AuthorisedTherapeutic exploratory (Phase II)Interventional

Neoadjuvant pembrolizumab in patients with stage IIb/c melanoma, a phase II double-blind placebo-controlled randomized trial NEOPRIME

This research study, called NEOPRIME, is investigating a new treatment approach for specific stages of skin cancer called melanoma (Stage IIb/c). It's a Phase II trial, meaning it's still in the earlier stages of testing. Patients involved will either receive a new drug called pembrolizumab (Keytruda) or a dummy treatment (placebo) before their surgery. Pembrolizumab is a type of immunotherapy designed to help your body's immune system fight cancer. Doctors want to see if giving this treatment before surgery can shrink the tumour more effectively, leading to a better outcome when the tumour is removed. They'll also be closely monitoring any side effects and how patients feel throughout the study. The main goal is to see how much of the cancer disappears in the removed tissue.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vaestra Goetalandsregionen

Enrolment target

Start

19 Jun 2025

Stage IIb/c melanoma

What is this study about?

This study is called NEOPRIME and focuses on a type of skin cancer known as melanoma, specifically when it's at an advanced stage (classified as Stage IIb/c). At these stages, the melanoma has grown thicker or has certain features that make it more likely to spread, but it hasn't yet spread to distant parts of the body.

The main idea behind this study is to try treating the melanoma with medication *before* surgery. This is called 'neoadjuvant therapy'. The medication being tested is called pembrolizumab, also known as Keytruda. It's a type of immunotherapy that works by boosting your body's own immune system to recognise and fight cancer cells. By giving pembrolizumab before surgery, doctors hope to shrink the tumour more effectively, making the surgery easier and potentially reducing the chance of the cancer coming back later.

This is a Phase II study, which means it's still in the early stages of testing this specific approach. Doctors will be carefully looking at how much the cancer shrinks (this is called the pathological response rate) in the tissue removed during surgery. They will also be tracking any side effects, how well patients recover, and the likelihood of the cancer returning or spreading, to see if this new treatment strategy could improve the lives of people with this type of melanoma.

Key takeaways

This study tests a new treatment (pembrolizumab) for advanced melanoma before surgery.
It aims to see if this pre-surgery treatment improves surgical outcomes and reduces cancer recurrence.
Patients will either receive the active drug or a dummy treatment (placebo).
It's a Phase II study, so it's still in the earlier stages of research.
Participation involves regular clinic visits, infusions, and monitoring.
The main goal is to see how much the melanoma shrinks after the treatment.

Who may be eligible?

To join this study, you would need to be an adult, meaning 18 years old or older. There is no upper age limit for taking part.

Both men and women can participate in this research. The study is specifically looking for people who have been diagnosed with advanced melanoma, classified as Stage IIb or IIc.

To find out if you meet all the specific requirements, including other health conditions or treatments you might be having, it's essential to talk to your doctor or the study team. They will have a complete list of criteria to check if this study is right for you.

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 Stage IIb or IIc melanoma?
Are you able to attend regular clinic appointments for treatment and follow-up?
Are you willing to potentially receive a placebo during the study?
Do you understand that this is a research study with potential risks and benefits?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the study drug (pembrolizumab/Keytruda) or a dummy treatment (placebo) through an intravenous drip, meaning directly into your vein. This treatment would be given before your planned surgery to remove the melanoma.

You would have regular visits to the clinic for these infusions, along with various assessments. These assessments might include blood tests, physical exams, and possibly scans or other tests to monitor the melanoma and check for any side effects. After your surgery, you would continue to be monitored for some time to see how you are recovering and to track the long-term results of the treatment.

The doctors will also be looking at detailed information about your tumour, including how it changes before and after treatment, and trying to find markers that predict how well the treatment might work. The total duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving an advanced treatment (pembrolizumab) that might improve the outcome of your melanoma compared to standard care. However, because it's a research study, there's no guarantee of direct personal benefit. There are also potential risks involved, including side effects from the medication, which can range from mild to severe, or unforeseen reactions. The study team will explain all known potential side effects. You have the right to withdraw from the study at any time, for any reason, without affecting your future 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
Sweden

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that develops when skin cells called melanocytes, which produce melanin (the pigment that gives skin its color), start to grow out of control.

What does Stage IIb/c melanoma mean?

This refers to an advanced stage of melanoma that is thicker or has other high-risk features, but has not yet spread to nearby lymph nodes or distant parts of the body.

What is pembrolizumab (Keytruda)?

Pembrolizumab is an immunotherapy drug that helps your body's immune system find and fight cancer cells more effectively. It's often used for different types of cancer.

What is a 'placebo'?

A placebo is an inactive substance or treatment that looks exactly like the real treatment but contains no active drug. It's used in studies to compare the effects of the active drug.

Why is treatment given before surgery?

Giving treatment before surgery, called neoadjuvant therapy, aims to shrink the tumour, making surgery more effective and potentially reducing the chance of the cancer coming back.