RecruitingPHASE3INTERVENTIONAL

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

This study is for people in the UK with advanced melanoma that hasn't been treated yet. We want to see how a new experimental drug, brenetafusp (also known as IMC-F106C), works when given with nivolumab. We'll compare this combination to the standard treatments that already exist, which include nivolumab alone or nivolumab combined with another drug called relatlimab. The main goal is to find out if the new combination treatment is more effective for people with advanced melanoma. To join, your body needs to have a specific genetic marker, and your melanoma must be advanced and measurable. It's a Phase 3 study, meaning it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Immunocore Ltd

Enrolment target

680

Start

05 Jun 2024

Estimated completion

16 Oct 2027

Advanced Melanoma

What is this study about?

Melanoma is a type of skin cancer. When it's called 'advanced,' it means the cancer has spread from where it started to other parts of the body, or it can't be removed by surgery. For people with advanced melanoma, doctors often use treatments like nivolumab, which helps your body's immune system fight the cancer.

This study is looking at a new treatment combination: brenetafusp plus nivolumab. Brenetafusp is an experimental drug designed to specifically target certain melanoma cells. By combining it with nivolumab, researchers hope to create a stronger attack against the cancer. We want to find out if this new combination works better than the current standard treatments that use nivolumab, either on its own or with another drug called relatlimab.

Taking part in this study means you would be randomly assigned to receive either the new combination treatment or one of the standard nivolumab treatments. This comparison helps doctors understand if the new treatment is a safe and more effective option for people with advanced melanoma that hasn't been treated before. It’s an important step for potentially finding better ways to help people living with this condition.

Key takeaways

This study is for people with advanced melanoma that hasn't been treated previously.
It's comparing a new drug combination to existing standard treatments.
Participation involves regular visits and health checks.
You would need to have a specific genetic marker (HLA-A*02:01) to be considered.
There are potential benefits and risks, which your doctor will explain carefully.

Who may be eligible?

To be able to join this study, you would need to meet certain requirements. First, your body must have a specific genetic marker called HLA-A*02:01. Also, your melanoma must be advanced (Stage III that can't be removed, or Stage IV) and not have been treated with modern cancer medicines before. Doctors will also need to be able to measure your cancer to see if the treatment is working, and know if your cancer has a specific change called a BRAF V600 mutation.

There are also some reasons why you might not be able to join. For example, if you have had other cancers in the past (unless they were minor and completely treated), or if your cancer has spread to your brain and is causing problems. You also can't have certain serious heart or lung conditions, or a serious autoimmune disease that needs strong medication. If you've had a bad reaction to similar drugs in the past, or if the study doctors think it wouldn't be safe for you, you also wouldn't be able to take part.

If you are a man or woman who could have children and are sexually active with someone who hasn't had a sterilisation operation, you'll need to agree to use effective birth control methods during the study and for five months after your last dose of treatment.

Quick self-check

Do you have advanced melanoma that has not been treated before?
Has your doctor confirmed you have the HLA-A*02:01 genetic marker?
Are you generally healthy enough to participate, with no serious heart, lung, or autoimmune conditions?
Are you willing to use effective birth control if applicable?
Have you not had any serious reactions to similar types of cancer drugs in the past?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of the treatment groups: either the new brenetafusp plus nivolumab combination, or one of the standard nivolumab treatments. This means you won't get to choose which treatment you receive. You'll have regular visits to the hospital or clinic for blood tests, physical examinations, and possibly scans to check your health and how the treatment is working. You will receive your study medication as infusions, which are given directly into your bloodstream, usually through a drip. The doctors and nurses will explain exactly how often and for how long you'll receive your treatment.

Throughout the study, you'll be closely monitored for any side effects. You'll need to report any new or worsening symptoms to your study team. After your main treatment finishes, there will be follow-up visits to continue checking on your health and how you're doing in the long term. The total duration of your participation in the study will depend on your individual response to treatment, but it typically involves several months of active treatment and then ongoing follow-up.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could be more effective than current options, which is a potential benefit. However, there's also a chance the new treatment might not work for you, or it might have side effects that are unknown or more severe than standard treatments. As with any medication, there are always potential risks and side effects, and some might be serious. Your doctors will discuss all known potential risks before you decide to join. It's really important to remember that participating in a study is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (211)

University of Arizona
Tucson, United States· Recruiting
University of California - San Diego
La Jolla, United States· Recruiting
The Angeles Clinic and Research Institute- West Los Angeles
Los Angeles, United States· Recruiting
ESC Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
UCLA Hematology/Oncology
Los Angeles, United States· Recruiting
Stanford Cancer Institute - Stanford Cancer Center Palo Alto
Palo Alto, United States· Completed
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, United States· Recruiting
University of Colorado, Anschutz Medical Campus
Aurora, United States· Recruiting
The Melanoma & Skin Cancer Institute
Denver, United States· Recruiting
UConn Health-Farmington (University of Connecticut Health Center (UCHC))
Farmington, United States· Completed
Georgetown University
Washington D.C., United States· Recruiting
Mayo Clinic Florida
Jacksonville, United States· Recruiting

+199 more sites — see the official record for the full list.

Common questions

What is advanced melanoma?

Advanced melanoma means the skin cancer has spread to other parts of your body or can't be removed by surgery.

What is nivolumab?

Nivolumab is a type of medicine that helps your body's own immune system fight cancer cells more effectively.

What does 'HLA-A*02:01-positive' mean?

This refers to a specific genetic marker within your body. The study treatment is designed to work best in people who have this marker.

Will I know which treatment I'm getting?

Because this is a 'randomised' study, you won't get to choose which treatment you receive, and you might not know which one it is (this is called 'blinding').

Can I stop being in the study if I change my mind?

Yes, you can choose to leave the study at any time, and this won't affect your ongoing medical care.

How to find out more

Immunocore Medical Information

medical.information@immunocore.com 844-466-8661 Official trial record

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