A trial looking at MK-3475A for non small cell lung cancer (MK3475A-F84)
Cancer type:
Status:
Phase:
This trial is comparing a new drug called MK-3475A with pembrolizumab for non small cell lung cancer (NSCLC).
It is for people:
- who are having their first treatment for NSCLC that has spread to another part of the body
- with a large number of cancer cells that have a
biomarker called PD-L1
More about this trial
Lung cancer that has spread to another part of the body is advanced or metastatic cancer. You might have pembrolizumab to treat non small cell lung cancer (NSCLC) that has spread. Pembrolizumab is an . It helps the
to find and kill cancer cells.
Doctors are looking for ways to improve treatment for metastatic NSCLC. In this trial, they are looking at a drug called MK-3475A. It is a combination of pembrolizumab and a drug called MK-5180.
MK-5180 is also called hyaluronidase. It is a new drug that helps the body to absorb pembrolizumab and distribute it around the body. The usual way to have pembrolizumab is as a drip into a vein. In this trial, you have MK-3475A as an injection under the skin.
Some people in the trial have pembrolizumab and some have MK-3475A.
The main aims of the trial are to find out:
- how safe it is to have MK-3475A
- which treatment works best
- what happens to MK-3475A in the body
- how treatment affects
quality of life - what the side effects are
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
squamous cell or non squamous cell non small cell lung cancer (NSCLC) that has spread to another part of the body. Your doctor will know this.
- have a
biomarker called PD-L1 in more than half of your cancer cells
- have an area of cancer that your doctor can measure on a scan
- have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- 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
small cell lung cancer or a mixture of small cell and non small cell cancer cells
- have a change (
mutation ) in the EGFR gene, the ALK gene or the ROS1 gene in your lung cancer cells. This means you are suitable for a specific treatment. Your doctor will know this.
- have cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you have had treatment, the cancer is stable and you have stopped taking steroids.
- have already had treatment to the whole body for NSCLC that has spread to another part of the body. You can take part if you have had chemotherapy, radiotherapy or both before surgery for NSCLC that hadn’t spread and you finished this treatment within 12 months of being diagnosed with metastatic NSCLC.
- have had an
immunotherapy or a similar treatment in the past. Your doctor will know this.
- have had any other cancer treatment to the whole body within 4 weeks of starting trial treatment
- have had radiotherapy within 2 weeks of starting trial treatment or you have side effects from radiotherapy and need to have steroids
- have had radiotherapy to the lung that is more than 30
Gray within 6 months of starting trial treatment. Your doctor will know this.
- have side effects from other cancer treatments that are causing you problems and the trial team think that this could prevent you from taking part
- have had another cancer that is getting worse or needed treatment in the last 3 years. You can join if you had successfully treated
non melanoma skin cancer or
carcinoma in situ . You can’t take part if you have carcinoma in situ of the bladder. You might be able to take part if you have
early prostate cancer.
- are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 4 weeks of joining this trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have a problem with how your
immune system works or you had treatment that damps down the immune system. This includes steroids within 1 week of starting trial treatment unless it was a low dose.
- have or had an
autoimmune condition that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this.
- had scarring on the lungs or inflammation of the lungs (
pneumonitis ) that needed steroid treatment or you have either of these conditions
- have HIV, a hepatitis B infection in the past, an active hepatitis C infection or you have another infection that needs treatment
- have had a
stem cell transplant with somebody else’s cells or you have had an
organ transplant - haven’t recovered from major surgery or you have ongoing complications from surgery
- have another medical condition, mental health condition or the trial doctor thinks there is another reason that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have had a
live vaccine within 30 days of the start of treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
- are allergic to pembrolizumab, MK-5180 (hyaluronidase) or anything they contain
- are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The trial team need 160 people to take part including 6 people from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have 1 of the following:
- MK-3475A (group 1)
- pembrolizumab (group 2)
Everyone has treatment for up to 2 years as long as it is working and the side effects aren’t too bad.
MK-3475A group
You have MK-3475A as an injection under the skin once every 6 weeks. You have up to 18 treatments. This takes up to 2 years.
Pembrolizumab group
You have pembrolizumab as a drip into a vein once every 6 weeks. You have up to 18 treatments. This takes up to 2 years.
Further treatment with MK-3475A or pembrolizumab
If your cancer gets worse after you have had 18 treatments, you might have more treatment. This is the same treatment you had before. Your doctor will talk to you more about this if it applies.
Samples for research (both groups)
The researchers might ask to take a tissue sample () if there isn’t a previous sample that they can use. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about NSCLC
- look for substances called
biomarkers to help work out why treatment might work for some people and not for others
The team will also ask your permission to store some samples for future research. You don’t have to agree to this.
Quality of life
The trial team ask everyone to fill out some questionnaires:
- before you start treatment
- at set times during and after treatment
The questionnaires asks about side effects and how you are feeling. This is called a quality of life study.
Hospital visits
You see the doctor for a and have some tests before you can take part. These include:
- blood tests
- urine tests
- a heart trace (ECG)
- a CT scan, an MRI scan or a PET scan
You might also need to have a bone scan.
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
You might have a visit at home from a nurse for some of the appointments. The trial team will talk to you more about this if you are interested in this option.
Follow up
You see the trial doctor once or twice within a month of stopping treatment.
If you stop treatment but your cancer hasn’t got worse, you see the trial team at the hospital:
- once every 6 weeks for the first 4 ½ months and then
- once every 9 weeks for the next 6 months and then
- once every 3 months until your cancer gets worse or you start a new treatment
When you stop having follow up visits, a member of the trial team will call you every 3 months. This is to see how you are.
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-3475A is a new drug. It is a combination of 2 drugs called pembrolizumab and MK-5180. So we don’t know what all the side effects are. Only a few hundred people have had MK-3475A so far.
In this trial, you have MK-3475A as an injection under the skin. The trial team think the side effects of having pembrolizumab in this way will be similar to having it as a drip into a vein. Having it as a drip into a vein is the usual way to have pembrolizumab.
The most common side effects of having MK-3475A as an injection under the skin include:
- tiredness (fatigue)
- feeling sick
- constipation
MK-3475A can also cause the following side effects at the injection site:
- a change to the skin colour or rash
- redness and swelling
- pain
- itchiness
It is also possible that you might have an allergic reaction to MK-3475A. Some of the signs could include:
- a skin rash or itching
- a high temperature
- shortness of breath
- feeling sick
- feeling dizzy due to low blood pressure
Your doctor or nurse will monitor you and treat any problems straight away.
Pembrolizumab can affect the 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. |
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.
We have more information about having pembrolizumab as a drip into a vein.
Location
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.
Chief Investigator
Dr Toby Talbot
Supported by
Merck Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040