Melanoma Trialfinder

For patients

What is a Clinical Trial?

Clinical trials are medical research studies which involve participants (people) to look at new ways of treating melanoma. This could be new ways of giving treatments, comparing different types of new treatments to the current treatments available, or testing potential new drugs. Researchers test potential new drugs in the laboratory to begin with and if they seem safe and effective, they will then carefully test them in people.

Clinical trials for people with melanoma may include:

  • Looking at the risks of developing melanoma and causes of melanoma
  • Finding ways of preventing melanoma
  • Developing tests to find melanoma earlier (screening)
  • Investigating how new tests or scans can be used to diagnose melanoma
  • Testing new treatments for different stages of melanoma
  • Finding better ways of giving melanoma treatments
  • Looking at ways to control any symptoms or side effects of treatment
  • Exploring the best way to provide support and information, for the person with melanoma and their family or friends

Why Should I Consider a Clinical Trial?

Your goal is to find the best treatment available for your melanoma whenever you make a treatment decision with your doctor. Clinical trials aim to find new treatments that can help people with melanoma live longer and improve the quality of their daily life. Clinical trials can offer you access to new melanoma treatments and also the opportunity to improve the understanding of melanoma and its treatment options; all while receiving high quality, patient-centred care.

The Aim of Clinical Trials

Trials aim to find out if a new treatment or procedure for melanoma:

  • is safe
  • is effective
  • has any known or unknown side effects
  • works better than the currently used treatment or procedure
  • affects your quality of life

There are two main types of clinical trials or studies:

Interventional trials aim to find out more about a particular intervention, or treatment for melanoma. Often people taking part are split into different groups, so that the research team can compare the results.

This process often uses a computer system that will select at random to put people into specific groups, called randomisation. This can be dividing people into the group who will receive the new treatment or procedure (investigational group) versus people who will receive no treatment (placebo) or the current standard treatment option (control group).

Observational studies aim to find out what happens to people in different situations, or who are receiving different interventions, tests or treatment. These studies don’t affect what treatments people have and the people taking part aren’t split into treatment groups. The people taking part will just be observed in the situation that they are currently in.

How do Clinical Trials Work?

Drugs and treatments are usually looked at in three different stages before they can be considered as a standard treatment option. Each stage, or clinical trial phase, is designed to answer a specific set of questions about whether a new drug or treatment will be helpful, harmful, or no different than current practice and this is measured by specific criteria, which means there are strict guidelines about who can take part in the trial.

Phase 1 (I)

In many cases, a phase 1 trial will be the first time the treatment has been tested outside the laboratory and they are often called ‘first in human’ studies. A small number of people, around 30 or fewer, are chosen to take part. It will usually be people with advanced melanoma, that may have already had all other currently available treatments.

The aim of a phase 1 trial is:

  • to find a safe dose of the treatment
  • to look at the possible side effects
  • to see how well the body copes with the treatment
  • to see if there are early signs that the treatment is effective against melanoma.

Researchers will monitor how people feel, and any side effects that they may experience, to confirm the best dose of the drug. Some people in phase 1 studies will benefit from the new drug but many won’t, as this is still in a very early testing stage.

Phase 2 (II)

Phase 2 trials usually involve up to 100 people and will build on the results from the phase 1 trials, which improved the knowledge of the safety and potential side effects of the treatment and decided the best dose of the treatment to give.

The aim of a phase 2 trial is to:

  • confirm if the best drug dose has been chosen
  • continue to look at the side effects of treatment and how to manage them
  • look at whether the treatment is having a positive effect on the melanoma to be able to move to the next phase.

Phase 3 (III)

A phase 3 trial compares the new treatment with the best standard available treatment for melanoma and involves the largest number of people, with hundreds or even thousands of people taking part, often from hospitals across the country and world.

The aim of a phase 3 trial is to see if the new treatment improves a person’s overall survival or how long they stay free from melanoma, as well as their quality of life and continuing to monitor possible side effects.

Phase 4 (IV)

This phase will happen after the drug has been licensed for routine use and continues to monitor the medicine on an ongoing basis to see if there are any unexpected side effects, or if it causes problems in certain people.

Trials covering more than one phase

Occasionally you may see trials written as phase I/II or phase II/III. This means that that trial covers more than one phase as it progresses.

For anyone who would like more in-depth information about clinical trials, please watch our video ‘Taking part in clinical trials: How Patients can make a difference‘ presented by Simon Rodwell.

Taking part in clinical trials: How Patients can make a difference

Why are Clinical Trials Important?

Clinical trials contribute to our knowledge of melanoma and help us progress in fighting against it. If a new treatment proves effective in a study, it may soon become a new standard treatment that will help many patients in the future. Remember all current standard melanoma treatments came from clinical trials.

There are lots of reasons why people enter clinical trials, but make sure you find out as much as possible about the trial to help you to decide if you do want to take part. You can also leave a clinical trial at any time, without it affecting your care.

Possible advantages of clinical trials

  • You may have access to new melanoma treatments, which could be more effective
  • Your quality of life could be better due to less side effects with the new treatment
  • You may have more regular tests and monitoring and are assigned a dedicated nurse, which some people find reassuring
  • You may help to improve future melanoma treatments and medical knowledge

Possible disadvantages of clinical trials

  • The new treatment may not be any better than the current available treatment
  • You may experience new side effects to the treatment
  • Trial schedules and monitoring often mean that you may have to go to hospital more often for tests and treatment, which can be inconvenient
  • The trial may not be available at a location convenient to you
  • You may not like the uncertainty of not knowing whether you are taking a new treatment, the standard treatment, or a placebo

There are strict rules for joining clinical trials to make sure that the results can be relied upon, and not all treatment centres are involved in clinical trials. Your oncologist should know what is possible, but sometimes you may need to ask specifically about clinical trials if you are interested. They can see if you may be suitable to be included in the clinical trial through a review of your medical background and performing some medical tests.

You might want to ask

  • What trials are available to me at my treatment centre?
  • If you’re willing and able to travel; What is available at another centre?
  • What is the aim of the trial?
  • What is the evidence that this new treatment might be effective in treating my melanoma?
  • What are the possible risks and benefits of taking part in the trial?
  • What will taking part involve, compared to not taking part?

You may also be asked to take part in observational research studies, for example into your wellbeing, which may involve taking part in interviews and surveys

How to find a Melanoma Clinical Trial

Talk to your Oncologist
Use the Melanoma TrialFinder

The Melanoma TrialFinder will allow you to search for UK melanoma trials according to your particular type and stage
of melanoma.

Find a trial