicin and paclitaxel are 2 possible chemotherapy treatments. 
 
Doctors are looking for new ways to help women with advanced womb cancer. In this trial, they are looking at lenvatinib and pembrolizumab. 
 
Lenvatinib (Lenvima) is a targeted drug. It works by blocking certain proteins that help cells to grow blood vessels. All cancer cells need blood vessels to survive and grow. 
 
Pembrolizumab (Keytruda) is a type of immunotherapy. It stimulates the body’s immune system Open a glossary item to fight cancer cells. 
 
Everyone taking part in this trial has 1 of the following: 
  • lenvatinib and pembrolizumab 
  • doxorubicin or paclitaxel 
The main aim of this trial is to find out whether lenvatinib and pembrolizumab help people with advanced womb 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. 
 
Who can take part
You may be able to join this trial if all of the following apply:
  • you have womb cancer that has come back (recurrent) or spread to other parts of the body (metastatic) 
  • your cancer got worse after treatment with a platinum chemotherapy such as cisplatin or carboplatin 
  • there is a suitable tissue sample available (archival tumour sample) that doctors can use to look for certain changes (or you are willing to have a new sample taken)
  • you have at least 1 area of cancer that can be seen and measured on a scan 
  • you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) and this hasn’t changed in the past week 
  • you have satisfactory blood tests results
  • your heart is working well 
  • you are at least 18 years old
  • you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any possibility that you could become pregnant 
Who can’t take part
You cannot join this trial if any of these apply. 
 
Cancer related
You can’t take part if: 
  • you have a type of womb cancer called carcinosarcoma, endometrial leiomyosarcoma or endometrial stromal sarcoma
  • you have cancer spread in your brain unless you have had treatment, it hasn’t got worse in the past 4 weeks and you are no longer taking steroids
  • your cancer has spread to a major blood vessel Open a glossary item and your doctor thinks you have a high risk of bleeding 
  • you have had a large bleeding from your cancer in the past 2 weeks 
  • you have had more than 1 chemotherapy regimen Open a glossary item that included a platinum drug unless you had it before or after your main treatment (adjuvant Open a glossary item or neoadjuvant treatment Open a glossary item)
  • you have had chemotherapy, surgery or a targeted drug in the past 28 days
  • you have had radiotherapy in the past 3 weeks, or 2 weeks if it was radiotherapy to help with symptoms (palliative)
  • you have moderate or severe side effects from previous cancer treatment apart from hair loss and numbness or tingling in fingers and toes 
  • have had pembrolizumab or any other similar drug 
  • have taken part in another clinical trial looking at pembrolizumab and lenvatinib
  • you have had another cancer in the past 2 years apart from early cancer (carcinoma in situ Open a glossary item) of the cervix, breast and bladder or a non melanoma skin cancer 

Medical conditions
You cannot join this trial if any of these apply. You:

  • are taking part in another clinical trial or have taken part in a trial looking at a new treatment (drug or device) in the past 4 weeks 
  • have problems with your gut and you can’t absorb tablets 
  • have had, or you currently have, lung problems such as pneumonitis Open a glossary itemthat needed treatment with steroids  
  • have an abnormal opening (fistula) between organs or to the outside of your body 
  • have coughed up a large amount of blood in the past 2 weeks 
  • have heart problems such as high blood pressure (hypertension) that isn’t controlled, unstable angina, an abnormal heart rhythm or you have had a heart attack in the past 12 months 
  • have had a stroke in the last year  
  • have an infection and you need antibiotics that reach your whole body 
  • have taken drugs that damp down your immune system (immunosuppressants) in the past week, unless it was a very small dose 
  • have an autoimmune disease Open a glossary item that needed treatment in the past 2 years, apart from treatment to replace something that the body makes such as insulin or thyroxine
  • have had an organ transplant Open a glossary item or a bone marrow or stem cell transplant from a donor (allogeneic transplant Open a glossary item)
  • have protein in your urine 
  • have HIV 
  • have hepatitis B or hepatitis C 
  • have any other medical condition or mental health problem that the trial team think could affect you taking part 
  • take an amount of drugs or drink an amount of alcohol that is a concern for the trial team 
Other
You cannot join this trial if any of these apply. You:
  • are pregnant or breastfeeding 
  • have had a live vaccine Open a glossary item in the past month 
  • are sensitive to the drugs used in this trial or anything they contain 

Trial design

This is an international phase 3 trial. Researchers hope that around 780 people worldwide and 35 people from the UK will agree to take part. 
 
