Rare Cancers (non-specific) / Posted 2 years ago

A trial looking at lenvatinib and pembrolizumab for people with advanced solid tumours (LEAP-005)

This trial is for people with one of the following solid tumours :
breast cancer whose cells don’t have receptors for the protein Her2 and the hormones oestrogen and progesterone (triple negative breast cancer)
ovarian cancer
stomach cancer
bowel cancer
a type of brain tumour called glioblastoma multiforme (GBM)
bile duct cancer
gallbladder cancer
It is for people whose cancer continued to grow or spread to other parts of the body despite treatment (advanced solid tumours).

The main aims of this trial are to:
find out how well lenvatinib and pembrolizumab work as a treatment for advanced solid tumours
learn more about the side effects

  • Inclusion Criteria :
    • One of the following: triple negative breast cancer, ovarian cancer, bowel (colorectal) cancer, a type of brain tumour called glioblastoma multiforme (GBM), bile duct cancer , gallbladder cancer.
    • your cancer has spread to other parts of the body (metastatic) or continued to grow despite treatment
    • doctors think that you can’t have treatment to cure your cancer
    • you have at least 1 area of cancer that can be seen and measured on a scan
    • you are willing to have a sample of cancer taken (biopsy ) if there isn’t a suitable sample available
    • you are at least 18 years old
    • you have satisfactory blood test results
    • your heart is working well and your blood pressure is normal
    • you are well enough to carry out your normal activities apart from heavy physical work (performance status of 0 or 1)
    • you are willing to use reliable contraception during treatment and for at least 4 months afterwards if there is any possibility that you or your partner could become pregnant As well as the above, there might be specific entry conditions for your cancer type. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial.
  • Exclusion Criteria :
    • you have cancer spread in your brain or spinal cord unless you have had treatment, it has been stable for the past month and you have stopped taking steroids more than 2 weeks ago
    • you have a tumour in your brain stem
    • you have cancer spread in the thin layers (membranes) that surround the brain (carcinomatous meningitis)
    • your cancer has spread to a major blood vessel and your doctor thinks that you have a high risk of bleeding
    • you have had lenvatinib, pembrolizumab or any other similar drug
    • you have had anti cancer treatment that reached your whole body in the last month
    • you have had radiotherapy in the past 2 weeks and still have moderate or severe side effects from it, or you have had radiotherapy in the past week if it was radiotherapy to help with symptoms (palliative)
    • you still have moderate or severe side effects from previous anti cancer treatment, unless it is numbness and tingling in fingers and toes
    • you have had another cancer in the past 3 years unless it was non melanoma skin cancer or a carcinoma in situ of the cervix and breast
    • are taking part in another clinical trial or have taken part in a trial looking at a new drug or device in the last month
    • take or have taken drugs that damp down your immune system such as steroids in the past week unless it was a very small dose
    • have an autoimmune disease that needed treatment that reached your whole body (systemic) in the past 2 years unless it was treatment to replace something that the body makes such as thyroxine or insulin
    • have or have had lung problems such as pneumonitis
    • have an active infection that needs antibiotics that reach your whole body (systemic)
    • have problems with your gut and can’t absorb capsules
    • have protein in your urine
    • have coughed up a large amount of blood in the past 2 weeks
    • have heart problems such as an abnormal heart rhythm, congestive heart failure, angina that isn’t stable or you have had a heart attack in the past year
    • have had a blood clot in one of the main blood vessels in the past year
    • have a wound or a break in a bone (fracture) that hasn’t healed
    • have had a drug that encourages the bone marrow to make white blood cells in the last 2 months such as G-CSF
    • have had an organ transplant from a donor
    • have HIV
    • have hepatitis B or hepatitis C
    • have active tuberculosis
    • have any other serious medical condition or mental health problem that the trial team think could affect you taking part
    • take an amount of drugs or alcohol that is a concern for your doctor
    • are sensitive to any of the drugs used in this trial or anything they contain have had a live vaccine in the last month
    • are pregnant or breastfeeding
  • Study start date : 08/05/2019
  • Study end date : 13/02/2020
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Juanita Lopez

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