Active not recruitingPHASE2INTERVENTIONAL

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

This research study is testing a new medication called botensilimab, sometimes given alone and sometimes with another drug called balstilimab, for people with advanced melanoma. Advanced melanoma is a type of skin cancer that has spread. The study is specifically for those whose cancer has not improved with standard immunotherapy treatments. The main goals are to understand how effective these new drugs are at treating the cancer, to see if they are safe, and to find out how people's bodies process them. This is a Phase 2 study, meaning it's still in the earlier stages of drug testing, after initial safety tests. Participants will receive either botensilimab by itself or a combination of botensilimab and balstilimab. The study is open to adults over 18 and will involve up to about 220 people.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Agenus Inc.

Enrolment target

150

Start

12 Dec 2022

Estimated completion

01 Feb 2028

Advanced Melanoma

What is this study about?

This research study is exploring a new way to treat advanced melanoma, a type of skin cancer that has spread to other parts of the body or cannot be removed by surgery. Often, people with advanced melanoma are treated with medicines called immunotherapy, which help their own body's immune system fight the cancer. However, sometimes these treatments stop working or don't work at all.

This study is focusing on a new drug called botensilimab, which might be given on its own or together with another drug called balstilimab. The researchers want to find out if these new treatments can help people whose melanoma has not responded to previous immunotherapy drugs. They will be looking closely at how well the new treatments work, whether they cause any side effects, and how the body handles the drugs.

This is a 'Phase 2' study, which means it's one of the earlier stages of testing a new medicine in a larger group of people, after initial safety checks. The information gathered from this study will help doctors understand if these new drugs could be a promising option for treating advanced melanoma in the future.

Key takeaways

This study is for adults with advanced melanoma that hasn't responded to other treatments.
It's testing a new drug called botensilimab, sometimes with another drug, balstilimab.
The main goals are to check if the treatment works and if it's safe.
You'll have regular hospital visits for treatment and check-ups.
You can stop participating in the study at any time.
This is an early-stage study, meaning these are new treatments being investigated.

Who may be eligible?

To be part of this study, you must be an adult aged 18 or older and have advanced melanoma that has either spread or cannot be removed by surgery. Your melanoma must also have been diagnosed by a specialist.

Crucially, your previous immunotherapy treatments for melanoma must not have worked or your cancer has progressed afterwards. In some parts of the study, you might need to have tried and not responded to even more types of immunotherapy. The doctors will also check if your general health and body functions are strong enough to take part.

There are also specific medical details your doctors will check, such as your cancer's genetic makeup, to see if this study is suitable for you. You'll need to be able to have regular scans and check-ups, and generally be well enough to manage the demands of the study.

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?
Have you been diagnosed with advanced melanoma that has spread or can't be removed?
Has your melanoma not responded to previous immunotherapy treatments?
Are you generally well enough to manage hospital visits and treatments?
Are you willing and able to participate in regular tests and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new drug botensilimab on its own, or botensilimab combined with balstilimab. These drugs are typically given through a drip (intravenously). You'll need to visit the study clinic regularly for your treatments and checks.

During your time in the study, you will have various tests and assessments. These usually include blood tests, physical examinations, and scans (like CT or MRI scans) to see how your body is responding to the treatment and to monitor the melanoma. These tests help the doctors understand if the treatment is working and if it's safe for you.

The total length of your participation will vary depending on how you respond to the treatment. You will continue to have regular follow-up appointments even after your treatment phase ends, to keep track of your health and the long-term effects of the medication. The study team will explain the full schedule of visits and procedures in detail.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment that isn't widely available, which might help your condition when other treatments haven't worked. However, there are also potential risks; new drugs can have side effects that are not yet fully known, and the treatment might not work for everyone. The study team will carefully monitor you for any side effects and manage them as best they can. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (51)

Scottsdale Healthcare Hospitals DBA HonorHealth
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Scottsdale, United States
Virginia K. Crosson Cancer Center at St. Jude Medical Center
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Fullerton, United States
Providence Saint John's Health Center
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Santa Monica, United States
Yale University School of Medicine - Yale Cancer Center
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New Haven, United States
Georgetown University Medical Center
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Washington D.C., United States
Dana-Farber Cancer Institute
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Boston, United States
John Theurer Cancer Center at Hackensack University Medical Center
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Hackensack, United States
Universitair Ziekenhuis Brussel
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Jette, Belgium
Oncosite - Centro de Pesquisa Clinica Em Oncologia
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Ijuí, Brazil
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
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Jaú, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
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Porto Alegre, Brazil
INCA II - Instituto Nacional de Cancer Jose Alencar Gomes da Silva
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Rio de Janeiro, Brazil

Common questions

What is advanced melanoma?

Advanced melanoma is a type of skin cancer that has either spread to other parts of your body or cannot be completely removed by surgery.

What does 'refractory to checkpoint inhibitor therapy' mean?

This means your cancer has not responded well, or has stopped responding, to a type of immunotherapy called checkpoint inhibitors.

What are botensilimab and balstilimab?

These are new investigational drugs being tested in this study to see if they can help treat advanced melanoma.

Will I definitely get the new treatment?

Yes, everyone in this study will receive either botensilimab on its own or botensilimab with balstilimab. There is no placebo group.

How long will I be in the study?

The length of your participation will depend on how your body responds to the treatment. The study team will discuss the expected duration with you.