A trial looking at cemiplimab and chemotherapy for penile cancer that has spread (EPIC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding cemiplimab to chemotherapy. It is also looking at how well cemiplimab works on its own.
It is for people with penile cancer that has spread to:
- nearby areas of the body (locally advanced) or
- a distant site in the body (metastatic)
More about this trial
Chemotherapy is a common treatment for penile cancer that has spread to nearby or distant sites in the body. There are several different chemotherapy drugs and drug combinations available.
Doctors are interested in how to improve treatment for penile cancer that has spread. To do this, they are looking at a new immunotherapy drug called cemiplimab.
It is a type of drug called a 
. It works by triggering the and helping it to attack the cancer cells.
Researchers are looking at cemiplimab on its own and with chemotherapy drugs.
The aims of this trial are:
- to see how well cemiplimab works on its own, and with chemotherapy, for penile cancer that has spread
- to learn more about the side effects of treatment
- to find out about the
quality of life of people taking part
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 have squamous cell cancer of the penis or squamous cell cancer of the penile and one of the following:
- your cancer has spread to a distant part of the body (metastatic penile cancer)
- you have cancer in the
lymph nodes in your pelvis or your cancer has spread outside the wall of a lymph node - you have cancer in 3 or more lymph nodes in the same side of your
groin or in at least one lymph node on either side of your groin. And your team do not think surgery would be suitable for you. - your cancer has spread into the spongy erectile tissue of the body of the penis (corporus cavernosum). It may or may not have spread to the urethra.
- your tumour has grown into nearby body parts such as the
prostate gland , the sac of skin that surrounds the testicles (scrotum) or pubic bone
You may also be able to join this trial if all of the following apply. You:
- have cancer that doctors can see on a scan
- are able to look after yourself, but unable work and you are up and about more than half the time. Or you are more active than this (ECOG performance status 0,1 or 2).
- are willing to use a reliable method of contraception during the trial and for a year after if there is a chance your partner could become pregnant
- have satisfactory blood test results
- are generally well enough to cope with having chemotherapy
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply:
- you have verrucous penile cancer
- you have had chemotherapy for penile cancer before. You might be still able to take part if you had chemotherapy and radiotherapy treatment (
chemoradiation ) before it was found your cancer had spread. - your doctor thinks the trial drugs would not be suitable to you
- you have had radiotherapy to areas of your penile cancer before. And there are no other areas which have not been treated with radiotherapy that can be measured on a CT scan. You might still be able to take part if there are other areas that can be measured on a CT scan.
- you have had another cancer within the last 5 years. You might be able to take part if the cancer was successfully treated and there was very little chance of it spreading. Your doctor will explain more.
- you have uncontrolled
diabetes - you have another serious illness or medical problem that the trial team think would make it unsafe for you to be on the trial
- you are allergic to any
monoclonal antibodies or to drugs that contain polysorbate 80. Your doctor can explain more. - you have HIV
- you have hepatitis B or hepatitis C
- you have an infection needing medication that reaches the whole body
- you have had an
autoimmune condition within the last 5 years which has needed treatment to dampen down the immune system. You might be able to take part if you have type 1 diabetes, childhood asthma that is better now, vitiligo or some other conditions. Your doctor can explain more. - you have had inflammation of the lung tissue (
pneumonitis ) within the last 5 years - you have one of a number of conditions affecting the lung tissue called interstitial lung disease
- you have recently had medications that affect your immune system. Your doctor can tell you more.
- you have had immunotherapy in the past and the side effects got so bad you needed to stop taking it.
- you have had drugs that block PI3K in the past, such as idelalisib
- you have been on another clinical trial and had a clinical trial drug within the 30 days before joining the trial. You might have to wait longer than 30 days depending on the type of drug. Your doctor can explain more.
- you have had a live vaccine in the 28 days before you take part
Trial design
This is a phase 2 trial. The researchers need around 47 people to take part.
Your doctor decides which is the best treatment group for you. This depends on if they think chemotherapy would be a suitable treatment for you.
You have one of the following:
- cemiplimab and chemotherapy (group 1)
- cemiplimab (group 2)
Group 1
You have chemotherapy in . A cycle means that you have a combination of drugs and then have a rest to allow your body to recover. Each cycle is 3 weeks. And you have 4 cycles of chemotherapy.
Your doctor will let you know which chemotherapy plan they think is best.
Chemotherapy drugs you might have include:
You have chemotherapy as a drip into a vein. Your team will let you know how long each drip takes.
On day 1 of each cycle, you also have cemiplimab as a drip into a vein. The drip takes 30 minutes to 1 hour.
When you have finished your 4 cycles of chemotherapy, you carry on with cemiplimab every 3 weeks until you reach around 2 years of treatment. During this time, you have it for as long as it is working, and the side effects are manageable.
Group 2
You have cemiplimab as a drip into a vein. The drip takes 30 minutes to 1 hour. You have cemiplimab every 3 weeks. This is one cycle of treatment.
You have it for up to 2 years, as long as it is working, and the side effects are manageable.
Quality of life
The study team will ask you to fill out questionnaires before you start the study drugs and around every 3 cycles during the trial.
The questionnaires will ask about side effects and how you’ve been feeling.
This is called a quality of life study.
Future research samples
The researchers would like to use the tissue sample you gave for future research. It is stored at your hospital. You do not have to give another tissue sample.
They will ask your permission for this. You can say no and still take part in the trial.
The trial team aim to use the tissue sample to find out:
- about
genetic changes and the difference between people’s cancers - why treatment might work better for some people than others
Hospital visits
You see a doctor and have some tests before you join the trial. These might include:
- physical examination
- a photograph of any lesions on your skin – this is not often needed, your team will talk with you about this
- measurement of your height, weight, pulse, blood pressure, oxygen saturation and temperature
- CT scan of your chest, tummy (abdomen) and pelvis
- blood tests
- heart trace (
ECG )
You see your trial doctor before each cycle of treatment. You have a physical examination and blood tests. This is to make sure it is safe for you to continue with treatment.
During treatment you have a CT scan and a photograph if this is needed every 6-9 weeks. This is so the trial team can see how well the treatment is working.
End of treatment
You see the trial doctor and have some tests. These include:
- physical examination
- a photograph of any lesions on your skin – if this is suitable for you
- measurement of your height, weight, pulse, blood pressure, oxygen saturation and temperature
- CT scan of your chest, tummy (abdomen) and pelvis
- blood tests
Follow up
The trial team would like to keep in touch with you after treatment ends. This is to see how you are getting on.
They would like to see you every 3 months for the first year. Then every 6 months until the end of the second year.
Some of the later follow up visits can be over the phone.
You would have a CT scan and possibly a photograph every 12 weeks during follow up.
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.
| Cemiplimab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. 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. |
The most common side effects of cemiplimab are:
- inflammation of the intestine (colitis)
- skin changes, including redness, blistering and dryness
- inflammation of the lung tissue (pneumonitis)
- inflammation of the liver
- changes to hormone levels made by the
thyroid gland , you might feel tired, have weight changes, feel constipated or depressed. - sore mouth
- having a reaction when the drug is being given into the vein. You might have chills, fever or problems breathing. Your team monitor you carefully and treat you quickly if this happens.
The most common side effects of chemotherapy are:
- increased risk of infections
- feeling or being sick
- changes to your kidneys (these are usually mild)
- numbness or tingling in your hands and feet
- taste changes
We have more information on chemotherapy including possible side effects.
You can choose your chemotherapy drug from our cancer drugs A-Z list for more information.
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
Professor Amit Bahl
Supported by
Sanofi-Genzyme
University Hospitals Bristol and Weston NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
