Active not recruitingPHASE3INTERVENTIONAL

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

This study is investigating if combining two experimental drugs, fianlimab and cemiplimab, works better than a standard, approved drug called pembrolizumab. The aim is to prevent or delay melanoma (a type of skin cancer) from returning in people who have already had surgery to remove it. This research is for individuals considered to be at a high risk of their melanoma coming back. The study will also carefully look at any side effects the drugs might cause, how the body handles the drugs, and if the treatment improves a person's overall quality of life. This is a Phase 3 study, meaning it's a large trial to confirm if the new combination is safe and effective.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Regeneron Pharmaceuticals

Enrolment target

1,564

Start

16 Jan 2023

Estimated completion

15 Feb 2030

Melanoma

What is this study about?

This clinical trial is designed to investigate a new approach to help patients who have had surgery for melanoma, a serious type of skin cancer. Even after surgery, there's a chance melanoma can return, especially for those at higher risk. This study wants to find out if a combination of two new drugs, called fianlimab and cemiplimab, can be more effective at stopping the cancer from coming back compared to a medicine currently used for this purpose, called pembrolizumab.

Think of it like this: your doctors have removed the visible cancer, but some tiny cells might still be lurking. This study aims to give your body an extra layer of protection to tackle those cells and reduce the likelihood of the melanoma returning. Pembrolizumab is already an approved treatment in some places for this very reason, but researchers are always looking for even better options.

The study will also carefully check for any side effects from the new drug combination and how it affects your body. They'll also see if it makes a positive difference to your day-to-day well-being. By taking part, you could be helping to find better ways to treat melanoma for yourself and others in the future.

Key takeaways

This study investigates new treatments for melanoma that has been removed by surgery.
It compares a new drug combination (fianlimab + cemiplimab) with a standard medicine (pembrolizumab).
The main goal is to see if the new combination is better at preventing melanoma from returning.
Participation involves regular hospital visits, blood tests, and scans.
You will be closely monitored for side effects and how you are feeling.

Who may be eligible?

To join this study, you must have been diagnosed with a specific stage of melanoma (Stage IIB, IIC, III, or IV) that has been completely removed by surgery. This surgery must have happened relatively recently, within three months before you might start the study, and your wound needs to have healed properly.

Before you can join, doctors will also need to confirm that there's no visible sign of melanoma left in your body through a thorough check-up and scans.

However, some conditions would mean you cannot take part. For example, if you have a very specific type of melanoma called uveal melanoma, or if scans show there's still some cancer left after your surgery. Also, if you have certain autoimmune conditions (where your body's immune system attacks itself), an uncontrolled infection like HIV or hepatitis, or another serious cancer that needed recent treatment, you would not be able to join. Very young patients (under 12 years old or teenagers under 40kg) and those with a history of heart inflammation (myocarditis) are also not eligible.

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.

Have I had surgery to remove melanoma?
Was my surgery within the last 12 weeks and has my wound healed well?
Do scans and check-ups show no signs of melanoma left in my body?
Do I have a specific stage of melanoma (IIB, IIC, III, or IV)?
Do I have any significant autoimmune conditions, serious ongoing infections (like uncontrolled HIV or hepatitis), or other active cancers?
Am I at least 12 years old?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be given either the new combination of fianlimab and cemiplimab, or the standard treatment, pembrolizumab. You wouldn't get to choose which one; it's decided randomly, like flipping a coin. You will receive these drugs through an infusion, which means they go directly into your bloodstream, usually through a drip in your arm, similar to many hospital treatments. The study team will explain how often and for how long you'll receive these infusions.

Throughout the study, you'll have regular hospital visits. These visits will involve various check-ups, blood tests to monitor your health and how the drugs are working, and scans to make sure the melanoma hasn't returned. You'll also be asked about any side effects you experience and how you're feeling overall, as monitoring your quality of life is an important part of the research. The total duration of your participation in the study, including follow-up appointments after your treatment finishes, will be fully explained by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new experimental treatment that might prove to be more effective than current options in preventing your melanoma from returning. You'll also receive very close medical monitoring throughout the trial. However, all medicines have potential side effects, and the new drugs might cause unexpected reactions. While the study aims to find better treatments, there's no guarantee that the experimental drugs will work better than the standard treatment, or even work at all for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (211)

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

UC San Diego
Verified postcode
La Jolla, United States
UCSF Medical Center at Mission Bay
Verified postcode
San Francisco, United States
John Wayne Cancer Institute (JWCI)
Verified postcode
Santa Monica, United States
The Melanoma And Skin Cancer Institute
Verified postcode
Englewood, United States
Miami Cancer Institute at Baptist Health, Inc.
Verified postcode
Miami, United States
Orlando Health
Verified postcode
Orlando, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Northwestern University
Verified postcode
Chicago, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Karmanos Cancer Institute
Verified postcode
Detroit, United States
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in the cells that give skin its colour. If caught early, it's often treatable, but it can spread if not found quickly.

What does 'Phase 3' mean for a clinical trial?

Phase 3 is a large study that compares a new treatment with the standard treatment. It aims to confirm if the new treatment is safe and more effective, often involving many people.

What are fianlimab, cemiplimab, and pembrolizumab?

These are all types of drugs called immunotherapies. They work by helping your body's own immune system fight cancer cells. Fianlimab and cemiplimab are being tested together, while pembrolizumab is a standard treatment.

Will I know which treatment I'm getting?

No, in this study, you won't know if you're getting the new drug combination or the standard treatment. This is to ensure the results are fair and unbiased.

What if I experience side effects?

The study team will closely monitor you for any side effects. You should report any new symptoms or changes in how you feel immediately, and they will provide care and advice.