Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

This research trial is investigating a new way to treat advanced melanoma, a type of skin cancer that has spread or cannot be surgically removed. Doctors are comparing a new treatment that combines two medicines, relatlimab and nivolumab, against nivolumab given on its own. The main goal is to find out if the combination of relatlimab and nivolumab is more effective at treating this type of melanoma. If you have been diagnosed with advanced melanoma and are considering treatment options, this study could be relevant to you. It's a key step in understanding potential new ways to manage this condition.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

714

Start

11 Apr 2018

Estimated completion

15 Dec 2030

Melanoma

What is this study about?

This study is focused on advanced melanoma, which is a skin cancer that has either spread to other parts of the body (stage IV) or is extensive and can't be completely removed by surgery (unresectable stage III). When melanoma reaches this stage, finding effective treatments is very important.

The trial is testing a combination of two medicines, relatlimab and nivolumab. Nivolumab is an immunotherapy drug that helps your body's immune system fight cancer. Relatlimab is another type of immunotherapy that works by targeting a specific pathway to further boost the immune response against cancer. Researchers want to see if giving these two medicines together works better than giving nivolumab on its own.

The findings from this study could help doctors understand if this new combination treatment offers a more effective option for people living with advanced melanoma. This is an important step in finding better treatments and improving care for patients.

Key takeaways

This study is for people with advanced melanoma that has spread or cannot be removed by surgery.
It tests a new combination of immunotherapy drugs, relatlimab and nivolumab.
The aim is to see if the combination works better than nivolumab alone.
You must not have had previous systemic treatment for advanced melanoma.
Participation involves regular clinic visits for treatment and monitoring.
You can discuss this study with your doctor to see if it's right for you.

Who may be eligible?

To join this study, you must have been diagnosed with advanced melanoma (stage III that cannot be removed by surgery, or stage IV that has spread). It's important that this is your first time receiving medication for your advanced melanoma; you cannot have had other treatments for it yet.

Also, your doctors will need a small sample of your current tumour tissue. This sample will be used to look at specific markers that might help understand how the treatment works.

There are also some reasons why you might not be able to join. For example, if your melanoma has spread to your brain or the lining of your brain or spinal cord, you unfortunately wouldn't be able to take part. The study also cannot include individuals with a type of melanoma called uveal melanoma, which affects the eye. You also can't have an active or suspected autoimmune disease, which is when your body's immune system attacks healthy cells.

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.

I have been diagnosed with advanced melanoma (stage III unresectable or stage IV).
I have not received any prior medication treatments specifically for my advanced or metastatic melanoma.
I do not have melanoma that has spread to my brain or spinal cord lining.
My melanoma is not uveal melanoma (a type of eye cancer).
I do not have an active serious autoimmune disease.

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study medication, either the combination of relatlimab and nivolumab, or nivolumab alone, given through an infusion (into a vein). The doctors and nurses would carefully monitor your health and how you respond to the treatment. This will include regular check-ups, blood tests, and scans to see how the melanoma is responding. There would also be follow-up appointments after your treatment period ends to continue monitoring your health. The total duration of your participation, including treatment and follow-up, would be discussed in detail by the study team.

Potential risks and benefits

While we hope this new combination treatment will be more effective for melanoma, there's no guarantee it will work for everyone. Potential benefits include the possibility of better control of your cancer. However, all medications can have side effects, and immune-based therapies can sometimes cause inflammation in different parts of the body. The study team will explain these potential risks and side effects in detail. Remember, joining a clinical trial is always your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (127)

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

Local Institution - 0010
Verified postcode
Tucson, United States
Local Institution - 0020
Verified postcode
Los Angeles, United States
Coastal Integrative Cancer Care
Verified postcode
San Luis Obispo, United States
Local Institution - 0116
Verified postcode
Santa Barbara, United States
Local Institution - 0012
Verified postcode
Washington D.C., United States
Local Institution - 0013
Verified postcode
Jacksonville, United States
Local Institution - 0117
Verified postcode
Orlando, United States
Local Institution - 0007
Verified postcode
Tampa, United States
Local Institution - 0038
Verified postcode
Atlanta, United States
Local Institution - 0016
Verified postcode
Chicago, United States
Local Institution - 0114
Verified postcode
Fort Wayne, United States
Local Institution - 0077
Verified postcode
Baltimore, United States

Common questions

What is advanced melanoma?

Advanced melanoma is a type of skin cancer that has either spread to other parts of the body (metastatic) or is too extensive to be removed by surgery (unresectable).

What are relatlimab and nivolumab?

These are both types of immunotherapy medicines. They work by helping your body's immune system to recognise and fight cancer cells.

Why are doctors combining these two medicines?

Researchers want to see if using these two immunotherapies together can be more effective at treating advanced melanoma than using one of them alone.

Will I know which treatment I'm getting?

In some trials, you might not know if you're getting the combination treatment or nivolumab alone. The study team will explain this process, often called 'blinding'.

What happens if the treatment doesn't work for me?

The study team will closely monitor your progress. If the treatment isn't working, or if you experience significant side effects, they will discuss other treatment options with you.