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.

Cancer type:

Melanoma
Skin cancer

Status:

Closed

Phase:

Phase 2

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 (biopsies Open a glossary item) of the areas where the melanoma has spread to. Looking at how cancer cells respond to treatment can help doctors find out which people benefit most.

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
 
Cancer related 

  • 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 antibodies Open a glossary item in 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 cancer Open a glossary item or carcinoma insitu of the cervix (CIS) that has been successfully treated

Medical conditions

  • Have problems with your immune system Open a glossary item or take drugs such as steroids Open a glossary item that 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 disease Open a glossary item such 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 

Other 

  • Are pregnant or breastfeeding
  • Have had a live vaccination  Open a glossary itemin the month before starting study treatment

Trial design

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 biomarkers Open a glossary item to help work out why treatment might work for some people and not for others. They might use these samples for other tests in the future if you agree to this. 

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • a physical examination
  • heart trace (ECG Open a glossary item)
  • 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

Side effects

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 
  • cough
  • 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.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr James Larkin

Supported by

Cancer Research UK London Research Institute
Merck Sharp Dohme
The Royal Marsden NHS Foundation Trust 
University College London Cancer Institute

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12710

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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