AuthorisedTherapeutic exploratory (Phase II)Interventional

NEOSTART Study - NEOADJUVANT PEMBROLIZUMAB IN PATIENTS WITH HIGH RISK, STAGE IIB/IIC CUTANEOUS MELANOMA: A SINGLE ARM PROOF OF CONCEPT PHASE IIA STUDY

The NEOSTART study is a clinical trial investigating a new treatment approach for specific types of high-risk skin cancer, called melanoma. We are looking at giving patients a medicine called Keytruda (pembrolizumab) before they have surgery. This type of treatment, given before surgery, is sometimes called 'neoadjuvant' treatment. The main goal is to see if Keytruda can significantly reduce the amount of cancer in the tumour before it's removed. We'll also be checking carefully for any side effects and how patients recover from surgery after this treatment. This research could help us find better ways to treat melanoma and improve patient outcomes.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Regional Universitaire

Enrolment target

Start

02 Sep 2025

melanoma

What is this study about?

Imagine you have a serious type of skin cancer called melanoma that doctors say is 'high risk.' This means it has a higher chance of coming back or spreading. Currently, surgery is often the main treatment. But what if we could shrink the cancer first, before surgery, to make the operation more effective?

That's exactly what the NEOSTART study is trying to find out. We're testing a medicine called Keytruda (its active ingredient is pembrolizumab). Keytruda is a type of immunotherapy, which means it helps your own body's immune system fight the cancer. We want to see if giving Keytruda before surgery (this is called 'neoadjuvant therapy') can make a big difference in how much cancer is left in the tumour when it's removed.

The main thing we'll be looking for is called a 'Major Pathological Response.' This is a medical term that basically means how much of the cancer has been destroyed or shrunk by the treatment. Ideally, we want to see very little or no living cancer cells left in the tumour after treatment and surgery. We will also carefully check for any side effects of the treatment and how well patients recover.

Key takeaways

The study helps us learn if treating melanoma with Keytruda before surgery is effective.
It aims to shrink the cancer before removal, potentially improving surgical outcomes.
Patients receive Keytruda via a drip, followed by their planned surgery.
Researchers will closely monitor treatment effectiveness and side effects.
It's for adults with high-risk Stage IIB/IIC melanoma.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to be an adult, aged 18 or older. The study is open to both men and women.

More specifically, you'd need to have a type of skin cancer called melanoma that doctors consider 'high risk,' specifically classified as Stage IIB or IIC. Your doctors will be able to confirm this. You would also need to be healthy enough to undergo the treatment and surgery involved in the study.

The study team will carefully review your medical history and test results to make sure you fit all the criteria for safely taking part. They will explain everything to you in detail.

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.

Are you 18 years old or older?
Have you been diagnosed with high-risk melanoma (Stage IIB or IIC)?
Are you able to undergo intravenous treatment and surgery?
Are you willing to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join the study, you would receive the study drug, Keytruda, through a drip into your arm (intravenously) before your planned surgery. This is called 'neoadjuvant treatment' and typically involves several treatment cycles over a period of time. You would have regular appointments for health checks, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects.

After completing the neoadjuvant treatment, you would then have your surgery to remove the melanoma. Following surgery, there might be further treatments or follow-up appointments to monitor your recovery and long-term health. The total duration of your participation in the study, including treatment and follow-up, would be fully explained to you by the study team.

Potential risks and benefits

Potential benefits of taking part could include receiving a new treatment that might shrink your melanoma before surgery, potentially leading to better outcomes. However, there's no guarantee the treatment will work for everyone, and it's possible you may not benefit. All medicines have potential side effects, and Keytruda is no exception; these will be fully explained to you. The study team will carefully monitor your health to manage any risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'melanoma'?

Melanoma is a serious type of skin cancer that can spread to other parts of the body if not treated.

What is Keytruda?

Keytruda is a medicine that helps your body's own immune system fight and kill cancer cells.

What does 'neoadjuvant' mean?

Neoadjuvant treatment means you receive medicine, like Keytruda, before you have surgery for your cancer.

What is a 'Major Pathological Response'?

This is how doctors measure how much of the cancer has been destroyed or shrunk by the treatment before surgery. We hope to see very little or no cancer cells left.

Will I still need surgery if I join this study?

Yes, if you join this study, the plan is for you to still have surgery after receiving the Keytruda treatment.