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

Status:

Closed

Phase:

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 that has spread (advanced cancer )
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
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 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

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
have a piece of cancer tissue (biopsy ) 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 for your NSCLC that has spread
are able to have certain targeted drugs to treat your cancer. Or the cancer cells have certain genes . 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) . 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 or a carcinoma in situ (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 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 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 or immunotherapy 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 )
have had an organ transplant
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

Other
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 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 ). 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

KEYVIBE-007 trial randomisation diagram

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:

carboplatin with paclitaxel or
carboplatin with nab paclitaxel

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 in the cancer cells
look for biomarkers 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
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 )

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 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.