A trial of MK-7648A for non small lung cancer (KEYVIBE 007)

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

Cancer type:

Lung cancer
Non small cell lung cancer
Secondary cancers




Phase 3

This trial is looking at a drug called MK-7648A for non small cell lung cancer.

It is open to people:

  • with non small cell lung cancer Open a glossary item that has spread (advanced cancer Open a glossary item)
  • and who haven’t had treatment for their advanced cancer

More about this trial

Doctors can treat advanced non small cell lung cancer (NSCLC) with:

  • chemotherapy
  • immunotherapy Open a glossary item
  • or a combination of both

The chemotherapy doctors can use include:

  • carboplatin
  • cisplatin
  • pemetrexed

MK-7648A is a combination of pembrolizumab and vibostolimab. 

Pembrolizumab is an immunotherapy that doctors can use to treat NSCLC. Pembrolizumab works by blocking a protein called PD-1. By blocking PD-1 this helps the immune system Open a glossary item find and attack the cancer. 

Vibostolimab (MK-7648) is also an immunotherapy. It works by blocking a receptor Open a glossary item that affects how well T cells Open a glossary item work against cancer. T cells are part of the immune system. By blocking this receptor, T cells are better able to attack cancer cells. Vibostolimab is not yet had approval for doctors to use. 

Researchers think that MK-7648A with chemotherapy might work better than pembrolizumab with chemotherapy. 

In this trial, half the people will have MK-7648A and chemotherapy. The other half will have pembrolizumab and chemotherapy. 

The aims of the trial are to find out:

  • how well MK-7648A in combination with chemotherapy works
  • more about the side effects
  • how this combination affects quality of life Open a glossary item

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 non small lung cancer (NSCLC) that has spread to another part of the body (stage 4)
  • have an area of cancer that the doctor can measure on a scan Open a glossary item
  • have a piece of cancer tissue (biopsy Open a glossary item) that the trial team can access. If this isn’t available you are willing to have a fresh biopsy taken.
  • are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • 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
  • 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 already had systemic treatment Open a glossary item for your NSCLC that has spread 
  • are able to have certain targeted drugs to treat your cancer. Or the cancer cells have certain genes Open a glossary item. Your doctor will know about this.
  • have cancer spread to the brain, spinal cord or the tissue surrounding them. You might be able to join if you have had treatment for this, it is stable and you haven’t taken steroids for at least 2 weeks before starting trial treatment.
  • have had radiotherapy to the lung within 6 months of starting treatment and the dose was more than 30 Gray (Gy) Open a glossary item. Your doctor will know the dose.
  • have radiotherapy within 2 weeks of starting treatment. Or have had lung inflammation caused by radiotherapy.
  • still have ongoing side effects of radiotherapy 
  • have had another cancer that had got worse or needed treatment in the past 3 years. You can join if you have had successfully treated non melanoma skin cancer Open a glossary item or a carcinoma in situ Open a glossary item (CIS). This is apart from CIS of the bladder.
  • have taken an experimental drug or used a device as part of a clinical trial within the 4 weeks before starting treatment in this trial

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

  • have a disease or illness that affects how well your immune system Open a glossary item works
  • are taking medication that affects how well your immune system works within the week of starting trial treatment. This is apart from a low dose of steroids. Your doctor will know what the dose is.
  • have an autoimmune disease Open a glossary item that needed treatment in the past 2 years. This is apart from treatment that replaces what the body would make, such as insulin for diabetes or thyroxine for a thyroid problem.
  • had inflammation of the lungs not caused by an infection and are taking steroids for it. Or you have this type of lung inflammation whether or not you are taking steroids.
  • have HIV, hepatitis B, active hepatitis C or any other active infection that needs treatment
  • have had certain targeted cancer drugs Open a glossary item or immunotherapy Open a glossary item drugs. Your doctor will know whether you have had any of these.
  • have had a stem cell or bone marrow transplant from a donor (allogeneic transplant Open a glossary item)
  • have had an organ transplant Open a glossary item
  • have not fully recovered from having major surgery 
  • have any other medical condition, mental health problem or social situation that could affect you taking part in the trial

