A trial of MK-6482 for kidney cancer (MK-6482-005)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Kidney cancer
Renal cell cancer
Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is comparing a drug called MK-6482 with everolimus for kidney cancer. 

It is open to people with kidney cancer that has spread to another part of the body or to the surrounding tissue. And it can’t be removed with surgery.

More about this trial

Doctors use everolimus to treat advanced kidney cancer. Everolimus is a targeted drug Open a glossary item called a growth blocker. It works by blocking the growth of blood vessels to the cancer. This slows down the growth of the cancer. 

MK-6482 is a targeted drug that is a growth blocker. It works in a different way to everolimus to slow down the growth of cancers. 

Researchers think that MK-6482 might be better than everolimus. To find this out they will compare MK-6482 with everolimus. In this trial half the people will have MK-6482 and the other half will have everolimus. 

The main aims of this trial are to find out:

  • if MK-6842 is better than everolimus
  • about the safety and side effects of MK-6842 compared to everolimus
  • how well people tolerate MK-6482
  • how MK-6482 affects quality of life Open a glossary item
  • what happens to MK-6482 in the body

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 clear cell renal cell cancer that has spread to the surrounding tissue or to another part of the body and can’t be removed with surgery
  • have had a scan Open a glossary item that shows the cancer has got worse during or after the last treatment and the doctor can measure the cancer on the scan
  • have had an immunotherapy Open a glossary item drug and a growth blocker Open a glossary item drug to treat the cancer. Your doctor can tell more about this.
  • are willing to use contraception during treatment and for a period of time after if there is any chance you or your partner could become pregnant
  • can look after yourself but might not be able to do active work (Karnosfky performance score 70 to 100)
  • have satisfactory blood test results
  • are at least 18 years old  

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

  • have had more than 3 different treatments for your cancer
  • have cancer that has spread to the brain or spinal cord unless it has been treated and is stable
  • have had another cancer that has got worse in the past or needed treatment in the past 3 years apart from successfully treated non melanoma skin cancer Open a glossary item or carcinoma in situ Open a glossary item
  • have had growth factors Open a glossary item such as G-CSF or GM-CSF to help your body make more blood cells within 28 days of being put into a treatment group (randomisation Open a glossary item) in the trial
  • have already had MK-6482, everolimus or similar drugs, your doctor will know about this
  • have had radiotherapy within the 2 weeks before randomisation
  • have had a monoclonal antibody Open a glossary item within the 4 weeks before randomisation 

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

  • need to use oxygen or have a low level of oxygen in the blood – your doctor will do test for this
  • have had a heart attack or chest pain (angina) within the 6 months of starting treatment or you have any other major heart problem Open a glossary item
  • have high blood pressure that isn’t controlled by medication
  • have moderate to severe liver problems
  • can’t swallow tablets or capsules
  • have a problem with the digestive system Open a glossary item that affects how well your body absorbs medication
  • have had major surgery within 3 weeks before randomisation or the wound has not healed well enough
  • are taking medication or herbal treatments such as phenobarbital, enzalutamide, phenytoin or St Joh’s Wort that affect the CYP enzymes. You might be able to join if you can stop taking them. Your doctor can tell you more about this.
  • are taking medication such as cyclosporin, ketoconazole or ritonavir that affects a protein called P-gp. You might be able to join if you can stop taking them. Your doctor can tell you more about this.
  • have HIV, hepatitis B, hepatitis C, active tuberculosis (TB) or an active infection needing treatment
  • have an immune system Open a glossary item that isn’t working well or are taking drugs such as steroids that damp down the immune system
  • have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part

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

  • are taking an experimental drug or using an experimental device as part of another clinical trial
  • have had a live vaccine Open a glossary item within 30 days of randomisation
  • are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The trial team need 736 people worldwide to join with 45 people in the UK. 

It is a randomised trial. There are 2 groups. Neither you nor your doctor can choose which group you are in. 

Half the people have MK-6482. The other half have everolimus. 

MK-6482 are tablets you take once a day every day. 

Everolimus is a tablet you take once a day every day. 

You continue having treatment for as long as it is helping and the side effects aren’t too bad. 

During the trial you should not eat grapefruit or Seville oranges or drink the juice of these fruits. You should not take St John’s Wort as a tablet or a tea.

You have a card that says you are taking part in this trial. Always carry this card with you as it has important information about the trial.  

Quality of life
You fill in a few questionnaires before you start treatment and then at:

  • 1 week
  • 3 weeks
  • 5 weeks
  • 9 weeks then
  • every 4 weeks while having treatment then
  • at the end of treatment and
  • a month after

The questions ask about your:

  • general health and wellbeing
  • signs and symptoms
  • what you can do

These are quality of life questionnaires

Research samples
You give a fresh tissue sample (biopsy Open a glossary item) before starting treatment. If this isn’t possible the team will ask for a sample of tissue from a previous biopsy. They will use this sample to learn more about kidney cancer. 

You give blood samples before starting treatment and a number of times during treatment. Your doctor will tell you how often this is. They will use these samples to find out more about kidney cancer and about what happens to MK-6482 in the body.

Hospital visits

You see the doctor to have tests before taking part. These include:

During treatment you see the doctor at:

  • week 1
  • week 5
  • week 9
  • week 13 and then
  • every 4 weeks

You have more scans during treatment. Your doctor will tell you when and how often.

You see the doctor at the end of treatment. Then you see them 30 days later or before you start another cancer treatment which ever one comes first. 

After treatment, if your cancer has not got worse you continue to have scans every 8 weeks or 12 weeks. Your doctor will tell you about this. 

The trial team will follow you up every 3 months until your cancer gets worse or you start another treatment. 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

The most common side effects of MK-6482 are:

  • a drop in red blood cells in the blood (anaemia)
  • tiredness and lack of energy (fatigue)
  • feeling or being sick
  • shortness of breath
  • headache
  • dizziness
  • joint pain 
  • not enough oxygen getting to a part of the body
  • swelling of the hands and legs
  • loss of appetite
  • muscle pain
  • an increase of a liver enzyme in the blood
  • an increase of creatinine in the blood 
  • high blood pressure

We have information about everolimus and its side effects. 

Your doctor or a member of the trial team will talk to you about the possible side effects of the treatments before you agree to join the trial.

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 Naveed Sarwar

Supported by

Merck Sharp & Dohme (UK) Limited

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17242

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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