A trial of pembrolizumab and chemoradiotherapy for anal cancer (CORINTH)
Cancer type:
Status:
Phase:
This trial is looking at adding pembrolizumab to chemoradiotherapy to improve treatment for anal cancer.
More about this trial
Having chemotherapy and radiotherapy together is called 
. This is the for people with anal cancer that hasn't spread to distant parts of the body.
Pembrolizumab is an immunotherapy. It stimulates the to find and kill cancer cells. Doctors think that having pembrolizumab alongside chemoradiotherapy could improve treatment for anal cancer. They aren’t sure so want to find out more.
The main aims of the trial are to find out:
- how well pembrolizumab and chemoradiotherapy work
- the best time to add pembrolizumab to chemoradiotherapy
- more about the side effects
- how treatment 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
squamous cell anal cancer - have cancer that has spread into surrounding tissues. It may or may not have spread to nearby
lymph nodes but it hasn’t spread elsewhere in the body. This is TNM stage T3 or T4 anal cancer. - have a sample of tissue available for the trial team to do some tests on or you are willing to give a new sample
- are fully active or but might not be able to carry out heavy physical work (performance status of 0 or 1)
- have satisfactory blood tests results
- are willing to use reliable contraception during the trial and for a 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 an anal
sarcoma - have cancer that has spread to other parts of the body
- can’t have chemoradiotherapy for any reason
- have had pembrolizumab or a similar drug in the past
- have another cancer that is getting worse or needs treatment. You can join if you have
non melanoma skin cancer carcinoma in situ (CIS ) of the cervix, abnormal cells in the lining of the vagina (VIN) , vulval cancer that was successfully treated or breast cancer that was treated more than 5 years ago. - are taking an experimental drug as part of another clinical trial. This is if it is within 28 days of starting trial treatment.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had treatment that damps down the immune system. This includes steroids within 7 days of starting trial treatments unless it was a low dose.
- have HIV, an active hepatitis B or hepatitis C infection,
tuberculosis or another active infection that needs treatment - have had a
monoclonal antibody within 4 weeks of starting treatment or you have side effects that aren’t getting better after 4 weeks - have had chemotherapy, targeted small molecule therapy or radiotherapy within 2 weeks of starting trial treatment. Your doctor will know this.
- have moderate to severe side effects from past treatments that aren’t getting better. You can join if you have moderate to severe numbness and tingling (
peripheral neuropathy ) in your hands or feet. - have an
autoimmune condition that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this. - have scarring on the lungs or active inflammation of the lungs (
pneumonitis ) - have any other 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 allergic to pembrolizumab or anything it contains
- have had a live
vaccine in the 30 days before you start trial treatment - are pregnant or breastfeeding
Trial design
This is a phase 1/2 trial. The team need 50 people to take part.
There are 2 groups in this trial:
- group 1 have chemoradiotherapy and start pembrolizumab in the 4th week of chemoradiotherapy. This group is closed to recruitment.
- group 2 have chemoradiotherapy and start pembrolizumab on the same day as chemoradiotherapy. This group is open to recruitment.
Trial treatment for group 2
Everyone has chemoradiotherapy and pembrolizumab.
Your exact treatment plan will depend on what your doctor thinks is best for you. Your chemoradiotherapy takes about 5 to 6 weeks. You have chemoradiotherapy as follows:
- radiotherapy, every day, Monday to Friday
- capecitabine tablets, twice a day, Monday to Friday.
- mitomycin C or cisplatin chemotherapy as a drip into a vein. You have this once on the same day you start radiotherapy.
You also have pembrolizumab once every 3 weeks. You have it as a drip into a vein. It takes about 30 minutes each time. It takes 6 months in total. You start it on the same day you start chemoradiotherapy.
Some people might have fluorouracil (5FU) instead of capecitabine. If this is the case, you have 5FU over 4 to 5 days during the first and the last week of radiotherapy treatment. You may need to stay in hospital to have this or you may be able to go home with a small pump you can carry around. Your doctor will tell you if this applies to you.
Samples for research
The researchers ask for some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They also ask to take 3 extra samples of cancer tissue (a ).
They plan to use the samples to:
- see how well treatment is working
- look at
genes to understand more about anal cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others
You can say no to giving the extra samples if you don’t want to. It won’t affect you taking part in the rest of the trial.
Quality of life
The trial team ask you to fill out some questionnaires:
- before you start treatment
- at set times during treatment and after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor and have tests before you can take part. These include:
- blood tests
- a
physical examination - heart trace (
ECG ) - MRI scan
- PET-CT scan
You have radiotherapy and some of your chemotherapy at the hospital. You see the doctor once a week during chemoradiotherapy. You also see them each time you have pembrolizumab.
You have an MRI or PET-CT scan after you finish chemoradiotherapy at:
- 3 months and
- 6 months
You would have these scans even if you weren’t taking part in the trial.
You see the doctor for a check up one month after you finish chemoradiotherapy. You then see them at:
- 3 months
- 6 months
- 9 months
- 1 year
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.
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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 most common side effects of pembrolizumab include:
- skin rash or itchy skin
- diarrhoea
- cough
- joint or back pain
- high temperature (fever)
- loss of skin colour
- not enough thyroid hormone (
hypothyroidism) . This might cause tiredness, weight gain, feeling the cold more or constipation. - low levels of salt in the blood. This can cause tiredness, confusion, headaches, muscle cramps, and feeling or being sick.
The trial doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask any questions you may have.
We have more information about:
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
Supported by
Cardiff University
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