It is a randomised trial. The people taking part are put into 1 of the following treatment groups by computer:
  • lenvatinib and pembrolizumab 
  • doxorubicin or paclitaxel 
Neither you nor your doctor are able to decide which group you are in.
 

Lenvatinib and pembrolizumab
You have:
 
lenvatinib as tablets that you swallow whole every day
pembrolizumab as a drip into a vein over 30 minutes, every 3 weeks 
 
You continue lenvatinib and pembrolizumab for as long as it helps you and the side effects aren’t too bad. You can have treatment for up to 2 years. 
 
After 2 years, you may be able to continue having treatment for another year. This is called the second course treatment. Your doctor can tell you more about this. 
 
Doxorubicin or paclitaxel 
You have doxorubicin or paclitaxel as a drip into your vein over an hour. You have:
  • doxorubicin every 3 weeks
  • paclitaxel every week for 3 weeks, followed by a week off 
Your doctor can tell you which treatment you have. This continues for as long as treatment is helping you and the side effects aren’t too bad. 
 
Blood tests
You have extra blood tests as part of this trial. You have them before the start of treatment and then:
  • every 3 or 4 weeks 
  • at the end of treatment
Doctors want to look for certain proteins (biomarkers Open a glossary item) that can tell how well the treatment is working. And find out what happens to lenvatinib in your body (pharmacokinetics Open a glossary item). 
 
Tissue sample
The trial team ask to use a tissue sample of your cancer taken when you had surgery or a biopsy Open a glossary item. You need to have a new sample taken if there isn’t a suitable sample available. 
 
Researchers want to look for certain changes (mutations) in a gene Open a glossary item called the mismatch repair gene. 
 
Quality of life
Everybody taking part completes quality of life questionnaires before the start of treatment and:
  • every 3 to 4 weeks 
  • at the end of treatment 
  • a month after finishing treatment 
The questionnaires ask about how you have been feeling and what side effects you have had. 

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:
  • a physical examination
  • heart trace (ECG Open a glossary item) and heart scan (MUGA Open a glossary item
  • blood tests
  • urine test
  • a CT scan or MRI scan
  • a bone or brain scan (if you have cancer spread in your bones or brain) 
During treatment, you see the trial team regularly. How often you see them depends on the treatment you have. You have blood tests and a physical examination every time you see them. 
 
You have a CT scan or MRI scan every 8 weeks. You may also have a bone and brain scan if you have cancer spread in the bones or brain. 
 
Your treatment continues for as long as it is helping you and the side effects aren’t too bad. 
 
When you finish treatment, you see the trial doctor after a month. You then see or speak with the trial team every 3 months.  

Side effects

The trial team monitor you during treatment and afterwards. 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 treatment.
 
Pembrolizumab has an effect on the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. 
 
These side effects could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
 
The most common side effects of pembrolizumab are:
  • skin rashes, itching and changes to your skin colour
  • loose or watery poo (diarrhoea)
  • cough 
  • pain in your joints, back and tummy (abdomen)
  • high temperatures
  • thyroid problems that can cause tiredness and feeling cold 
  • low levels of salt in your body that may cause you to feel tired, have headaches and muscle cramps
We have more information about the possible side effects of pembrolizumab
 
The common side effects of lenvatinib are:
  • a stroke or bleeding in the brain that might cause numbness or weakness on one side of your body
  • a blood clot in the veins of your legs or lungs 
  • heart problems such as palpitations or a heart attack 
  • an abnormal opening (fistula) between organs or to the outside of your body 
  • a hole in your bowel (bowel perforation) 
  • bleeding from the gut 
  • feeling or being sick 
  • diarrhoea 
  • loss of fluid in your body (dehydration) 
  • heart problems that can cause shortness of breath 
  • liver problems which may cause yellowing of the skin and eyes (jaundice), tiredness, fever and confusion
We have information about the side effects of:

Location

Brighton
Cambridge
London
Southampton

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

Dr Rebecca Kristeleit  

Supported by

Eisai Inc. 
Merck Sharp & Dohme Corp. 

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15860

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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