A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.
This study is for people with advanced melanoma, a type of skin cancer, specifically those whose cancer has a gene change called an NRAS mutation. Participants will have already tried other treatments, including a type called anti-PD-1/PD-L1 therapy. The main goal is to find out if a new medicine called belvarafenib is safe and how well it works. Researchers are testing belvarafenib on its own, and in combination with either cobimetinib, or with both cobimetinib and nivolumab. This is an early-stage study (Phase 1), designed to understand the drugs' effects and safety before testing them on larger groups of people.
At a glance
What is this study about?
This research study is about finding new ways to treat advanced melanoma, which is a type of skin cancer that has spread. Specifically, it's for people whose melanoma has a particular gene change called an NRAS mutation. Doctors have found that this gene change can sometimes make melanoma grow and spread.
Participants in this study will have already received other treatments for their melanoma, including a type of immune therapy called anti-PD-1 or anti-PD-L1 therapy. The main focus is on a new drug called belvarafenib. The study will test belvarafenib on its own, and also in combination with other medicines: either with cobimetinib, or with both cobimetinib and nivolumab.
The main purpose of this study is to see how safe these new treatments are and what effects they have on the body. It also helps doctors understand how the medicines move through the body. This kind of early-stage (Phase 1) study is really important for developing new cancer treatments, as it helps us learn if they are safe and potentially helpful before moving on to larger studies.
Key takeaways
- This study is for advanced melanoma with a specific gene change (NRAS mutation).
- It's testing a new drug called belvarafenib, alone or with other medicines.
- Participants must have already received anti-PD-1/PD-L1 therapy.
- The main goals are to check the treatments' safety and how well they work.
- It's an early-stage (Phase 1) study.
- Regular health checks and monitoring are part of taking part.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. You must have advanced melanoma that has the specific NRAS gene change and has already been treated with certain other therapies, like anti-PD-1 or anti-PD-L1 drugs. Your cancer must have shown signs of getting worse despite these previous treatments.
You would also need to be well enough to take part, meaning you can largely look after yourself and handle daily activities with little help. Doctors will also check that your body and organs, like your blood and kidneys, are working well enough. It's also important that your doctors can get a sample of your tumour for testing.
However, you would not be able to join if you have used certain other melanoma drugs in the past, or if you have specific heart, liver, or autoimmune conditions. If cancer has spread to your brain and is causing problems, or if you had severe side effects from previous immune therapies that made you stop them permanently, you might not be suitable for 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 at least 18 years old?
- Do you have advanced melanoma with an NRAS gene change?
- Has your melanoma been treated with an anti-PD-1/PD-L1 drug and progressed?
- Are you generally well enough to manage your daily activities?
- Do you have no active problems from cancer in your brain?
- Have you discussed your past treatments with your doctor to check for exclusions?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. You would receive the study medication (belvarafenib, with or without cobimetinib or nivolumab) as prescribed by the study doctors. These visits will include checks on your health, blood tests, and scans to see how your body is reacting to the treatment and whether your cancer is responding. The total duration of your participation could vary, but you would be regularly monitored, and the healthcare team will explain the schedule of visits and assessments. There will also be follow-up appointments after you stop taking the study medication.
Potential risks and benefits
Locations (17)
- California Pacific Medical Center Research InstituteVerified postcodeSan Francisco, United States
- UCSF Helen Diller Family CCCVerified postcodeSan Francisco, United States
- University of Colorado Cancer CenterVerified postcodeAurora, United States
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterVerified postcodeBaltimore, United States
- Washington University School of MedicineVerified postcodeSt Louis, United States
- Memorial Sloan KetteringVerified postcodeNew York, United States
- Calvary Mater NewcastleVerified postcodeWaratah, Australia
- Peter MacCallum Cancer Centre-East MelbourneVerified postcodeMelbourne, Australia
- Linear Clinical Research LtdVerified postcodeNedlands, Australia
- Ottawa Hospital Regional Cancer CentreVerified postcodeOttawa, Canada
- Princess Margaret HospitalVerified postcodeToronto, Canada
- Charité - Universitätsmedizin BerlinVerified postcodeBerlin, Germany
Common questions
What is an NRAS mutation?
It's a specific gene change found in some melanoma cells that can make the cancer grow. This study is for people whose melanoma has this change.
What is a 'Phase 1' study?
It's an early stage of clinical research. The main aims are to check if a new treatment is safe, what side effects it might cause, and how much of it the body can handle.
What if I've already had melanoma treatment?
This study is specifically for people whose advanced melanoma has been treated with anti-PD-1/PD-L1 therapy, and whose cancer has progressed despite this.
Will I definitely get the new drug?
The study tests different combinations of drugs, including belvarafenib on its own, or with other listed medications. The study team will explain which treatment arm you may be in.
How long does the study last?
The duration of treatment and follow-up will be discussed with you by the study team, but it involves regular visits and monitoring over a period of time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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