All studies
RecruitingPHASE3INTERVENTIONAL

Duration of Anti-PD-1 Therapy in Metastatic Melanoma

This study investigates the best way to give a common cancer treatment, called a PD-1 inhibitor, to people with advanced melanoma. Currently, this medicine is often given continuously for up to two years. Researchers want to find out if taking planned breaks from the treatment, also known as intermittent therapy, is just as effective at helping patients live longer as taking it non-stop. They are comparing these two approaches to see if reducing treatment time could still give good results, potentially meaning fewer hospital visits, fewer side effects, and a better quality of life for patients, alongside saving money for the NHS.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Canadian Cancer Trials Group
Enrolment target
614
Start
31 Oct 2016
Estimated completion
31 Dec 2029

What is this study about?

This study is looking into a type of cancer treatment called PD-1 inhibitor therapy. This treatment is often used for a type of skin cancer called melanoma, especially when it has spread (metastatic) or cannot be removed by surgery (unresectable). PD-1 inhibitors are a kind of immunotherapy, which means they work by boosting your body's own immune system to help it fight off cancer cells. Medicines like pembrolizumab and nivolumab are examples of PD-1 inhibitors that have been shown to shrink tumours and help people with melanoma live longer.

Currently, people usually receive PD-1 inhibitors continuously, meaning without long breaks, for up to two years. This two-year period was chosen because it seemed sensible and has worked well in previous studies. However, some doctors wonder if taking shorter breaks from the treatment, or giving it on an 'intermittent' schedule, might also be just as effective. They are asking whether patients might still do just as well even if they don't take the medicine non-stop for the full two years.

The main goal of this study is to compare these two ways of giving the treatment: continuously (non-stop) versus intermittently (with planned breaks). If taking breaks from the medicine works just as well, it could mean a lot of good things for patients. For example, it might lead to fewer trips to the hospital, fewer side effects from the medication, and generally a better quality of life. It could also help reduce costs for the NHS. But we don't know for sure if it will work this way yet, which is why this study is so important.

Key takeaways

  • This study compares continuous vs. intermittent PD-1 inhibitor therapy for advanced melanoma.
  • The goal is to see if taking breaks from treatment works as well as taking it non-stop.
  • If successful, intermittent treatment could mean fewer side effects and better quality of life.
  • This is an important study to find the best way to use existing, effective cancer treatments.
  • Participation involves regular check-ups and completing questionnaires.

Who may be eligible?

To join this study, you must be at least 18 years old. You need to have melanoma that has spread or can't be removed by surgery, and your doctor must be able to assess how well the treatment is working. This is important even if the exact size of your cancer can't be measured precisely.

You must also be eligible to receive a PD-1 inhibitor treatment that is paid for by the government in the UK. If you have melanoma that has spread to your brain, you might still be able to join, but only if it's stable and hasn't grown or changed for at least four weeks. This applies whether you've had surgery or radiotherapy for it or not.

Finally, you should be able to understand and answer questionnaires about your health and quality of life in English. You'll need to agree to take part by signing a consent form before you start.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have metastatic (spread) or unresectable melanoma?
  3. Are you eligible for government-funded PD-1 inhibitor treatment?
  4. Can you understand and complete health questionnaires in English?
  5. If you have brain metastases, are they stable and haven't grown recently?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you will either receive your PD-1 inhibitor treatment continuously (non-stop) or with planned breaks. The study will involve regular visits to the clinic so doctors can monitor your health and the effects of the treatment. You will also be asked to complete questionnaires about your quality of life. The total duration of your participation will depend on which treatment group you are in and how you respond to the treatment, but standard treatment is typically up to two years.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a treatment schedule that could lead to fewer side effects, less time spent in hospital, and a better quality of life, if the intermittent approach proves to be effective. However, it's also possible that taking breaks could mean the treatment is less effective for your cancer. As with all medical treatments, there are potential risks and side effects associated with PD-1 inhibitors, which your doctor will discuss with you. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

  • Mildura Base Public Hospital
    Approximate
    Victoria, Australia· Recruiting
  • Coffs Habour Health Campus - NCCI
    Verified postcode
    Coffs Harbour, Australia· Recruiting
  • Calvary Mater Newcastle Hospital
    Verified postcode
    Waratah, Australia· Recruiting
  • Westmead Hospital
    Verified postcode
    Westmead, Australia· Recruiting
  • Sunshine Coast University Hospital
    Verified postcode
    Birtinya, Australia· Recruiting
  • Cairns Hospital
    Verified postcode
    Cairns, Australia· Recruiting
  • Gold Coast University Hospital
    Verified postcode
    Southport, Australia· Recruiting
  • The Queen Elizabeth Hospital
    Verified postcode
    Woodville, Australia· Recruiting
  • Monash Medical Centre
    Verified postcode
    Clayton, Australia· Recruiting
  • Alfred Hospital
    Verified postcode
    Melbourne, Australia· Recruiting
  • Royal Brisbane and Womens Hospital
    Verified postcode
    Herston, Australia· Recruiting
  • Cross Cancer Institute
    Verified postcode
    Edmonton, Canada· Recruiting

Common questions

What is a PD-1 inhibitor?

It's a type of medicine that helps your body's own immune system fight cancer cells by essentially 'waking it up' to attack the tumour.

What does 'unresectable/metastatic melanoma' mean?

This means your melanoma has spread to other parts of your body or cannot be completely removed by surgery.

What does 'intermittent' treatment mean?

It means you take planned breaks from your treatment, rather than taking it continuously without long pauses.

Will this study change my standard treatment?

This study is comparing two ways of giving an approved standard treatment. You will either continue with continuous treatment or try the intermittent approach, but both are aiming to find the best way to manage your condition.

What if I get worse during the study?

Your health will be closely monitored. If your cancer gets worse or you have severe side effects, doctors will review your treatment plan, and you may be taken off the study treatment.

How to find out more

Janet Dancey

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Duration of Anti-PD-1 Therapy in Metastatic Melanoma…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.