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.
Auf einen Blick
Worum geht es in dieser Studie?
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.
Wichtige Erkenntnisse
- 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.
- Sie können die Teilnahme an der Studie jederzeit beenden.
- This is an early-stage study, meaning these are new treatments being investigated.
Wer könnte berechtigt sein?
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.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Sind Sie 18 Jahre alt oder älter?
- 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?
Was beinhaltet die Teilnahme?
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.
Potenzielle Risiken und Vorteile
Standorte (51)
- Scottsdale Healthcare Hospitals DBA HonorHealthVerifizierte PostleitzahlScottsdale, Vereinigte Staaten
- Virginia K. Crosson Cancer Center at St. Jude Medical CenterVerifizierte PostleitzahlFullerton, Vereinigte Staaten
- Providence Saint John's Health CenterVerifizierte PostleitzahlSanta Monica, Vereinigte Staaten
- Yale University School of Medicine - Yale Cancer CenterVerifizierte PostleitzahlNew Haven, Vereinigte Staaten
- Georgetown University Medical CenterVerifizierte PostleitzahlWashington D.C., Vereinigte Staaten
- Dana-Farber Cancer InstituteVerifizierte PostleitzahlBoston, Vereinigte Staaten
- John Theurer Cancer Center at Hackensack University Medical CenterVerifizierte PostleitzahlHackensack, Vereinigte Staaten
- Universitair Ziekenhuis BrusselVerifizierte PostleitzahlJette, Belgium
- Oncosite - Centro de Pesquisa Clinica Em OncologiaVerifizierte PostleitzahlIjuí, Brazil
- Centro de Pesquisas Clinicas da Fundação Doutor Amaral CarvalhoVerifizierte PostleitzahlJaú, Brazil
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e PesquisaVerifizierte PostleitzahlPorto Alegre, Brazil
- INCA II - Instituto Nacional de Cancer Jose Alencar Gomes da SilvaVerifizierte PostleitzahlRio de Janeiro, Brazil
Häufige Fragen
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.
Wie lange werde ich an der Studie teilnehmen?
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.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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