A trial of Belzutifan (MK-6482) for kidney cancer (MK-6482-013)

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 2

A trial of belzutifan for kidney cancer that has grown into the nearby tissue or spread to another part of the body. It is for people who have a type of kidney cancer called renal cell cancer

More about this trial

Belzutifan is a targeted drug Open a glossary item. It works by blocking a substance that cancer cells need to divide and grow. Researchers want to find out whether belzutifan might help people with renal cell cancer.  

In this trial half the people take a small dose of belzutifan. And the other half take a larger dose. 

The aims of the trial are to find out:

  • the best dose of belzutifan 
  • how belzutifan affects the body
  • what happens to belzutifan in the body
  • more about the side effects

Who can enter

The following bullet points are a summary of 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 renal cell cancer that contains the clear cell type and has spread outside the kidney to the surrounding tissue or to another part of the body (stage 4
  • have cancer that the doctor can measure 
  • have a sample of tissue (biopsy Open a glossary item) that the trial team can access. If this isn’t available you must agree to have a new sample taken. 
  • have had at least 2 doses of PD-1 or PD-L1 treatment but no more than 1 course of treatment Open a glossary item with a PD-1 or PD-L1 drug for the cancer spread. Your doctor will know this.
  • have had treatment for your cancer spread with a PD-1 or PD-L1 treatment. And during treatment or after treatment your cancer has got worse. 
  • can take care of yourself but might not be able do your normal activities or do active work (Karnofsky performance score 70% or more)
  • are willing to use contraception during treatment and for a while after if there is any chance you or your partner could become pregnant
  • 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 cancer spread to the brain, tissue surrounding the brain or spinal cord. You might be able to join if you had treatment, it is stable and you aren’t taking steroids for at least 2 weeks before starting the trial treatment. 
  • have had more than 3 different courses of treatment that affected the whole body (systemic therapy Open a glossary item) for your cancer spread 
  • have ongoing side effects from previous treatment apart from certain side effects. Your doctor will know which ones these are. 
  • have another cancer that has got worse or needed treatment within the past 3 years. You can join if you had successfully treated non melanoma skin cancer Open a glossary item or an in situ carcinoma Open a glossary item
  • have had belzutifan before or another drug that works the same way. Your doctor will know if you have. 
  • have a certain type of targeted drug Open a glossary item within 2 weeks before going into a treatment group (randomisation Open a glossary item). Your doctor will know which type it is.
  • have cancer treatment that reaches your whole body (systemic treatment) within 4 weeks of randomisation
  • have radiotherapy within 2 weeks of starting the trial treatment or still have side effects. For radiotherapy for symptom control (palliative radiotherapy) it is 1 week. 

Medical conditions

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

  • have lower level of oxygen in the blood. Your doctor will do a test for this. 
  • need to use oxygen sometimes or all the time
  • had a heart attack within the past 6 months or another heart problem Open a glossary item that could affect you taking part
  • have moderate or severe liver problems Open a glossary item
  • had blood cell growth factors Open a glossary item such as G-CSF, GM-CSF or EPO within 28 days of starting the trial treatment
  • have a problem with your digestive system  Open a glossary itemthat means you are unable to take medication by mouth or you are unwilling to do so
  • have major surgery within 3 weeks of starting the trial treatment
  • are taking medications including herbal and complementary that strongly affect the CYP enzymes unless you can stop them during the trial. Your doctor will know which medications these are. 
  • are taking experimental drugs or using a device as part of another clinical trial
  • have an infection that needs treatment which reaches your whole body
  • have HIV, hepatitis B, hepatitis C or active tuberculosis (TB)
  • have a problem with your immune system Open a glossary item that means it isn’t working well enough
  • have another medical condition or mental health problem that could affect you taking part

Other

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

  • are sensitive or allergic to belzutifan or any of its ingredients
  • pregnant or breastfeeding 

Trial design

This is an international phase 2 trial. The team need 150 people worldwide to take part with a target of 15 people from the UK. 

This is a randomised trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you go into. The groups are:

  • 200mg of belzutifan 
  • 100 mg of belzutifan

You and your doctor will know which dose you are taking. Belzutifan is a tablet. You take it once a day every day. Your doctor will tell you how many to take. You continue taking belzutifan as long as it is helping and the side effects aren’t too bad. 

You should not eat, drink or take certain medications while taking belzutifan. This includes:

  • grapefruit and grapefruit juice
  • Seville oranges and Seville orange juice
  • St John’s Wort tablets or St John’s Wort tea

Your doctor will tell more about this before you start taking belzutifan. 

You have a patient card that says you are in the trial. You should carry it with always. It contains important information about the trial.   

Sample for research
You give extra blood samples as part of the trial. Where possible the team take these when you have routine blood tests. 

The team ask for a tissue sample (biopsy Open a glossary item) when you join the trial. They might use tissue from a previous sample if it isn’t safe to take a new one. 

They will use these samples to:

  • find out how belzutifan affects the body and what happens to it in the body
  • look for substances (biomarkers Open a glossary item) including 2 genes that might show how well treatment is working 

The team will ask if you are willing to have these samples stored for future research. You don’t have to agree to this. You can still take part in the trial.

Hospital visits

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

During your treatment you see the doctor:

  • every 2 weeks for 9 weeks then
  • every 4 weeks 

This is to see how you are and for blood tests. 

A month after finishing treatment you see the doctor for the same tests you had before starting treatment. Your doctor will then tell how often they want to see you. This could be either every 8 weeks or every 12 weeks. 

You have a scan at week 9 and then:

  • every 8 weeks to week 49 then
  • every 12 weeks until your cancer gets worse

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. 

Belzutifan is a new drug and there might side effects that we don’t know about yet. The most common side effects of belzutifan we know of are:

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

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

Mark Tuthill

Supported by

Merck, Sharp & Dohme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17741

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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