Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study of pembrolizumab in advanced melanoma (ADAPTeM)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at taking tissue samples to check how pembrolizumab is working at certain time points during treatment. The study is for people whose cancer has spread to another part of the body (advanced melanoma).
More about this trial
Pembrolizumab is a type of immunotherapy. This type of treatment stimulates the body’s immune system to fight cancer cells.
It targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
In this study, researchers plan to take tissue samples (
The aims of the study are to find out:
- how pembrolizumab affects cancer cells at various time points
- if it is possible and safe to take a number of biopsies during treatment
The study team hope the information they gain from this study will help to improve treatment for people with advanced melanoma in the future.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You might be able to join this study if all of the following apply.
- You have melanoma that has spread to another part of the body
- You have areas of melanoma spread to lymph nodes or skin that can be easily biopsied
- Your cancer can be measured on a scan
- There is an old tissue sample available for the study team to do some tests on or you have provided a new sample
- You have had a number of different treatments for your cancer or this will be your first
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use 2 different types of reliable contraception during the study and for 4 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this study if any of these apply. You
- Have cancer that has spread to your brain or the tissues surrounding your brain - you might be able to take part if you have cancer spread to your brain that has been successfully treated, has not got any worse in the last 4 weeks and you haven’t taken steroids for at least a week
- Have had
monoclonal antibodiesin the last 4 weeks or you haven’t recovered from side effects of any treatment unless they are mild
- Have had chemotherapy, small molecule therapy such as dabrafenib or trametinib or radiotherapy within 2 weeks of starting study treatment or haven’t recovered from side effects unless they are mild apart from nerve damage
- Have already had a drug that targets PD-1, PD-L1, PD-L2, CD137 such as nivolumab, pembrolizumab, a combination of ipilimumab and nivolumab or any other trial immunotherapy drugs
- Have had or are having experimental treatment or used a device as part of an experimental study in the 4 weeks before joining this study
- Have another cancer apart from
non melanoma skin canceror carcinoma insitu of the cervix (CIS) that has been successfully treated
- Have problems with your
immune systemor take drugs such as steroidsthat damp it down or you have used any other type of treatment that supresses your immune system in the 7 days before starting study treatment
- Have an
autoimmune diseasesuch as rheumatoid arthritis, inflammatory bowel disease or multiple sclerosis that is severe or needed treatment in the last 3 months. If you have an auto immune condition related to hypothyroidism and are on a stable dose of thyroid replacement hormone you might be able to take part in the study. And if you a condition called Sjorgen’s syndrome you might also be able to take part.
- Have a condition affecting your lungs called interstitial lung disease or pneumonitis
- Have an infection that needs treatment
- Have HIV
- Have hepatitis B or hepatitis C
- Have any other serious medical condition or mental health problem
- Are pregnant or breastfeeding
- Have had a live
vaccinationin the month before starting study treatment
This phase 2 study is based at the Royal Marsden Hospital. The researchers need 40 people to take part.
Everyone will have pembrolizumab. You have it as a drip into a vein. You have treatment once, every 3 weeks.
You have pembrolizumab for up to 2 years as long as it works and the side effects aren’t too bad.
You have 3 extra biopsies and some extra blood samples as part of the study. You have these:
- before you start treatment
- 6 weeks after you start treatment
- when you stop treatment
The doctor will take the tissue samples from the tumour in the skin or from an area of melanoma spread to a lymph node.
They will look for substances called
You see a doctor and have some tests before you can take part. These include:
- a physical examination
- heart trace (
- blood tests
- urine tests
- a tissue sample (biopsy) of your cancer
- CT scan of your chest, tummy (abdomen) and area between your hip bones (pelvis)
You have your treatment at the hospital. At each visit you see the doctor for a check up and blood tests.
You have a CT scan every:
- 9 weeks in the first year of the study
- every 3 months in the 2nd year
When you stop treatment, you see the study team a month later. They will repeat some of the tests you had when you joined the study
The most common side effects of pembrolizumab include:
- tiredness and lack of energy (fatigue)
- constipation or diarrhoea
- itchy skin
- problems with your thyroid gland causing tiredness, feeling cold and weight gain
- joint pain
- liver problems that might cause your skin to go yellow (jaundice)
- loss of appetite
- shortness of breath
- high levels of sugar (glucose) and fat (triglycerides) in the blood
- low levels of salt (sodium), calcium and albumin in the blood
After having a biopsy you might have some discomfort or pain. This is usually mild and simple painkillers should help. There is a very small risk of bleeding or infection.
The study doctor will explain all the possible side effects before you join the study.
We have more information about pembrolizumab.
How to join a clinical trial
Dr James Larkin
Cancer Research UK London Research Institute
Merck Sharp Dohme
The Royal Marsden NHS Foundation Trust
University College London Cancer Institute