AuthorisedTherapeutic exploratory (Phase II)Interventional

Extended Follow-up of Patients with Melanoma Treated with Fianlimab Plus Cemiplimab in Expansion Cohorts from R3767-ONC-1613

This study is a follow-up for people who have been treated for melanoma, a type of skin cancer. They received a combination of two medicines, fianlimab and cemiplimab (also known as LIBTAYO). The main goal is to understand how long people live after this treatment. Researchers are also looking at how often the cancer shrinks or disappears, how long any improvements last, and if the cancer comes back or gets worse. An important part of the study is also to track any side effects or unwanted reactions to the medicines, and to see if patients needed other cancer treatments afterwards. It's a Phase II study, meaning it's exploring how safe and effective these new treatments are.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

04 Jul 2025

Melanoma

What is this study about?

This study is about a type of skin cancer called melanoma, which can be serious if it spreads. Doctors are always looking for better ways to treat it. This research is a follow-up to a previous study where patients received a combination of two specific medicines: fianlimab and cemiplimab (which you might know as LIBTAYO). These medicines are a type of treatment that helps your own immune system fight the cancer.

The main thing the researchers want to find out in this follow-up study is how long people live after having this combination of treatments. They're also checking several other important things. For example, they're looking at how well the cancer responds to the treatment – does it shrink, disappear, or stop growing? They also want to know how long these good effects last, and if patients need more cancer treatments later on.

Another very important part of the study is to keep a close eye on any side effects or problems caused by the medicines. This helps doctors understand how safe these treatments are when used together. By gathering this information from patients over a longer period, researchers can learn more about the complete picture of how effective and safe fianlimab plus cemiplimab are for treating melanoma.

Key takeaways

This study is for people who've previously had a specific melanoma treatment.
It's looking at the long-term effects of two medicines, fianlimab and cemiplimab.
The main goal is to see how long people live after this treatment.
Researchers are also checking if the cancer comes back, and any side effects.
You won't receive new study drugs in this follow-up.

Who may be eligible?

To be part of this study, you would need to be 18 years old or older. The study is open to both men and women. Importantly, this is an extended follow-up, which means it’s for people who have already been part of the original study (R3767-ONC-1613) and received the fianlimab and cemiplimab treatment.

Because this study is a continuation, it focuses on people who have already started these specific treatments. If you haven't been in the original study, you would not be able to join this follow-up.

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.

Am I 18 years old or older?
Have I been diagnosed with melanoma?
Did I previously take part in study R3767-ONC-1613?
Did I receive fianlimab and cemiplimab treatment in that study?

Answer every question to see your result.

What does participation involve?

If you were part of the original study, your participation in this extended follow-up will mainly involve continued monitoring. This might include occasional visits to the clinic, phone calls, or reviews of your medical records. The researchers will be checking on your general health and specifically looking for any updates regarding your melanoma and any further treatments you may have received. You won't be given any new study medication. The total duration of your participation will depend on how long the researchers need to collect information about your health and the long-term effects of the treatment you received in the first study.

Potential risks and benefits

The main benefit of participating in this follow-up study is contributing valuable information that can help future melanoma patients. While you won't receive new treatment in this particular follow-up, the information collected helps doctors understand the long-term effectiveness and potential side effects of fianlimab and cemiplimab. The risks are generally low, as you are not taking new medication; however, clinic visits or assessments might take some time. Remember, you can choose to stop being part of the study at any time, for any reason, without it affecting your usual 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
Ireland

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that can spread to other parts of the body.

What are fianlimab and cemiplimab?

These are two medicines that work with your body's immune system to fight cancer cells.

Why is this study happening?

This study is following up on patients who previously received these medicines to understand the long-term effects and how well they worked.

Do I get new medicine in this study?

No, this study is a follow-up for people who already received the treatment in a previous study. You won't be given new study drugs.

Who can join this study?

This study is for adults over 18 who were already treated with fianlimab and cemiplimab in the original study R3767-ONC-1613.