Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A MULTICOHORT, OPEN LABEL, PHASE 2 STUDY OF BOTENSILIMAB (AGEN1181) FOR TREATMENT OF ADVANCED MELANOMA REFRACTORY TO PRIOR CHECKPOINT INHIBITOR THERAPY

This research study is looking into new treatments, botensilimab and balstilimab, for advanced melanoma in adults. Melanoma is a type of skin cancer, and 'advanced' means it has spread. This study is for people whose melanoma has not gotten better with standard treatments called 'checkpoint inhibitors'. The main goal is to see if these new medicines can make the cancer shrink. Researchers will also look at how long people live without their cancer getting worse, how long any improvements last, and overall survival. Both men and women aged 18 and over can take part. This is an early stage study to understand how well these new treatments work.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Agenus Inc.

Enrolment target

120

Start

28 Oct 2022

Advanced melanoma refractory to prior checkpoint inhibitor therapy

What is this study about?

This study is about finding new ways to treat advanced melanoma, which is a serious type of skin cancer that has spread to other parts of the body. Sometimes, standard treatments don't work, or the cancer comes back. This study is for people in that situation, specifically those whose cancer has not responded to a type of treatment called 'checkpoint inhibitor therapy'.

The researchers are testing two new medicines, botensilimab and balstilimab. These medicines are designed to help your own body's defence system, called the immune system, fight the cancer. They are hoping these new treatments can make the cancer shrink, or at least stop it from growing for longer periods.

We need to find better treatments for advanced melanoma, especially for those who haven't had success with existing options. Early studies like this are very important for gathering information about how new medicines work, how safe they are, and if they could help people in the future.

Key takeaways

This study tests new medicines for advanced melanoma.
It's for people whose cancer hasn't responded to previous treatments.
The main aim is to see if the new medicines can shrink the cancer.
It's an early-stage study to gather information on treatment effectiveness and safety.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and over. Both men and women can take part.

To be considered for this study, you must have advanced melanoma that has already been treated with a specific type of medication called a 'checkpoint inhibitor', but your cancer either didn't get better or it got worse after that treatment.

There will be other health checks and criteria to make sure this study is safe and right for you, which the study team will discuss in detail.

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 advanced melanoma?
Has your melanoma been treated with a 'checkpoint inhibitor' and not responded?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either botensilimab or balstilimab medication. This is a 'Phase 2' study, which means we are trying to find out more about how well the medicine works and also its safety.

Taking part will involve regular visits to the hospital or clinic for assessments. These will include check-ups, blood tests, and scans to see how your body is responding to the treatment and whether your cancer is shrinking or staying stable. The study team will monitor you closely for any side effects.

We don't know the exact total duration for every participant, as it depends on how you respond to the treatment, but you will have ongoing follow-up for a period after your main treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new medicines help shrink or control your melanoma, especially if other treatments haven't worked. However, these are new medicines, and like all treatments, they come with potential risks, including side effects that could be mild or more serious. The research team will explain all known and potential risks to you. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Belgium
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Unverified
Germany
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Unverified
Italy
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Unverified
Spain
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Unverified
France

Common questions

What is advanced melanoma?

Advanced melanoma means a type of skin cancer that has spread to other parts of your body.

What is a 'checkpoint inhibitor'?

Checkpoint inhibitors are a type of medicine that helps your immune system fight cancer. This study is for people whose cancer didn't respond to them.

What are botensilimab and balstilimab?

These are the new medicines being tested in this study. They aim to boost your body's immune system to fight the cancer.

How long will I be in the study?

The length of time you participate can vary depending on how you respond to the treatment and other factors. The study team will discuss this with you.

Will I receive treatment for free?

All study-related medication and assessments are provided at no cost to you.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.