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

  • are allergic or very sensitive to any of the treatments or their ingredients
  • have had a live vaccine Open a glossary item within 30 days of starting treatment. The COVID-19 vaccine and some seasonal flu vaccines are not live vaccines.
  • are pregnant or breastfeeding

Pemetrexed chemotherapy
You cannot join this trial if you are to have pemetrexed and any of these apply. You:

  • are not able to stop taking aspirin or any other non steroidal anti inflammatory drug (NSAID Open a glossary item). This is apart from a low dose of aspirin for a short period of time. Your doctor will know about this.
  • are not able to or not willing to take folic acid or vitamin B12 supplements

Trial design

This is an international phase 3 trial. The team need 700 people worldwide to take part with 20 people from the UK. 

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

  • MK-7648A and chemotherapy
  • pembrolizumab and chemotherapy

Neither you nor your doctor will know if you are having MK-7648A or pembrolizumab. But your doctor will be able to find out if this is necessary. 

Which chemotherapy you have depends on whether you have a squamous cell type of NSCLC or a non squamous cell type of NSCLC. Your doctor will explain which is best for you. 

Squamous cell NSCLC
You have one of the following chemotherapy treatments:

Non squamous cell NSCLC 
You have one of the following chemotherapy treatments:

You have MK-7648A, pembrolizumab and the chemotherapy as a drip into a vein. You have treatment in periods of 3 weeks. Each 3 weeks is a cycle of treatment Open a glossary item.

You have all the following once during each cycle of treatment:

  • MK-7648A
  • pembrolizumab
  • carboplatin
  • cisplatin
  • paclitaxel

You have nab paclitaxel once a week every week during the cycle of treatment. 

You have treatment for about 2 years as long as it is helping and the side effects aren’t too bad.

Quality of life
You fill in questionnaires:

  • before starting treatment
  • during treatment
  • at the finish of treatment
  • after treatment

The questions ask about:

  • your general health
  • side effects and how they affect your daily living
  • what you can do

These are quality of life questionnaires

Samples for research
The team ask for a piece of tissue from a previous tissue sample (biopsy Open a glossary item). If you haven’t had a previous biopsy or it isn’t available the team will ask for a fresh biopsy. 

You give blood samples during the trial. Where possible the team take these when you give blood as part of your routine care. 

Researchers use these samples to:

  • look at the genes Open a glossary item in the cancer cells
  • look for biomarkers Open a glossary item that might show how well treatment is working
  • develop and improve tests for people with NSCLC

Hospital visits

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

  • a physical examination Open a glossary item
  • blood tests
  • urine test
  • scans such as a CT scan, an MRI scan or bone scan. Your doctor will tell you which scans you are to have.
  • heart trace (ECG Open a glossary item)

You see the doctor regularly during treatment. This is to see how you are and for blood tests.

You see the doctor when you finish treatment and then:

  • a month later
  • then every 3 months

From the start of treatment you have a scan at:

  • 6 weeks
  • 12 weeks
  • 18 weeks 
  • then every 9 weeks for about 18 months 
  • then every 12 weeks until you start another treatment or your cancer comes back

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. 

MK-7648A and pembrolizumab can affect the immune system Open a glossary item. This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.


MK-7648A is a new drug combination and there might be side effects we don’t know about yet. 

The most common side effects of MK-7648A we know of so far are:

  • tiredness (fatigue)
  • feeling or being sick
  • skin rash or itchy skin
  • diarrhoea
  • chills
  • high temperature (fever)
  • an increase in the amount of enzymes the pancreas makes which could be caused by inflammation of the pancreas
  • an increase in the amount of enzymes the liver makes which could be caused by inflammation of the liver

We have information about:

Your doctor will talk to you about the possible side effects of the treatments and answer any questions 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

Professor Samreen Ahmed

Supported by

Merck, Sharp & Dohme

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Last reviewed:

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