Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma

This research study is investigating a new treatment approach for people who have had advanced melanoma (skin cancer that has spread) surgically removed. The study aims to see if combining two existing anti-cancer drugs, nivolumab and relatlimab, works better at preventing the cancer from returning after surgery, compared to using nivolumab on its own. Participants will receive one of these treatments, and doctors will carefully monitor how long it takes for the cancer to potentially come back, or for any other health changes. This is a large, advanced-stage study designed to confirm if the combination treatment is effective and safe for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

601

Start

07 Feb 2024

Participants with completely resected Stage III or Stage IV melanoma

What is this study about?

This research study is trying to find out if a new combination of medicines can help people who have had advanced skin cancer, called melanoma, removed by surgery. When melanoma has spread to nearby lymph nodes or other areas (Stage III or IV) but has then been completely taken out by an operation, there's always a worry it might come back.

Doctors are comparing two different ways of treating patients after surgery. One group of patients will receive a combination of two drugs, nivolumab and relatlimab. The other group will receive nivolumab on its own. Both are types of immunotherapy, which work by helping your body's own immune system fight cancer cells.

The main goal is to see which treatment is better at stopping the cancer from returning for as long as possible. The study will also look at how long people live, how long it takes for the cancer to spread further away, and any side effects people might experience. This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available.

Key takeaways

Tests a new combination immunotherapy for advanced melanoma after surgery.
Compares two drugs together (nivolumab and relatlimab) against nivolumab alone.
Aims to see if the combination better prevents cancer from returning.
For adults with fully removed Stage III or IV melanoma.
Involves regular infusions and health check-ups.
This is a large, final-stage clinical trial.

Who may be eligible?

This study is for adults who have had a type of skin cancer called melanoma completely removed by surgery. This means the cancer was at a more advanced stage, either Stage III or Stage IV, but doctors believe they've taken all of it out.

If you're aged 18 or older and have undergone this specific type of surgery for Stage III or IV melanoma, you might be able to join. Both men and women are welcome to take part.

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 am 18 years old or older.
I have had melanoma that was classified as Stage III or Stage IV.
My melanoma has been completely removed by surgery.
I am willing to receive either the combination treatment or nivolumab on its own, decided by chance.

Answer every question to see your result.

What does participation involve?

If you join this study, you'd be randomly assigned to receive either the combination of two drugs (nivolumab and relatlimab) or nivolumab by itself. You wouldn't choose which treatment you get, and neither you nor your doctors would typically know which one you're receiving – this helps make sure the results are fair.

The treatments are given as infusions, meaning they go directly into your vein. You would have regular hospital visits for these infusions, as well as check-ups and tests to see how you're responding and to monitor for any side effects. This might include blood tests, scans, and physical examinations. The study will follow you over a period of time to track your health and whether the melanoma returns.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new combination treatment that might be more effective than standard care for preventing your melanoma from recurring. However, there are also potential risks, as any medication can have side effects. These will be carefully explained to you by the study team. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (13)

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

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Unverified
Czechia
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Unverified
Denmark
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Unverified
Belgium
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Unverified
Finland
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Unverified
Germany
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Unverified
Italy
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Unverified
Greece
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Unverified
Norway
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Unverified
Sweden
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Unverified
Romania
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Unverified
Austria
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Unverified
France

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in cells called melanocytes. It can spread to other parts of the body.

What does 'completely resected' mean?

It means the surgeons have removed all visible signs of the cancer during your operation.

What are nivolumab and relatlimab?

These are medications called immunotherapies. They work by boosting your body's own immune system to help it fight cancer cells.

Will I know which treatment I'm getting?

No, typically in this type of study, neither you nor your doctors will know which treatment you are receiving. This helps make the study results as fair and accurate as possible.

What are 'Phase 3' studies?

Phase 3 studies are large research studies that compare a new treatment with an existing one or a placebo. They are a crucial step before a new treatment can become widely available.