Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Open-label, randomized Phase II trial with BNT111 and cemiplimab in combination or as single agents in patients with anti-PD 1/PD-L1-refractory/relapsed, unresectable Stage III or IV melanoma

This important study is investigating new treatment options for people with advanced melanoma (skin cancer) that has already been treated with other medicines but hasn't got better. Researchers are exploring a new drug called BNT111, either by itself or together with an approved drug called Libtayo (cemiplimab). The main goal is to find out if these treatments can shrink tumours or stop their growth. This is a "Phase II" trial, meaning it's an earlier stage study focused on understanding how well the treatments work and if they are safe. Participants will be closely monitored, and findings will help doctors understand better ways to manage this challenging type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

BioNTech SE

Enrolment target

157

Start

05 Apr 2024

Melanoma (Stage III and IV)

What is this study about?

This study is designed to explore new treatment options for people living with advanced melanoma, a serious type of skin cancer. Specifically, it's for those whose cancer is either Stage III or IV and hasn't responded to, or has come back after, previous treatments that block certain immune pathways (anti-PD-1/PD-L1 therapies). This means the usual treatments haven't worked well enough for them, and doctors are looking for other ways to help.

The main aim of the study is to see how effectively a new drug called BNT111 works, both on its own and when given together with another approved medication called Libtayo (cemiplimab). Libtayo is an existing cancer drug that helps your body's immune system fight cancer cells. By combining these treatments, researchers hope to find a more powerful way to tackle the disease.

This is a Phase II clinical trial, which means it's an important step in developing new medicines. It focuses on understanding if the treatments are effective enough to warrant further study and to carefully monitor any side effects. The results will help doctors decide if these new approaches could become standard treatments for people with this type of melanoma.

Key takeaways

This study is for people with advanced melanoma where previous treatments haven't worked.
It tests a new drug called BNT111, alone or with an existing drug, Libtayo.
The main aim is to see if these treatments can shrink tumours or stop them from growing.
Participants will be closely checked for how the treatment is working and for any side effects.
It's a Phase II trial, meaning it's an earlier study focused on effectiveness and safety.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, 18 years or older, with a diagnosis of advanced melanoma.

Crucially, your melanoma must be either Stage III or Stage IV. This means it has spread from the original site. Also, previous treatments that work by boosting your immune system (called anti-PD-1 or PD-L1 therapies) must not have worked effectively for you, or your cancer must have returned after such treatments. You must also have melanoma that cannot be removed by surgery.

The study team will check many other things to make sure the trial is safe and appropriate for you, such as your general health, organ function, and any other medical conditions you might have. It's important that you discuss all your medical history with the study doctor.

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.

Are you 18 years old or older?
Do you have Stage III or Stage IV melanoma?
Has your melanoma not responded to, or come back after, previous immune-boosting treatments (like anti-PD-1/PD-L1)?
Is your melanoma unable to be removed by surgery?
Are you generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either BNT111 on its own, Libtayo on its own, or a combination of BNT111 and Libtayo. All patients will be monitored very closely throughout the trial. This will involve regular visits to the clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to keep an eye on any side effects.

The drugs will be given as an infusion into your vein. The schedule for these infusions will vary depending on which treatment group you are in. You'll have regular appointments to assess how your melanoma is responding and to monitor your overall health and well-being. This will include tests to check your blood, vital signs (like blood pressure and heart rate), and how you feel generally. The study will continue for as long as your cancer is stable or improving, and the treatment is safe for you. There will also be a follow-up period after you stop treatment to continue monitoring your health.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments for your melanoma that aren't yet widely available. There's a chance the treatments might help shrink your tumour or control its growth. However, like all medicines, these treatments can have side effects, some of which could be serious. The study team will closely monitor you for any side effects and manage them as best as possible. It's important to remember that there's no guarantee the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Germany
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Unverified
Italy
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Unverified
Poland

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that develops from pigment-producing cells. It can spread to other parts of the body if not treated early.

What does 'Stage III or IV' melanoma mean?

Stage III means the cancer has spread from the original skin site to nearby lymph nodes or skin areas. Stage IV means the cancer has spread to distant parts of the body, such as the lungs, liver, or brain.

What does 'refractory/relapsed' mean?

Refractory means your cancer did not respond to previous treatments. Relapsed means your cancer came back after it had been treated before.

What is BNT111?

BNT111 is a new investigational drug being tested in this study. It's a type of immunotherapy designed to help your immune system recognise and fight cancer cells.

What is Libtayo (cemiplimab)?

Libtayo is an approved medication that is already used to treat certain cancers. It works by blocking a protein called PD-1, which helps activate your immune system to attack cancer cells.