A trial looking a lenvatinib and pembrolizumab for people with womb cancer (KEYNOTE-775)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
- cisplatin
- carboplatin
- oxaliplatin
More about this trial
- lenvatinib and pembrolizumab
- doxorubicin or paclitaxel
Who can enter
- 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
- 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 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 that included a platinum drug unless you had it before or after your main treatment (adjuvant or neoadjuvant treatment)
- 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) 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 pneumonitisthat 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 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 or a bone marrow or stem cell transplant from a donor (allogeneic transplant)
- 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
- are pregnant or breastfeeding
- have had a live vaccine in the past month
- are sensitive to the drugs used in this trial or anything they contain
Trial design
- lenvatinib and pembrolizumab
- doxorubicin or paclitaxel
- doxorubicin every 3 weeks
- paclitaxel every week for 3 weeks, followed by a week off
- every 3 or 4 weeks
- at the end of treatment
- every 3 to 4 weeks
- at the end of treatment
- a month after finishing treatment
Hospital visits
- a physical examination
- heart trace (ECG) and heart scan (MUGA)
- 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)
Side effects
- 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
- 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
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
Dr Rebecca Kristeleit
Supported by
Eisai Inc.
Merck Sharp & Dohme Corp.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040